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    Health Claims on Foods

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    37 views4 pages

    Health Claims On Foods

    Uploaded by

    David Schoneker

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    Health Claims Unraveling their Language on Food Labels by Mary L. Klatt and Rosean B. Termini ‘oatmeal because it is made from whole grain oats, a {good source of fiber, and helps lower cholesterol. We cat fruit for antioxidants and drink milk because calcium is good for our bones. We eat these foods each morning to main- {ain healthy diets, We read the labels on these foods and trust the health claims that appear on them, However, should we? ‘Avbealth claim isan expressed or implied daim on a label that characterizes the relationship ofa substance toa disease or health-related condition.’ A health claim has two components. First, there must bea substance, such as food, food compo: nent, ora dietary supplement. Second, there must bea disease ‘or health-related condition. “Calcium may reduce the risk af “osteoporosis” provides an illustration ofa health claim “Health claims garnered the spotlight inthe 1980s, when mar- keting strategies began emphasizing the role nutrition played in E ach morning we wake up ta healthy breakfasts, We eat promoting health. For example, the Kellogg Company launched an advertising campaign in 1984 for its All-Bran cereal urging consumers to maintain a healthy weight and eat a well- balanced diet consisting of low-fat, high-fiber foods, fresh rits and vegetables, The National Cancer Institute contributed to the advertisement. The health message stated thatthe National Cancer Institute “believes eating the right foods may reduce your risk ofsome kinds of cancer|" The public responded, as evidenced by the 37 percent increase in sales of high-fiber cere- alsin just one year? “However the US. Food and Drug Administration (FDA) did not recogoize health claims on food labels. Such labeling infcema tion about disease was deemed a drug claim’ FDA’ relnetance to allow health-related claims was rooted inthe Federal Food, Drug, and Cosmetic Act (DCA). The FDCA charged FDA with the duty to safeguard the public rom false and misleading health Ms, Kliatt is a 2007 graduate of the Widener ‘School of Law. FDL Ms. Termini isa food and drug lawyer who recently published Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements. “oan va| Urata 3 ‘information, Essentially this consumer protection stance resulted ina health- ‘elated claims ban’ Subsequent, FDA. relaxed is position based on the emerg- ing evidence linking diet and disease as ‘well as the public heightened interest in health and nutrition. easoned thatthe food label was an “appropriate vebicle” for ‘consumer education.? Health Claims under NLEA ‘Congress passed the Nutrition Labeling and Education Act (NLEA) in 1990. Considered milestone legislation, NLEA established a uniform system for labeling, ‘conventional foods and delegated to FDA the duty to both evaluate the validity of health claims and the regulation of their use." NLEA health daims must moet the significant scientific agreement (SSA) standard, codified by statute: ‘The Secretary shall proml- cate regulations authorizing claims... only ifthe Secretary determines, based on the total: ity of publicly availabe scien- tif evidence... that there is significant scientific agreement, ‘among experts qualified by sci- entific taining and experience to evaluate such claims, thet the claim is supported by such evidence. LEA required FDA to evaluate seven initial substancetdisease relationships under the SSA standard. In 1993, FDA approved these claims: calcium and osteo porosis; dietary lipids and cancer; sodium. and hypertension; dietary saturated fat and cholesterol and risk of coronary heart disease; fiber-containing geain products, fruits and vegetables and cancer; fruits, ‘vegetables and grain products that con- tain fiber, particularly soluble fe, and 1k of coronary heart disease and fruits and vegetables and cancer! Few additional dims have mastered the scientific credibility to meet the ‘SSA standard. The rigor ofthe standard thas been a source of contention among, ‘manufacturers attempting to promote thelr products through the use ofhealth claims, Critics have found the standard paternalistic shielding consumers from valuable health information when the ‘evidence supporting a claim falls short ‘ofthe standerd." Marketers have also attacked the standard for being imper- rmissibly vague and stifling free speech, In 1999, FDA was forced to clarify what the SSA standard meant following the landmark case of Pearson v Shalala In Pearson, FDA rejected four health dims for dietary supplements. FDA argued the evidence supporting the claims was “in- conelusve" and filed to give rise to “sig, nificant scientific agreement.” Rejecting DAsanalysis, the court stated that FDA never explained how it measured “signif cant” or otherwise defined the phrase" I hold that FDA was required to give some “definitional content to the phrase ‘ig- nificant scientific agreement™ ing why the claims were rejected.” Following Pearson, FDA issued guidance on the meaning of “significant scientific agreement FDA explained thatthe standard represented the agency’ best judgment in determining ‘whether qualified experts would likely agree thatthe scientific evidence sup. prs the proposed health claim. Wile "unanimous agreement is not demanded, in explain- sno magical number exists for determin= ing when the scientific community's ‘agreement becomes significant. "In the process of scientific discovery, sgnificent scientific agreement occurs well afer the stage of emerging science, where data and information permit an inference, but before the point of unanimous agreement within the relevant scientific community that the reference is valid” Subsequently, FDA approved afew ad ditional claims under the SSA standard folate and neural tube defects dietary sugar aleohol and cavities dietary soluble fiber, such as that found in whole oats and paylium seed husk and coronary ar tery diseases plant sterol estersand heart

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