Docket Nurnbe,r 2004N-04,6

Department of Health and Human Services Food and. Drug Administration

Cakxies

C
.besi ty

Report of the Working Grou

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public HealthService Food andDrug Administration

Memorandum
Date

February 11,2004 Chair and Vice Chair, Obesity Working Group Working Group Report ,andRecommendations MarkB. McClellan, M .D., Ph.D. Commissioner of Food and Drugs

From

Subject

TO

We are pleased to transmit the final report and recommendationsof the Food and Drug Administration’ (FDA) Obesity Working Group (OWG). You establishedthe OWG on s August 11,2003. The OWG met eight times from August 28,2003, to January 22,2004. In addition, the OWG held one public meeting, one workshop, two roundtable discussions(one with health professionals/academicians, one with representativesof and consumer groups), and solicited comments on obesity-related issues. The public meeting examined FDA’ role and responsibilities in addressingthe major health problem of s obesity, focused on issuesrelated to promoting better.consumerdietary and lifestyle choices that have the potential to significantly improve the heath and i?lell-being of Americans, and obtained stakeholder views on how best to build a framework for messagesto consumers about reducing obesity and achieving better nutrition. The science-basedpublic workshop, which was co-sponsoredand funded by the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, collected data relevant to FDA efforts to help consumer make betterinformed weight managementdecisions. In addition, some members of the OWG met with representativesfrom various sectors of the packaged food and restaurant industries. To accomplish its work, the OWG organized several subgroups (i.e., messages, education, food label, restaurants/industry,therapeutics, research, and stakeholder investment), each designed to focus on a particular aspect of thesoriginal charge to prepare a report that outlines an action plan to cover critical dimensions of the obesity problem from FDA’ perspective and authorities. In addition, in order to inform its work, s the OWG created a knowledge base subgroup. All the subgroups, in turn, met separately and developed respective analysesand recommendations,which serve as the basis for this report. The report that follows provides, for your consideration, a range of short- and long-term recommendationsthat are responsive to the charge. The OWG believes that, if the report’ recommendationsare implemented, they will make a worthy contribution to s confronting our Nation’ obesity epidemic and helping consumers lead healthier lives s through better nutrition. The report also contains a number of appendices,including your

Page2 - Mark B. McClellan,M.D., Ph.D. origiml chargememo,,thelist of OWG members subgrcwps, ather sup~rhg and and
material.

We appreciate opporhmityto haveservedFDA as leadersof the OWG, and we stand the ready-tq f8cilitat.e implementation the,OWG’recM the of s

DeputyCommissioner of Food and Drugs Applied %?rition

Calories Count Report of the Food and Drug Adninistratian Working Group on Obesity EXECUTIVE SUl%lMA.RY

Obesityis a pervasivepublic health problemin the United States. Sincethe late 198Os, adult obesityhas steadilyand substantiallyincreased the United States.Today, 64 in percentof all Americansareoverweightand over 30 percentare obese;in 2988through 1992,fewer than 56 percentwere overweightand fewer than 23 percentof American adultswere obese. The trendsfor children are evenmore worrisome. Recentresearchby the U.S. Centersfor DiseaseControl and Prevention’ (CDC) showsthat 15 percentof children and adolescents aged6 to 19 are overweight-double the rate of two decades ago (CDC,.2003). As Americansget heavier,their health suffers. Overweightand obesity increase risk for coronaryheart disease, 2 diabetes,and certaincancers. the type According to someestimates, least400,000deathseachyear may be attributedto at obesity(Mokdad,et al., 2004). To help confront the problemof obesityin the United Statesand to help consumers lead healthierlives throughsbetter nutrition, on August 11,2003, Mark B. McClellan, M.D., Ph.D., Commissioner Food and Drugs, createdthe Food and Drug Administration’ of s (FDA) ObesityWorking Group (OWG). He chargedthe OWG to preparea report that outlinesan actionplan to cover crit.icaldimensions the obesityproblem from FDA’ of s perspective authorities. and This report reflectsthe work of the OWG to meetthe Commissioner’chargeand is s organizedlargely aroundthe specificelementsof the August 11,2003, charge. The problem of obesityhasno single cause. Rather,it is the result of numerousfactors acting togetherover time. Similarly, therewill be no singlesolution; obesitywill be broughtunder control only as a result of numerouscoordinated, complementary efforts from a variety of sectorsof society. Nor can this problembe solvedquickly. Any longlasting reversalof this phenomenon itself be a long-termprocess. will The OWG’ recommendations centeredon the scientific fact that weight control is s are primarily a function of balanceof the calorieseatenand caloriesexpendedon physical and metabolicactivity (seeAppendix B Text Boxes in the report for a fuller discussion). The recommendations containedin this report thereforefocus on a “calories count” emphasis FDA actions. The box on the next pagecontainsthe OWG’ principal for s recommendations. body of this report detailsthe underlyingrationalefor eachof The theseprincipal recommendations additionalrecommendations. and Takentogether,they represent plan of action, foundedon science, a FDA’ public healthmissionand legal s authorities,and the importanceof consideringconsumerand other stakeholder views and needsin addressing obesity.
’ See Appendix A for a list of acronyms and abbreviations used throughout this report.

OWG

PRINCIPAL

RECOMMEh#DED

ACTlQM

tTEMS

Food Labeling Calories: Issue an advance notice ofproposed rulemaking (ANEW

to solicit public comment on how to the give more prominence to calories on thefood label. As examples, increa8sing font sizefor calories, including a percent Daily Value (%Dv) column for total calories, andeliminating the listingfor calories from fat.

ServingSizes: Encourage manufacturers immediately to take advantage of the flexibility in current
regulations on serving sizes and label M a single-serving thosefoodpackagei where the entire content of the package can reasonably be consumed at a single-eating occasion. For example, a 20 oz bottle of soda that currently states 1IO calories per serving and 2.5 servings per bottle could be labeled as containing275 calories per bottle. Carbohydrates: File petitions and publish a proposed rule during summer 2004 to provide for nutrient content claims related to carbohydrate content offoods, including guidance f”or use of the term “net” in relation to the carbohydrate content offooh.

Comparative LabelingStatewnts: Encourage manufacturers to use appropriate comparative labeling statements that make it easierfor consumers to make healthy substitutions including calories (e.g., “instead of cherry pie, try our delicious low fat cherry yogurt - 29 percentfewer calories and &percent lessfat “7. Enforcement Activities . Together with the Federal Trade Commission (FTC), increase enforcement against weight loss products
havingfalse or misleading claims. . Consider enforcement action against products that declare inaccurate serving sizes,

Educational Paitnerships . As part of a larger DHHS eflort, establish relationships with, among others, youth-oriented organizations
such as the Girl Scouts of the USA and the National Association State Universities and Lund Grant Colleges (4-Hprogram), to educate Americans about obesity and leading healthier lives through better nutrition ,

Restaurants . Urge the restaurant industry to launch a nation-wide, voluntary, andpoint-of-sale nutrition information
campaign for consumers.

Therapeutics
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Convene a meeting of a standing FDA advisory committee to address challenges, as well as gaps in knowledge, about existing drug therapiesfor the treatment of obesi@. Revise 1996 dra$ guidance on developing obesity drugs and re-issuefor comment.

Research
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Support and collaborate, as appropriate, on obesity-related research with others, including NII-I. Pursue research on obesity prevention with U.S. Department of Agriculture/Agricuhural Research Service (USDA/ARs).

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CALORIES COUNT REPORT OF THE FirOD AND DRUG ~~IS~TION WORKING GROUP ON OBESITY TABLE OF CONTENTS 1 I. Introduction .................................................................................................................. 1 ............................................................................................. A. Public Health Impetus 3 ................................................................................ B. FDA Obesity Working Group 3 II. Foundations of this Report ......................................................................................... 3 ................................................................................................. A. Scientific Principles ...........................................4 B. FDA’ Public Health Mission and Legal Authorities s 6 C. Stakeholder Participation ....................................................................................... 6 D. The OWG’ Work ................................................................................................... s 7 III. Messages..................................................................................................................... 7 A. Obesity Knowledge Base ........................................................................................ 8 B. Obesity Messages..................................................................................................... C. OWG Message Recommendations ......................................................................10 IV. Education Program to Deliver the Message..........................................................10 A. Need for Education Programs ..............................................................................11 B. OWG Education Recommendations ....................................................................12 14 V. Supporting the Message ........................................................................................... 15 ............................................................................................................ A. Food Labels 15 1. The Food Label .................................................................................................. 2. FDA Focus Groups on Food Labels .................................................................17 3. OWG Food Label Recom.mendations ..............................................................19 24 B. Restaurants/Industry ............................................................................................ 1. FDA Focus Groups on Restaurants .................................................................25 2. OWG Restaurant Recommendations ...............................................................26 3. OWG Diet Plan Recommendations ..................................................................28 29 C. Therapeutics ........................................................................................................... 29 1. Background ........................................................................................................ 30 2. FDA’ Draft Guidance ....................................................................................... s 30 ............................................................................................. 3. Existing Therapies 4. OWG Therapeutics Recommendations ...........................................................30 31 D. Research ................................................................................................................. 1. Joint Research with USDA/ARS .......................................................................31 31 2. Survey of Research ............................................................................................ 33 VI. Stakeholder Investment to Help Ensure Results .................................................. 34 A. Background ........................................................................................................... B. OWG Stakeholder Investment Recommendations ............................................36 36 VII. Overall Conclusions ............................................................................................... 38 .............................................................................................................. VIII. References

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List of Appendices Appendix A - List of Acronyms and Abbreviations Appendix B - Text Boxes on Body Mass Index (BMI), Energy (CaIorie) Balance, and Carbohydrates and Other Macronutrient Contributions to CaIoric VaIue Appendix C - Notice Concerning July 30,2003, Secretary’ Roundtable on s Obesity/Nutrition Appendix D - August, 11,2003, Charge Memorandum Appendix E - FDA Obesity Working Group Membership Appeudix F - FDA Obesity Working Group - Subgroup Members Appendix G - Report from the Division of Market Studies Office of Scientific Lead Healthier Lives Analysis and Support, FDA CFSAN - Helping Consumers

through Better Nutrition: A Social Sciences Approach to ~o~su~~.~nfor~atio~, Food Choicesand WeightManagement
Appendix H - Developing Effective Consumer Messages Appendix I - Power of Choice

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I. Introduction A. Public Health Impetus The nation is currently facing a major l,ong-term public health crisis. In recent years, unprecedentednumbers of Americans of all ages have become either overweight or obese.2 This trend toward overweight and obesity has acceleratedduring the past decade and is well documented (see Box 1) by numerous scientific analyses. (For convenience, future use in this document of the term obesity includes both overweight and obesity*) Unfortunately, this trend towards obesity shows no signs of abating, If it is not reversed, the gains in life expectancy and quality of life resulting from modern medicine’ advances on diseasewill.erode, and more s health-related costs will burden the nation’ healthcare systems. For these reasons, the trend s toward obesity must be reversed.

Box I- Facts and Figures on Overweight and Obesity
The scope of the growing and urgent public health problem of obesity is outtjned in the Surgeon General’ Call to Action (RHHS, 2001). in 19992000,64% of U.S. adults were s overweight, an increase from 56% when surveyed in 1988-1994;30% of adults were obese, an increase from 23% in the earlier survey (DHHS, 2003; Flegat et al., 2002). In addition, among children and adolescents age 6 through 19 years, 15% were overweight, compared with IO to 11% in the earlier survey (CDC, 2003; Ogden et al., 2002). Overweight and obesity are associated with increased morbidity and mortality. It is estimated that about 400,000 deaths per year may be attributed to obesity, and overweight and obesity increase the risk for coronary heart disease, type 2 diabetes,,and certain cancers (Mokdad, et al., 2004). The total economic cost of obesity in the United States is up to $117 billion per year (DHHS, 2003), including more than $50 billion in avoidable medical costs, more than 5 percent of totai annual health care expenditures (DHHS, 2001; DHHS, 2003). The prevalence of overweight and obesity varies by gender, age, socioeconomicWstetus, and race and ethnicity (DHHS, 2001). For example, although overweight has increased among all children, the prevalence of oveweight and obesity is significantly higher among non-Hispanic black and Mexican-Americanadolescents than among non-Hispanicwhite teens (12-I 9 years old) (Ogden ef al., 2002). A majority of non-Hispanic black women over 40 are ovennreight or obese (Flegal et a/., 2002).

2 NationalInstitutesof Health(NIH) clinical guidelines (http://~.nhlbi.nih.gov/health/public~e~obesi~/lose-~~sk.h~#limi~ions) define“overweight” adultsas in a body massindex @MI) of 25.0to 29.9,and“obesity”as a BMI of 30.0or higher. BMI (seeText Box at AppendixB) is definedas the ratio of a person’bodyweightin kilogramsdividedby the square his or her height s of in meters.

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The problem of obesity in America has no single cause. Rather, obesity is the result of multiple factors acting together over time, including genetic (I.,oos and Bouchard, 2003) and environmental factors (Hill and Peters, 1998; Hill et al., 2003).3 Similarly, there will be no single solution to the problem of obesity; it will be brought under control only as a result of coordinated, complementary efforts from a variety of sectors of society. The obesity epidemic also will not be solved quickly. Any long-lasting reversal of this phenomenon will itself be a long-term process. Obesity is associatedwith significant health problems in the pediatric age’ group and is an important risk factor associatedwith adult morbidity and mortality. The causesand mitigation of childhood obesity have been and continue to be the focus of much attention (Hill and Trowbridge, 1998; Barlow and Die&, 2998; Ashton, 2004; Bowman, ez al,, 2004). A policy statement of the American Academy of Pediatrics proposes strategies for early identification of excessive weight gain by using BMI,4 for dietary and physical activity interventions during health supervision encounters, and for advocacy and research (AAP, 2qO3). According to Ritchey and Olson (1983), parental behavior is a dominant influence on children’ eating habits. s For adults, the literature discusseshow having a specific behavior goal for the prevention of weight gain (e.g., increasing physical activity or eating less at each meal)may be key to arresting the obesity epidemic (Wyatt and Hill, 2002; Hill, 2004). In similar fashion, the Dietary Guidelines for Americans includes a chapter on physical activity, linking physical activity with nutrition. The combined efforts of Federal, state and local governments, the packaged food industry, the restaurant industry (including both quickservice and other types of restaurants), the professional health community (including primary care physicians, nutritionists, dietitians, and’ others), consumer advocacy groups, schools, the media and, of course, committed individuals will all be required to contribute to the solution to the problem of obesity. The current crisis has been recognized by many of these groups, including a number of our stakeholders, for some time, and many wide-ranging efforts to address and reverse the trends that lead to obesity are already underway. Within the DHHS, Secretary Tommy G, Thompson has led efforts, to addressthe public health problem of obesity. On July 30,2003, Secretary Thompson convened a roundtable on obesity/nutrition involving experts fmm academia, the health professions, industry, and government to consider the role that the Department can play in reducing or reversing the weight gain that leads to obesity (see Appendix C for the five questions presented at the roundtable). DHHS also established a Docket in FDA. (Docket No. 2003N0338) to gather additional information on this topic. Each group now working on the problem of obesity brings unique resources and expertise to bear on it. Among the major Federal government entities with a responsibility and-a capability to addressthe problem, FDA, within the broader context ofDHHS, is bringing its own unique strengths to bear, including relevant legal authorities.

3 For additional information on factors contributing to obesity see CDC webpage (htt$:llwww.cdc.~ovlnccdphpldn~a/obesitvkontributine factors.htm) 4 In children, the BMI is expressed as percentil;egr5wth that is based on gender-and age -specific growth charts.

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B. FDA Obesity Working Group In a memorandum dated August 11,2003 (see Appendix D for the August 11 memorandum), Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D., created the OWG and gave it its charge. FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D., chairs the OWG; the Director of FDA’ Center for Food SaEetyand Applied Nutrition (CFSAN), Robert E. s Brackett, Ph.D., is the vice-chair? Other members of the OWG (see Appendix E for list of OWG members) were selected from across FDA to provide expertise and knowledge in a range of relevant scientific and other disciplines. The Commissioner requested that the OWG deliver, in six months, a report that outlines an action plan covering critical dimensions of the obesity problem as outlined in the charge and to help consumers lead healthier lives through better nutrition. During its tenure, the OWG met eight times; received briefings corn several invited experts from other government agencies; held one public meeting, one workshop, two roundtable discussions (one with health professionals/academicians,and one with representativesof consumer groups); and solicited comments on obesity-related issues, directing them to the Docket that DHHS establishe<d July 2003 (Docket No. 2003N-0338). In addition, some members of the OWG in met with representatives from various sectors of the packaged food and restaurant industries. To accomplish its work, the OWG organized several subgroups (see Appendix F for list of OWG subgroups), each designed to focus on a particular aspect of the Commissioner’ original charge. s In addition, in order to inform its work, the OWG created a knowledge basesesubgroup, the All subgroups, in turn, met separately and developed respective analyses and recommendations, which serve as the basis for this report. This report presents the OWG’ recommendations that s are responsive to the Commissioner’ charge, and that the OWG believes can contribute to s confronting obesity in the United States. II. Foundations of this Report Any FDA effort to addressobesity must be based on the following: (a) adherence to . fundamental scientific principles; (b) conformance with FDA’ public health mission and legal s authorities; and (c) consideration of consumer and other stakeholder views and needs. A. Scientific Principles Fundamentally, obesity represents an imbalance between energy intake (e.g., calorie intake) and energy output (expended both as physical activity and metabolic activity; see text box on Calorie (Energy) Balance at Appendix B). Although there is much discussion about (1) the appropriate makeup of the diet in terms of relative proportions of macronutrients (fats.[lipids], carbohydrates, and protein) that provide calories and (2) the foods that provide these

’Whenthe OWG was formed,Joseph Levitt was the Directorof CFSAN;andthe OWG vice-chair. As of A. January 5,2004,Dr. Brackettbecame directorof CFSAN,andassumed role of vice-eh&r. the

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macronutrients, for maintenance of a healthy body weight it is the consumption and expenditure of calories that is most important. In other words, “calories count.“6 1. Calories Quite simply, the OWG’ recommendations center on the scientific fact that weight control s requires caloric balance. Food supplies the energy that provides fuel for the body and for rebuilding the “wear and tear” one is subjected to during the day. The traditional unit for expressing the energy value of foods is the kilocalorie (kcal). The term caloric is commonly used in place of kilocalorie. One calorie is equal to 4.184 kilojoules (kjoules) a common unit of energy used in the physical sciences and internationally in nutrition labeling. The caloric intake that is appropriate for an individual depends on a number of factors, including height, weight, gender, and age. 2. Calorie Contribution of Macronutrients Attention to caloric intake is a key element of weight control (the other is caloric expenditure). The three macronutrients that provide energy in our diets are carbohydrate, protein, and fat (see text box on Carbohydrates and Other Macronutrient Contributions to Calorie Value at Appendix B). (Alcohol is also a source of energy, yielding 7 calories per gram, but it is not a nutrient:) These macronutrients yield different amounts bf energy in the form of oalories per unit weight. 0 Carbohydrate = 4 calories per gram 0 Protein = 4 calories per gram 0 Fat = 9 calories per gram To maintain a constant bodyweight over time, “energy in” from fo,od must equal “energy out” as a result of resting metabolism plus physical activity. In other words, calories eaten should equal the calories expended on a daily basis. Bodyweight will change if one alters this basic balance. If one consumes even slightly more calories than one expends over time, one will eventually gain weight (Wright, et al., 2004). Conversely, if one consumes fewer calories than one expends over time, one will eventually lose weight. B. FDA’ Public Health Mission and Legal Authorities s FDA’ mission is to promote and protect the public health. It seeksto accomplish this mission s by enforcing the laws it is charged with administering and by conducting educational and public information programs relating to its responsibilities.

6 For a furtherdiscussion energybalance Dietary Re$rence Intakes - Energy,Carbohydrate, of see, Fiber,Fat,Fatty Acids, Cholesterol, Proteinand‘ AminoAcids Part2, Chapter12 PhysicalActivity; 12:l-39-(Instituteof Medicineof the NationalAcademies, 2002)andreferences therein. cited 7 Althoughalcoholicbeverages not a focus’ this report,thereis someinterestin havingcalorieand other are of nutrition informationdeclared the Iabelof suchbeverages, evidenced a recentpetitionfrom the Centerfor on as by Science the Public Interest(CSPI)submitted the Tax andTradeBureauof the Treasury in to Department.In a letter datedDecember 17,2003,to DHHS Secretary Thompson, CSPl requested DHHS supportthe petition. that

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The Federal Food, Drug, and Cosmetic Act (the Act) as amended by the Nutrition Labeling and Education Act of 1990 (NLEA, Public Law 101-535), together with FDA’ implementing s regulations, established mandatory nutrition labeling for packaged,foods to enable consumers to make more informed and healthier food product choices in the context of the total daily diet. The statute and the regulations were also intended to provide incentives to food manufacturers to improve the nutritional quality of their ‘ products. The cornerstone of the NLEA is the Nutrition Facts panel (NFP), which lists the total number of calories derived from any source, as well as the total number of calories derived from total fat. The amounts of total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and protein in the food are also listed in the NFP, both as the quantitative “amount per serving” (grams or milligrams) and, with the exception of sugars and protein, as the percent of a dietary reference value, called the “percent Daily Value” (%DV). FDA requires the declaration of nutrients as a O/oDV,in part to help consumers understand the role of individual foods in the context of the total daily diet. Also, to help consumers determine how their individual dietary needs compare with the reference daily values used on the label, the NFP includes a footnote that specifies that the reference daily values are based on a 2,000 calorie dietv .On larger packages, the footnote goes on to list the daily values for total fat, saturated fat, ,chobsterol, sodium, total carbohydrate, and dietary fiber for both a 2,000 and a 2,500 calorie diet. As part of FDA’ regulations implementing the NLEA, the agency established reference amounts s customarily consumed (RACCs) for 139 food categories that manufa&urers are to use in developing serving sizes that are then expressedin household measures(ag., teaspoons, cups, pieces). These serving sizes become the basis for reporting the amount of each nutrient present and enable consumers to compare the nutritional qualities of similar food products. Under the NLEA, FDA also has authority over health claims and nutrient content claims for foods. Appropriate health claims and nutrient content claims, like nutrition labeling, further the statutory objectives of enabling consumers to make more informed and healthier food product choices and encouraging manufacturers to improve the nutritional quality oftheir products. A health claim is a claim that characterizesthe relationship between a food, or a food component, and a disease or a health-related condition, and may only be made in accordance with an authorizing regulation issued by FDA. An example of a health claim is: “Although many factors affect heart disease; diets low in saturated fat and cholesterol may reduce the risk of heart disease.” A nutrient content claim is a claim that characterizesthe level of a nutrient in a food, and it, too, must be made in accordance with an authorizing regulation issued by the agency. Nutrient content claims describe the level of a nutrient or dietarysubstance in the product, using terms such as ‘ free,” “high,” and “low,” or they compare the level of a nutrient in “ a food to that of another food, using terms such as “more,” “reduced,” and ‘ lite.” More “ information on FDA’ implementation’ these authorities can.be found at s of http://www.cfsan.fda.9ov/-dms/hclaims.html. Restaurants, unlike the manufacturers of packaged foods, are not required’ the NLEA to by provide nutrition information for a menu item or meal unless a nutrient content claim or a health claim is made for such item or meal. When such a claim is made, the restaurant need only

provide information on the amount of the nutrient that is the basis ofthe claim. Thus, for example, if a restaurant claims that a particular menu item is “low in fat” (i.e., makesa nutrient content claim with regard to fat) then this requirement is satisfied by adding; ‘ low fat - provides “ fewer than 3 grams fat per serving” (i.e., the basis of the “low fat” claim}..: The restaurant may provide information about the nutrient for which the claim is made in various ways, including in brochures. In other words, restaurantsneed not provide such information on the menu or menu board. A restaurant making such a claim also would not be required to provide complete nutrition information; its decision to provide nutrient content information about one nutrient does not trigger a requirement to disclose complete nutrition information for that item or meal. C. Stakeholder Participation From the outset, FDA asked stakeholders to identify obesity issuesthat FDA should address. Prior to the creation of the OWG, DHHS convened a round table discussion in late July 2003 (bringing together experts from academia, the health professions, industry* and government) to consider how best to addressthe obesity issue, as reflected in five questions presented to the round table for discussion (see.Appendix G for the five questions). As noted above, DHHS also established a Docket in FDA (Docket No. 2003N-0338) to gather information on this subject, Following the creation of the OWG, FDA provided several opportunities for stakeholder participation: a public meeting on October 23,2003; a workshop on November 20,2003, that was co-sponsored and funded by.the DHKS Office of the Assistant Secretary for Planning and Evaluation (OASPE); roundtable meetings with health professionals/academiciansand consumer groups respectively, on December 1Sand 16,2003; and meetings with representatives of the packaged food and restaurant industries. FDA used these opportunities to solicit‘public comments on the obesity issue, as reflected in six questions the agency asked (these questions are set out in section VI.A. of this report). FDA used the Docket established in JuIy 2003 (Docket No. 2003N-0338) to gather additional comments; the OWG organized the~commentsto this docket into a searchable databasethat informed preparation of this report, D. The OWG’ Work s The remainder of this report reflects the work of the OWG subgroups:
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Obesity Knowledge Base: Gathered information on existing obesity, weight m’ anagement,and nutrition related programs. Messages: Identified existing obesity-related messagesin the public and private sectors; conducted focus groups to test five messages;recommended a calorie focus for FDA’ s action plan. Edtication: Explored and is initiating a number of new and enhanced private and public sector partnerships to focus on obesity education. Food Label: Explored options’ enhancing the food label in relation to efforts to for address obesity.

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Restaurantsflndustry: Explored options for providing consumerswith nutrition information on food consumedoutside the home; consideredthe potential health consequences using diet plans and related products. of Therapeutics: Surveyedexisting therapies for m itigating obesity; recommendednext ste:ps updating the 1996 draft guidanceentitled ‘“Guidancefor the Clinical Evaluation for of W e ight-Control Drugs,” Research: Identified gaps in obesity knowledge and areasfor further biomedical and social sciencesresearch. Stakeholder Investment: Held meetingsand a workshop to solicit stakehotderviews; anidorganized the commentsto Docket No. 2003N-0338 into a searchabledatabase that informed preparation of this report.

III. Messages The Commissioner chargedthe O W G to set out specific means for developing and implementing a “clear, coherent, and effective FDA message(within the broader context ofDHHS) that will unify various public and private efforts to reversethe current obesity epidemic.” This part of the chargewas expandedwith an eye toward establishing a broader theme that focuseson calories* as a fulcrum for further action, in the context of an overall healthful diet as defined by the DHHSIUSDA Dietary Guidelinesfor Americans. A. Obesity Knowledge Base Prior to considering obesity messages to ensurethat it was aware of the range of current and public and private efforts to addressobesity, the O W G formed a subgroupto collect information on existing and planned obesity-relatedactivities in the.United States; assemblea centralized repository of the information gathered;and report out to the full O W G on the scope/contents of the repository. A majority of the activities listed in the repository and databaseare programs that provide advice on nutrition/diet and/or physical activity. Most associations,agencies,a&organizations identified are sending out the message that diet and physical activity should be addressed together in the fight against obesity. Many partnershipsor collaborations exist between governmentagenciesand/or private entities. There are several areas,however, where different groups managesimilar programs. These similar programs, if merged into a larger partnership, could have a greater impact. To determine whether various programs, activities and initiatives are effective in reducing and/or preventing overweight and obesity in the United States,program evaluation must improve. In addition, improvements are neededin educationaloutreachto convey the messages and implement the initiatives that government and non-governmententities have developed.

* As noted earlier in Section II.A.l., there is much discussionin the field of nut+tion concerning the specific macronutrient source of calories, but given the chargeto focus on obesity, the OWE believes that a primary focus on calories is appropriate.

B. Obesity Messages Message Recommendatiofl Highlight: m Develop messagestied to a @caloriescount” focus.. ,p. 10

The OWG formed a subgroup to identify existing messagesin the public and private sectors and to set out specific means for developing simple, clear, coherent, and ef%eetive FDA messages around the theme of “calories count” based on the scientific fact that net calorie gain or loss over time is the root cause of obesity. 1. Identifying Existing Messages Today, consumers are inundated with a range .of messagesabout food. Some of these messages are in the form of food advertisements or marketing efforts that focus on product convenience, taste and value. Other messagesrelateto weight-loss programs or produets, or weight management. Some of the messagesin each of these areasmay not necessarily direct consumers toward wise dietary choices. The Federal government tries to provide long-term sound nutrition advice to consumers (e.g., government-sponsoredpublic health campaigns). For example, DHHS collaborates with the USDA to establish and promote the DietaJy GuideZines Amehcans, which provide guidance for on choosing a lifestyle that combines sensible eating with regular physical activity. An important recent effort of DHHS is Steps to a HeaMierUS.g In support of the President’ s HeaZthierUS1u initiative, the DHHS e@ortemphasizespersonal responsibility for the choices Americans make to ensure that policy makers support prevention programs that foster healthy behaviors,

’ For moreinformationon Steps to a Hea&hieWS seeh~:il~.~~l~ie~s.~ovlst~psf~n~ex.html lo For moreinformationon the HealthierUS Initiative seehttp://www.healthierusgov/
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2. FDA Focus Groups on Obesiky Messages Box 2 - FDA Focus Groups
FDA conducts its own consumer research to evaluate the appropriatenessand effectiveness of its messages. For exa,mple,FDA conducted consumer research before the implementation of NLEA, to determine the usefulness of potential choices for the NFP format. Since NLEA, FDA ‘ other researchers have studied how consumers use the and NFP, nutrient content claims, and health:claims (separately and in combination) to make dietary choices. Consumer research is used to assess people’ knowledge, attitudes, perceptions, and s preferences for a topical subject area or reactionsto any type of stimuli. Research methods may include qualitative studies, such as focus groups; quantitative, nationally representative surveys, using structured questionnaires; experimental studies of consumer responses to labeling and package variations; and intervention studies of the effects of point of purchase labeling. In November-December2003, FDA, with OASPE funding, conducted focus group research. There were 8 groups of 7-l 0 participants. Groups were segregated by gender and education level. All participants were at least 18 years old, had been grocery shopping and had eaten in a fast food and/or quickservice restaurant in the past mdnth. The purpose of the groups was to explore (I) how consumers use the nutrition information on food labels; (2) what type of nutrition information they would like to see in quick&vice restaurants; and (3) which messages would be effective as pert of a public information and education effort aimed toward encouraging consumers to use the food label. Participants discussed and reacted to variations in the NFP and the’ principal display panel (PDP) on food packages and to various presentations of nutrition information at restaurants. It is important to emphasize that the findings from these focus groups are based on qualitative research with small sample sizes. They should not be viewed as nationally representativeor projectable. Quantitative experimental dataare necessary to make reliable and verifiable conclusions. However, these focus group resuktsshed some interesting light on the complex issues discussed in this report and are useful in identifying quantitative research needs. The focus group findings discussed in this report are preliminary and,are based on observations recorded by the observer, as well as post-group discussions with the focus group moderator and other observers.

In November and December 2003, FDA focus groups were convened to evaluate, among other things: (1) how consumers use the nutrition information on food labels; and (2) which messages would be effective as part of a public information and education effort aimed toward encouraging consumers to use the food label (see Appendix G for FDA Division of Market Studies report, referenced in this report as FDA, 2003).’* Appendix H contains a discussion on the development of effective consumer messages, The findings from the FDA focus group efforts are discussed below.
l1 In addition,the focusgroupsexplored what type of nutrition informationthey would Bketo seein quickservice restaurants sectionV.B.l.of this report). Participants (see discussed reacted variouspresentations nutrition and to of informationat restaurants.

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FDA developed five NFP-based messagesthat the agency tested through its focus groups. The messagesand materials were intended to remind people where to find the NFP, why it is there, and how to use the information; while at the same time reinforcing various “promises” (i.e., motivators) associatedwith regularly using the NFP. The messagestested were as follows: 1. 2. 3. 4. 5. “R.ead it before you eat it - Always look at the Nutrition Facts” “Calories count and fat matters ‘ Always look at the Nutrition Facts’ ” “DO you know the serving size? - Always look at the Nutrition Facts” “What you eat is what you are -)Always look at the Nutrition Facts” “If you read labels for things you put on your body, why wouldn’ you read labels for t what you put in your body?”

Overall, none of these “slogan-type” messagesresonated.particularly well with the FDA focus group participants. Nevertheless, FDA focus group participants believed that reminder messaging about the NFP would be helpful for them in making food choices. In addition, the results of (otherfocus groups indicate that messaging should emphasize small, incremental steps versus major life changeswith respect to weight management and obesity prevention, and should addressthe importance of “planning ahead”as a necessarystep for eating right (Borra et al., 2003; IFIC, 2003). C. OWG Message Recommendations The OWG recognizes that some focus group (Borra et al., 2003; FDA, 2UQ3;IFIC, 2003) and some quantitative data (Derby and.Levy, 2000; Levy, 2004; Lin, 2004” indicate that not all consumers pay enough attention to calorie information in the NPP. Nevertheless, given the fact that obesity, at its most fundamental level, is a direct function of caloric imbalance, the OWG believes that “calories count” must be the focus for its recommendations, Accordingly, in relation to messages,the OWG recommends the development and testing of messagestied to this focus. IV. Education Program to Deliver the Message

Education Recommendirtion Highlight: . Establish partnerships to educate Americans about obesi@and leading healthier lives through better nutrition. . . p. 13

The Commissioner directed the OWG to outline an FDA program (component of DHHS program) for educating Americans about obesity and the means to prevent chronic diseases associatedwith it.

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A. Need for Education Programs Consumer perceptions regarding weight and dietary habits are significant in the fight against the obesity epidemic. Consumers who are not aware of their own weight status and its medical implications are unlikely to be receptive to public health “efforts to alleviate obesity. This point extends to parental perceptions of children’ weight status and dietary habits as well, given that s parents have significant influence over their children’ environment, habits, and health. Lack of s knowledge about weight status and its health implications undermine consumers’“promise” or motivation, a key component of messaging; therefore the OWG identified education as a critical adjunct to effective messaging about caloric balance. Recent focus group studies conducted by the International Food Information Council (IFIC)12 suggestthat consumers distinguish between “overweight” and “obesity,” and consider the first to be of relatively little health significance (IFIC, 2003). Therefore, consumers who consider themselves to be merely “overweight” may have less incentive to take action. There is also evidence to suggestthat both adults (Kuchler and Variyam, 2003) and teenagers(Kant, 2002) misperceive their weight status, although the form of misperception can vary with gender, socioeconomic status, age and race and ethnicity. For example, men were found to be more likely than women to underestimate the level of their weight status; healthy or underweight women were more likely to consider themselves overweight. Lower income and education were also associatedwith underassessmentof weight status; higher income and education levels were linked to overestimation of weight status. Parents also~ appear prone to misjudge their children’ s weight status and its health significancl: (Borra et al., 2003; Content0 et ab., 2003; Maynard et al, 2003). Many parents with overweight children consider their children to be at a healthy weight. In some casesthis may be due to cultural perceptions of appropriate weight (Bruss et al., 2003; Content0 et al., 2003). In some caseswhere parents do accurately judge their children’ s weight sta.tus,they may believe that the child will outgrow their overweight or obese status and, therefore, be less likely to take action. Consumers may have difficulty accurately assessingthe nutritional quality of their diet. Although consumers report in focus group studies that they understand what comprises a healthy diet (IFIC, 2003), approximately 40 percent of one sample (almost 3000 household meal preparers drawn from USDA 1994-l 996 Continuing Survey of Food Intakes by Individuals (CSFII) data) perceived the quality of their diets to be better than the calculated diet quality (Variyam et al., 2001). Parents, in particular, do not always have a clear picture of their children’ diets. In a recent series of focus-groups and phone/Internet surveys conducted by the s American Dietetic Association Foundation (Moag-Stahlberg et ai., 2003), parents significantly underestimated the frequency with which children ate outside of regular mealtimes, such as after

l2 IFIC states its missionis to communicate that science-based informationon food &kty andnutritionto healthand nutritionprofessionals, educators, journalists,government officials andothersprovidinginformationto consumers. IFIC states its purpose to bridgethe gapbetween ihat is science communications collectingand and by disseminating scientificinformationon food safety,nutrition andhealthandby working with anextensive rosterof scientificexpertsandthroughpartnerships helptranslate to research understandable usefulinformationfor into and opinionleaders ultimately,consumers. and IFIC is supported primarily by the faod, beverage agricultural and industries.

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dinner and while engaged in sedentary activities like television viewing. A recent report by the Kaiser Family Foundation discussesthe role of media in childhood obesity (KFF, 2004). Qualitative research by Borra and colleagues (Borra et al., 2003) also suggeststhat children (aged S-12 years) give little thought to good health, although they associateachieving “good health” with what they eat, rather than with physical activity. For many of the children involved in the research by Borra and colleagues, the term “healthy” had negative &onnotations; for example, it meant having to eat fruits-and vegetables they did not like or not eating their favorite foods. In terms of weight, children between 8 and 10, regardless of their own weight, did not think about food choices. Equally disturbing, some 1 l-1 2 year olds who were overweight said they tried to lose weight by skipping meals, rather than by eating differently. Among a group of children perceived to be above normal weight for their age, Borra and colleagues found that although the children knew it was important to eat healthfully becausetheir parents stressedit at home and they learned about nutrition in school, this teaching provided little useful information for the children. These qualitative findings are supported by a recent unpublished survey conducted for the nonprofit Dole Nutrition Institute of more than 6,000 children between grades 1-S in 194 classrooms (Dole, 2003). The responsesto survey questions “What is obesity?’ and “Which statement is true [about being overweight]?“ indicate that many children seem to have either ’ misperceptions or are misinformed about (1) the meaning of obesity and (2) the value of exercise in preventing or mitigating health problems due to overweight. B. OWG Education Recomm,endations The OWG recommends that FDA focus its education strategy on infhtencing behavior, as well as imparting knowledge, in the context of healthy choices for consumers. Any such efforts will require a long-term agency commitment. Education programs should help consumers make more informed food choices that result,in better weight management; should direct messagesto large audiences on a frequent basis; and should be crafted to reach a variety of audiences. The OWG recommends that FDA implement education programs incrementally and design them to be flexible enough to take into account new research findings and policy decisions and possible changes in the food label (e.g., revisions to the content or format ofthe NFP). Education efforts, however, shouId not’ delayed pending such changes, Education programs be should be simple to understand and apply, and should focus on showing consumers how to achieve a specific goal.

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Given the resources and time that FDA would need to develop and implement new education programs for multiple subpopulations, the OWG recommends that FDA,. as part of a larger DHHS initiative, establish relationships with private and public-sector partners for educational outreach. Such efforts will have the ability to reach larger and more diverse audiences on a more frequent basis, and will enable calorie-focused education campaigns to begin more quickly. Given the prevalence of obesity among children, establishing relationships with youth oriented organizations is especially important. For this reason, the following par&&ships are being pursued as a part of a larger DHHS initiative:
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Girl Scouts of the USA: FDA and Girl Scouts of the USA seek to launch an initiative entitled “ Healthy Living.” Building on current Girl Scout resourcesand programs, the ‘ initiative will provide girls and their families with the skills, knowledge, and support needed to make healthier food choices, engage in physical activity,>build self-esteem, and maintain a healthier lifestyle. This initiative includes developing a charm of the food label as a part of the Studio B teen collection. National Association of State Universities and Land Grant Col@es (4-H program): Youth health and obesity is one of three strategic priorities for 4-B Youth Development, FDA envisions a partnership that will use 4-H for targeted population evaluation of obesity/nutrition message(s),and use the 4-H network of over 3,500 professional Cooperative Extension programs across the United States for education and delivery of the message(s).

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In addition, FDA, along with other components of DHHS, is participating in the “Shaping America’ Youth” initiative to identify actions being taken to addresschildhood and adolescent s inactivity and excess weight. Information collected for this initiative in an on-line survey will be used by “Shaping America’ Youth” to prepare a report that provides an overview of current s public and private programs that target physical activity and nutrition in our nation’ children. s As of the date of this report, Shaping America’ Youth has registered over 1950 programs s directed aLthe childhood obesity issue,,collected surveys of funding and tactical information from over 1150 organizations and entities, and assemblednearly 800 fully completed in&depth surveys from programs representing all 50 states and the District of Columbia. Public sector partnerships should have the goal of developing programs similar to the “Power of Choice” program FDA developed with, the USDA, which teacheschildren who are 1 l-l 3 years of age how to make smart food and physical activity choices in real-life settings,, Learning how to use the NFP to make healthy food decisions is a major skill throughout the “Power of Choice” program (see Appendix I for additional information about “Power of Choice”). One way to help better ensure collaboration and cooperation with our public health partners is for FDA to coordinate its messagesand educational material with those of its partners. 0 Centers for Disease Control and Prevention: FDA is pursuing a collaboration between the agency and the CDC to develop a holistic approach to healthy living for children that will enable the FDA to meld a caloric intake messagewith a CDC caloric output message on physical activity.

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Department of Education: FDA has made preliminary contact with the Department of Education to join in supporting‘ programsthat target school-agechildren. Department of Agriculture: FDA plans to work through DHHS with counterpartsat USDA to ensurethat the agency’ f&us on calories is consideredas USDA revises its s Food Stamp ProgqmWIC (Women, Infants, and Children) programs and its Food Guide Pyramid, and as DHHS and USDA collectively revise the Dietary %uideZines for Americans.

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The O W G recommendsthat FDA work through a facilitator to establisha,forum for stakeholders to seek consensus-based solutions to specific aspectsof the obesity epidemic in the United States,with a particular focus on the needsof children. As a first step, the Q W G further recommendsthat the initiation of such a dialogue be raised at the next meeting of the FDA ScienceBoard. V. Supparting the Message It is important to support any message(s) through appropriate actions and policies where the “calories count” focus is 1i:kelyto have an impact on consumer‘ knowledge,behavior, and/or treatment (i.e., food labels, restaurants,therapeutics,and research).

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A.

Food Labels

Food Labeling Recommendution Highlights: 0 Calaries: o Issue an ANPRM to solicit public commenton how to give moreprominence to calories on thefood label.. lp. 19 o Considerauthorizing a health claim on “Peduced” “low” caloriefoods...p. 19 or o Issue an ANPRM about serving sizes...p. 20 0 Serving Sizes: o Encourage muizufaeturers immediate&to take advantageof th~~~ib~i~ in current regulations on serving sizesand label as a single-servingthosefood packageswhere the entire contentscan reasonablybe consumedat a sing~ene~t~~g oceasion...p.19 o Highlight enforcementuf serving sizesin F@A‘ food labeling complianceprogram s and considerenforcementaction againstproducts that declare&accurate serving sizes...p. 20 l Carbohydrates: o File petitions and publish a proposedrule to providefgr mdtie#ztcontent claims related to carbohydratecontent offoods, including guidancefor use~oftheterm “‘ in net” relation to the carbohydratecontent offoods,..p. 21
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ComparativeLabeling Statements: o Encourage manufacturersto use appropriatecomparativelabehng statementsthat make it easierfor consumersto make healthy substitutions,including calories (eg., “instead of cherry pie, try our delicious low fat cherryyogurt - 29percentfewer calories and 84percent lessfat”). . .p. 23

The Commissioner directed the OWG to “develop an approach for enhancing and improving the food label to assist consumers in preventing weight gain and reducing obesity.“ ’ 1. The Food Label The Act, as amended by the NLEA, and FDA’ implementing regulations require an NFP on the s label of most packaged foods. The NFP lists the serving size, the number of servings per container, the number of calories per serving and the amount and %DV’ per serving for 3 specified nutrients.
l3 The %DV indicates amountof a nutrientpresent a servingin relationto reference the in levelsfor a daily diet. The reference levelsfor vitaminsandminerals’ based Recommended are on Dietary Alowances established the by NationalAcademies; reference the levelsfor macronutrients based recommendations the L)ie6ary are on in Guidelines@Americans asestablished public healthorganizations. macronutrients or by For whoserecommended intakelevelsarebasedon calorjcintake(e.g.,saturated intakeshou!d,be than 10%of calories), %DV is fat fess the calculated a 2,000caloriediet. for

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Before recommending any changes in the NFP relevant to obesity, it is important to understand how consumers currently use the NFP and to assesswhether the NPP has been effective in facilitating positive dietary change. Research shows that most consum.ersare familiar with the nutrition information on food labels (Marietta el al, 1999; Neuhouser ct al., 1999; Kristal et al., 200 1; FDA, 2003), which they use primarily for evaluating the nutrition quality of specific food products, but the percentage of consum,erswho use NFP information productively for weight management purposes is low (Barone et uZ., 1996; FM& 1996; Ford et al., 1996; Levy et al., 1996; Mitra et al., 1999; Roe et al., 1999; Garretson and Burton, 2000; Levy et aZ., 2000; IOM, 2003; FDA, 2003) (e.g., see Table I below).

Table I. Recent Trends in Reported Food Label Use: “1QQ4-2002 Suweys (Derby and HDS Levy, 2009; Levy, 2004; Lin, 2004) 1994 1995 2002 (1,945) (1,001) (2,743) % population % popullation %popdation (weighted) / (weighted) 1 (niched) (1) Percent who us& fetid labels “often”’ oi ‘ 6spm$times”Lvhen buyiing a”$tiod product for the first timZI Sample size (N)

___

To see if food is high or low in calories, salt, vitatiins, fat. etc.

77

83

” information, when available?

29 I

26

Not Asked

’Based only on label users who “often”or “sometimes”use labels when they buy a food roduct for the first time. I?Based on all respondents.

Associations between dietary behavior and food label use have also been identified, although the body of literature is relatively small (IOM, 2003). A low-fat diet, for example, has been positively correlated with food label use, both in the general population and among family clinic patients. Clinic patients with health conditions (e.g., high blood pressure or‘ high cholesterol) as well as consumers who are in action or maintenance stagesof dietary change tiere also more likely to use the food label (Kreuter et aZ., 1997; Marietta et al., 1999; Neuhouser et al., 1999; Kristal et QZ., 2001). In addition, label claims (e.g., low sodium and low fat) may allow consumers to avoid specific ingredients or make food substitutions (Balasubramanian and Cole, 2002), resulting in changes to dietary patterns. Kim and coworkers (K.im et.aZ.,2001) analyzed data from the USDA’ CSFII and the Diet and Health Knowledge Survey, Their findings s

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indicate that food label use is positively correlated with measurable increasesin the Healthy Eating Index (Kim et al., 200 1).14 Despite reports of a positive correlation between label use and certain positive dietary characteristics, the trend toward obesity has acceleratedover the past decade. It may be that consumers do not take advantage of the available information on the food label to control their weight, perhaps becausethey do not appreciate how the information could be used for weight management purposes or perhaps becausethey find it toohard to apply the available information to such purposes. In any case, it is clear that consumers would benefit ifthey were to pay more attention to and make better use of information, including calories, on food labels. Providing encouragement and making it as easy as possible for consumers to do so are worthy public health objectives. 2. FDA Focus Groups on Food Labels As described in Box 2, FDA recently conducted focus group research in which it asked general nutrition questions as well’ how consumers use the nutrition information on food labels. as The questions covered under general nutrition dealt with three topics: (1) attitudes towards nutrition; (2) macronutrients; and (3) %DV. Those covered under food label modification dealt with six topics: (1) large package sizes; (2) serving versus package; (3) cdorie-related variations:; (4) serving size,variations; (5) calorie cues; and (6) ““healthier”symbo1. For additional information on FDA’ focus group fmdings, see Appendix G+ s Attitudes toward8 nutrition. In many of the groups, especially the women’ groups, participants s cared about nutrition and report using the NFP. At the same time, however, many also said that they do not always consider nutrition when. deciding what to eat. Taste, convenience, price, what kind of mood they are in, and what their family eats were often at odds with healthy eating. Although participants were interested in calories, many pointed to multiple concerns that went beyond calories such as the level of saturated fat, total fat, cholesterol, carbohydrates and sodium. Many participants reported not wanting to spend a lot of time reading labels. Macronutrients. In general, individual participants tended to care more about some macronutrients than others, depending on their individual dietary practices. In most groups, at least one participant was familiar with the Atkins diet and many of these participants were most concerned.about carbohydrates and sugars. Others were concerned about’ and saturated fat. fat Some participants checked the NFP mostly for information about sodium, Those who were on the Weight Watchers diet were concerned about calories and fiber. %DV. Very few participants reported using the %DV column on the NFP. Either they did not understand the meaning of %DV or they thought that it was not relevant to them since they did not consume a 2000 calorie diet. Those who did use or might use %DV thought that is was a
I4USDA’ HealthyEatingIndex is a summary s measure overalldiet quality. It provide a pkture of the type and of quantityof Ibodspeopleeatandthe degree which dietscomplywith specificrecomm+dations the Dietary to in Guidelinesjbr Americans andUSDA’ FoodGuidePyramid. For furtherinformationgo to s http://www.usdagov/cnpp/healthyeating.html

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good way to estimatehow much of a particularnutrientthey were eatingor to gaugea healthy and balanceddiet. were presented a.mock-uplabel of a 20 with Large package sizes. In all the groups,participants ouncesodaand a largepackaged muffin. Both of theseproductsarethoughtto be commonly consumed one sitting, but havemore than one servinglisted. in thoughtit was misleadingto list either product Serving vwsuspackage. In general,participants as having more than one serving. Many participantsdid realizethat if the entire packageis eaten,the numberof servingsshouldbe multiplied by the amountof the nutrient of interest, though someparticipantswere confusedand mademistakeswhen trying to calculatethe total amountin their heads.
Calorie-related variations. The first test label addeda %DV for calories,removedthe calories from fat line, enlargedthe caloriesline, and changed way servingsizewas declared. In the

generalthesechanges were not noticedby participants.Whenthe new wording for servingsize was pointedout, most participantsdid not think it was an improvement over the existing language. test Serving size variations. The second label had two %DV columnson the NFP, one for a specifiedservingsizeand one for the entirepackage.In the first four groups,the absolute quantitiesof macronutrients were only”listedfor the specifiedservingsize. After comments from thesegroups,the label was modified to havethe absoluteamountfor both the specified servingsizeand the entireIproduct. Participants reactedpositively to this modification,but some thoughtit was not necessary list the amountfor a specifiedservingsize, to with the caloriesper servingand- white squarewith calories a Calorie cues. Both a “starburst” per whole producton the package’PDP were tested. Many participantsthoughtthat the s starburstwas misleadingbecause thoughtthe manufacturer trying to indicate the entire they was with the total caloriesperproductgot producthad fewer caloriesthan it did. The white square mixed reactions,but many participants saidthat they recognized just theseas high calorie productsand would stayaway from them. “healthy’ meat lasagna ” with a purple keyhole “Healthier ” symbol. Half of the groupstesteda ‘ symbol on the PDP. Therewas generallypositivereactionto includinga .Eont-of-package symbol indicatingthat a productwas “healthy,‘as long as participantsunderstood definition ? the believedthat they would haveto be of the symboland could trust that it was true. Participants educated to the meaningof sucha symbol. Someparticipantsmentionedthat they would look as for the symbolwhen they were in a hurry in the store. They expressed someconcernthat these productswould costmore or that they would lack in taste.

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3. OWG Food Label Recommendations

The OWG recommends FDA (1) developoptionsfor revising or adding caloric and other that nutritional information on ‘ packaging(examples food providedbelow); (2) obtain information on the effectiveness theseoptions in affecting consumer of understanding ‘ and behavior relevantto caloric intake; and (3) evaluatethis informationto makeevidence-based decisionson which option(s)to pursue.
a. Calories and Serving Siis

In light of the critical importanceof caloric balancein relation to overweightand obesity,the OWG recommends FDA: (1) solicit commenton how to give more prominenceto calories that on the food label; (2) considerauthorizinga health claim on “reduced”’ “‘ or low”calorie foods; and (3) reexaminethe agency’ regulationsabout servingsize. s
Solicit comments on how to give more prominence to calories on the food EabeL Many of the

written and public commentssubmittedto the agencysuggested FDA developways to that emphasize calorieson the food label. To address the OWG recommends FDA publish this, that an ANPRM requestingcomments how bestto give more prominence calories. Possible on to changes the NFP include: (1) increasing font size for calories;(2) providing for a %DV for to the calories;(3) eliminating“calories from fat” listing as this takesthe emp’ away from “total hasis calories;”and (4) increasingthe font size for servingsize in order to give it more prominence.
Consider authorizing a health claim on “reduced” or “law If calorie foods. A numberof

commentssubmittedto the agency,including thosefrom-theFTC, suggested FDA permit that health claims on reducedcalorie foods as a way .to reducethe risk of certainchronic diseases associated obesity,suchas diabetes, with coronaryheartdisease cancer, To address and this suggestion, OWG recommends FDA publish an ANPRM on whetherto allow a health the that claim suchas “Diets low in caloriesmay reducethe risk of obesity,which is associated with diabetes,heart disease, certaincancers” certainfoods that meetFDA’ definition of and on s that “reduced”or “low” calorie. In addition,the OWG recommends FDA encourage manufacturers use dietary guidancestatements to (e.g.,“to manageyour weigbt, balancethe caloriesyou eat with your physicalactivity; have a carrot,not the carrot cake;and as a snack have an appleratherthan a servingof potatochips”).
Reexamine the agency’ regulations on serving sizes. The comments s that FDA hasreceivedat

its public meetingsand to the docket (including commentsfrom the FTC),.express concernabout the servingsizesusedin nutrition labeling,particularly on packaged productsthat can readily be consumed one occasionbut that indicatethey represent at more than one serving. To address this issue,the OWG recommends following: the
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In the short-term,that FDA encourage manufacturers immediately. take advantage to of the flexibility in currentregulationson servingsizes(21 CFR 1.01,9(b)(6)) allows that food packages be labeledas a single-serving the entire contentof the packagecan to if reasonably consumed a single-eating be at occasion.

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In the long-term,that FDA developtwo separate ANPRMs. The first would solicit comment whetherto require: on add,itional columns within the nutrition labelto list the quantitative amounts %DV of the entirepackage thoseprodu&sand package and on sizes that canreasonably consumed one eatingoccasion alternatively, be at or, declare the whole package a singleserving. This ANPRM would alsosolicit informationon as products package and sizesthat canreasonably consumed oneeatingoccasion.The be at second ANPRM would solicit comments which, if any,RACCs of food categories on appear havechanged mostover the pastdecade thereforeneedto be updated. to the and

The servingsizeis critical to nutrition labelingsinceall of the informationon nutrientlevels depends the amountof the productrepresented. statute, servingsizeis to be based on By the on the “amount[of the food] customarily consumed” (section403 of the Act). Accordingly,when implementing NLEA, FDA reviewedfood consumption obtainedfrom USDA’ 1977-78 data s and 1987-88 NationwideFoodConsumption Surveys based the results-of review, and, on that established RACCs for 139food categories FR 2229,January (58 6,1993). Inasmuch thereis as evidence Americans eatinglargerportionsthanthey did in the 1970s 198Os, that are and the O W G recommends FDA determine that whetherand,if so,how to updateRACCs. The accuracy the informationin the NFP is crucialforconsumers usethis informationto of who monitortheir intakeof caloriesandnutrients. Currentenforcement effortstargeted the NFP as at described FDA’ FoodLabelingCompliance in s Program”aredirectedat ‘ ensuring actual that nutrientlevelsarewithin 20% of declared values. More lim ited’ resources beendirectedat have ensuring servingsizesare caloulated declared that and accurately.Comments other and informationsubmitted FDA express to concernaboutthe inaccuracy servingsizedeclarations o.f usedin nutrition labelingand reiteratethe importance accurate of serving declarations size because of the informationon nutrientlevelsis dependent the amountof the product all upon represented. address issue,the b W G recommends FDA highlight enforcement To this that of servingsizesin the FoodLabelingCompliance Programby April 2004,and consider enforcement activitiesagainst thoseproducts declareinaccurate that servingsizes.
b. Carbohydrate? Labeling

Todaythereis increasing interestin low carbohydrate (seetext box on Carbohydrates diets and OtherMacronutrient Contributions CaloricValue in AppendixB). FDA hasrecentlyreceived to petitionsrequesting the agency that providefor nutrientcontentclaimsrelptedto the carbohydrate contentof foods. Claimsfor carbohydrate contentof foodshavebecome increasingly commonin the marketplace while, at the sametime, the level of Carbohydrates in foodsmarketed underthe variouscarbohydrate claimsappears vary widely. In orderto ensure to that termsareconsistently definedandthat carbohydrate claimsare not falseor m isleading, the
I5TheFoodLabeling Compliance Program givesinstructions FDA F ieldO fficesthat describes labeling to food enforcement strategies identifies/highlights and specificareas whereresources should targeted regard the be with to ~curacy of ,thefood label.(currently the Internet http://www.~~fsan~fd~.gov/-ctrmm/cp21008.h~1) on at: For a furtherdiscussion carbohydrates, Dietary Referencektaks - Energy, on sek Carbohydrate,iber,Fat,Fatty F Acids, Cholesterol, Protein Amino AcidsPart 1, Chapter DietaryCarbohydrates: and 6 Sugars Starches l-57 and 6: (Instituteof M e d icine theNationalAcademies, of 2002)andreferences therein” cited 20

OWG recommends FDA file thesepetitionsand publish a proposed. to provide for that rule nutrient contentclaimsrelatedto the carbohydrate contentof foods,including guidancefor the useof the term “net” in relationto carbohydrate contentof foods.
c. Other LabelingJssues

The OWG considered comments from the FTC on the issuesof (1) reduced/fewer calorie comparisons, comparison food of different portion size,(3) comparison food of different (2) to to producttype, and (4) disclosurerequirements comparative for claims.
Reducedjbwer caZorie comparisons. The underlyingprinciple for FDA’ ‘ s regulationis that food reductionsbe significant iompared.tothe.reference (21 CFR 101.60(b)(4).FDA

determined percentage that reductionslessthan 25% were too small to be meaningfulbecause of normal productvariability; Suchvariability may be caused factorssuchas: naturalnutrient by variability of the food dueto season ofthe year, soil type, variety, and weatherconditions; variability in processing; roundingrules (e.g.,roundingto the nearest5 caloriesup-to 50 calories and to the nearest10 caloriesabove50:calorie.s); analyticalvariance(rangingf?om+/- 3-4% to +/- 30 % with an average varianceof about-t/- 15%); samplingprocedures; shelf life and and stability of nutrientsin the product. As a result,2 1 CFR 101.9(g)allows for a 20% excessin the actual(analytical)nutrient content of calories,sugars, total fat, saturated cholesterolor sodiumof a productcompared the fat, to declarednutrient valuesfor that product(and consequently qualifying valuesfor nutrient the contentclaims)beforethe food is considered be misbranded.Therefore,nutrientreductions to lessthan 25% are virtually within the allowableproductvariability and arenot considered significant. The minimum absolutereduction(e.g.,equivalentto the value of “low”) was changed permit claimscompared referencefoodsthat were not already‘ to to “low” in the nutrient because was the agency’ conclusion, benefitsderivedfrom severalservingsof it s that nutritionally modified nutrientdensefoodsover a day could havea signif$ant impactprovided that the reductionwas significant,i.e., 25 % or more. FDAtirther concludedfoods already “low” in that nutrient were below the level at which the amountof nutrient in the food becomes significantrelative to the total diet and thereforeshouldnot be usedas referencefoods. For relative claims,the OWG notesthat the CodexAlimentariusCommission17 requiresthat therebe a differenceof at least25% in energyvalue or nutrient content(exceptfor micronutrientswhere a 10%differencein the nutrient reference valuewould be acceptable) with a minimurn differencebetweenthe comparedfoods equivalentto a Yo.w”.vJue (FDA’ s proposedrequirements “less”). Moreover,Canada for requiresthat corn arativeclaims be based l$ on differenceswhich are both nutritionally and analyticaIlysignifiaant, Canadian regulations’ considerreductionsof lessthan 25% from the reference valueto be of questionable nutritional significance. Canadadoesnot allow claimson reductionsof lessthan 25%.

I7 Guidelines Use of Nutrition Claims(CAC/GL 251997). for ‘ Guideto FoodLabelingandAdvertising. Section NutrientContentClaims6.1.9(c). * VI.

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The OWG recommends agencybe receptiveto sucha claim, ifthe proponentof sucha claim the is able to provide dataand information, substantiate to that: 1. The claim is not misleadingdue to the known variationsin food compositionand analyticalmethods,and 2. The claimedreductionsarenutritionally significant.
Comparison to foodof d@j$rentportioq size. FTC has suggested FDA Consider that “allowing food marketers maketruthful non-misleading to label claims comparingfoods of different portion sizes.”FTC providedthe exampleof a 10 oz chickenand rice casserole labeledas having 33 percentfewer caloriesthan 15 oz. of the samechickenand,rice,casserole. Consuminga smallerportion size of the samefood simply decreases caloric consumption proportionally. To enableconsumers makemeaningfulcomparisons caloriereduction, to for FDA requiressuchclaims,tobe basedon the amountper RACCs, or per 100gmm in the caseof meal-typeproducts. Thus,underFDA’ currentregulations(2 1 CFR 101,60(b)),a comparative s calorie claim of the type that FTC proposes would not be allowed. Nevertheless, usingthe food label to promoteconsumption smallerportionsmay have merit. of This is especiallytrue if consumers understand (a) the caloriereductionis solely a function that of the reductionin portion,size,and (b) that the smallerportion size is actuahylessthan what they usuallyconsume.Thus,the OWG recommends FDA issuean ANPRM to solicit that comments truthful non-misleading usefulapproaches promotingconsumption on and for of smallerportion sizes,including FTC”s suggestion. Comparison to food of d@erentproduct type (which the O?TG refers to as comparative labeling statements). FTC suggests FDA “‘ that consider allowing food companies make label claims to

that comparethe caloriesof foods [across]different productcategories,”FTC points out that switchingfrom one categoryto anothercategoryoften can be an effective-,means reducing of calories,suchas substitutingcarrot sticks for potatochips or fruit for cookies. FTC notesthat comparative caloric claims acrosscategories could help consumers make thesehealthy substitutions.FTC offered as an example,“insteadof cherr$l try our deliciouslow fat cherry pie, yogurt - 29 percentfewer caloriesand 86 percentlessfat.“’ CurrentFDA regulationsdo in fact permit certaincomparative claims. In addition to the examplethat FTC provided,the OWG offers the following as examples comparative of claims that are permissibleundercurrentregulations:
l

l

One mediumapple(80 calories)contains47% fewer caloriesthan a one ounceservingof potatochips (150 calories). Carrotshave 93% fewer caloriesthan carrot cake. One 7-inch carrot (78 g) contains35 calorieswhile one slice of carrot cakewith icing~(12.5 contains500 cabries. g)

lg This example contains express also an nutrient,content claim (“try our deliciouslow fat yogurt”), andtwo relative claimsr29 percent fewer calories” “$6 perceritlessfat”). Hence, statement, written,would needto meet and the as the regulatory requirements thesetypesof claims,andwould alsoneedto‘ for protide servingsize informationthat would aIlow for appropriate comparison between cherrypie andthe cherryyogurt. the

22

a Air-poppedpopcorn(without addedtoppings)containsone-halfthe caloriesof a plain granolabar (98 caloriesper ~-CUP servingof popcorn,200 caloriesper 1.5 ouncegranola bar). The OWG recommends FDA encourage that manufacturers useappropriatecomparative to labelingstatements make it easierfor-consumers makehealthysubstitutions, that to including calories. Suchcomparisons provide valuableinformationthat can be usedin making food for that choices. Moreover,thereis a flexible standard productcategories is intendedto facilitate useful comparisons foodsthat are generallyinterchangeable the diet (for example,“apples for in have less,fatthan potatochips’ while prohibiting meaningless misleadingclaims(58 FR “) or 2302 at 2363, January6, 1993). Manuftiurers haveto usejudgmentin developingclaimsto ensurethat the claimscomply with the regulationsand are not falseor misleadingundersection 403(a)ofthe Act. that Disclosure requirementsfir comparative claims. FTC suggests FDA “evaluatewhether unnecessarily cumbersome disclosurerequirements havedeterredtruthful, non-misleading comparative label claimsfor foods.” As always,FDA is opento dialogueon suchan issue, particularly when a proposalis supported relevantdataand informa,tion. by To make a comparative nutrient claim,,a food marketermust provide informationon the referencefood, the percentage which the nutrient in the referencefood hasbeenchanged, by and the absoluteamountof the nutrient in the labeledand referencefood (21 CFR 101.13(j)(2)). The agency,however,is not wholly,prescriptive to the actualwordsusedor whereall the as information is placedon the label. FTC offered as an example,a bakedpotatochip that is lower in both caloriesand fat than a regularpotatochip, and indicatedthat label claimsexplainingthe benefitswould be awkwardto place(and read) on the front panel. Accordingto FTC, underFDA regulations,the claim would read as follows (italicized phrases be placedon the backnutrition label): may “Reducedfat and fewer caloriesthan our ClassicPotatoChips.Fat-reduced 85 by percent,fiom 10 grams per ounce to 1.5 gramsper ounce. Caloriesreducedby 27 percent, from 150 calories per ounce to I1 0 calories per ounce.” The OWG notesthat the FTC examplecould be more succinct. As FTC suggests, more than 50% of the text may be placedon the backnutrition label. Beyondthat, under FDA’ current s regulations(2 1 CFR 101.13(j)),the PDP could simply read: 85% lessfat and 27% fewer caloriesthan our ClassicPotatoChips.

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B. Restaurants/Industry

RestaurantsllndustryRecommendation Highlights:
l

Short-term o Urge restaurunt industry to launch a nation-wide, v&+ary, andpointof-sale nritrition~infor#nut~on campaignfor const4mers...p~ 26 o Encourage consumersroutinely to requestnutrition ~f~r~ion in restaurants...p.26 Long-term o Developmentof a seriesof optionsfor providing vohm , stuudardized, simple, and understatzdable rzutrBioninform&U, i~~ud~~gcalorie information, at the point-of-sale to consumersin restaurants...p. 27 m FDA to seekpart&@ating resta?rants 4 pilot progrim to study for theseoptions in well controlled studies...p, 2 7 m FDA to provi& incentives,if necessary, v#lu~t~~ industry for pa@ipation in the pilotprogrum..,p. 27 = FDA to evaluateresults of the pi~ot~rog~amIfo~term~e whether further researchis warrantedbefore such a progrm & implemented-on loge scale,..p.27 a o Exploratiqn of the eonce#tof third-party cert#%utjonof weight-lossdiet plans and,relatedproducts.,.p. 28 Enforcement o Togetherwith the FTC, increaseenforcement;aga@s$ weight loss products havingfalse or misleadingclaims...p. 29

l

l

The Commissioner directed the OWG to ‘ develop an approach for working with the restaurant “ industry to create an environment conducive to better informed consumers.‘ Y In light of the growing proportion of American meals consumed outside of the home, it is important to enlist the assistanceand support of restaurants in addressing population obesity. Since the late 1990s and projecting through 2004, American households arespending approximately 46 percent of their total ,food budget on food consumed outside the home (ERS, 2003; NRA 2004). During 1994- 1996; food consumed outside the home, especially from restaurants and quickservice food establishments,contributed 32 percent of daily intakes of Thus, food energy calories, 32 percent of added sugars, and 37 percem of fat (ERS, 2@OO), consumed away-from-home is an important part of American diets and more informed dietary choices away-from-home could help reduce calorie over-consumption ad the risk of obesity and its associatedhealth problems.

24

The distribution of meal sources also shiftedover the past few decades, this shiR may be has and anothersignificantfactor in weight gain. Food consumed outsidethe homehas increased from approximately33 percentof U.S. consumers’ budgetin 1970to approximately47 percent food as of 2002 (ERS,2003;Young and Nestle,.2002). Over a similar period,total caloriesfrom food consumed outsidethe home,especiallyfrom quickservice restaurants, increased from 18 percent to 32 percent. In addition,food consumed outsidethe homewas higher per meal in calories, total fat and saturated as well as was lower in fiber, calciumand iron on.a per-caloriebasis fat, (Guthrie et uZ.,2002). As noted above,underthe laws administered FDA, restaurants not requiredto provide by are nutrition informationunlessa nutrientcontentor healthclaim is madefor-a food or meal. When claims are made,however,the restaurant needonly provide informationaboutthe amountof the nutrientthat is the subject*ofthe claim. Restaurants may, and many do, provide nutrition informationon a voluntary basis. Nevertheless, nutrition informationis often in the form of this posters,placemats menu icons,or on the Internet;ratherthan at the point-of&ale. Such or informationis not alwaysreadily availableor observable the point-of-sale. at
1. F’ Fqcus Groups~on Restaurants DA

As describedin Box 2, FDA recentlyconducted focus group researchin,which it askedquestions aboutwhat type of nutrition informationparticipants would like to seein :quickservice restaurants.Participants discussed reactedto variouspresentations nutrition information and of at restaurants.The questions dealtwith four topics: (1) nutrition information;,(2)menuboard information; (3) menuboard section;atld (4) “healthier”symbol. For additionalinformationon FDA’ focus groups,seeAppendix G. s
Nutrition information. Most participantsseemed interested havingnutrition information in

availableto them when they eat at fast food and/orquickservice restaurants, thoughthey might not useit every time they eat out. Participants suggested this informationcould be presented that in many locationsin the restaurant including food wrappers,tray liners, brochures,on the takeaway bags,postersnearthe counter,and the menuboards. reactedto multiple versionsof a:menuboardfor a typical Menu board information. Participants fast food restaurant.In general,participantsliked having calorieslisted after meal itemsand after combomeals. Thosewho tend to order a la carte preferredto have calorieslisted after eachitem, while thosewho usually order a combomeal preferredto havecalorieslisted for the entire meal. Although participantswere-concerned multiple ma~ronutrients foods, with for havingjust calorieslisted ivas enoughfor many of them. Participants ,thought%that caloriescould be a signalfor the level of other macronutrients. also reactedfavorablyto the ideaof placing healthier Menu board section. Most participants options,including meals,in a separate sectionof the menuboard so they could find healthier optionsat a quick glance.
“Healthier ” symbol. Many participantsalso reactedfavorablyto a purple keyholesymbol for

healthiermeals,but somethoughtthat the exactnumberofcalories shouldbe listed as well.

25

Again, the symbolwould haveto be trustedand consumers would haveto understand the meaningof the definition. 2. OWG Restaurant Recommendations The OWG recommends FDA encourage that restaurants provide more,,and to more readily available,nutrient contentinformation:atthe point-of-sale. The restaurant industry hasvoiced concernthat requiring nutrition labelingfor all menu itemsis infeasibleb$cause recipeschange frequently,and patronsoften requestcustomization their mealsand the numherof options of availablefor customization large. For example,recentNational Restaurant is Association research indicatesthat 70%‘ consumers of customize their mealswhen eatingin restaurants.2o Nevertheless, OWG believesthat the restaurant the industry could provide somelevel of nutrition informationto its patrons~ enhance to their ability to makewise food choices. Calculatingnutrition informationmay have beena difficult task for most membersof this industryin the past,when suchinformationhad to be determined dire@chemicalanalysis. by This task,however,is easiertoday because nutrient compositiondatabases softwarefor and labelingare readily available. Possibilitiesfor providing nutrition info~a~on. to consumers include: segregating “healthier”menu itemswith simplenutrition informationin a separate sectionof the menu;providing icons for individual “healthier”menuitems; and presenting nutrition informationin locationsin the restaurant wherepatronscanreadily useit (i.e., at the point-of-sale). The OWG alsorecommends FDA encourage that consumers routinely to requestnutrition restaurants respondto consumer demand(as evidencedby information in restaurants.Because comments madeby membersof the restaurant panelat the November20,2003, workshop),such demandmay help createan impetusfor more restaurants provide suchinformation. to The OWG believesthat there is a needfor research determine bestway(s) to present to the nutrient contentinformationto consumers that they will makehealthierchoiceswhen eating so food away from home. The OWG recognizes, however,that suchresearch take a substantial will period to plan and complete. In the interim, the pervasiveness the obesityepidemicmeans of that more nutrition informationmust be presented consumers restauram to in settings. Accordingly, the OWG hasdeveloped both short-termand long-termrecomJnendations The OWG recommends in the short-term, that FDA urge, restaurant the industryto launcha nation-wide,voluntary,and point-of-salenutrition informationcampaignfor customers.

2oFrom remarks HudsonRiehleof the NationalRestaurant by Association the Novqmber 2003,workshop at 2Q, “Exploringthe Connections Between WeightP&.nagement FoodLabelsandPackaging” and (h~p:Nwww.fda.govlohnns/docketsldockets/O3nO338/03n0338-tr.hlm)

26

Over the long-term,the OWG recommends that:
(1) Options be developedforprovtding voluntary standardized simple, ana’ understandable nutritional information9 including calorie information, at the point-ofsale in a restaurant setting.

Ideally theseoptionsshouldfocus on the caloric contentand nutritional compositionof complete mealsratherthan individual menu items. Although a focuson total caloriesis the most useful singlepieceof information in relationto managingweight, additionalinformationon nutrient contentofthe meal is also important. This is true, for example,for peoplewith diabetesor coronaryheartdisease needto more carefully control their consumptiun certainnutrients who of (e.g., carbohydrates, sodium,fat). An alternativeto listing detailednumericinformation is to use a graphicalrepresentation conveysthe sameinformationusing a picture or symbol. ,that
(2) FDA seekparticipating restaurants for a pilot program to stu@ these options in well controlled studies.

The numberof restaurants participatingin the pilot programshouldbe large enoughto includea variety of locations,cuisines,and average price of menuitems. The pilot programneedsto be long enoughto accountfor any time requiredto understand new menuformatsand nutrition the information. Participatingrestaurants would needto provide item-by-itemsalesdatabefore, during, and after the pilot. Experimentaleconomics methodscould.substitute partly but not wholly for actualmarketdatato assess: impactof variouslabelingopti:ons consumer the on behavior. FDA could also usethis pilot programto exploreengagingthe restaurant industry as a powerml distribution systemfor the agency’messages obesityand its educationprograms. s on
(3) FDA provide incentives, if necessary, voluntary industry jxxrticipation in the pilot for program.

Suchincentivescouldinclude allowing restaurants useFDA’ nameto promotethe pilot in to s advertising,on stickers,and on their menus;and/orcoupiingthe pilot grafnwiti m overall FDA educationcampaign, which may include spaceon restaurant menusor on separate handouts for FDA messages healthylifestyles. on
(4,’ FDA evaluate results of the pilot program.

FDA would needto analyzethe results. any pilot programto determinewhetherfurther of research warrantedbeforesucha programis implemented a largescale. . is on In order to pursuethesemore long-termrecommendations, OWG recommends FDA the that work througha facilitator to provide a forum for stakeholders seekconsensus-based to solutions to specificaspects the obesityepidemicin the United States, of with a par@uIarfocus on food consumed away from home. As a first:step,the OWG further recommends the initiation of that sucha dialoguebe raisedat the next meetingof the FDA Science Board.

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3. OWG Weight-Loss Diet Plan Recommendations

Justas consumers spenda significant amountof money for foods consumed outsidethe home, they spendsubstantialsumson weight-lossdiet plans and diet-relatedproducts. Suchplansand productshave the potentialto affect all food choicesby at least someconsumers. The long-term weight or healtheffects of theseand other weight control measures remainsunclear(Connors and Melcher, 1993;Ayyad and Andersen,2000; Saris,2001; Anderson,e#crl.,2001; and Phelan, et al., 2003). This raisesthe questionof whetherconsumers who foll’ theseplansand buy ow theseproductsunderstand health implkations, particularlythe systematic the difficulties of longterm weight management.For thesereasons, OWG also considered’ health consequences the the of using weight-lossdiet plansand relatedproducts. The OWG concludedBrat,in the long-term, research needsto be doneoutsideofFDA to determinewhetherclaimsfor suchdiet plansand relatedproductshave beenor can be substantiated.Thus,the OWG recommends there be an that explorationof the conceptof third party certificationof weight-lossdiet plansand related products. The goal is to improve consumerinformation aboutthe healthoonsequences their of overall dietary choices. With respectto diet-relatedproducts,on Decemberl&2002, FDA armounced significant a enforcement initiative targetedat misleadingclaims aboutdietary supplement-associated health benefits. Dietary supplements usedby an estimated158 million Americans,and so are misleadingclaims abouttheir healthbenefitsmay have significant consequences not only for wasting consumers’ money but also for lurmg consumers interestedin improving their health in wrong directions. Although FDA’ enforcement s goalsrelatedto truthful and non-misleading statements abouthealth benefitsapply to all of the productsthe agencyregulates, initiative this was especiallyfocusedon productsthat in recentyearshavebeenthe subjedtof important misrepresentation. As part of the December18 announcement, released “‘ FDA the DietarySupplement Enforcement Report”that pledgedto closely scrutinizeand bring enforcement actionsagainstproducts identified as “clearly problematic.”Dietary supplements falsely claim effectiveness that as treatments overweightwere includedamongthose identified as “clearfy problematic.” for CFSAN and the Office of RegulatoryAfftirs have focusedtheir dietary supplement enforcement budgetsprincipally on targetedinspections and, whereappropriate, recommending enforcement action againstpartieswho ,violatethe Dietary Supplement Health and EducationAct (DSHEA). In terms of the strategies usedto enforceDSHEA, FDA hasproceeded severalfronts: (1) on traditional enforcement activities (e.g., inspections, warning letters,seizures, injunctions, and criminal enforcement); inter-agency internationalenforcement; (3) consumerand (2) and and industry education. More recently,in December2003, FTC staff released report,Deceptjon in Wgight-Zoss a Advertising Workshop: Se&kg Opportunities and Building partmrs&ips to Stop Weight-Loss Fraud (FTC, 2003). This FTC staff report lays out a numberof opportunitiesfor industry and mediato assume leadershiprole in addressing a deceptiveweight loss advertising. To

28

complement theseefforts, the QWG recommends FDA continueits enforcement that initiative targetedat misleadingclaimsaboutdietary supplement weight loss products,
C. Therapeutics

Therapeutics Recomm;?ndation ,Bigh@ghts: Convenean FDA advisorycommitteemeetingto addressihaeengeg,as well as.gaps in knowledge,about existing drtig therapiesfor the treatmentof &@y...p. 30 m Continue discussions pharmaceuticalarzdTdical devicesp;onsoss with about development new obesitytherapies...p.31 of m Revise1996 draft g&dance 012 $evelopingobesi&drugs and r&sue for comment...p. 31
n

The Commissioner directedthe OWG to “developan approach facilitating the development for of therapeutics the treatmentof obesity.” for The role of obesityin many acuteand chronic diseases well documented.The contributionof is r obesityto premature mortality through,increased of diabetes, risks heart disease, stroke,and cancer,amongothers,mandates aggressive, an proactivestanceby the entire medical community.
1. Background

Modern medicine’ experience weight loss drugsdatesto the late nineteenthcenturywhen s with initial enthusiasm the weight losspropertiesof thyroid extractwere eventuallytempered for by the negativeeffectsthat iatrogenichyperthyroidismhad on leanmusclemass,bone,the central nervoussystem(CNS), and cardiacfunction (Schwartz,1986;Bray, 1976), The next centuryof obesitydrug development the introductionof a numberof drugsthat provedto have saw significantsideeffects:Dinitrophenol(cataracts, neuropathy) 2934;Amphetamine(addiction, in CNS and cardiactoxicity) in 1937;Rainbowpills, or digitalis and diuretics(cardiacarrest)in 1967;Aminorex (pulmonaryhypertension) 1971;and Redux (cardiacvatvulopathy)in 1996 in (Bray and Greenway,1999). Prior to 1996,all approvedobesitydrugswere labeledfor short-termtreatmentof obesitybased on pre-approvalclinical trials of up to 12 weeks’ durationand of limited sizes today’ by s recognitionof severalfats have led to changes standards.Over the past 10-l 5 years,increasing in the approach the treatmentof obesityand thus to the study of new drugsfor this condition: to (1) obesityis a chronic conditionwith long-termmorbid and mortal sequelae; maintenance (2) of weight loss,evenwhile on continueddrug therapy(and certainlyaftt?rdiscontinuation drugs) of is the rare exceptionratherthan the rule; and (3) maintenance a “healthy”weight (ratherthan of weight “cycling”) is the key to reducedrisk for obesity-associated adversesequelae.

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2. FDA’ Draft Guidance s

In 1996,FDA issueddraft guidanceentitled “Guidancefor the Clinical~Evaluation Weightof for Control Drugs.” The draft guidancegives recommendations the designand conductof phase l-3 clinical studiesaimedat demonstrating effectiveness safetyofweight-loss the and medications.21 guidanceproposedtwo alternativecriteria for effectiveness drug This for therapies: 0 Mean weight loss in the drug-treated group is 5% greaterthan the meanweight loss in the placebogroup following one year of treatment. l The proportionof patientsthat lose at least5% of their baseline:weight greater is in the drug vs. the placebogroup.
3. Existing Therapies

Under the criteria in the 1996draft guidance,three drugshave beenapprovedfor the long-term treatmentof obesity:dexfenfluraminepedux) in 1996(withdrawn in 1997for safetyreasons), sibutramine(Meridia) in 1997,and orlistat (Xenical) in 1999. In addition, a numberof drugs were approvedprior to 1996for the short-term(e.g.,a few weeks)treatmentof obesity (e.g., phentermine(Adipex) and diethylpropion(Tenuate)). FDA-approveddrugs for the long and short-termtreatmentof obesityare indicatedfor use by thosepatientswith: (1) a body massindex of > 27 kg/m2when accompanied obesity-related by comorbiditiessuchas hypertension, diabetes,and dyslipidmeia;or (2) a bsdjl massindex > 30 kg/m2. For patientswith extremeobesity(thosewith BMIs at or over 40), for whom no other measures have beeneffective in promotingweight loss,surgicalor device-mediated gastroplastyis increasinglyemployed. Worldwide, over 100,000of thesedeviceshave beenimplantedover the past 8 years. In the United Statesalone,tensof thousands devicesare implantedeachyear to of restrict the size of the stomachand thus severelylimit food intake. Despiteserious complications,gastroplasty procedures well as deviceimplantationsare effective for some as individuals,with averagedurableloss of 3540% of excess(over ideal) weight,
4. OWG Therapeutici Recommendations

Ideally, individual consumers avoid becomingoverweightor obesethrough diet and will that exercise. Yet the OWG recognizes obeseand extremelyobeseindividuals,are likely to need medicalinterventionto reduceweight and mitigate associated diseases other adverse and health effects. The OWG concurswith agencyplansto (1) convenean EDA advisorycommittee meetingto address challenges, well as gapsin knowledge,about existingtherapies(i.e., headas
” On January 26,2004 (69 FR 3588),FDA issueda Federal Registernoticespe~ifkaily tqsolicit comments this on previouslypublished draft guidance.FDA is &terested incorporating latestscientificadvances the field of ia the in obesityanddrugdevelopment an amended ipto obesityguidance document.Oncethe agencyrevisesthe draft,EDA will issuethe guidance againfor comment beforefinalizing the guidance.

30

to-headcomparisons marketeddrugs,cardiovascular of endpointstudies);(2) continue discussion with pharmaceutical medicaldevicesponsors and aboutnew obesitymedical products;and (3) revise 1996draft guidanceon developingobesitydrugsand t’ e-issue ’ for comment.
D. Research

l l

.p. Pmsue researchon obesityprkve&io-re with USDA/GRS.. $1
Support and collaborate, cd;s appropriate, on obesity-related resemzh with others, including NIH.. .p.32

o Parsue obe$ty related researchifa thefollowing five areas: o Information, usedto fac%tate commners’weight management decisions...p. o ReWonship betweenoverweight/obesity andfoodpattmzs..+p. 32 o IncentzVes product refor&ulation...p. 32 to o Potentialfor FDA regzdategproducts unintentionally to contribute to or result in obqi@...p. 33

The Commissioner directedthe OWG to “identify appliedand basicresearch ne&ds relative to obesitythat includethe development healthierfoods aswell & ‘ betterunderstanding of a of consumer behaviorand motivation.”
1. Joint Research with USDA/AM

As part of its research efforts, the OWG r&commends FDA cbllaborate that with YSDAIARS on will a nationalobesitypreventionconference be held in October20041The con%rence draw to on the expertiseof both the public and :privatesectorscientificcommunities provide guidance to for research agendas the short-and long-termto address in obesitypreventionfrom a variety of diet scientific and other disciplines. Suchqisciplineswill include’ and nutrition, behavioraland economicscience, research and involving exercise,education,integratedprograms,and outreach.
2. Survey of Research

The OWG focusedon threeareasof research relatedto its charge: (1) “labeling informatiorP2’ and consumer perceptions dietary behaviorswith regardto weight management; (2) :and and supportfor safetyevaluationwith respectto the potentials FDA regulatedproducts for unintentionallyto contributeto or result in obesity;and (5) translationalresearch conducted by FDA’ National Centerfor ToxicologiqalResearch CFSAN’ Office of -AppliedResearch s and s and SafetyAssessment. ‘ to enable agencyto usethe basicscientificrekarch conducted the by
” For the purposes V.D.2., “1abeIing of information” includes possible changes the NFP, possible to changes the to PDP,graphicdevices, caloric/nutrient densityindicators, nutrientwntent claims. and

31

suchagencies the NIH in FDA’ regulatoryactivities. Of thesethree,the GWG considers as s the first two to be more directly and immediatelyrelevantto its charge, Tranrslational research, because its link to basicnature,takesa,longtime to yield practicalresults. ,Nevertheless, of the OWG believesFDA shouldcontinueto conducttranslationalresearch order to gain a better in understanding obesity. of Basedon a review of the relevantresearch well as comments as provided.during variety of a public meetings, OWG has identified severalknowledgegapsrelatedto the two research the that research conductedin the be areasabove. The OWG recommends further obesity-related following areas: (1) informationusedto facilitate consumers’ weight manage,ment decisions,(2) the relationshipbetweenoverweight/obesity food consumption and patterns;(3) incentivesto productreformulation,and (4) the potentialfor FRA-regulated productsunintentionallyto contributeto or result in obesity,and (5) the extensionof basicreseamh findings to the regulatoryenvironment throughtranslational research.In addition,the OWG recommends that FDA pursuecollaborations with other groupswho areundertakingobesityresearch suchas NIH, which hasrecentlyissuedan obesityresearch agenda, CDC. and
Information used to facilitate consumers’weight managementdecisions. The BWG

recommends conductingadditionalqualitativeand quantitativeresearch with an emphasis (1) on consumer reactionto and effectiveness currentpackaged of food labelingand possiblechanges to the food label (e.g.,highlighting calories,listing the quantitativeamountsfor all nutrientsin multi-sizepackages, using “healthy”symbols,graphicdevices,or caloric/nutrientdensity and indicators),(2) consumer reactionto and effectiveness currentrestaurant of nutrition information and possiblechanges (e.g., listing nutritional informationsuchas calories,fat and sodiumfor both a la carte itemsand mealsand using “healthy”symbols),and (3)consumerdietary behavior and attitudestoward weight management.
Relationship between obesity andfood,consumption patterns. The OWG recommends

conductingresearch evaluate relationshipbetweenobesityin adults” children and the to the and frequencyof foodsobtainedfrom and/orconsumed different locations(e*g.,homecooked in meals,packaged foods,and quickserviee establishments/restaurants) with respectto and socioeconomic statusand vulnerablepbpulations(e.g.,HispanicAmericans,African Americans, AmericanIndians,and the elderly). This research would be conductedin collaborationwith the EconomicResearch Serviceof the USDA using CDC and National Health and Nutrition EducationSurveydatato evaluate theserelationships. conductingfurther research with Incentives to product reformulation. The OWG recommends the packaged food and restaurant industriesin additionto that currentlybeing conducted by OASPE in collaborationwith FDA (FDA, 2003). This research would (1)examinewhetherthe incentives(e.g., label prominenceand other label characteristics calorieajld weight of management information)and barriers‘ (e.g.,food additive and claimsapprovalprocesses the and regulatorypolicy relatedto standards identity and fortification) to reformulationidentifiedby of the packaged food industry during previousdiscussions real or perceived,and (2) expandthe are scopeof the research conducted OASPEto includeadditionaldiscussions key restaurant by with industry,including qUiGkSerdGe,personnel regardingthe barriersand incentivesto the development/reformulation healthierrestaurant of foods.

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Potential. FDA-regulatedproductsto unintentionallycontributeto or pesu2g obesity. for in Although mostFDA-regulatedproductsare intendedto be usedor consumed purposes for other than weight management, ‘ weightgain may be an unintentionaladverseside effect associated with use of someof theseproducts. In general,for both foods and drugs,weight gain or obesity hasnot consistentlybeenmeasured, evaluated, considered an adverse or as effect when to designingstudyprotocolsor evaluatingsubmittedresearch results, Strategies systematically evaluatethis endpointare neededas part of the safetyassessment IiDA-regulatedfoods and for drugs. Thus,the OWG recommends conductingresearch investigate(I) the promotionof to weight gain as an adverse effect of FDA-regulateddrugsand whetherthis is a factor that side shouldbe taken into accountregardingdrug safetyand (2) the development,ofanimal model assessment strategies encompass evaluationof along-term that the effects‘ weight gain as a on safetyassessment parameter. TranslationaZ research. Translational research essential FDA to usebasicresearchfrom is for other agencies academic and institutionsin developingregulatorypolicies and actions. Thus,the OWG recommends extendingbasicresearch (1) developmental on imprintingz3 differentiate to amongfood components eatingbehaviorsof neonates, nutrient/foodcomponentexposures and or of fetusesvia maternaldiets,with regardto weight management challenges adolescence in and adulthood,(2) biomarkerand effects-evaluation techniques through, eme proteomicsand metabolomics technologies identify how FDA-regulated to productsmodify risk factorsand susceptibilities weight gain, obesity,and co-morbidities, (3)development for arid’ of animal modelsto evduate the effectsof diets and dietary components, therapies, drug and medicaldeviceuseson long-termweight maintenance, healthand longevity. The OWG further recommends FDA take into accounttranslationalas well as other obesity-related that research being doneby NIH, as it considers future research theseareas. in
VI. Stakcholder Investment to Help IEnsure Results

StakeholderInvestmentRecommendation Highlight: Continue to promote and engagein activedialogHew&h Gwested ytakehoJders...p. 36
n

The Commissioner chargedthe OWG to setout specificmeansfor develapingandimplementing “an activedialoguewith outsideinvestedstakeholders including consumers groups,academia, and the food and restaurant industryan developinga frameworkfor consumers receive to messages aboutreducingobesityand achievingbetternutrition.”

23The developmental imprintinghypothesis suggests the increase childhoodobesityis, in part, a resultof an that in epigenetic effectof poor nutritionor exposure sometoxic agentduringthe perinatai to periodwhenmetabolic pathways beingestablished the fetusandneonate, are in creatinga dysfknctional metabolic pathway.As the child ages, thesedysfunctional metabolic pathways, conjunction in with otherfactbrs,SW&as inadequate exercise, may become sufficientto cause contribute overweight obesity. This developmental or to or programming hypothesis, developed from epidemiological hasalsoheenrecentlyextended animalmodels.’ data, to

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A. Background

Recognizingthe high level of interestin obesityamongFDA’ many stakeholders, OWG s the initiated a.processfor establishingongoingrelationships with individuals,andorganizations ‘ from all sectors.A key aspectof this processincludedproviding the public with multiple opportunitiesto becomeinvolved in a dialoguewith the OWGon its activities and the issues associated helping consumers with address problemof obesity. the As one of its first major outreachinitiatives,the OWG sponsored publid meetingon October a 23, 2003,“4to accomplishseveralobjectives: To initiate a discussionof FDA’ role and responsibilities addressing major public s fin the health problemof obesity; l To focus on issuesrelatedto promotingbetterconsumerdietary and lifestyle choicesthat havethe potentialto significantly improvethe health and well-being of Americans;and 0 To obtain stakeholder views on how bestto build a frameworkfor messages to consumers about reducingobesityand achievingbetter nutrition.
l

Approximately320 attendees representing diversestakeholder viewpointsregistered to participatein this discussion, with nineteenorganizations making formal Qresentations issues on associated the six focus questions.Thesenineteenorganizations with represented science/research, academia, consumers, healthand medicalassociations, industry,and advocacy groups, In addition to the formal presentations given at the October23 public meeting, interested concernedstakeholders and submittedwritten comments DocketNo. 2003%0338 to on variousaspects the six focus questions. of The scopeof the discussionat this meeting,and at two subsequent roundt+ble meetings(held with health professionals/+ademicians with consumergroups,on Dmember H-16,2003, and respectively)centeredon the following six focus questions:
1. What is the availaele evidence on the ej4ectiveness variozkseducation campaigns to of reduce obesity?

Stakeholders regardededucationas an essentialcomponentof FDA? contributionto public health efforts to confront the problem of obesity. Stakeholders. consistentlyreinforcedFDA’ s leadership in educatingthe public aboutthe food label, good nutrition, and healthy diets. role Stakeholder commentsfocusedon four key areas: (a) effectiveness exsstingeducation of campaigns; type of educationcampaigns (b) needed;(c) what campaigns shouldaddress; (d) and what messages likely to affect weight gain, weight management, weight loss. are or
2. What are the top priorities for nutiition research to redwe obesity in chiidren?
24In the FederalRegisterof October8,2003 (68 FIR58117),FDA announced public meeting. Transcriptof the this meetingis availablein FDA DqcketNo. 2003I$-0338, as of the.date and ofthis report,availableon the Internetat (http:~/~.fda.gov/ohPms/dockets/dockets/03~0338103n0338-tr,htm).

34

Stakeholders were particularlycancerned aboutchildhoodobesity. Stakeholders emphasized the importanceof parentalinvolvementin efforts to address childhoodobesity.,The views focused on the scopeof the problem,as well as on the research activitiesthat areneededto address on the issueof childhoodobesity.
3. What is the available evidence that FDA ccm look to in prder to guide rational9 efleetive public efforts to prevent and treat obesity by behavioral or medical interventions, or combinations or both?

Stakeholders expressed rangeof views and perspectives a aboutwhat would inform FDA decisionsin preventingand treatingobesity.
4. Are there changes needed to food labeling that err&d result in the development of healthier, lower ctilorie foods by industry and the selection of hea&hier, lower calorie foods by consumers?

Stakeholders were highly interested participatingin the areaof food labehng. The views in focusedon (a) generaladvice;(b) calories;(c) energybalance;(d) servingsizes;(e) current health-related informationon the label; (f) consumer educationon the food label; (g) messages on the food label; and (h) expandingnutrition informationavailability in restaurants.
5. What opportunities exist for the development of healthier foodsidiets and what research might best support. the development of healthier foods? ”

Stakeholders provideda diversearray of research needs,creativeincentivp;s the development for of healthierfoods/diets, generaladvice. and
6. Based on the scienttjk evidence available today, what are the most importumthings that FDA could do that would make’ significant d@?erence eflorts to address the problem a in of overweight and obesity?

Stakeholder views relatedto threemajor categories:(a) food labels;(b) research; (c) and education,,

35

On November20,2003, FDA, in conjunctionwith OASPE*sponsored workshopon a “Exploring the Connections BetweenWeight Management and,Food Labelsand Fackaging.‘ “25 The two major issuesexploredat this workshopwere: 1. 2. Currentfood,labelsand packaging: Effects on weight management reduced and risk of overweightand obesityand Data supportingoptionsfor change

This daylongworkshopinvolved presentations researchers, by academicians, public health and officials, who discussed issuessuchas,theeffect of portion/package shapeand structureon size, consumption (e.g., comments Brian Wansinkin transcriptof November20 workshop);and by presentations representatives the irestaurant by of industry,who addressed issuessurrotmding provision of nutrition informationin restaurants. The OWG organizedthe oomments Docket No. 2003N-0338into a searchable to database that informed preparation this report. of FDA also met with representatives the packaged of food and restaurant in+lustries learn about to their obesity-related activities.
B. OWG Stakeholder Investrhent Recommendations

The OWG believesit is worthwhile to maintaincontacts with stakeholders concerned aboutthe obesityissueboth to benefit from their,continuedinvolvementand to ensurethat, to the extent possible,collectiveobesityefforts are mutually supportive.
VII. Overall Conclusions

In response the chargeto the OWG, this report providesa rangeof reconnnendations to for address multipie facets of the obesity addressing obesityepidemic. Theserecommendations the problemunderFDA’ purview, including developingappropriateand effective consumer s messages aid consumers makingwiser diemrychoices;formulatingeducationalstrategies to in in the form of partnerships, supportthe dissemination understandiag thesemessages; to and of speciticnew initiativesto improvethe labeling of packaged foods with respectto caloric and other nutritional information; initiativesenlistingand involving restaurants the effort to in combatobesity;the development new therapeutics; designand’ of the condu@of effective research the fight againstobesity;and the continuinginvolvementofst&eholders in the in process. As notedpreviouslyin this report, achievingultimatesuccqss againstobesitywill occur only as a result of the complementary efforts over time by many concerned sectorsof our society. It is the
On ” In the Fedferal Register of October17,2003(68FR 59795), ‘ FDA announced public Mrorkshop. this November19,2003(68 FR 653031, FDA amended originalannouncement reflectthat the agency its to was requesting comments regarding,the workshop., Transcript the workshopis availablein FDA DocketNo. 2003Nof 0338,and asof the dateof this report,available the Internetat on (http://www.fda.gov/ohrms/dockets/dockets/

36

belief and the hope of the b WG that the recommendations contained in this ,report, when carried out by FDA in concert with the complementary ongoing and planned efforts. of other sister DHHS agencies and other ‘ agenciesof government, will.mak& a significant impact in reversing current trends.

37

VIII.

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39. Kristal A, Hedderson M, Patterson’ Neuhauser M. Predictors of SelfInitiated, Healthful R, Dietary Changes. Journal of the Amerkan Dietetic Association. 2001; 301: 762-766. 40. Kuchler F, Variyam J.iMistakes Were Made: Misperception As A Barrier To Reducing Weight. International Journal of Obesity. 2003; 27: 856-861. 4 1. Levy A, Fein S, Schucker R. Performance Characteristics of Seven Nutrition Label Formats. Journal ofPublic Policy & Marketing. ~1996;15: I-15. 42. Levy A. Analysis of 2002 Health and Diet Survey; Personal communication. 2004. 43. Levy IL, Patterson R, Kristal A, Li S. How Well do Consumers Understand PercentageDaily Value on Food Labels? American Journal of Health Promotion. 2000; 14: 157- 160. 44. Lin C-TJ. Analysis of Health and Diet Survey. Personal communication. 2004. 45. Loos RJ, Bouchard C. Obesity-is it a genetic disorder? Journal of Internal Medicine.
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46. Marietta A, Welshimer K, Anderson S. Knowledge, Attitudes, and Behaviors of College Students Regarding the 1990 Nutrition Labeling Education Act Food Labels, Journal of Zlw American Dietetic Association. 1999; 99: 445-449. 47. Maynard L, Galuska D, Blanck H, Serdula M. Maternal Perceptions of Weight Status of Children. Pediatrics. 2003; 111: 1226-1231. 48. Mitra A, Hastak M, Ford G, Ringold D. Can the Educationally Disadvantaged Interpret the FDA-Mandated Nutrition Facts Panel In The PresenceOf An hnplied Health Claim? Journal of Public Policy & Marketing. 1999; 18: 106-l 17. 49. Moag-Stahlberg,A, Miles A, Marcello M. What Kids Say They Do and What Parents Think Kids Are Doing: the ADAF/Knowledge Networks 2603 Family Nutrition md,Physical Activity Study. Journal of the American Dietetic Association. 2003; 103: 1541 - 1546. 50. Mokdad A, Marks J, Stroup D, Gerberding J. Actual Causesof Death in the United States, 2000. Journal of the American Medical Association. 2004; 291: 123&1Z45. 5 1. National Restaurant Association. 2004 Restaurant Industry Forecast &ecutive Summary. Available at: www.restaurant.oralfa’ acl,cfm, (Cited as NRA, 2004) 52. Neuhouser M, Kristal A, Patterson R. Use of Food Nutrition Labels Is Associated With Lower Fat Intake. Journal of the American Dietetic Association 1999; 99:‘ 45-53. 53. Ogden C, Flegel K, Carroll M, Johnson C. Prevalence and Trends in Overweight Among US Children and Adolescents 1999-2000. Journal of the American Medical Association. 2002;
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APPENDIX A - List of Acronyms and Abb~~v~~t~~~s ANPRM BMI CDC CFSAN CNS CSFII CSPI DSHEA DHHS FDA FTC FR IFIC IOM NFP NIH NLEA OASPE OWG PDP RACCS the Act USDA USDA/ARS %DV 21 CFR Advance notice of proposed rulemaking Body masse index Centers for Disease Control and Prevention Center for Food Safety and Applied Nutrition Central nervous system USDA 1994-l 996 Continuing Survey of Food Intakes by Individuals Center for Science in the Public Interest Dietary Supplement and Health Education Act of 1994 U.S. Department of Health and Human Services Food and Drug Administration Federal Trade Commission Federal Register International Food Information Council Institute ofMedicine Nutrition Facts panel National Institutes of Health Nutrition Labeling and Education Act of 1990 DHHS Office of the Assistant Secretary for Planning and Evaluation FDA’ Obesity Working Group s Principal display panel Reference amounts customarily consumed Federal Food, Drug, and Cosmetic Act U.S. Department of Agriculture U.S. Department of Agriculture/Agricultural Research Service Percent Daily Value Title 2 1, Code of Federal Regulations

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APPENDIX B - Text Boxes ou Body Mass Index (BMQ, Energy (Calorie) Balance, Carbohydrates and Other Macronutrient Contributions to ,Caloric Value

Body Mass Index (B&II)
Body mass index (BMI) is a way of characterizing weight status. For example, an ad&s weight status is classified as underweight (BMI c 18.5), normal (BMI = 18.5 - 24.9), overweight @Ml = 25.0 - 29S),.or obese (BMI 2 30.0). For children and adolescents, somewhat differendBMI ranges are used to classify their wei$ht statws. The BM1has gained increasing use by health professionals beeause it is highly ,correlatedwith body fat: The l3MI values used to classify adults as underweight, normal, overweight, or.obese are based on their ability to predict the effect of body weight on the risk for some diseases. For example, cdmmon cdndijions a&Mated with increased risk in adults classified as being qyennreightor obese inrjude premstuieddeath, &&ovaseular disease, high blood pressure, osteoarthritis, some cancers, and,diabetes. Although BM! is only on&of many factors used to predict the risk of these diseases, it is an imcortant factor and one that can.be modified.by individual changes in eating and physical activity behaviors. For adults, BMls are calculated from mathematical formulas that take.into account an in~iyidual’ height and weight. s BMI can be calculated using pounds artd inches with this equation: BMI = (weight in pounde/(height in inches x height in inches) x 703 A calculator that automatically estimates the BMl for an individual is available on the CDC~ Web page (htto:l/~.cdc.aovlnc~#ho/dnoa/bm~lcalc-bmE.htm). BMI values for children and teens are used to assess their body fatness changes over the years as they grow. Unlike adults, where the same BMI ranges are used for both men and women and aQoas:all ages, gender- and agespecific BMI values are used to classify the weight status of children and teens. This id necessary because children’ body fat levels change over the years es they grow. Also, girlsand boys differ in their body fat levels as s they mature. BMI decreases during the presthool years and subsequenfly increases into.ac@lthood. BMI-for-age tools are useful for children and teens because they conipare well to laboratory measures of body fat levels and can be used to track body size throughout life. More information on BMI vatues for children is available on the CDC Web page (http://www.cdc.~ov/nccdohold~oaibtniIbmi-for-aae. htm). For some individuals such as athletes who have a muscular body with relatively small amounts of body fat, the use of BMI values may inappropriately classify them as ovetweight. For these individuals, the additional use of other estimates of body fat such as waist circumference may help to more accurately estimate their weight status. For example, a waist measurement grebter than 40 inches in men and 35 inches‘ women is usually indicative of iir excessive abdominal fat, which is an independent predictor of risk factors and ailments’ associated with obesity.

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Calorie (Energy) Balance’
Overweight and obesity result from an imbalance that occurs when the calories consumed exceeds the calories expended. Even small imbalances over time can result in weight changes. For exampie, adifference of one 12-02 soda (approximately 150 calories) or 30 minutes of brisk walking most days can-add orsubtract approximately 10 pounds of body weight per year. There are many physiojogical,factors (e.g., gut hormones) that operate to maintain body Weight at a constant level even though calorie intake often varies considerably from day to day and week to week* The physiologicai fa&ors regulating food intake tend to be more effective in defending against weight lossthan against weight gain. This is thought to be an adaptive meChanism that protected humans from the adverse effects of famine and stsrvation. However, the physiological factors that tend to maintain calorie balance can be overwhetmeci by environmental and behavioral factors that favor high oalorieconsum-ption or low physicalactivity.’ When weight gain occurs, a person’ s energy balance thermostat is reset to achieve oalarie balance atthe new, higher level c$ body weight, Thus once weight gain occurs, a new calorie b&lance level is established. The body,then tends to defend against weight lass ’ from this new, larger weight status. Although the tendency for overweight and obesity is a product of complex intera&on,s between physiological, genetic, environmental, and behavioral factors, the rapid increase in rates of overweight and obesity in the United States over the last several decades has occurred too rapidly for changes in genetic of physiological mechanisms to be solely the cause. Therefore, the emerging obesity epidemic is almost certainly due to changes in consumer food choices and physical activity levels resulting in an overall positive calorie balance and weight gain. Total calorie intake refers to all energy consumed as food and drink. Proteins, carbohydrates, fat, and alcohol provide 4, 4, 9, and 7 calories, per gram, respectively. Some calories (e.g., approximately 1.5 calories per gram) are obtained from dietary fiber that undergoes bacterial degradation in the large intestine to produce volatile fatty acids which are then absorbed and used as energy in the body. Physioal activity such as Waking 2 miles in 30 minutes burns approximately 150 calories. The body ‘ stores excess calories as body fat, regardbss of whether the excess calories are caused by inadequate physical activity or excessive intakes of calories from sny,of the nutrient sources of calories. Reductions in large body fat fesenrea, which have often accumulated graduaky over long periods of time, and subsequent maintenance of healthy body weight, will likely require long-term commitments to changes in eating
and physical activity.

’ The tern, “energy balance” is commoniy used to describe the relationship betv@en the number of c@ones consumed from foods energy and the calories used by the body. For purposes of this document, however, the term “calorie halan@’ ia used in place of’ balance” since calories are the unit of energy measurement used for nutrition labeling and be&t uridetitood by consumers, Therefore, in this document, the terms “energy balance” and “caloric balance”are used interchangeably. 2 Among the factors affecting body weight are body site and fat-free mass (i.e., the weight of rhe’ body fess the weight of its fat mass) and also to a lesser degree age, gender, body composkion, nutritlonal status, inherited variations, and/or differences in the hormonal status. Physical activity is the most variable of the calorie expendkures among individuals.. For some individuals, physical activity is only a small proportion of the total catarie requirements; for very active indiviouals, it dan be a significant proportion of daily calorie needs. ,Body weight is a’ major determinant of the c&one expenditure from physical activity. For indi$dual and 58 calories for a person example, the calorie cost of walkinga mile at a moderatepace is 69 calories for a 246 pound ‘ weighing 1 ‘ pounds. The intensity of physical activity can also affect calorie expenditure. For example, more calories are I4 expended when jogging than when walking for the same amount of time.

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Carbohydrates and Other M&cronutrient Contributions ta Caloric Value
Macronutrients are the components of food that provide energy (i.e., calories). There are,thrae categories of macronutrients: carbohydrates, proteins andfats. Carbohydrates represent aver half, and fats about a third, ofthe energy intake of typical Western diets. Understanding the caloric contribution of macronutrients to the diet requires knowledge of their chemical composition,
Carbohydrates - Carbohydrates (sugars, e.g., glucose, sucrose; and starches) provide ehergy to cells in the body starches are broken down to gluoose and the and glucose is a primary source of~energyfor the brain. Sugars and ‘ (e.g., sorbitol, maltiiol) energy provided is 4 calories per gram. Other types of carbohydrates such as sugar a@ohol.s and dietary fiber are not well absorbed by the small intestine and are fermented by bacteria in the large intestine. Carbohydrates that are fermented in this manner provide a lower energy value per gram.

The rapidity and extent of carbohydrate absorption by the body directly influence the speed and extent of the rise in blood glucose (i.e., glycemic response), ,whidh, in turn, triggers an insulin response. The glysemic?index of carbohydrate-containing foods has been proposed as a way to,quantify the blood glucose response fallowing their consumption (Jenkins et al., 1981). Many factors can affect the glyoemic index of a single food, especially when the food is consumed in a meal. Foods or meals that have a high glycemic index trigger the release of insulin into the blood. Elevated blood insulin levels stimulate the uptake of,fat from the blood into fat cells, and inhibit the breakdownand r&ase of stored fat from fat cells. Some scientists believe that consuming a high glycemic index food (e.g., a food that contains sugar or starch) can result in an increase in stored body fat. Weight loss plans based on greatly restricting~,c.$bohydrate intakes have been promoted for more than a decade. “Low”carbohydrate products are being promoted as a way to reduce weight and to assist diabetics in their control of carbohydrate intake; however, not all carbohydrates raise blood glucose levels; nor deliver the same energy value per gram. In addition, when one macronutrient is restricted in a food product, it is often rcpl&ed with another macronutrient. For example, when “10~ fat products were introduced several years ago, carbohydrates often were the replacement macronutrient. In many of the current “low” carbohydrate products marketed today, fat is often the replacement macronutrient. Also today many ofthe low carbohydrate products repl&ethe high glycemic index carbohydrates (e.g., sugars and starches) with other carbohydrates such as sugar aloohds, which have no’ measurable glycemic index and may provide:fewer calories per gram. Thus, it is important to look at the NPP to determine the calorie content of and the type of carbohydrate in a product.’
Fats (lipids) -A major source of energy for the body is derived from fats (lipkis). Fats aid-in the absorption of fatsoluble vitamins and carotenoids, There aretwo essential fatty acids, a-linofenic and linoleic. Fats contribute 9 calories per gram. There are’ three major components: saturated fatty acids, ‘ frans fatty.acids and unsaturated fatty acids (monounsaturated fatty;acids and potyunsaturated fatty acids). All yield thdsamecalodc vatue, but may affect metabolism differently. Saturated fatty acids:and trans fatty acids r&se blood lipid fevels, esp,ecialiy cholesterol and low density lipoprotein cholesterol, which have known adverse heatth.effects. There is no known requirement for frans fatty acid for specific body functions.

Acceptable Macronutrient Distribution Range (AMDR) has been estimated for individuab. The AMDR is the range of intake for a particular energy source that is associated with reduced risk of chronic dis&ee while providing adequate intakes of essential nutrients. The AMDR for carbohydrates and fats is estimated to be.45 to 65 and 20 to 35 percent of energy, respectively, for all adults Consumption of carbohydrates and fats within these ranges reduces the risk for obesity, as well as, certain chronid diseases such as coronary heart disease and diabetes.
Proteins - Proteins make up the major structural components of cells and are composed of amino acids, There are 20 essential amino acids. Proteins function as enzymes, hormones, and have other important functions in the body. Proteins provide 4 calories per gram. Animal protein sources (e.g., meat, milk, eggs) generally contain‘ balanced amounts of the essential amino acids whereas vegetable protein sources frequently ha&a limited amount of one of the essential amino acids. Foods that are low in fat tend also to be low in pro&&n;food& that are low in carbohydrate tend to be high in protein and fat.
’ FDA has received petitions requesting that the agencyprovidefor nutrientcontentclaimsrelatedtc the carbohydrate contentof foods. As discussed in section V:A.3.b., the 0WG;recommends that FDAf%e these-petiionsand publisha proposed to provide rule for nutrient content claims related to the carbohydrate content of foods, includin& guidance for the ush Of4he term “net” in relation to carbohydrate content of foods.

APPENDIX C - Notice Conclerning July 30,2003, Secretary’ Roy&able s Obesity/Nutrition Departmentof Heaith and Human Services Secretary’,Roundtable Obesity/Nutrition s on Wednesday, 30,2003 July 1O:OO - 12:OO a.m. noon Washington,DC Public Docket 2003N-0338

on

The Departmentof Health and Human Services(HHS) hasestablished public docket a 2003N-0338to receiveadditional information,perspectives, suggestions and from participantswho attendedthe Secretary’Roundtableon Obesity/Nutritionon July 30,2003. s this Obesityis a growing and urgent public healthproblem in the United States. To address problem, HHS SecretaryTommy G. Thompsonhas:ledtheDepartmentin its efforts to encourage healthyhabits continuesto such as healthydiets,more exercise,and making healthychoices. SecretaryThompsOn challengeHHS agencies the leadershipof the public health and, communityto intensify theirefforts to realizetheseimprovements.The Secretary’Roundtableon s Obesity/Nutritionis intendedto enhance HHS discussion an with leadingthi&ers and expertsin the public healthcommunityon the role that HHS can play in reducingor reversingthe weight gain that leads to obesity. The Roundtableagendaincludedthe following five focus questions: 1, What is the availableevidenceon the effectiveness variouseducationcampaigns reduce of to obesity? 2. What are the top priorities for nutrition research reduceobesityin children? to 3. What is the availableevidencesupportingwhetherpublic efforts shouldprioritize behavioral interventions preventobesityversusmedicalinterventionsto treat obesity? to 4. What changes food labeling could result in the development healthier,lower calorie foods to of and the selectionof ,healthier, lower calorie foods by consumers?What.opportunitiesexist for the development healthierfoods/dietsand what research of might bests&port the development of healthierfoods? 5. Basedon the scientific foundationavailabletoday, what is the one thing that HHS could do that would make a significant differencein efforts to address problem of obesity? the The Departmenthas openedpublic docket2003N-0338to receiveadditional information,references, or thoughts-fromRoundtable participantsin follow up to the July 30 discussion W ”ewould appreciate receiving all follow up information and viewsby Tuesday,Sephqnber30, ?I83. You should submit written comments the DocketsManagement to Branch (FDA305),, Foodand Drng Admin@ration,5630 FishersLane, Room 1061, Rockville, MD 20852. You may also submit commentselectronicallyto http://www.fda.govldockets/ecommentsby email to FDADOCKETSO,o~.f~~ -Werequestthat you or submittwo copiesof any written comments;individualsmay submit one copy. Pleaseensurethat you include the docket number2003N-0338in your submission.All commentssubmittedto the public docketare public information and may be postedto the FDA website(h~~://w~.fda~~ov) for public viewing.

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APPENDIX D - August l&2003, Charge M~mo~a~~~rn

DATE: SWCT:

August 11,2003 FDA Obesity

3. Sung

tbeiMessage.

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APPENDIX E - FDA Obesity Working Group Mtmbership NAME MEMBERS Lester Crawford (Chair) Robert Brackett (Vice Chair)27 Patricia Kuntze (Executive Assistant) Peter Salsbury (Executive Secretariat) Alan Rulis Susan Bond Donna Howard Anne Crawford Christine ‘ Taylor Elizabeth Yetley Kathy Ellwood Richard Williams David Acheson David Orloff Peter Pitts Michael Landa Tomas Philipson TITLE / AFF~L~TI~N Deputy Commissioner/Food and Drug Administration (FDA) Director/Center for Food Safety and Applied Nutrition (CFSAN) Sr. Advisor for Consumer Affairs/FDA Acting Director, Executive Operations StaftXFSAN Senior Advisor for Applied Nutrition/ CFSAN Special Assistant to the Deputy Commissioner/FDA Special Assistant to the Senior Advisor for Applied NutritionlCFSAN Assistant to the Senior Advisor for Applied Nutrition/CFSAN Director, Office of Nutritional Produtis, Labeling, and Dietary Supplements (ONPLDS)/CFSAN Lead Scientist for NutritionlCFSAN Director, Div. of Nutrition Programs and Labeling, ONPLDS/CFSAN Director, Div. of Market Studies, Of&e of Scientific Analysis and Support {OSAS)/CFSAN Chief Medical Officer/CFSAN Director, Division of Metabolic and Endocrinologic Drugs/Center for Drug Evaluation and Research (CDER) Associate Commissioner for External Relations/FDA Deputy Associate Counsel, Food ad:Drug Division, Office of General.Counsel Senior Economic Advisor to the Commissioner/FDA

” Whenthe OWG was formed,‘ Joseph Levitt wasthe Directorof CFSAN,andthe OWG vice-chair. As of A. January 5,2004,Dr. Brackettbecame director‘ CFSAN,andassumed role of vice-khair. of the

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ADJUNCT MEMBERS (support workgroup,as needed)

Virginia Wilkening StevenBradbard Lisa Lubin Rick Canady Jeff Shuren SusanBernard SusanWood JoanneLupton
EXTERNAL LIAISONS

Deputy Director/ONPLDS/CFSAN SupervisoryPsychologist, Division if Market Studies, OSASEFSAN ConsumerSafetyOfficer, Office &Food Additive Safety (OFAS)/CFSAN SeniorSciencePolicy Analyst, Office of Science Coordinationand Communication(QSCC)/FDA AssistantCommissioner Policy, OEice of Policy, for Planning,and Legislation(OPPL)/FDA SeniorPublic Health Advisor, CPPL/OC Director, Office of Women’ Health, OSCCIOC s Visiting Scholar,CFSAN

Van Hubbard Karen Donato William Dietz

Judith McDivitt Karyl ThomasRattay

JonelleC. Rowe

Director, National Institutesof Health (NIH) Division of Nutrition Research Coordination Coordinator,NIH National Heart, Lung, and Blood Institute ObesityEducationInitiative Directorj-Divisionof Nutrition and Physical Activity/Centersfor DiseaseControl and Prevention @DC) TeamLeaderfor Health Communications, Division of Nutrition and PhysicalActivity/CDC PhysicalActivity, Nutrition and Children’ Health s Advisor, Office of DiseasePrevent$onand Health Promotion/US.Departmentof Health and Human Services (DHW SeniorMedical Advisor, Office of Women’ HealthDHHS s

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APPENIjHX F - FDA Ob@y Working Group - Subgroup: Members
OBESITY KNOWLEDGE BASE

Lead: Donna Howard Members: Rick Canady,ElizabethYetley, Rich Williams, Kathy Koehler, TheresaMullin,

SusanBernard,Anne Crawford,Brian Somers
MESSAGE

Lead (Mmsage): PeterPitts Members:. ChristineTaylor, Naomi Kulakow, StevenBradbard,Vicky Kao, SusanBernard,

Nancy Ostrove
EDUCATIOE

Lead (Education): SusanBond Members:: Marjorie Davidson,Naomi Kulakow, StevenBradbard,Jeannie Ertter-Prego,Susan

Wood, Kimberly Rawlings,Susan Bernard,Vicky Kao
FOOD LABS

Lead: Kathy Ellwood Members: Virginia Wilkening, Felicia’ Satchell, Amy Lando, Alan Levy, Mary Brandt, Lori

LeGault, Ritu Nalubola

Co-Leads: TomasPhilipsonand SusanBond Members: Mike Landa,FayeFeldstein,GlendaLewis, Rich Williams, Clark Nardinelli, Carolyn

Young, Andrew E&in, Mark Schwartz
THIERAPE~TI~~

Lead: David Orloff Members: Eric Colman,PatriciaBeaston

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RESEARCH

Lead: David Acheson Members: William Slikker, Kathy Ellwood, Rick Canady, Elizabeth Ye&y, Lisa Lubin, Virginia Wilkening, Richard Williams, Jeremiah Fasano, Shirley Blakely, Eileen Parish, Kathleen Koehler

Lead: Pat Kuntze Members: Lisa Lubin, Brian Somers, Jonathan Chappell, Juanita Yates, Amber Jessup, Ray Formanek, Jennie Butler, Darlease Hyman, Mary Hitch, Alyson Saben, Patricia Alexander, Alta Hayes, John Henkel, Susan Cruzan, Jane Peterson
REPORTWRITING

Lead: Alan Rulis Members: Mike Landa, Paulette Gaynor, Pete Salsbury, Arme Crawford, Brian Somers, Virginia Wilkening, Cindy Wise

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APPENDIX G - Report from the Division of Market Studies Office af Scientific Analysis and Support, FDA CFSAN

Office of Scientific Analysis and Support Center for Food Safety and Applied Nutrition, FDA In support of the ‘ Obesity Working Graup, F December 28,20@3 Study Authors: Richard A. W illiams - Director, DMS Amber Jessup- Project Officer Amy Lando - Project Officer Cristina McLaughlin - Project Officer David J. Zorn - Project Officer Kathleen M. Koehler - Primary Writer and Steve Bradbard - Team Leader, Consumer Clark Nardinelli - Team Leader, Economics Contributors to Literature Review: Steve Bradbard, Andrew Estrin, Amber Jessup,Kathleen Koehler, Amy Lando, Jordan Lin, Clark Nar;dinelli, Linda Verrill, David Zorn, Judy Labiner
* This report was prepared for MS, Laina Bush of the O ffice of the Assistant Secretary for Planning and Evaluation, DEI[HS. Ms. B nded the studies the survey of and is a Project O fficer on all of the individual studies restaurant Web sites.

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Helping Consumers Lead Healthier Lives t~~oug~-~et~er Nutrition: A Social Sciences Approach to Coqsumer Information, Feed Chsices aud Weight Management A Report from the Division of Market Studies Office of Scientific Analysis and Support, FDA CF;SS*AN January, 2004 Executive Summary This summarizes an interim report on the social science research on weight management done for both the Obesity Working Groups in FDA and the Office of the Assistant Secretary for Planning and Evaluation, DHHS. In these studies, we examined how‘ consumers use existing food labels for weight management; how changesto food labels might improve those practices; how restaurants are currently labeling; how consumers would react to different kinds of labels; and what policies could induce manufacturers to producehealthier foods. Our research has included both review of the current social sciences literature and some new studies. First, in qualitative studies, consumers claim they do not wish to spend a signifrc.ant amount of time reading and comprehending labels. This is borne out by the fact that many use health or nutrient content claims as signals as to the quality of the entire product and do not check the nutrition facts panel on the back. Also, consumers appear to be confused by serving sizes, particularly by multiple servings listed on small packages,as well as by percentage daily values listed in the nutrition facts panel. Consumers use food labels for multiple reasons, including diet plans and pre-existing health conditions such as diabetes and heart disease,and lookfor macronutrients of concern. Although we found some labeling in restaurants (by examining their websites), consumers clearly want more nutrition information in restaurants although most claim they will use it only part of the time. In fact, the limited number of studies we exaniined showed mixed results as to whether restaurant labels would be used but studies also show a correlation of overweight with a higher percentage of food consumed away from home. ,Consumers state qualitatively that they would like all nutrition information in restaurantsbut would even find calorie labeling helpful. Finally, consumers appear to be interested in signals of healthy foods, both in supermarkets and restaurants. In interviews, manufacturers state that to encourage production of healthier foods FDA should examine not justlabeling policies, but other areas that affect product formulations such as food standards. Two projects underway are not far enough along to give interim reports. The first is the creation of an economic model of food choice that will answer such-questionsas, “ do food labels help ‘ consumers maintain their desired weight”? In addition, we are in the process of getting a restaurant chain to investigate actual market consumer reactions to nutrition labeling on menu boards. The source of our suggestedmenu board changeswill be the results of our focus group studies. Beyond these initial studies, additional research could be done for food labels to investigate both whole package labeling (instead of serving sizes) and nutrient density labeling (e.g., calories per cup). To give consumers better signals, we could also investigate the use of a logo on the front of the package to both signal consumers to the presence of a healthy (or

56

healthier) food and to serve as a motivator for production of such foods. Alternatively, we could evaluate the effectiveness of educating consumers on both the use of daily values and how servings sizes should be evaluated in light of portion sizes. The relationship between eating out and weight management could be investigated both for various kinds ofrestaurants and for different socioeconomic groups. Finally9 there are a number of existing FDA policies such as food standards and nutrient content claims that could be examined to see how changes could encourage more reformulation toward lower calorie or healthy foods. I. Purpose In August, 2003, FDA Commissioner Mark B. McClellan declared FDA’ intention to s confront the current obesity epidemic in the United States and to develop new and innovative ways to help consumers lead healthier lives through better nutrition. FDA’ Center for Food s Safety and Applied Nutrition (CFSAN) plays a leadership role in nutrition issues at FDA. Within CFSAN, the Division of Market Studies (DMS) in the Office of Scientific Analysis and Support (OSAS) provides expertise in Social and Population Science issues related to CFSAN’ s mission, including expertise in Economics and Consumer Sciences. Our first charge was to undertake a group of short-term studies on: a) how consumers use.currentfood labels to maintain weight; b) how consumers would use potential changes in food labels, including new labeling in restaurants; and, c) how manufacturers reabt to labeling requirements with new products and product reformulation. Our second charge was to develop a longer term research agenda on labeling and weight management. The research goal is to develop knowledge on how to lower the cost (time and effort in choosing foods) to consumers of managing their weight, using labeling and education. In choosing foods for healthy eating, consumers must solve a series of in~o.~atio~ problems including: 1) determining what constitutes a healthy diet; 2) finding products that meet their nutritional needs; and, 3) evaluating nutritional characteristics of particular products. This information comes from a variety of sources such as media, friends, school, physicians and, of course, food labels and restaurant menus. From the standpoint of consumer behavior, or the “demand side” of the market, we will -examinethe psychology of people’ perceptions, eating s habits and desires relative to healthy eating and weight management. From the standpoint of producer behavior, or the “supply side” of the market, we examine bow producers make decisions to make and market healthy foods (including decisions about serving and package sizes) and provide information about those foods. Our research follows the natural division of packaged food products in grocery stores and food consumed in restaurants, although issues in these two areas often overlap. Our results are cross-cutting, with relevance to several areas, including food labels, restaurants and research. II. General Concepts of Weight Management Public health importance. The scope of the growing and urgent public health problem of obesity was outlined in the Surgeon General’ Report (US DHHS 2001). In 1999-2000,65% s of U.S. adults were overweight, increased from 56% when surveyed in 19g&-1994; 30% of adults were obese, increased from 23% in the earlier survey (Flegal2002). Among children age 6 through 19 years, 15% were overweight, compared with 10 to 11% in the ,earlier survey (Ogden

57

2002). Overweight and obesity are associatedwith increased morbidity and mortality. It is estimated that about 300,000 deaths per year may be attributed to obesity,.and overweight and obesity increase the risk for coronary heart disease,type 2 diabetes, and certain cancers (Allison 1999, US DHHS 2001). The total economic cost of obesity in the United States is about $100 billion per year, including more than $50 billion in avoidable medical costs, more than 5 percent of total annual health care expenditures (US DHHS 2006, Rinkelstein 2083). Energy balance. Weight gain occurs when there is an energy imbalance, with “energy in” (calories from food) exceeding “energy out” (resting metabolism plus physical activity). This report addressesissues related to the “energy in” side of the energy b&mce equation: food choices and the food environment. A general consideration of increasing ~“energyout’ through * physical activity, while important, is beyond the scope of this report. However, we do consider how information about the physical activity equivalent of food calories might affect consumer food choices. Genes and tbe elivironment. Genetic influences on obesity are complex and are just beginning to be elucidated (Shuldiner 2003). Based on twin, adoption and family studies, it is estimated that 40 to 70% of the current population variation in body mass ,index (BMI) can be explained by genetic factors (Shuldiner 2003, Allison 2003). However, even relatively modest decreasesin the remaining, non-genetic, “environmental liability” for obesity can nevertheless be predicted to result in meaningful decreasesin BMI and corresponding health risks (Allison 2003). Weight management and the food environment. Evidence from research on taste preferences, eating regulation and weight-loss interventions suggeststhat overweight individuals and those prone to overweight may be particularly vulnerable to the modern food environment (Lowe 2003). This “obesigenic” environment features unlimited quantitim of a variety of foods high in caloric density (which tend to be foods high in fat, sugar, or both), together with minimal need for energy expenditure (Lowe 2003), perhaps making it more difficult for obesity prone individuals to regulate energy intake. A promising approach to improving weight control is therefore to focus on changes in the food environment: the availability, struettire, composition and portion size of foods. There is potential for changes in the food e~vir~~e~t both at the general (or population) level and at the,level ofthe individual (personal food environment). For example, a change in the food environment at the population level might be the availability of more food choices that facilitate weight control, A change in the personal,food environment might be to stock one’ home with ingredients and foods that facilitate weight control (Lowe, s 2003). A current challenge is to provide information and assistanceto enhance the ability to determine one’ personal food environment. s The role of food labeling. Since passageof the Nutrition Labeling and Education Act 10 years ago, consumers have had nutrition labeling on most packaged foods’ (smal1 product lines were excluded as were foods packaged on premises in supermarkets and delis). As discussed later, it is clear that consumers both like and use the nutritioninformation on the back of food packages and the health and nutrient content claims on the front of packages. However, it is not clear how successful consumers have been at using labels to eat healthy diets. Research is necessaryto establish whether the food label is as useful as it could be in assisting consumers by making weight management as easy as possible. The role of restaurants. Unless restaurants make nutrient content or health claims, they are not required to provide consumers with any information on the nutrient content of their foods, an obvious gap in information. This exclusion applies to all eating glaces away Corn

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home, including school cafeterias, nursing homes, military establishments and hospitals. Research is needed on how to addressthe current information gap by tailoring labeling to the special circumstances of eating places away from home. Unlike packaged food, restaurant food is characterized by frequent recipe changes,both for routine use and at the request of consumers for special preparation. This may have been an insurmountable hurdle for most restaurants in the past, when nutrition information had to be.determined by direct chemical analysis. However, this hurdle may be decreasedat present with the ubiquitous availability of nutrient composition databasesand software for labeling, coupled with the explosive growth in personal computers and personal digital assistants,even if the restaurant labeling lacks the precision of that now required of packaged foods, A changing environment. In the quantum uncertainty principle in physics, observation of a system perturbs the system, resulting in measurementuncertainty. Si~milarlywith the restaurant industry, recent attention by public health offtlcials, litigators and the media on restaurants and weight management issueshas resulted in changes in the marketplace, Restaurantshave begun offering more nutrition information and featuring healthier menu selections. Research is needed to describe current restaurant practices, and to evaluate their effectiveness in assisting consumers with weight management. Additiunally, although the introduction of healthier food selections by packaged food manufacturers ‘ datesto before the passageof NLEA, the current interest in weight management is likely to speed the introduction of products for healthier eating. III. Overview of Current Issues and Related Literature A. Current Issues. In responseto current concern about problems of obesity and weigbt management, some specific issueshave emerged in articles, statements,presentations, and dialogue among consumers, industry, scientists and public health officials. Consumers and packaged food labels. Even though food labels are widely used and accepted in the population, there are potential problems that may be limiting food label use or its effectiveness as a tool in weight management. l Nunferical calories. Is the numerical calorie designation prominent enough on the food label? Do consumers understand and use the numerical calorie designation? Do consumers do the math needed to kalculate their daily caloric intake using food labels? Should they do so? Can or should,consumersknow how their own-recommended calorie intake compares with the 2000 calorie per day reference on the food label7 l Daily Values. Do consumers understand or use the.percent Daily Value (%DV) figures on food labels? If they neither use nor understand them, can consumer education develop an appreciation and understanding.of these figures? How can the food label best help consumers place the calorie content of foods in the context of a daily diet: for example, add a %DV for calories, add a qualifier such as “high”, ‘ medium”, “low”, use symbols “ to indicate “high”, “medium”, “low”, etc? l Serving sizes. Larger package sizes that are commonly consumed in one sitting may contain two or more standard servings for nutrition labeling. If consumers are not aware of the number of serving sizes, they may believe they are consuming fewer calories than they are if they consume the entire package.

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l

Nutrition goals. Because consumers interested different ty are in

informationfrom food labelsdepending their particularhealthconcernor diet, do they on want to know, in a global sense, whetheror not a food is “healthy’ Wouldconsumers “? benefitfrom qualitativesymbolsor cueson labelsof “healthy”foods? l Trade-offs. Ratherthannumericallycalculate “daily diet”, consumers rathertry a may to choose foodsthat arehealthywhenthey are inclined. Theymay balance healthy a choiceif they havemadean unhealthy choicein the previouseatingoccasion, not but quantitatively.How canthe food labelusequalitativesymbolsor cuesto build on consumers’ inclinationsfor qualitative“trade-offs”? l reactsto a particular “Halo” effects of claims. A “halo”effect occurswhena consumer positiveclaim abouta productandassumes the entireproducthaspositiveattributes. that For example, low fat claim may signalto someconsumers the productis alsolow a that calorie. How canthe food labeluseclaimseffectivelyto assistconsumers weight in management, while avoidinghalo effectsor otherunintended consequences claims? of the of Restaurants. As notedabove, absence calorieandnutrition labelingof restaurant food represents informationgap. an 0 Portion size and calories. In part because largeportion sizesin manyrestaurant of offerings,the caloriecontentof restaurant mealsmay be muchhigherthan consumers realize. Additionally, restaurant oEerings may havehighercalorieand saturated fat better density(per weight or volume)than similar foodseatenat home. WouXd availabilityof calorieinformationin restaurants consumers weight help with management? 0 Restaurant information format. Somerestaurants voluntarilyoffer nutrition information,but it is often not in an accessible form&. The informationis often available only after purchase, may haveconfusingchartsor formatsandvery smalltype size. and what is the currentstatusof voluntaryrestaurant nutrition inform#ion andwhat guidelines format and availabilitywould besthelpthe consumer weight for with management? l Menu item variability. Are therecreativeapproaches would make restaurant that nutrition labelingfeasiblein spiteof the variationsin menuitem preparation?
Food Formulation. Changes food labelsand shifts in consumer in perceptions public and

healthconcerns change incentives constraints can the and food,manufacmrers in producing face may the andmarketingfoods. Producers decideto change formulationof foods if their expected privatebenefitsexceed their expected privatecosts. Reformulation existingproductsor of introductionof new products occurred a resultof the appearance healthclaimson food as of packages the 1980’ the mandatory in s, listing of fat contenton food labelain the 1990’and s awareness proposed and labelingoftrans fat in the late 1990’ s. l W e ight management aud fooa reformulation. Haveproducers formulatedproducts to be low in caloriesor to respond the weight management to issue?Whatare the barriers or incentives food formulationfor weight management? couldthesebarriersbe to How removedor incentives provided?

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B. Related Literature. [Contributors to literature review: Steve Bradbard, Gndrew Es&in, Amber Jessup, Kathleen Koehler, Amy Laudo, Jordan Lin, Cfark NurdinellI, kind9 Verrill, David Zorn] The importance of social science principles in formulating and implementing nutrition policy was recognized years ago with the work of the National Research Council’ Committee s on Food Habits during World War Two (Gifford 2002). More reeently, FDA conducted consumer research before the implementation of NLEA, to determine the usefulness of potential choices for the Facts panel format. Since NLEA, FDA and other researchershave studied how consumers use the Nutrition Facts panel, nutrient content claims, and health claims (separately and in combination) to make dietary choices. Consumer research is used to assesspeople’ knowledge, attitudes; perceptions, and s preferences for a topical subject area or reactions to any type of stimuli. Research methods may include qualitative studies, such as focus groups; quantitative, nationally representative surveys, using structured questionnaires; experimental studies of consumer responsesto labeling and package variations; and intervention studies of the effects of point of purchase labeling. Food label use and diet. Research.clearly shows that most Americans are familiar with and use the Nutrition Facts panel. In a 2002 FDA survey, 69 percent of the U.S. population reported using food labels often or sometimes when they buy a product for the fast time (FDA, 2003). Our more detailed review of the literature on food label ,useis in Appendix A. The literature on food label use was also recently reviewed by the Institute of Medicine (IOM 2003). In FDA’ survey, people reported using the food label for many reasons, most commonly s to see how high or low the food is in calories and in nutrients such as fat, Sodium, or certain vitamins (FDA 2003). However, although consumers report using the food label to make dietary choices, they may not fully understand,all of the information on the Nutrition Facts panel, particularly the %DV (Appendix A, IOM 2003). Evidence from experimental studies suggests that %DV information can help consumersjudge the healthfulness of a food better than absolute amounts of nutrients alone (Levy, Fein, and Schucker, 1996 and Barone et al, 1996). However, in some surveys the majority of respondentscould not accurately define or use the %DV for fat (FM1 1996, Levy et al 2000). In experimental studies, consumers could correctly use the Nutrition Facts panel on the back of food packagesto verify and evaluate the health and nutrient contern claims on the front of packages (Garretson and Burton, Mitra et al, Ford et al., Roe et al.), However, when there was no Nutrition Facts panel, consumers were misled by claims into thinking a product was healthier than it really was (Ford et al., Roe et al.) and when consumers were not specifically directed to consult the Nutrition Facts panel some cut short their information search and drew conclusions based on health or nutrient content claims (on the front of the package) alone (Roe, Levy and Derby). As noted by the Institute of Medicine, the body of literature on the association of food label use and diet is relatively small (IOM 2063) Several studies have reported correlations between food label use and diet (Appendix A). For example, survey respondents who used the Nutrition Facts panel were more likely to consume a lower fat diet9both in the general population and among family clinic patients (Neuhouser et al, Kreuter et al). Clinic patients with health conditions such as high blood pressure and high cholesterol were more likely to look on the label for sodium and cholesterol information, respectively (Kreuter et ai).

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The calorie contentof food is a commonuseof the food label, and was amongthe top threepiecesof information soughtby $0 percentof label readersin one survey(TOM2003). However,therehasbeenlittle research the relationshipbetweenlabel useand weight on management/weight or gain. loss The useof “healthy”food logoson food packages recentlyreviewed(Smith et al was 2002). Suchprogramsfeaturea packagelogo or symbolon food meetingcertain nutrition criteria set by the program’ administering s body. Examplesincludethe US. AmericanHeart Association“Heart Check”,the Canadian Heartand Stroke, Foundation“Health Check”,the Australian“Pick the Tick” and the Swedish“GreenKeyhole”. In general,consumers report supportfor the programsand are able to interpretmeaningaccurately(Smith et al 2002). Some evidencealso indicatesthe programshave a positiveeffect on food formulation, Additional research neededon the effect of suchprogramson food purchase consumption(Smith et al is and
2002). Restaurants. A numberof experimental studieshaveexaminedconsumer behaviorin

cafeteria,restaurant vendingmachinesettings response nutritioninformation or health and ‘ in to messages. resultsof thesestudiesare mixed; differencesin resultsamongstudiesmay be The due to differencesin experimental designs,including sizeof sample,demographic characteristics of participants,experimental setting,lengthof study,type of nutrition informationor health message type of behavioraloutcomestudied(AppendixA). and In general,consumers havemixed reactionsto nutrition information in cafeteriasand restaurants.Both healthclaimsand listing of nutrition informationhavebeenfound to be capableof producingpositiveinfluenceson consumer evaluations menuitems and the of influencesappearto be strongest when nutrition informationaboutalterna$ive menu itemsis absent. Although nutrition informationmay influencechoicesand attitudes,other factorsmay be more salient:whetherthe respondent on a diet, attitudestoward nutrition, price of food, health is claim vs. nutrition information,taste/perceived taste. An analysisof studiesreceivedfrom the USDA EconomicResearch Service(their own and others)showsthat eatingaway from home,particularlyincreasingconsumption fast food in restaurants, correlatedwith increases BMI. Further,~ per capitanumberof restaurants is in the in a statewas positively relatedto individual’ BMI and the probability of being overweight. See s Appendix A for chartssummarizing thesestudies,usedcourtesyof USDA ERS. Motivation. The process consumers’ of motivationand readinessforlifestyle changes suchas weight management described a behavioral’ are by sciences model,the Transtheoretical Model of Change(Prochaska).The model identifiesfive stages-of-changePre-contemplation, Contemplation, Preparation, Action, and Maintenance; and.emphasizes a messages be th&t must matchedto a respectivestagein order to be most effective (e.g.,messages’ targeting consumers in the action stagewill likely be ineffectivefor consumers the pre-contemplation in stage). Thus, the effectiveness food and restaurant of labelingor messages weight management for would dependin part on consumer readiness stageof change. and Portion sizesand energy density. Although consumer motivation is importantfor weight management, there is also interestin other factorsthat facilitateweight management in the current“obesigenic” environment.Two aspects the food environment of havebeenrecently highlightedas having implicationsfor weight control: increased portion size andthe energydensityof foods. Portion sizeof restaurant foods increased from the 1970’ throughthe 1990’ s s (Rolls 2003). National surveydatashow that portion sizesof food eatenboth in the homeand away from home increased from 1977to 1998(Rolls 2003). Energydensityrefersto the number

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of caloriesper given weight or volume of food. The fat contentof food increases energy the densityand the water contentlowersthe energydensity. Although energydensitycan be decreased decreasing fat contentof the food, this approach be self-limiting because by the can decreasing fat contentalso decreases the satiety,the extentto which the foo satisfiesthe urge to eat. Research shownthat increasing proportionof water-richvegetables mixed dishes has the in suchas casseroles decreases energydensitywithout decreasing the satiety(Rolls 2003). Eating cues. Other research examined has consumer behaviorin the contextof the eatingenvironment.Resultsindicatedthat people’ eatingresponses often automaticand s are respondto cuessuchas packagesize,shapeand structure(Wansink2003). For example, research participantsate more food when they were given larger containers,‘ when the food even was unpalatable stalepopcorn. Peoplealsoreducedconsumption autom.atically response in to cuessuchas packagestructureor dividers,for example,red potatochips at intervalsin a tube of regularchips (Wansink). This research suggests changes food packagingand presentation that in can be complementary labelingand nutrition informationin assistingconsumers weight to with management.
Weight management and ecolnomic theory

One economicrationalefor government action is a situationcalled. marketfailure, in which there is a consumer demandnot ‘ beingmet by the market. Qie possiblemarket failure is the absence nutrition labelingin restaurants, of whererestaurateurs know more aboutthe nutritional contentof their mealsthan their clients.Further,informationremediesprovidedby the government work best if information is structuredin a way that bestassists consumer understanding use. It is not clear after ten yearsof experience and whetherthe label on packaged food, including both claimsand the nutrition factspanel,is presented the optimal way for in consumers. However,althoughmany consumers clearly wish to,loseweight, survey’ showthat they s believethis is primarily the responsibilityof eachindividual. It is not clear exactly which market can help consumers control their own eatinghabitsalthoughweight lossand diet information to and programsand clubs are widely availableat reasonable prices. Ahhough there is no obvious marketfailure, there is a sense FDA could do more to assistconsumers the important that with public health issueof weight management. theory of constitutionaleconomics The holds that peopleoften turn to government constraintheir choicesto assistthem in their long-termgoals to (Brennanand Buchanan,1985,especiallypp. 67-8,1), this theory can provide a rationalefor and government action on weight management. Consumers prefer to have food choices may externallyconstrained ratherthan to bearthe cost of restrainingtheir own food consumption.If FDA can take actionsthat alter the set of food choicesofferedto consumers, consumers be may betteroff even if thosechanges eliminatefoods that are currentlyconsumed.An exampleis stimulatingreformulationof currentfoodsthroughchanges: labeling. If labeling causes in changes the food offeredto consumers, the set of availablefoods hasbeenaltered. in then Consumers prefer this form of externalrestraintto voluntarily restrainingtheir daily food may consumption.
C?mngesin product formulation. Evidence suggests that not on& do consmters respond to labeling, but producers also respond to consumers’concerm about diet by producing healtiaier products. Decisions’ change the com@sitiofi offwds will depend OH to whether producers anticipate that the expectedprivate bepsej%ts ofc~a~~~~g the formulation 63

for will exceedthe expected private costsof doing so. Analysesconducted FDA have examinedthe effect of hypotheticallabelingpolicy changeson ~~~f~~~~eps~ expected decisionsto reformulatefoods (Honeycuttet al 1998, White et al 2002, et al 2003). Further researchis neededwith respectto weight management andfoo~formulatian; to evaluatehow labeling changesmight motivateproduct ,refQrmula~o~, provide opportunities for marketing healthfulproducts, and stimulate competitionbasedon nutrient and health claims that assistconsumerswith weightmanagement.
III. Current Research Projects. The Division of market Studies is currently engagedin four short-term projects to address current issues in weight management. The projects are: 1) focus groups on consumer responseto nutrition information on packaged food and in restaurants;2) a survey of nutrition information available on restaurant web sites; 3) discussionswith manufacturers regarding incentives and barriers to food formulation; 4) a quantitative social sciencesmodel of dietary and weight management behavior. Preliminary results, currently available for the first three projects, make possible some suggestionsfor further research and indicate issuesfor further consideration. We plan to conduct further analysis of the complete results and consideration of’ relationships the among the four projects. 1. Focus Groups on Food and Restaurant Labeling and Weight ~u~~ern~nt [Amy Lando, Steve Bradbard] In responseto FDA’ concern over the rise in obesity and overweight in the United s States,we conducted a series of eight focus groups, funded by HHS/AS?& to explore: (1) how consumers use the nutrition information on food labels; (2) what type of nutrition information they would like to see in quick service restaurants; and, (3) which messageswould be effective as part of a public information and education effort aimed toward encouraging consumers to use the food label. Participants discussedand reacted to variations in the Nut&ion Facts Panel and the principal display panel on food packagesand to various presentationsof nutrition information at restaurants. The focus groups were held in November and December 2003, in Calverton, Maryland, Philadelphia, San Antonio, Texas, and Chicago. The groups, which each had between 7 to 10 participants, were segregatedby gender and education. All focus group participants were at least 18 years old, had been grocery shopping and had eaten in a fast food and/or quick service restaurant in the past month. TOPLINE RESULTS: The following findings are preliminary and are based on observations recorded by the observer, as well as post-group discussions with the focus group moderator and other observers. These topline results are not based on a complete analysis of the focus group tapes and/or transcripts, which will be used to compile.the Final Report. Also, since these findings are based on qualitative research with small sample sizes, they should not be viewed as nationally representative or projectable.

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General Nutrition: 1. Attitudes towards nutrition. In many of the groups, especially the wornens groups, people cared about nutrition and report usiug the Nutrition Facts Panel (NFP), Many were quite savvy about nutrition. At the same time, however, many also said that they don’ always t consider nutrition when deciding what to eat. Taste, convenience, price, what kind of mood they are in, and what their family eats were often at odds with healthy eating. While participants were interested in calories, many pointed to multiple concerns that went beyond calories such as the level of saturated fat, total fat, cholesterol, carbohydrates and sodium. 2. Macronutrients, In general, individual people tended to care more about some macronutrients than others depending on the diet that person was following. In most groups, at least one person was familiar with the Atkins diet and many ofthese people were most concerned about carbohydrates and,sugars+ Others were concerned about fat and saturated fat. Some people checked the NFP mostly for information about sodium. Those who were on the Weight Watchers diet were concerned about calories and fiber. 3. % Daily Value. Very few participants reported using the % Daily Value (%DV) column on the NFP. Either they did not understand the meaning of %DV or they thought that it was not relevant to then since they did not consume a 2000 calorie diet. Those who did use or might use O/oDVthought that is was a good way estimate how much of a particular nutrient they were eating or to gauge a healthy and balanced diet. Food Label Modification: 4. Large package sizes. In all the groups participants were presentedwith a mock-up of a 2002 soda and large packaged muffm. Both of these products are thought to be commonly consumed in one sitting, but have more than one serving size listed. Most participants said that neither the muffin nor the soda was a healthy food. They pointed out that the soda had a lot of sugar and calories and that the muffin was high in fat, calories, and carbohydrates. 5. Serving versus package. In general, participants thought it was.misleading to list either product as having more than one serving. Many did realize that if you eat the entire package you would need to multiply the serving size by the nutrient of interest,,though some were confused and made mistakes when trying to calculate in their heads. They were not surprised to see these products labeled as multiserving packages. 6. Calorie-related variations. The first test label added a %DV for calories, removed the caZories)om fat line, enlarged the calories line, and changed that way serving size was declared. In general these changeswere not noticed by participants. When the new wording for serving size was pointed out, most did not think it was an improvement over the existing language. 7. Serving size variations. The second test label had two %DV columns on the NFP, one for a single serving and one for the entire package. In the first four groups,~theabsolute quantities of macronutrients were only listed for the single serving size. After comments from these groups, the label was modified to have the absolute amount for both a serving and the entire product. Participant reaction to this modification was positive, but some thought it was not necessaryto list the amount for a single serving, and others preferred to have the absolute amount replace the %DV in the columns. 8. Calorie cues. We tested both a starburst with the calories per serving (first four groups) and a white square with calories per whole product (last four groups). The starburst was misleading to many since they thought the manufacturer was trying t&indicate the entire product had fewer calories than it did. The white square with the total calories per product

got mixed reactions,but manyjust saidthat they recognized theseas high calorieproducts and would stayaway from them. 9. “Healthy” (keyhole) symbol. In half of the groupswe testeda “healthy”meat lasagna with a purple keyholesymbol on the front of<the package.Therewas generallypositivereactionto including a front of packagesymbolindicatingthat a productwas healthy,as long as they that understood definition of the symboland could trust that it was true. They believed~ the they would haveto be educated to the meaningof-sucha signal.Somementionedthat they as would look for the keyholewhen they were in a hurry in the store. They expressed some concernthat theseproductswould cost more or that they would lack in taste.
Restaurant Labeliw: 10. Nutrition information. Most peopleseemed interested having nutrition information in

availableto them when they eat at fast food and/orquick servicerestaurants, thoughthey that might not use it everytime they eat out. They suggested this info~ation could be presented many locationsin the restaurant in including food wrappers,tray liners, brochures, on the take-awaybags,postersnearthe counter,and the menuboards. 11. Menu board information. Participants reactedto multiple versionsof a menuboardfor a typical fast food restaurant.In general,peopleliked having calorieslisted after meal items and after combomeals. Thosewho tend to order a da carte preferredto have calorieslisted after eachitem, while thosewho usually order a combo’ preferredto have calorieslisted meal for the entire meal. While‘ participants were concerned multiple macronutrients with for foods,havingjust calorieslistedwas enoughfor many people. They thaughtthat calories could be a signal for the level of other macronutrients. 12. Menu board section. Most participants also reactedfavorablyto the idea of placing healthier options,including meals,in a separkte sectionof the menuboardso they could find healthier optionsat a quick glance. 13. “Healthier” (keyhole) symbol. Many alsoreactedfavorablyto the purple keyholesymbol for healthiermeals,but somethoughtthat the exactnumberof caloriesshouldbe li,stedas well. Again, the symbolwould haveto be trustedand consumers would haveto understand the meaningof the definition.
Messages: 14. Therewas no one message participants that universallythoughtwas meaningfulor liked.

Different groupshad different preferences, many thought somemessage but would be good remindersfor them to look at the NPP, and also good for promptingchildrento examinethe label. In summary,many consumers they are very interested nutrition informationand they said in in report usingthe NFP to help them determinewhat to buy and eat. They are interested many different nutrientsin additionto calories. In all the groups,participantsfelt that multiserving productsthat are commonlyconsumed one sitting shouldbe labeledas such, Many consumers at saidthey are looking for labelsthat haveuniform and realistic servingsizes’ areinterestedin and having nutrition informationavailableto them at fast food restaurants. Basedon this preliminary analysis,thesefocusgroupssuggest somequestionsfor future research:

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How many consumersuse the %DV and how do they use it? Are there other ways to signal to consumersthat a product is high or low in a certain nutrient? Is a healthy symbol on the front panel useful for consumers? l Are there better ways to communicateserving sizeson the Nutrition Facts Panel? l How do consumersreact to nutrient content claims and health claims about calories on the front panel of packagedfoods? o W ill nutrition information on restaurantmenu boards or other locations changepurchasing behavior?
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2. Nutrition Information in Restaurant Menus: An Online Survey [Cristina McLaughlin] The restaurantindustry, especially the chain restaurantindustry, has used a variety of methodsto inform the public about the nutritional chara&eristics of menu items, in responseto current interest in the contribution of restaurantmeals to the American diet. One information source is restaurantcompany web pageson the Internet. The National RestaurantAssociation website includes a bulletin highlighting chain restaurantmenu offerings or information marketed a towards healthy lifestyles (NRA 2003). Each of the 19 restaurantentries inncludes short description of the health or nutrition-oriented menu feature, and a link to m e specific restaurant web site. A systematicsurvey of restaurantweb sites could provide an overview of available information, and could answer the following questions. What ~nutritionalinformation is currently available to consumerson the Internet regarding menu items at major s;hainrestaurants? Do restaurantweb sites indicate the availability and format of nutrition information found at the restaurantlocations? How are chain restaurantsrespondingto current concernsabout nutrition and obesity, as indicated by menu featuresand nutrient profiles on their web sites? The purpose of this project is to survey restaurantweb sites and compile a data baseof nutrition information in restaurantmenus available in the Internet. The list of restaurantswas basedon the top 100 United Statesrestaurantfirms by sales,obtained by searchingDunn & Bradstreet 2003). The top 100 firms identified in the searchown a total of 125 restaurantsand chains, including 71 casualdining, 28 fast food and 26 other (upscale,pizza delivery, buffets, etc). W e reviewed the websites fur each ofthe 125 restaurantsor chains,and summarizedthe information in an Excel spreadsheet.The next step of the project will be to convert the tabulated information to an Access database. Sample spreadsheet pagesfor the first 30 restaurants,ranked by total sales,are included provides the restaurantname and description’ followed by the in Appendix C. The spreadsheet site page (URL) addressthat includes the nutrition information or that brings us closestto it. The next columns summarizewhether nutrition information is available on the.site, and whether the information is interactive or in printable,(pdf or html) format; referenceto “‘Light” but no additional nutrition information; indication that nutrition information is available on premises and in what format (menu board, menu, tray liner, napkin, brochure, other); whether the nutrition information covers all menu items or partial or targeted items (such as dietary recommendations);and other information, including featuresmarketed for healthy lifestyles. Of the 125 restaurantweb sites surveyed,36 included nutrition information as either an interactive tool, such as a meal builder, a printable version or both. Of these, about 22 included printable versions only, 3 were interactive only and 12 provided laoth. Only 4 restaurant websites made referenceto “light” items in their menu without additio~~‘ ~utrition information.

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The nutrition information, when available online, generally included calories and nutrients covered by nutrition labeling of packaged foods: calories, calories from fat, total fat, saturated fat, sodium, etc. A few websites, such as Wendy’ and Au Bon Pain, even included information s on trans fat. Although nutrition information was often available online, it.“wasnot clear whether similar information would be readily available at the point of purchase. Only a few websites indicated whether the nutrition information available online would be available on premises as well. Further exploration of this question would require actual physical visits to the restaurants. Of the 36 restaurantswith nutrition information on their websites, 11 provided both complete nutrition information on all menu items and recommendations for special dietary requirements. Overall, 17 offered nutritional information on their whole menu, and 28 restaurants offered nutrition information on some items such as “Most Popular” or recommended items. Although a number of restaurant web sites provide fairly complete’ nutrition information online, often the nutrition information was not closely tied to the online menus themselves. Many online menu pages displayed little or no overall emphasis on calorie intake or weightmanagement-related information. The nutrition information, when provided, was generally in a separatefile from the online menu. A few online menus were available in a format that probably resembles the actual, on premises restaurant menu but none of these menus showed information on calories or fat. In summary, many restaurants, but not a majority, provide some nutrition information on their websites. The nutrition information is o&en displayed separately from the menu web pages, and of course is also separatefrom the actual point of purchase of arestaurant meal. Restaurant web sites also provide anecdotal, qualitative information about featured menu items related to nutrition, calories or weight management. Some examples of healthy eating menu features are indicated in the Notes section of our spreadsheets(Appendix C) and summarized in the NRA web page overview (NRA 2003). For future research,we plan to expand our survey to include the top 100 fast food firms, convert the information to a relational-(Access} database,and undertake a content analysis or other qualitative review ofthe restaurant web sites. This qualitative review will more fully describe the current status of restaurant initiatives to assist consumers with weight management. 3. Qualitative Investigation of Motiv&zm for Food Product ~forrn~~atio~ [David Zorn] Restructuring Consumers’ Choices: Changing the Foods Offered to Consumers Since implementing the NLEA labeling regulations in 1993, FDA has learned the enormous importance to health and nutrition that comes by changing the supply of food. When labeling gave consumers information on certain nutrients that they should consume less of, their net reduction was on average about 1% (Levy et al 1985). Consumers who chose different products reduced consumption by more than I%, but consumers who did riot use the labeled information did not benefit from the labeling of a static prod@ set. But ifan existing product is reformulated to reduce its calorie content, then all consumers ofthat product benefit, even if they are not actively seeking to reduce calories. And new products with fewer calories may attract consumers other than those actively engaged in weight management.

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Currently DHHS ASPE and FDA have paid a contractor to.condu&t confidential discussions with food manufacturers and restaurantsto provide input on what FDA could do to encourage them to provide consumers with different food offerings to assist in weight management. Because this research is not yet complete, we are reporting initial findings here (Muth and Kosa, 2003). This preliminary summary provides information on discussions with seven food manufacturers and seven restaurant chains regarding the char&teristics of food products and servings. Additional discussions are scheduled in the near future, Once all of the discussions are complete, the contractor will provide a formal report containing a full summary of the discussions and a description of the project background a&the methods of the study, including the process for conducting the discussions (Muth and Kosa, 2003) 0 Label Prominence Manufacturers respond to required information depending on how prominent it is required to be on the label. For an earlier project, some manufacturers had indicated that they would only reformulate to reduce trans fat in margarine if information on trans fat was going to be prominently mentioned on the label, either by placing it on a separateline in the Nutrition Facts panel or by allowing nutrition content claims.~(Honeycutt,et al., 19%). Currently, the signal on calories is weak relative to other signals on the label, Some manufacturers told us that: l the Nutrition Facts panel should focus more on calories and perhaps be simplified. e FDA should establish a seal related to weight management goals to give prominence to the issue. Other third party seals are very expensive to use. 0 Visual Cues We are learning that consumers use visual cues to judge their food consumption. Changing the packaging of products even with their existing formulations, would likely affect the amount of calories consumed. l Some manufacturers suggest allowing single serving packagesto contain only one serving rather than 2.5 servings; others suggestedreadjusting labeling serving size to represent the entire package or what people generally eat. l Dietary and Health Context It is important that consumers have a context for the information given to them. Currently, the Nutrition Facts panel gives calories only as a scalar number, with no context at all for a complete diet. Some manufacturers suggest l giving a daily value for calories, just as there is a daily value for almost every other macronutrient based on a 2000 calorie diet. * development of one messageon weight management common to ail federal agencies. * that consumers be educated about calorie balance, possibly illustrated by pictorials on packagesto correspond to energy expenditure activity equivalent to the calorie content of the food. l Reformulation Factors Four key factors affect how favorable a food category is to being reformulated: cost of reformulation, consumer sensitivity to sensory changes in the product, consumer sensitivity to what is on the product label, and the competitiveness of Arms within the food category. A labeling change required by FDA is most likely to result in reformulation when the combination of these factors favors the reformulation, such as for beverages, breakfast -foods,dairy products, egg products, infant foods, seafood, soups, and weight control foods (Mutb, et al., 2003). It may

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not be possible to influence reformulation of all foods. However, modest changes in food consumption can result in enormous improvements in public health. 0 Regulatory Policy Manufacturers suggestedseveral areas where current regulatory policy is a barrier to reformulation l The food additive approval process. One firm even supported user fees to fund a simplified and expedited review process. Improvements in the GR&S notification process have been helpful, but additional steps would encourage innovation. They especially mentioned faster review of artificial sweeteners,including cyclamate. Some manufacturers also recommended that FDA provide stronger advocacy and support for the use of fat and sugar substitutes, 0 The claims approval process. Some firms want to be able to make .factual nutrient content claims without disqualifying limitations relating to other nutrients, want less wordy claims, and they want the claim approval process expedited. Some manufacturers want to be able to label foods with 80-90 calories as low calorie because below this level it is difficult to provide enough nutrition; some want to be able to use “low carbohydrate” claims. l The standards of identity and fortification policy. Allow fortification ofreduced calorie products so that they can meet the standards of identity, For example, allow fortification of reduced calorie orange juice with folic acid. e Standard calorie values for macronutrients. One manufacturer wanted calories from soluble fiber like oligofiuctose not to be included inthe calorie count at the full 4 calories per gram. 0 Restaurants and Food Service Establishments Restaurateurshad the following suggestions. * Educate consumers about appropriate portion size, caloric balance, eating wisely, and asking for customized orders to reduce calories. * Educate consumers that small changes in diet can make significant differences for weight management. Restaurantswould disseminate on bags, cups and tray liners. 0 Educate consumers on using restaurant nutrition information that is increasingly available and be flexible on the format and placement of such information. l Assist restaurants with analytical methods for foods, 0 FDA and FTC need to be more flexible about comparative claims. Currently 20% calorie reductions can’ be claimed but they are significant for weight management t improvements. In summary, discussions with manufacturers indicated some areas in which labeling policy and other regulatory policy could provide incentives or remove barriers to manufacturer initiatives to assist consumers with weight management. As noted above, these are pr&minary results from the initial manufacturer discussions, which are still in progress. Note that <these findings are based on qualitative research with small sample sizes, therefore?they should viewed as suggestive, and not as representative or projectable to all manufacturers. In the near future, we will have information available on a complete analysis of the full set of discussions.

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4. Quantitative Social Sciences Modei of Dietary and Weight Management Behaviors [Amber Jessup]

Currentsocial sciences literatureand datasetscontaina wealth of information about consumerdecisionsaffectingweight, including attitudinal and behavioralfactorsrelatedto exercise,food choice,food quantity,and frequencyof eating. Realization,ofthe full potentialof this informationto address public health questionsabout obesitywill requireintensive, systematic review and model-building. FDA, in collaborationwith OASPE,is working with a contractor,ERG, to review the literatureand build a model focusedon food label use and weight management.The main components the project include: an annotated of biblio~aphy and written literaturereview, theoretical and empirical (data-based) modelsof label use for weight management a summaryof titure reseamh and needs. The model will address importantindividual and environmental factors that can influence consumerdietary and weight management behaviors. In our review of literaturein economics, psychology,nutrition, healthbehavior,and other social sciencediscipline% are identifying we critical factors affecting motivation and execution,suchas habit, risk perception,efficacy of behavior,availability of and access nutrition and health information,and education.We are to organizinginformation from selected articlesin a structured, annotatedbibliographywith brief summaries the article focus,economic/econometric of model used,data source,statistical methodology,results,including a critical review of strengths weaknesses, relation to the and and modelingproject. Examplesof the annotatedbibliographyformat are in Appendix B. We will next write a literaturereview synthesizing,the conclusions about label use,andweight management can be drawn from the,literature. that The theoreticalmodel will be basedon Grossman’theory of a householdhealth s productionfunction (Grossman 1972). In this framework,health is producedfrom a combinationof time,,purchased goods,and humancapital. This approachisappealingbecause health is typically not a commoditythat can be directly purchased, resultsfrom a but combinationof lifestyle choicesand purchases.Under the theory,the consumer maximizeshis or her utility from health,leisure,and consumption other goods,. of suchas food, This model acknowledges food may enter into consumers’ that utility function in multiple ways: directly, say,due to the pleasureof eatingchocolatecakeand indirectly, say,throughthe detrimental effectsof chocolatecakeconsumptionon health. Additionally, the consumeris constrained by both time and income. Information, in the form of labeling,may enter into his or her health production function by affecting the choiceof foods and into his or her time constraintby reducingthe time requiredto choosefoods. For building the empiricalmodel,nationally-representative on food choices,nutrient data intakes,and diet and health-related attitudesand knowledge(including nutrition label use)are availablefrom USDA’ Continuing Surveyof Food Intakesby Individuals (CSFII) and the Diet s and Health KnowledgeSurvey(DHKS), 1989-1991and 1994-96. To understand how consumers labelsto aid in managingtheir weight, we will model caloric intake as predicted use by label reading. The independent predictorvariableswill include other aspectsof health, or preferences attitudestowardsfood and nutrition and demographic and characteristics. Because the complexrelationshipsamongdietary knowledgeand attitudes,label of reading,and calorie consumption, there are limitations in the useof cross-sectional data,suchas CSFII, to infer causalrelationshipsbetweenlabel readingand dietary choices.For example, consumers high levels of knowledgeand concernaboutnutrition are likely to eat a healthier with

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who diet than consumers are unconcerned that aboutnutrition. Consumers are well informed aboutnutrition are also more likely to read labelsand will be betterableto uselabelsto guide their diet. Conversely,label readingmay inform consumers aboutnutrition. For example,health claimsmay inform consumers aboutthe relationshipbetweendiet and disease, the presence or of a macronutrienton the Nutrition Factspanelmay signalto consumers tha$.tbe macronutrient plays an importantrole in the diet. Thus,althoughsomestudieshave using simple,single equationmethodssuchas OLS or probit regressions describethe ~eIati~n~h~~ to betweenlabel useand nutrient consumption (Neuhauser al 1999,Kreuteret al 1997),this approachcan et establisha correlationbetweenlabeluseand diet, but doesnot establisha causalrelationship. Studiesusing more complextechniques, suchas a t&o-stageHe&man selectionmodel or an endogenous switchingregression model,have attempted control for the consumers’ to selfselectionto uselabels(Guthrie et al 1995,Kim et al 2000) However,neitherof thesestudies focusedon calories,a key dietaryvariablein weight control, andboth studieseontrolledfor selfselectionof label readingby using dataon nutrition knowledgeand attitudesto predict label use, But thesecharacteristics alsobe the result of self-selection thereforemay not be suitable may and controls. In order to overcometheseproblems,we will testthe robustness ofthe independent association label useand caloric intakeusing severalmodelingapproaches, of including a single equationmultivariatemodel, a two-stagemodel,an endogenous switchingregression model,and a model using the differencein label availability betweenwavesof data. The latter approach exploitsthe implementation the Nutrition LabelingEducationAct (NLEA) in 1994,between of wavesof the CSFII and DHKS, to conducta naturalexperiment the effect of label changes of on of consumers.Differencesin the effectiveness labeluse betweenwavesofthe CSFII and DHKS, while controlling for other observable factors,can be reasonably amibutedto increased availability and standardization labels. of This model will enhance understanding- the relationshipof dietary behaviorand of consumerlabel useand of consumercharacteristics influencethe effe&iveness label use. that of By consideringrelevantand importantindividual and environmental factors,this model can go beyondthe existingliteratureto help identify the role that food labelsplay in healthdecisions. The model will provide informationon the marginalbenefitsof label useon healthand can be usedin cost-benefitanalysisof currentlabeling,of possiblechanges la~e~~n~ in regulations, and of obesity-related policy issuesat FDA and HHS. We expectto usethe model to test the effectiveness policy interventionssuchas label of changes, productreformulation,and educational messages. datashouldalso enableus to The profile different groupsof consumers have different knowledge,attitude,and behavior;this who informationcan also be useful in identifying and prioritizing interventionand educationefforts. For example,the model will attemptto answerquestions suchas: l Do food labelshelp consumers maintaintheir desiredweight? 0 Are lesseduoated consumers ableto use food labelsto maintaina healthyweight less than more educated consumers? l How doesethnic@ and other cultural factorsaffectconsumers ability to usethe food label? * How doesmother’ useof the food label affect the healthof their tihildren? s

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The model developedin this projectwill useexistingdata,suchas the CSFIUDHKS,BLS price data,and supermarket scanner data. The projectwill also identify datagapsand recommend additionaldatacollectionand improvementof this social sciences model.
IV. Future/Potential research projects for addressing weight rna~~ge~e~t problems

Although not finished,somepreliminaryobservations be madefrom our research far. can so First, althoughconsumers clearly use food labels,includinghealthclaimsand the nutrition facts panel,the informationmay not yet be structuredin a way to optimizeunderstanding use. and Second, althoughour research uncoveredsomeinformationbeing offered in restaurants, has consumers appearto want more informationand in a more structuredformat, We have uncoveredseveralpromisingformatsincluding segregation mealsor logo indicatorsfor low of calorieor healthyalternatives.Finally, our research showsthat rn~~f~~ers will respondto changes labelingpoliciesto repositiontheir foodsto take advantage informationthat is in of prominentlyrequired. Thesepreliminary findings suggest someavenues future research. of
1. Food Labels

Research needed find out if thereareways to reformatthe nutrition facts panel (NFP) to is to make it easierto use and to provide incentivesfor manufacturers offer more lower calorie to foodsthat are also healthierthan the currentselection.From the existingliteratureand from the preliminary reportsfrom the currentprojects,somepossibleareasinclude: a. Daily values- either evaluate effectiveness an educationcampaignto seeif the of peoplewill startusing theseor possiblylook for replacements indicatewhether to nutrientsare high or low. Thesereplacements could be graphicaldevicesor wording changes suchas high or low. b. Servingsizes- Because consumers having diffiMiculty, are e&herbecause time or of ability, with the multiplication necessary calculatermtrientvaluesconsumed, to considerreplacingsomeor all nutrient informationwith total container informationor nutrient densityinformation. Research also neededto seehow we can provide bettersignalson the front of the label,the is principal displaypanel(PDP). Because consurners often do not look at the back of the label when there is a claim, and often take the claim to apply to.the,entireproduct,research is neededto seeif FDA can provide an alternativesignalthat addresses entire product. This the may be an indicatorof the healthiness the product,suchasthe Swedishkeyhole,or an of indicatorof caloriesin the product.
2. Restaurants

Research needed evaluate effectiveness variouskinds of nutrition labeling, is to the of including labelingcalories.andindicatorsof healthiness both a la carteitems and meals. for Different kinds of labelingmay work differently dependingon the type of restaurants, e.g., quick serveversusfamily style restaurants.The desirabilityof sometype of labeling was conclusivein qualitativeresearch morequantitativeresearch be necessary.Also, but may nutrition labeling in restaurants not be ableto be as preciseas labelingfor packaged may products. It is not clearwhetherpeoplewould usenutrition info~ati~n inrestaurantsin a different mannerthan they would for packaged food. Although there is someinformation providedto us by the EconomicResearch Service,it might be useful to more completely establish link betweenoverweightand the prevalence eatingout, both with respectto the of the typesof restaurants the socioeconomic and characteristics overweightconsumers of who

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eat out frequently It may also be usefulto know whetherpeoplewho perceivethemselves to be overweightin fact eat fewer mealsin restaurants because that fact and whetheror not, if of so, labelingwould increase numberof mealseatenout, the Finally, we havea potentialvolunteerchainof restaurants will usesomeof the that informationobtainedfrom the focusgroupsto test in an actualmarketsituationhow consumers reactto this type of labeling. The final detailsare expected be worked out will to in the next month or two.
3. Food Reformulation

Someof FDA’ existingpolicies for nutrition labeling,food standards food additives s and may needto be examinedto seeif thereare barriersto reformulatingexisting foods. In addition,changes might be suggested food labelsor restaurant that to menu’ shouldbe s evaluated seehow it would changethe supply side of the marketand increase number to the of low calorie/healthy foods or mealsoffered.
VI. References References for General Issues in Weight Management

Allison DB, WeberMT. 2003.Treatmentand preventionof obesity:what works, what doesn’ t work, and what might work. Lipids.38 147-55. Allison DB, Zannolli R, NarayanKM. 1999.The direct’ healthcarecostsof obesityin the United States. J Public Health.89:1194-9. Am BrennanG, BuchananJ. 1985.The Reasonof Rules,CambridgeUniversity Press, NY. FinkelsteinEA, FiebelkornIC, Wang G. 2003.National Medical Spending Attributableto Overweightand Obesity:How Much, and Who’ Paying?Health Affairs. W3:219s 226(14 May 2003). Flegal KM, Carroll MD, OgdenCL, et al. 2002.Prevalence trendsin obesity amongUS and adults, 1999-2000. JAMA 288:1723-1727, Lowe MR. 2003Self-regulation energyintake in the preventionand treatmentof obesity:is it of feasible?ObesRes. 11~44%59s. OgdenCL, Flegal KM, Carroll MD, et.al. 2002.Prevalence trends in overweightamongUS and children and adolescents, 1999-2000. JAMA 288:1728-1732. Rolls BJ. 2003. The Supersizing ofAmerica: Portion Sizeand the ObesityEpidemic.Nutr Today. 38:42-53. ShuldinerAR, Munir KM. 2003.Geneticsof obesity:more complicatedthan initially thought. Lipids 38:97-101. U.S. Department Health and Human Services. of 2001.The SurgeonGeneral’call to actionto s preventand decrease overweightand obesity.[Rockville, MD]: U.S. Departmentof Health and Human Services, Public Health Service,Office of the SurgeonGeneral; [2001]. Available from: US GPO, Washington.

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Labeling references Barone, M.J., Rose, R.L. Manning, KC., and Miniard, P.W. 1996. Another Look at the Impact of Reference Information on Consumer Impressions of Nutrition Information. Journal of Public Policy and Marketing 15:55-62. Food and Drug Administration, 2003. FDA 2002 Health and Diet Survey,+mpublished data. Food and Nutrition Board, Institute of Medicine of the National Academies. 2003. Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification. Prepublication copy. Committee on Use of Dietary Reference Intakes in Nutrition Labeling. The National Academies Press: Washington, DC. Food Marketing Institute. 1996. Shopping for Health. Report. Washington, D.C. Ford, G T., Hastak, M, Mitra, A, Ringold, I3 J. 1996. Can Consumers Interpret Nutrition Information in the Presenceof a Health Claim? A Labaratory Investigation. Journal of Public Policy and Marketing. 15( 1): 16-27. Garretson, J A., Burton, S. 2000. Effects of Nutrition Facts Panel Values, Nutrition Claims, and Health Claims on Consumer Attitudes, Perception of Disease-Rel&ed Risks, and Trust. Journal of Public Policy and Marketing. 19(2):213-227. Gifford, KD. 2002. Dietary fats, eating guides, and public policy: History, critique, and recommendations. American Journal of Medicine 113(9B):89S-1crC;S. Guthrie JF, Fox JJ, Cleveland LE, Welsh S. 1995. Who Uses Nutrition Labeling, and What Effects Does Label Use Have on Diet Quality? Journal of Nutrition Education 27(4):163172. Kim, S.Y., R.M. Nayga Jr, and 0. Capps, Jr. 2000, The Effect of Food Label Use on Nutrient Intakes: An Endogenous Switching,Regression Analysis. Journal of Agricultural and Resource Economics 25(No. 1,July):2 15-231. Kreuter, MW., Schariff, DP., Brennan, LK., Lukwago, SN. 1997. Do Nutrition Label Readers Eat Healthier Diets? Behavioral Correlates of Adults’ Use of Food Labels. American Journal of Preventive Medicine. 13(4):277-283. Lin, J, Lee, J-Y. 2003. Dietary Fat Intake and Search for Fat Information on Food Labels: New Evidence. 2003 American Council on Consumers Interest Conference. Levy A, Fein S, Schucker S. 1996. Performance Characteristics of Seven Nutrition Label Formats.” Journal of Public Policy & Marketing 15: l-1 5. Levy L, Patterson RE, Kristal AR. 2000. How well do consumers unders&.ndpercentage daily value of food labels? American Journal of Health Promotion 14: 157-l 60. Lin, C.-T. J, Lee, J-Y. 2003. Dietary Fat Intake and Search for Fat Inform&on on Food Labels: New Evidence. In Consumer Interests Annual. 49.2003. Lin, C-T J, Food and Drug Administration, 2002 Health and Diet Survey, Unpublished Data, 2002. Mitra, A, Hastak, M,, Ford, G T., Ringold, D J. 1999. Can the Educationdly Disadvantaged Interpret the FDA-Mandated Nutrition Facts Panel in the Presenceof an Implied Health Claim. Journal of Public Policy and Marketing. 18( 1): 106-l 17.

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Neuhouser, ML., Kristal, AR., Patterson, RE. 1999. Use of Food Nutrition Labels is Associated with Lower Fat Intake. Journal of the American Dietetic Association. 99(1):45-53. Roe, B., Levy, AS., Derby, BM. 1999. The Impact of Health Claims on Consumer Search and Product Evaluation Outcomes: Results for FDA Experimental Data. Journal of Public Policy Making and Marketing. 18 (1):89-105. Smith SC, Stephen AM, Dombrow C, MacQuarrie D. 2002. Food information programs: A review of the literature. Canadian journal of Dietetic Practice andResearch 63:55-60. Teisl, MF., Levy, AS. 1997. Does Nutrition Labeling Lead to Healthier Eating? Journal of Food Distribution Research.October, 1997. Restaurant and eating cues references Aaron, J, Evans, R,. Mela, D. 1995. Paradoxical Effect of A Nutrition Labelling Scheme in a Student Cafeteria. Nutrition Research.15(9): 125l-1261, Almanza, BA., Hsieh, HM-Y. 1995. Consumer Preference Among Nutrit$on Labeling Formats in a Restaurant. Journal of the American Dietetic Association. 95(1):83-84. Almanza, BA., Nelson, D, Chai, S. 1997. Obstacles to Nutrition Labelingin Restaurants.Journal of the American Dietetic Association. 97: 157-l 61. Boger, A. Food Labeling for RestaurantsFact versus Fiction. 1995. Corn&l. Hotel and Restaurant Administration Quarterly. 36:62-70. Cinciripini, PM.. 1984. Changing Food Selections in a Public Cafeteria. havior Modification. 8(4):520-539, Colby, J, Elder, J, Peterson, G, Knisley, P, Carleton, RA. 1987. Promoting the Selection of Healthy Food Through Menu Item.Description in a Family-Style Restaurant. Am J Prev Med 3(3):172-177. Horgen, KB, Brownell, K. 2002. Comparison of Price Change and Health Message Interventions in Promoting Healthy Food Choices. Health Psychology. 2 1(5):505-5 12. Johnson WG, Corrigan S., Schlundt DG, 1990, Dubber-tPM. Dietary Restraint and Eating Behavior in the Natural Environment. Addictive Behaviors 15:285-290. Kozup JC, Creyer EH, Burton S. 2003. Making Healthful Food-Choices: The Influence of Health Claims and Nutrition Information on Consumers’Evaluations of Packaged Food Products and Restaurant Menu Items. Journal’ Marketing 67: 19-34. of Prochaska, J.O., Diclemente C.C., Norcross, J.C. 1992. In search of how people change: Applications to addictive behaviors. American Psychology 47, 1102-14. Rolls, B. 2003. The Supersizing of America. Portion Size and the Obesity Epidemic. Nutrition Today 38(2):42-53. Rolls, B. 2003. What Drives Consumption? Reflections on What We Know of Portion Size, Energy Intake, and Labeling. Institute of Medicine, Food Forum Meeting, July 29,2003: Stubenitsky, K., Aaron, JI, Catt, SL, Mela, DJ. 2000. The influence of recipe modification and nutritional information on restaurant food acceptanceand macronutrient intake. Public Health Nutrition. 3(2):20 l-209. Wansink, B. 2004. Marketing Nutrition: Soy, Functional Foods, Biotechnology, and Obesity,Champaign IL: University of Illinois Press, In press. Wansink, B. 2003. Institute of Medicine, Food Forum Meeting, July 29,2003.

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Reformulation references Honeycutt, A, Gibbons C, Wendling B 1998. Analysis of Changing Food Labels to Include Information on Trans Fatty Acids, RTI International, December 4, 1998. Muth, M, Karns S, Anderson D, Coglaiti M, Fanjoy M. 2003. Modeling the Decision to Reformulate Foods and Cosmetics, RTI International, October 2003. White, W, Glendhill E, Karns S, Muth M. 2002 Cost of Reformulating Foods and Cosmetics, RTI International., July 2002. Project 2 References. Online Restaurant Information Dunn & Bradstreet, 2003. File 516 Dialog Corporation. www.dialoap,com.Search performed on November 17,2003 at 16:28:37. Hewes C, Painter J. Nutritional Analysis Tool, NATS. A cell phone browser tool that accessesa databaseof food items found at popular fast food restaurants. 1996; University of Illinois at Urbana-Champaign. Current cell phone browser address for Fast Food NATS is nat.crgq.com National Restaurant Association. 2003. Market-driven solutions. Most recently accessedat http://www.restaurant.org/pressroom/market solutions.cfm on December 162003. Project 3 References. Qualitative Investigation of Motivation fox Reformulation Honeycutt, A, Gibbons C, WendIing B. 1998. Analysis of Changing Food Labels to Include Information on Trans Fatty Acids, RTI International, December 4, 1998. Levy, A, et al. 1985. The Impact of a Nutrition Information Program on Food Purchases,Journal of Public Policy & Marketing 4:1-13. Muth, M, Karns S, Anderson D, Coglaiti M, Fanjoy M. 2003. Modeling the Decision to Reformulate Foods and Cosmetics, RTI ‘ International, October 20Q3e Muth M, Kosa K. 2003. Interim summary of discussions with industry on,tbe characteristics of food products and servings. Memorandum to David Zom. RTI Intemational:December 22,2003 White, W, Glendhill E, Karns S, Muth M. 2002. Cost of Reformulating Foods and Cosmetics, RTI International, July 2002. Project 4 References. Social Science Model Grossman, M. 1972. On the Concept of Health Capital and the Demand for Health. Journal of Political Economy. 80(March-April, 1972a) 233-55. Guthrie, JF., Fox JJ, Cleveland LE, Welsh S. 1995. Who Uses Nutrition Labeling, and What Effects Does Label Use Have on Diet Quality? Journal of Nutrition Education 27(4): 163-172. Kim, S-Y, Nayga, MR Jr., Capps, 0 Jr. 2000. The Effect of Food Label Use on Nutrient Intakes: An Endogenous Switching Regression Analysis Journal of AgricuPural and Resource Economics 25(l): 215-231.

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Kreuter, M. W., Brennan, L. K., Scharff, D. P., & Lukwago, S. N. 1997. Do nutrition label readers eat healthier diets? Behavioral correlates of adults’ use of food labels. American Journal of Preventive Medicine 13(4):277-283. Neuhouser, M. L., Kristal, A. R., Patterson, R. E. 1999. Use of food nutrition labels associated with lower fat intake. Journal of the American Dietetic Association 99(1):45-50,53.

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VII. Appendices A. Review of Literature B. Sample Annotated Bibliography Entries C. Sample Pages fram Spreadsheet odRestaurant Web Sites

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Appendix A. Review of Literature Review of literature on nutrition.!abeling and restaurant pojnt-of-pu~~ba~ labeling [Contributors to literature review: Amy Lando, JardaB Lin, Andrew Estrin, Amber Jessup, David Zorn, Clark Nardinelli] Nutrition labeling

The Nutrition Labeling and EducationAct (NLEA) (1990) gaveFDA authority to require a Nutrition Factspanel on the label of most packaged foods. The Factspanel statesthe standardized servingsize,the numberof caloriesper servingand the amountand percentof the Daily Value (DV) per servingfor specifiednutrients. (The Daily Value is a referenceamountfor daily intake of a nutrient in a 2000 calorie diet.) BeforeNLEA, nutrition labelingwas required only in certaininstances, suchaswhen,claimswere madeaboutnutrient tiontent. In addition to the Nutrition Faotspanel,FDA also permitsspecifiednutrient contentclaims and health claims on food labels. FDA definescriteria for nutrient contentclaims,suchas “low in betweena food or fat” or “a good sourceof calcium”. Health claimshighlight a relationship. nutrient and a disease health-related or condition, suchas calcium intakeand reducedrisk of osteoporosis.
Social science research methods

Before NLEA, FDA conductedconsumer research about,theusefulness potentialchoices of have for the Factspanel format. SinceNLEA, a numberof researchers studiedhow consumers usethe Factspanel,nutrient contentclaims,and health claims (separately in combination)to and make dietary choices. Consumer research usedto assess is people’ knowledge,attitudes, s perceptions, preferences a topical subjectareaor reactionsto any type of stimuli. and for Dependingon the the goalsof the project, research methodsmay include-qualitative data collection, quantitativesurveysor experimentalstudies. * In qualitativeresearch, open-ended questionsare usedto elicit uns$ructured consumer reactionsand thoughtsto different topics or stimuli. Qualitativereseamh, including the focus group format, is useful for obtainingthe rangeof consumer opinionsabout a given topic and is often conductedas a preliminary step,beforequantitativesurveysor experimentalstudies.Unlike experimentalstudiesor quantitative surveys,resultsfrom focus groupsand other qualitativestudiesare not generalizable any population. to * In quantitativesurveys,information is collectedby structuredquestionnaires the and When the survey resultingdatacategorized demographic other characteristics. by and sampleis nationally representative, resultsprovide populationestimates and the the conclusionscan be generalized nationally. Nationally representative surveyscan help inform policy makers,risk assessors, health educators the knowledge,attitudes and of and self-reported behaviorof the US. public about a certaintopic. 0 Experimentalstudiestest consumer response manipulatedstimuli, such as real or to hypotheticalfood labelsthat vary in format or content. Eachrespondent randomly is assigned an experimentalgroupthat responds a particulartype of food label. The to to response eachgroup is recorded,and differencesdnresponse of acrossgroupsare attributedto the corresponding experimental conditionsor labels. Experimentalstudies

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l

can statisticallytest differencesin consumers’ understanding and ability to use of different label informationand formats. Interventionstudiesare anothertype of experimental study: Interventionstudiesmeasure differencesin peoples’ behaviorwhen specificconditionsare varied accordingto an experimental design. For example,interventionstudiesmay exam&~purchasing behaviorin grocerystoresor eatingbehaviorin restaurants which different types or in amountsof nutrition informationare presented.

Food label use

Research clearly showsthat most Americansare familiar with andusethe Nutrition Facts panel. In a 2002 FDA survey,69 percentof the U.S. populationreportedusingfood labelsoften or sometimes when they buy a productfor the first time (FDA, 2003). Peoplereportedusing the food label for many reasons, most commonlyto seehow high or low the food is in caloriesand in nutrientssuchas fat, sodium,or certainvitamins. Many consumers not fully understand informationon the Factspanel,evenas they do the use it to make dietary choices.One studysuggest percentDV informationhelpsconsumers that judge the healthfulness a food betterthan absoluteamountsof nutrientsalone(Levy, Fein, and of Schucker,1996). However,in a national survey(FMI, 1996)lessthan hatf of respondents could accuratelyidentify the meaningof the percentDV for fat and anotherstudy found that DVs are not helpful for consumers makecorrectjudgmentsaboutthe healthiness a product(Barone to of et al, 1996).. Someexperimental food label studieshave found that, when presented with nutrient contentclaimsor healthclaims in the absence the Nutrition Factspanel,consumers be of can misled into thinking a product is healthierthan it really is (Ford et al., Roe et al.). These misperceptions be remediedif consumers look at the Factspanel. For example, may also regardless the fat and fiber claimson the front of packages varying fat and fiber content, of with consumers were askedto readthe ,Facts who panelcould correctlyidentify a productas being low or high fat (Garretson Burton). Varying the level of fiber madeno differencein the and consumers’ perceptions the healthfulness the food, This suggests fat is a more salient of of that nutrient to consumers is fiber. Similarly, regardless their educationlevel, consumers than of presented the Factspanelcouldjudge producthealthfulness with corrrectIyevenin the presence of an implied claim abouthearthealth(“It DoesYour HeartV Good!“). However,without the Factspanel,consumers were significantlymore likely to be,influencedand potentiallymisled by healthclaims (Mitra et al). In the abovestudies,the research subjects were specificallydirectedto” consultthe Facts panel. However,in a studythat gaverespondents option to look at any part of a food the package,consumers not look at the Factspanelto verify claim inform&ion, but truncated did their examinationto just the claim on the front of the package (Roe,Levyand Derby). This resultedin incorrectinferences aboutthe producthealthfulness, particularly aboutnutrientsnot mentionedon the front. Although more research this areais needed, studyprovidessome in this evidence consumers not customarilyverify front panelinformationby consultingthe that do Nutrition Factspanel.

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Food label and diet

Correlationsbetweenfood label useand diet havebeenreportedin a numberof studies. For example,surveyrespondents usedthe Factspanelwere more likely to consumea lower who fat diet, both in the generalpopulationand amongfamily clinic patients(Neuhouseret al, and Kreuter et al). Clinic patientswith healthconditionssuchas high blood pressure high cholesterolwere more likely to look on the label for sodiumand cholesterolinformation, respectively(Kreuter et al). A limitation in interpretingcross-sectional surveysabout label useand diet is that consumers are concerned who abouttheir diet may be more likely to read’ nutrition label. the Thus, althoughlabel readingmay be correlatedwith healthy diet practices, causeof the the healthierdiet may be the concernaboutnutrition, not the label reading. For example,in one study that found lower total fat intake amonglabel usersthan non-users, consumers higher with fat intakeswere lesslikely to searchfor fat informationon the label and food label usewas strongly correlatedwith attitudestoward food labels(Lin and Lee). In anotherstudyusing statisticalanalysisto control for different characteristics label usersand non-users, of food label usershad lower average,percent caloriesfrom total and saturated cholesterol,and sodium of fat, than non-labelusers(Kim, Nayga, and Capps). In an interventionstudyusing grocerystoreshelf labelswith nutrition information,the nutrition shelf labelsincreased purchase healthieralternatives someproduct categories, the of in but decreased purchaseof healthieralternativesin other productcategories the (Teisl and Levy). The authorssuggested consumers that might use an implicit health risk “budget”to compensate for eatinghealthierfoods in somecategories wheretastedifferencesamongchoiceswere small, by eating lesshealthy foods in categories had greatertastedifferencesamongchoices. The that ability to make suchchoicescould be beneficialto consumers, althoughnot leadingto overall improvements diet. The resultssupportthe ideathat providing nutrientinformation may allow in consumers more easily switch consumptionaway from “unhealthy”productsin thosefood to categories where differencesin other quality characteristics relatively small. are
Labe1int-treferences

Barone,M.J., Rose,R.L. Manning,KC., and Miniard, P.W. 1996.Another Look at the Impact of Reference Information-onConsumerImpressions Nutrition Information.Journalof of Public Policy and Marketing 1555-62. Food and Drug Administration,2003. FDA 2002 Health and Diet Survey,:unpublished data. Food Marketing Institute. 1996.Shoppingfor Health. Report.Washington,, DC. Ford, G T., Hastak,M, Mitra, A, Ringold, D J. 1996.Can Consumers InterpretNutrition Information in the Presence a Health Claim? A Laboratoryinvestigation. Journalof of Public Policy and Marketing. 15(1):16-27. Garretson, A., Burton, S. 2000. Effects of Nutrition FactsPanelValues,Nutrition Claims,and J Health Claims on Consumer Attitudes, Perceptionof Disease-Related Risks, and Trust. Journalof Public Policy and Marketing. 19(2):213-227. Gifford, KD. 2002. Dietary fats, eating guides,and public policy: History, critique, and recommendations. AmericanJournalof Medicine 113(9B):89S-106s.

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Guthrie JF, Fox JJ, Cleveland LE, Welsh S. 1995. Who Uses Nutrition Labeling, and What Effects Does Label Use Have on Diet Quality? Journal of Nutrition Education 27(4): 163172. Kim, S.Y., R.M. Nayga Jr, and 0. Capps, Jr. 2000. The Effect of Food Label Use on Nutrient Intakes: An Endogenous Switching Regression Analysis. Journal of Agricultural and Resource Economics 25(No. l,July):2 15-231. Kreuter, MW., Schariff; DP., Brennan, LK., Lukwago, SN. 1997. Do Nutrition Label Readers Eat Healthier Diets? Behavioral Correlates of Adults’ Use of Food Labels. American Journal of Preventive Medicine. 13(4):277-283. Lin, J, Lee, J-Y: 2003. Dietary Fat Intake and Search for Fat Information on Food Labels: New Evidence. 2003 American Council on Consumers Interest Conference. Levy A, Fein S, Schucker S. 1996. Performance Characteristics of Seven Nutrition Label Formats.” Journal of Public Policy & Marketing 15: l-15. Levy L, Patterson RE, Kristal AR. 2000. How well do consumers understand percentage daily value of food labels? American Journal of Health Promotion 14: 157- 160. Lin, C.-T. J, Lee, J-Y. 2003. Dietary Fat Intake and Search for Fat Information on Food Labels: New Evidence. In Consumer Interests Annual. 49.2003. Lin, C-T J, Food and Drug Administration, 2002 Health and Diet Survey, Unpublished Data,
2002.

Mitra, A, Hastak, M., Ford, G T., Ringold, D J. 1999. Can the Educationally Disadvantaged Interpret the FDA-Mandated Nutrition Facts Panel in the Presenceof an Implied Health Claim. Journal of Public Policy and Marketing. 18( 1) : 106- 117. Neuhouser, ML., Kristal, AR., Patterson, RE. 1999. Use of Food Nutrition Labels is Associated with Lower Fat Intake. Journal of the American Dietetic Association. 99(1):45-53. nsumer Search and Roe, B., Levy, AS., Derby, BM. 1999. The Impact of Health Claims o Journal of Public Product Evaluation Outcomes: Results for FDA Experimental Policy Making and Marketing. 18 (1):89- 105. Smith SC, Stephen AM, Dombrow C, MacQuarrie D. 2002. Food information programs: A review of the literature. Canadian Journal of Dietetic Practice a&Research 63:55-60. Teisl, MF,, Levy, AS. 1997. Does Nutrition Labeling Lead to Healthier Eating? Journal of Food Distribution Research. October, 1997.
Restaurant labeling

In 1999, American households spent an average of $2,116 or 42 percent of their total food expenditure on food away-from-home (BLS 1999). According to the latest data, during 1994-6, away-from-home food, especially from restaurants and fast-food bcations, contributed 32 percent of daily intakes of energy calories, 32 percent of added sugars, and 37 percent of fat (ERS 2000). Thus, food away-from-home is an important part of American diets and more informed dietary choices away-from-home can potentially helpreduce the risk of health problems such as obesity. Nutrition labeling on menus, including the use of claims and symbols, is one way to help consumers make more informed dietary choices. The effectiveness of labeling, however, depends largely on how consumers respond to the measure. Although the
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NLEA does not mandate restaurant nutrition labeling, there is a body of research that has investigated consumer responsesto nutrition labeling on food away-from+home. A number of experimental studies have examined consumer behavior in cafeteria, restaurant and vending machine settings in responseto nutrition information or health messages. The results of these studies are mixed; differences in results among studies may be due to differences in experimental designs, including size of sample, demographic characteristics of participants, experimental setting, length of study, type of nutrition information or health messageand type of behavioral outcome studied. In a British college cafeteria, display of calorie and nutrient content of food items on the menu board had a negative effect, resulting in higher calorie and fat intake at lunch (Aaron et al 1995). The differences were greater for males and for less restrained eaters. The authors stated that the results indicate the importance of assessingthe motivational choibes of potential recipients of nutrition education programs. A second study in a British sit-down restaurant with a limited menu found fewer participants selected an entree marked as a lower fat option, although the difference was not statistically significant (Stubenitsky et al ). However, those selecting the lower fat entree had lower calorie and fat intake both from the entree and from the complete lunch. Sensory expectations and post-meal acceptancemeasureswere similar for the entree in its regular or lower fat version, both when the lower fat version was labeled and when it was unlabeled. In a cafeteria for the general public, prominent labeling of certain items as “lower caloric selections” had no effect on calories eaten or perceived calories eaten, either among restrained eaters (dieters) or unrestrained patrons (Johnson et al 1990), Restrained eaters did choose lower calorie meals, but their choices were not related to the presenceof the ‘ lower caloric selection” label. In a college cafeteria, changes in the proportion of patrons choosing items from various food groups resulted from labeling the Faloric content of food items, high~ghting healthier choices with a symbol, or providing tokens for monetary incentive for healthier choices (Cinciripini). Changes in food group selection with labels or tokens were&f&rent for males and females and for lean, normal or obese participants. Overall, calorie labeling decreasedthe selection of starchy foods and red meat items; healthier selection labeling ,with ,incentive tokens increased the selection of vegetables/soupKruit/lowfat dairy, chicke~~s~~rkey and salads and decreasedthe selection of high fat/dessert/sauces. In a family-style, table-service restaurant, special healthful entrees were highlighted by rotating messages:a nonspecific message,a healthfulness messageand a taste plus healthfulness message(Colby et al). Sales of the healthful chicken or tuna entrees were higher when the taste plus health messagewas used than with the health alone message. One recent study compared the effect of health messagesand and together, on the purchase of healthy food items in a counter-serv restaurant (Horgen and Brownell 2002). Price decreasesalone, rathe decreasesand health messages,were associatedwith increased purchases of some healthy food items over a 4-month period. The authors suggestedthat health messagesmay have paradoxical effects if foods labeled as healthy are assumedto taste bad. Restaurant patrons at a table-servioe restaurant for university students and staff indicated their labeling preferences among menus using an apple symbol to highlight healthy selections, menus using colored dots to highlight specific nutrition guidelines, or a leaflet listing numeric values for nutrient content (Almanza and Hsieh). Both the apple symbol and the leaflet were preferred over the colored dots, and were considered more attractive, less time-consuming and

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easier to use. The apple symbol was preferred over the leaflet by women patrons and those younger or less educated. However, this study did not examine whether patron labeling preferences were related to consumption behavior. Previous FDA research has suggestedthat label format preference does not necessarily equate to format effectiveness (Levy, Fein, and Schucker 1992). An experimental study, conducted by mail using a consumer household research panel of primary food shoppers, found interactions between the effects of a heart disease claim and a Nutrition Facts panel on either a package for a frozen lasagna entree or a menu listing a lasagna entree (Kozup, Creyer, and Burton 2003). When no nutrition informationwas present and there was a heart disease claim on the package or menu, subjects thought that regular consumption would reduce the risks of heart diseaseand stroke, and the claim had a positive effect on their attitudes toward the food, its healthiness, and intention to purchase the food. Regardless of presence or absenceof the heart diseaseclaim, better nutrient content had,a positive effect on perception of the food’ relationship to heart diseaserisk as well as a positive effect on attitude s toward the food, the healtfulness of the food and intention to purchase. Poorer nutrient content had corresponing negative effects. Addition of the claim to positive nutritian information further increased the perception of reduced heart diseaserisk, but did not increase other positive attitutes compared with nutrition information alone. Addition of the claim to neganve nutrition information (inconsistent with the claim) had no effect on product evaluationsand led to a negative impression of the credibility of the manufacturer or restaurant marketing the food. In a further experiment, evaluations of a menu item were afhectedby alternative items presented. If the nutrition information of alternative items was more favorable, then theevaluations of the item were less positive, and vice versa. This suggeststhat the alternative or nontarget menu items served as a reference for the target items. If the nutrition information of alternative items was present, then the positive effect of the heart diseaseclaim was limitedto perception of the food’ reduction of heart diseaserisk. s Practical problems in restaurant labeling and obstaclesto labeling as reported by large restaurant chains have been reviewed (Boger 1995, Almanza 1997). Problems include the fact that NLEA guidelines were developed for packaged foods, not restaurant food, with respect to serving sizes and criteria for health and nutrient content claims; different sized portions for lunch and dinner; variability of menu item from day to day. A suggestion for further research was whether consumers use nutrition information on packaged foods dift?erentIythan in restaurants (Almanza 1997). In summary, consumers have mixed reactions to nutrition information in ctieterias and restaurants. Both health claims and listing of nutrition information have been found to be capable of producing positive influences on consumer evaluations of menu items and the influences appear to be strongest when nutrition information about alternative menu items is absent. Although nutrition information may influence choices and attitudes, other factors may be more salient: whether the respondent is on a diet, attitudes toward nutrition, price of food, health claim vs. nutrition information, taste/perceived taste. Restaurant references Aaron, J, Evans, R,. Mela, D. 1995. Paradoxical Effect of A Nutrition Labelling Scheme in a Student Cafeteria. Nutrition Research.lS(9): 125f-1261. Almanza, BA., Hsieh, HM-Y. 1995. Consumer Preference Among Nutrition Labeling Formats in a Restaurant. Journal of the American Dietetic Association. 95(1):83-84.

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Almanza,BA., Nelson,D, Chai, S. 1997.Obstacles Nutrition Labelingin Restaurants. to Journal of the AmericanDietetic Association.97:157-161. Boger,A. Food Labelingfor Restaurants versusFiction. 1995.Cornell Hotel and Fact Restaurant AdministrationQuarterly.36:62-70. Cinciripini, PM.. 1984.ChangingFood Selections a Public Cafeteria.BehaviorModification. in 8(4):520-539. Colby, J, Elder, J, Peterson, Knisley, P>Carleton,RA. 1987.Promotingtie Selectionof G, Healthy Food ThroughMenu Item Descriptionin a Family-StyleRestaurant. J Prev Am Med 3(3):171-177. Horgen,KB, Brownell, K. 2002. Comparison Price Changeand Health Message of Interventionsin PromotingHeiilthy Food Choices.Health Psychology.21(5):505-512. JohnsonWG, CorriganS., SchlundtDG. 1990.DubbertPM. Dietary Restraintand Eating Behavior in the Natural Environment.Addictive Behaviors15:28!+2@. Kozup JC, CreyerEH, Burton S. 2003. Making HealthfUlFood Choices,: Influenceof Health The Claimsand Nutrition Informationon Consumers’ Evaluatiotx of Packaged Food Products and Restaurant Menu Items;Journalof Marketing 67:19-34. Stubenitsky, Aaron, JI, Catt, SL, Mela, DJ. 2000.The influenceof recjpemodificationand K., nutritional informationon restaurht food acceptance macron#rient intake.Public and HealthNutrition. 3(2):20l-209.
Restaurant studies from the Economic Research Service

An analysisof studiesreceivedTom the USDA ‘ Economic Researqh Service(their own and others)show that eatingaway Tom home,particularly increasing con$umption fast food in restaurants, correlatedwith increases BMI. Further,the per capitanuimber restaurants a is in of in statewas positively relatedto individual’ BMI and the probability of being overweight. These s studiesare summarized the following charts,usedcourtesyof USDA ERS. in

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he&on \uthor(s)

1 (and 4): Correlations Source

between BMI and Consumption Title Data Source

of Foods Away From Home (FAFH) Dependent Variable Estimated Effect of FAFH-Specific The average man who was 1.77m tall and consumed restaurant food was .Q kg heavier than those who did not eat at a restaurant. If he consumed food at FF places, he was .8 kg heavier. The average women who was 1.63m and consumed restaurant food weighed .2 kg more than a woman who did not consume FF. Estimated Effect of FAFH-General

linkley, tales, and iekanowski

International Journal of Obesity (2000) 24, 1032-I 039

“The relation between dietary change and rising US obesity“

CSFll 19941996 BMI

.in, Huang, ind French

;hou, ;rossman, ,nd Saffer

Submitted to the International Journal of Obesity “An Economic Analysis of Adult Obesity: Results from the behavioral risk factor surveillance system.”

‘ Women’ and Children’ s s Body Mass indices

NBER: Working Paper 9247 h~p:li~.n~r.orglpapers lwQ247

All Women: a 1% increase in FAFH was associated with an I:28 point 1994-I 996 increase in BMI. For high income and 1998 women, this was associated with a BMI CSFII 1.63 point increase in BMi Increasing the number of restaurants was estimated to increase BMI by ? .7% and increase the probablity af being obese (PO) by 9%. l&easing the price of fast, restaurant and ho’ me food was estimated to increase BMI by respectively, These 1984-1999 Reported and 5, .2 and .3?Y?? BRFSS Adjusted BMI prices were estimated to increase the All respondents: a 1% increase in FAFH was essociateql with an,.93 point increasein BMi. For women, this was asso&ated with a 1.24 point increase. No significant increase for men

For men, both fast food and restaurar consumption positively and significanky impacted BMI. For women, only FF consumption positively and significantly impacted BMI. For all women, increasing the percent of meals consumed away from home significantly increased BMI. When seperating by income, effect was still significant for higher in&me women (>I 85%, of poverty level). No such correlation for lower income women. No significant correlation for children either.

The per capita number of restaurants in a state ‘ was positvely related to an individuai’ BMI and probability of s being overweight. FF, Restaurant and Home Food prices were all negatively related to BMI ..

Luchler and .in

“The lnffuence of ln~~~d~al choices and attitudes on triternational Journal of adiposity’ Obesity (2000) 26

CSFII lQQ4BMI 1996

‘ ariyam

No title

ERS Presentation

NHANES I Follow-up BMI study

Overall, and for women, increasing the percent of meals consumed away fror home significantly increased BMI. Among those who consumed >I 0% c Among the individuals who consumed cals away-from-home 39.3% became <=lO% of cals away-from-home, overweight, and 18% went from 34.2% of healthy weight became overweight to healthy weight. (Note overweight over a 20-year period and this was only a simple bivariate 28% went from overweight t healthy anaysis, so keep the usual caveats in weight. mind.)

Mancino

PhD Thesis

“American‘ Food s Choices: The Interaction of Information, Infentions, and Convenience

CSFI I 19941996

Evaluated at the sample means an Evaluated at the sample individual who at a means and using the RDI, a meal from home, m&n whb ate a meal from a restaurant, or a home, a restaurant, or a fast fast food Per Meal food restaurant consumed restaurant Caloric Intake and average of 807, 1097 consumed an and Per Meal and 1041 calories at that estimated 24, 30, and 32 percent of Percent of meal. A woman consumed Calories From 503,70?, and 664 calories, his or her calories respectively from fat Fat

er is Are nutritive Labels Effective CSFII 19941996 calstiesikg less dense than FAFH

I

Varivam

In the works

88

Comparison

of Total Calories and Caloric Density of Foods Prepared

At Home and Food Prepared Away From Home

153

118

10s

142

IC

1222

1570

1588

1721

162

calories per 1,000 SampleChildren

6.4 aged 2-l 7

8.2

6.6

6.2

5.2

4.9

6.7 7.3 6.9 Source: Lin, Guthrie, and Frazao 2001

6.2

6.2

5

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Appendix B. Sample Annotated Bibliography Entries

Focus Kim et al. (2000) look at the impact that use of nutrition labeling has on five nutrient intakes (calories from total fat, calories from saturated fat, cholesterol, dietary fiber, and sodium). They use data from the 1994- 1996 Continuing Survey of Food Intakes by Individuals (CSFII) and the Diet and Health Knowledge Survey (DHKS). They control for self-selection to use labels with an endogenous switching regression model. Use of the endogenous switching regression model allows them to also look at factors that influence label usage.

As noted, the data comes from the 1994- 1996 CSFII and DHKS. They use observations on 5,203 individuals that completed both the day-l and day-2 surveys and that had complete data otherwise. No indication is given of the sample size relative to the total sample. In forming the variable that measures label use, they convert a four-point scale to a binary yes/no variable. Respondentswere asked about their frequency of label use for each of the five nutrients studied in the analysis. They were given four response options: “often,” ‘ sometimes,”“rarely,” “ and “never.” Kim et al. convert “often,“ “sometimes,”and “rarely’ responsesinto ‘ ’ ” yes” answers and “never” responsesinto “ no’ answers. This differs i2om the mapping used by Guthrie et al, ‘ ” (1995). Statistical Methodology The switching regression framework employed by Kim et al. is a standard application of this method. Maddala (1983, Section 8.3) provides a treatment of this method, In brief, the model involves estimating separateregressions for label users andnon-usersfor aach ofthe five nutrients. A third equation that uses the label use decision as a dependent variable is also estimated. The three equations (nutrient intake for label users, nutrient intake for label non-users, and the decision to use labels) are not independent and have non-zero correlations across the error terms. The system is estimated using full information maximum likelihood. To estimate the impact that food labels have on nutrient intakes, Kim et al. follow a standard method employed in switching regression models. First, they calculate the.predicted values for nutrient intakes for label users. This is done for each nutrient using the label user equation. Next,

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they calculate the predicted values of nutrient intakes for label users usingthe label non-users’ equation. That is, they take the label users and generate predicted values for nutrient intakes using the label non-users equation. The difference in the mean values of these ,predicted values representsthe impact of label use on nutrient intake. Results The results of their statistical analyses indicate that label use has beneficial impacts for each nutrient. The use of labels is associatedwith:‘ * 0 A 16.1 percent decreasein the intake of calories from fat; 0 A 15.1 percent decreasein the intake of calories from saturated fat: l A 2 1.O percent decreasein the intake of cholesterol; l An 87.1 percent increase in the intake of dietary fiber; and * A 0.9 percent decreasein the intake of sodium. None of the estimated impacts were judged for their statistical significance, even though this is possible in a switching regression model. Kim et al.‘ analysis also look at the factors that influence label use. Tbey:find that income, s education, a good knowledge of diet-health issues, being on a special dief exercising regularly, and being the family meal planner are all positively associatedwith label.use. Factors that are negatively associatedwith label use include: household size, age, being male, living in a nonmetropolitan area, using food stamps, and being a smoker. Relation to CFSAN Study This study is highly relevant for the CFSAN study.
l

* 0

The study focuses on the same issues that the CFSAN study will look at: how does use of labels affect nutrient intakes and what factors influence use of labels. The study uses the same data that will be used in the CFSAN analysis. We anticipate use of a similar method as is used in this analysis. Comments

l

l

The study looks at five nutrient intakes, which are likely to be rel@ed to one another. The method, however, does not attempt to account for any cross-equation relationships. We suggest that a seemingly unrelated regression (Z&JR)framework be investigated for use in combination with this method to capture cross-equation relationstips. The use of a binary variable for label use may be too simplistic. We expect that more than three categories can be specified: ““aLwaysuses labels,” “sometimes or rarely uses labels,”

28 Estimated percentages reflect our conversion resultsreported Table5 of the paperto percentage of in numbers. In calculating these, dividedthe “Before UsingNutrition Label”cohnnnby the “Net Change” we columnfor the “AverageNutrientIntakes.”

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l l

and “never uses labels.” This would complicate the switching regression framework, but not to an unmanageabledegree. This would also alluw CFSAN to look at how influencing consumers that are “never” users to become.“ sometimes?users would affect ‘ nutrient intakes. Additionally, CFSAN could look at how influenc.$ng“sometimes” users to become “always” users would affect nutrient intakes. The statistical method does not appear to account for sampling weights. Restricting to respondentsthat are in both the day-l and day-2 survey may result in sample selection that is uncontrolled by the switching regression &mework. Closely Related

Guthrie et al., 1995

Focus Gutbrie et al. (1995) look at the impact of the use of food labels on the intake of 26 food components (e.g., protein, total dietary fat, etc.). They use data t?om the 1989 Continuing Survey Survey (DHKS). of Food Intakes by Individuals (CSFII) and the Diet and Health Know1 They control for self-selection to use labels with Heckman’ se&selection model. As part of s their analysis, they also examine factors that influence the use of food labels.

The study uses data from the 1989 CSFII and RHKS. Their sample consists of 1,901 individuals that responded to the DHKS portion of the survey. The 1989 CSFII was designed to collect three days of food consumption data from respondents.The fiit day was (day-l) was collected using the 24-hour recall method (i.e., ‘ What did you eat in the last 24 hours?“). The second and third “ day data were collected through a a-day food record. Guthrie et al, only use the day-l data in this study. They note that 1,548 respondents (of the 1,901 that completed the DHKS) submitted a full three days of food consumption data. Their reason for using the day-l dam only is to maintain sample size. The study uses sampling weights in the statistical analysis, when appropriate. The sample design for the CSFIVDHKS calls for over-sampling of low-income households. Thus, the use of sampling weights in the analysis controls for the survey design.

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In forming the variable that measureslabel use, Guthrie.et al. convert a four-point scale into a binary yes/no variable. Respondentswere asked about their frequency of label use for each of the five nutrients studied in the analysis. They were given four response options: “often,” “sometimes,” “rarely,” and “never.” Guthrie et al. convert ‘ often” and ‘ sometimes”responses “ “ into “yes” answers and “rarely” and “ never” responsesinto “no” answers. This differs from the ‘ mapping used by Kim et al. (2000). Statistical Methodology The authors follow Heckman’ standard model of self-selection to generate the coefficient s estimates. In their analysis, individuals self-select.to use nutrition labels..They first estimate a probit model for label use and then calculate the inverse mills ratio for each individual in the data. The inverse mills ratio is then added to the regression models that use the 26 food components as dependent variables. They estimate only one label-use equation rather than one for each food component. This differs from the Kim et al. (2000) study, where a separatelabel use equation was estimated for each of the five nutrient intakes investigated. The basic regression equation for the food components regressesthe amount of the food component on a set of explanatory variables that includes a zero-one binary variable for label use. The addition of the inverse mills ratio to the equation controls for seli’ -selection to use labels. One interesting aspect of this study is its use of principal components analysis (PCA) to pare down the number of variables that reflect individuals’ “attitudes and values’ that guide them in ” making food choices. The DHKS asks a number of questions regarding thw:individuals’ preferences for either avoiding or ensuring the consumption of various food components. Inclusion of all of these variables in a regression framework would lead to significant multicollinearity. Using PCA, the authors are able to reduce the number of variables that reflect food choice values to two factors, thereby-overcoming the multicollinearity problem. Results In the article, the authors only present the estimated coefficient for the zero-one binary variable for label use and the coefficient for the inverse mills ratio rather than the full regression model results (26 equations). For the 26 equations, only two show a significant impact of label use: higher intake of Vitamin C and lower intake of cholesterol. Additionally, self-selection only appears to be an issue for Vitamin C and cholesterol intakes. Relation to CFSAN Study This study is highly relevant for the CFSAN study.
l

l l

The study focuses on the same issuesthat the CFSAN study will look at: how does use of labels affect nutrient intakes and what factors influence use of labels. The study uses the same, but earlier, data that will be used in the CFSAN analysis. We anticipate use of a similar method as is used in this analysis.

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Comments The study looks at 26 nutrient intakes,which are likely to be relatedto one another.The methoddoesnot attemptto accountfor any cross-equation relationships. suggest We that a seeminglyunrelatedregression (SUR) frameworkbe investigated usein for combinationwith this methodto capturecross-equation relationships. 0 The useof 26 nutrient intakesis very broad.It appears this restrictswhat they can that say on any one nutrient intake. l The study’ useof a binary variablefor label usemay be too,simplistic, We expectthat s threecategories be specified:“always useslabels,””sometimes rarely useslabels,” can or and “never useslabels.” l Restrictingthe sampleto the day-l dataonly may influencethe resultsto an unknown the degree.The useof day-l dataonly was basedon maintainingsam le size.Res&icting sampleto individualswith threedaysof datamay alsoresult in bias,however. Nevertheless, may be possibleto developa panelanalysis(individualsover days)that it accountsfor sampleattrition (i.e., individualsthat do not provide day-2 or day-3 data). This would expandthe nutrient inmkedata. * The resultsare not convincingthat labelsinfluencediet. Only two ofthe 26 food components, eight percentof the ‘ or regressions, a significant.,coefficient label have for use.At a five percentlevel ofsignificance we can expectto be “wrong” abouta statistical inferencefive percentof the time. This setof resultscomescloseto that critical cut-off. More convincingresultswould involve a significantcoefficientin one-thirdor more of the regressions. l Not providing the full regression resultslimits our ability to fully assess study.It this would be interestingto seethe signsand significanceof all other variablesincludedin the analysis.
l

CloselvRelated Kim et al. (2000)

94

C. Sample Pages from Spreadsheet of Restaurant Web Sites

95

1

I

1

I

lOdiiie m&i

with 06 nutrition infd

I

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APPENDIX H - Developing Effective Consumer Mesxsages Effective consumer health messagesabout weight management and obesity prevention should be research-basedand take into account the values, beliefs, mojtivations, needs and behavi.orsthat comprise the “consumer reality” of the target audience. It is important that these messagesbe clear, simple, and understandable and do not undermine the credibility and impact of public health agencies. There are six key questions to consider when developing research-basedmessagesthat encourage knowledge utilization:
1. What is the purpose?

2. 3. 4. 5. 6.

Who is the target? What is the promise (i.e., motivators)? What is the support? What is the image? Where are the best opportunities for delivering the messages?

In determining the target audience(s) for research-basedmessages,it is important to consider that communication theory holds that more direct, population subgroup-focused messagestypically have greater impact than messagesthat addressa wider audience (e.g., the general public). At the same time, overweight and obesity have been identified as a national health problem, so it seems important to develop focused messagesthat affect large population subgroups. Among private sector organizations, IFIC has been prominent in recent efforts to develop effective nutritional messages. IFIC uses a five-pa&system (Borra et $., 2003): 1. 2. 3. 4. 5. Defining the relevant issues Developing the initial message(s) Examining candidate messagesin focus groups Refining the messages Validating the messagesin quantitative surveys

IFIC has~drawna number of conclusions from its efforts, many of which are supported by other researchers(Marietta et al., 1999; Kennedy and Davis, 2000; Borra et al., 200 1; Patterson et al., 200 1; Balasubramanian and Cole, 2002; Ikeda ebaZ.,2002; Gans et al., 2002; Borra et al,, 2003; Gans et aZ.,2003; IFIC 2003): 1. Consumers will not react positively to messagesunless the messagesset forth concrete goals that consumers view as achievable. 2. Consumers perceive general nutrition guidelines as too abstract and requiring too much planning and calculation to translate into action.

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are that and 3. Consumers receptiveto messages makedirect, concretesuggestions thereforeprovide tools with which consumers exercisechoice, Consumers may resistbeing told what they must do. ratherthan monolithic so that consumers receive can 4. Goalsshouldbe incremental continuouspositive feedback.Concreteand incremental goalssustainand reinforceconsumers’ desirefor autonomy. Equally importantis that settingand achievingincrementalgoalsprovidesmore opportunitiesfor reinforcement(both self and external),which is importantfor sustaining positivebehaviors. Consumers view monolithic goalsas unrealisticbecause would haveto make they substantial changes diet and.habits. in on of 5. Overemphasis one or a few nutritional components a diet may impedethe overall goal of achievinga healthy,varied diet. shouldbe developed with an awareness the of 6. Health and nutrition messages varied cultural backgrounds found amongthe Americanpublic; different ethnic and cultural groupsexhibit different dietarypatternsand practices. In qualitativestudies,consumers claim they do not wish to spenda significantamountof time readingand comprehending labels, This is borneout by the fact that many use healthor nutrient contentclaimsas indicatorsas to the overall qualityof the productand do not checkthe nutrition factspanelon the back (Roe,, al., 1999). Also, consumers eb appearto be confusedby servingsizes,particularlyby multiple servingslisted on small packages, well as by the %DV listed in the nutrition factspanel. Consumers food as use labelsfor multiple reasons, including diet plansand pre-existinghealthconditionssuchas diabetes heart disease, look for macronutrients concern. On the other hand, and and of taste,convenience, price, mood and family preferences influencepurchases are often and for at oddswith healthyeating. Suchfactorspresentchallenges developingeffective messages. Other findings indicatethat adultsdo not like “diets”and do not believethey work over the long term (Borra et al., 2003). They also questionwhetherthere i$any new nutrition informationthat they will find useful. Also, the qualitativestudiesfound that encouraging parentsand childrento work togetherresonated, did messages as promoting needto hearnew kinds of information, betterappearance2’ seIf-esteem.Consumers and or a re-packaging old informationin new and relevantways,that will serveas of “motivation to jumpstartnew thinking and behaviors.”

2gAt this time, FDA doesnot intendto use“betterappearance” a motivatorfor any of its obesity as messages, giventhe largerconcern aboutthe effect sucha focusmay haveon thosewith eatingdisorders (e.g.,anorexia bulimia). and

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APPENDIX I - Power of Choice Power of Choice
The Power of Choice is an after-school program developedjointly by FDA and USDA’ Food and s Nutrition Service. The materials guide pre-teens toward a healthier lifesty@by motivating and empowering them to make smarter food and physical activity choices in real-lifa setiings. A Leader’ Guide, containing ten sequenced interactive sesQo+ engage adola?+?ntsin fun activities s that develop skiits and encourage persdnal developmsnt related to choosirig ,foodswisely, preparingfoods safely, and reducing sedentary behaviors. Most acfivities require little or no preplanning and are simple to do. The Leader’ Guide also includes easy sn k recipes, 170 Nutrition s Facts cards, and posters on four key topics, and a computer disk provides~upp~emen~tactivities to each of the IO sessions, a self-training video for the leader, community support suggestions, and much more. Current status: Currently, the Pawerof Choice is being.distributedeither in hard copy or it can be downloaded on the Team Nutrition Web site, USDA’Fabd ind Nutrition s&v&e~ (http://www.fns.usda.gov/tnlResources/power-of-choice.htm~). the origirtal 15,000 copies Of published, less than 4,000 copies remain for free distribution to those beloflging to USDA’ Child s Nutrition Programs (includes schools). Response from users has been vir&alfy unanimously positive: “One of the best government products I’ seen in a long time”; “1 love this material. ve Please send me more”; “I think it’ great! Exciting!! I’ been rieeding something like this-thank s ve you for doing such a great job”.

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