Executive Summary Dietary supplements, a category including everything from vitamin A to zinc, have long been regulated under

a different set of standards than those governing food or prescription and overthe-counter drugs. 1 During the 111th Congress, which ended in December 2010, lawmakers pushed legislation expanding regulatory agencies’ authority over the supplement industry. 2 The supplement industry increased spending on lobbying, successfully fighting several efforts to increase oversight and winning help from lawmakers who were among the largest beneficiaries of industry campaign contributions. Background The Food and Drug Administration (FDA) regulates dietary supplements under the Federal Food, Drug, and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA). 3 Under the DSHEA, supplement manufacturers and distributors are fundamentally responsible for ensuring product safety. 4 Since the passage of the DSHEA, the supplement industry has boomed. Sales of dietary supplements reached approximately $23.7 billion in 2007, up from $17.1 billion in 2000, and more than half of American adults use them. 5 Nevertheless, the FDA did not have premarket approval for dietary supplements except in cases of new dietary ingredients. 6 It took the FDA 10 years to meet the burden of proof to ban ephedra, a stimulant used in weight loss and bodybuilding products eventually linked to at least 155 deaths and thousands of health problems. 7 In 2006, in the wake of the ephedra scandal, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a law requiring supplement
                                                            
http://www.fda.gov/Food/DietarySupplements/default.htm. Dietary Supplement Safety Act of 2010, S. 3002, 111th Congress, February 4, 2010; FDA Food Safety Modernization Act, H.R. 2751, June 8, 2009. 3 http://www.fda.gov/food/dietarysupplements/consumerinformation/ucm110417.htm. 4 Id. 5 U.S. Government Accountability Office, Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding, GAO-09-250, January 2009; FDA’s Progress with Dietary Supplements, House Committee on Government Reform, 107th Congress (March 20, 2001) (Testimony of Joseph Levitt, Director of the Center for Food Safety and Applied Nutrition), available at http://www.fda.gov/NewsEvents/Testimony/ucm115229.htm. 6 Id. 7 Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding, GAO-09-250, Jan. 2009; U.S. Government Accountability Office, Dietary Supplements Containing Ephedra: Health Risks and FDA’s Oversight, GAO-03-1042T, July 23, 2003; Lauran Neergaard, FDA Finalizes Ephedra Ban; Sales Must Stop in April, Associated Press, February 6, 2004.
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manufacturers, packers, and distributors to report serious adverse events associated with the use of dietary supplements. 8 In 2009, a Government Accountability Office (GAO) report recommended the FDA request additional power to oversee the dietary supplement industry.9 In May 2010, GAO issued a another report, highlighting its discovery of trace amounts of at least one potentially hazardous contaminant - lead, mercury, cadmium or arsenic - in 37 of 40 herbal dietary supplements tested. 10 The report also found some dietary supplements commonly used by the elderly to be deceptively or questionably marketed, and the GAO said weaknesses in the regulatory system could increase the likelihood of unsafe products reaching the market. 11 Legislative Landscape In February 2010, Sens. John McCain (R-AZ) and Byron Dorgan (D-ND) introduced S. 3002, the Dietary Supplement Safety Act of 2010. 12 This bill would have required dietary supplement manufacturers to fully disclose ingredients. 13 It also would have given the FDA mandatory recall authority when a supplement was found to be unsafe or harmful, and it would have required reports to the FDA of even non-serious adverse effects. 14 Less than three weeks after he introduced S. 3002, Sen. McCain said “opponents to this bill and their well-paid Washington lobbyists have spread false statements and rumors about the legislation” and “proudly boast that they remain largely untouchable by the FDA.” 15 That proved correct. Less than a month later, dietary supplement trade groups declared victory. Trade groups credited Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA) with influencing Sen. McCain to pull back. 16 Sen. McCain released a March 4, 2010 letter from Sen. Hatch thanking Sen. McCain “for agreeing to withdraw your support for the provisions of S. 3002 that I believe would do great harm to the dietary supplement industry.” 17 Notably, Sen. Hatch was the largest recipient of industry contributions in the 2010 election cycle, even though he was not up for reelection. Sen. Harkin, chairman of the Senate Committee on Health, Education, Labor, & Pensions, which had jurisdiction over Sen. McCain’s bill, was the third largest recipient. 18
                                                            
Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006, Public Law 109-462, 109th Congress, December 22, 2006. 9 Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding, GAO-09-250, Jan. 2009. 10 U.S. Government Accountability Office, Herbal Dietary Supplements: Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice, GAO-10-662T, May 26, 2010. 11 Id. 12 Dietary Supplement Safety Act of 2010, S. 3002, Feb. 4, 2010. 13 Id. 14 Id.; Dietary Supplement Safety Act of 2010, S. 3002, Feb. 4, 2010. 15 Sen. John McCain, Remarks on S. 3002, Congressional Record, 111th Congress, February 22, 2010. 16 http://www.anh-usa.org/update-on-senator-mccain%E2%80%99s-anti-supplement-bill-dssa-s-3002/; Press Release, Natural Products Association, NPA Welcomes Senate Deal on S. 3002, March 11, 2010. 17 Letter from Sen. Orrin G. Hatch to Sen. John McCain, March 4, 2010, available at http://mccain.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore_id=02d6dc8f-2fa8-42bf-80ef8e285e6c7020. 18 Dietary Supplement Safety Act of 2010, S. 3002, Feb. 4, 2010; http://harkin.senate.gov/abouttom.cfm.
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Less than a week after Sen. Hatch’s letter, Sens. McCain and Dorgan sent a letter to Sens. Hatch, Harkin and Sen. Mike Enzi (R-WY) writing that they had found agreement on some points, including giving the FDA mandatory recall authority “if there is a reasonable probability that any dietary supplement is adulterated or misbranded or the use of such supplement could cause serious adverse health consequences such as death.” 19 Sens. McCain and Dorgan said they would work to add those agreed-upon provisions into existing food safety legislation. 20 Meanwhile, S. 3002 stalled in committee. 21 The food safety bill gave the FDA new powers to help it detect and respond to food safety problems, including the ability to order a recall of products (including dietary supplements) that could cause serious adverse health consequences or death. 22 Food safety legislation won final passage from both houses of Congress in December 2010. 23 President Obama signed H.R. 2751, the FDA Food Safety Modernization Act, on January 4, 2011. 24 Though dietary supplements are subject to the FDA’s new mandatory recall powers and other parts of the food safety bill, the industry’s lobbying efforts successfully blunted several provisions. After the bill passed the Senate, the Alliance for Natural Health-USA (ANH-USA), an industry advocacy group that promotes access to alternative treatment and dietary supplements, took credit for some modifications. 25 Those changes included the removal of criminal penalties the group said directly targeted supplement manufacturers who “violate complicated FDA rules.” 26 Another victory involved beating back a provision the industry said pushed the U.S. towards harmonizing its standards with international standards on food safety, which, ANH-USA feared, would lead the U.S. closer to adopting European restrictions on supplements. 27 ANH-USA successfully inserted language into the bill saying nothing in that provision should be construed to affect the regulation of dietary supplements. 28 The trade group also said it plans to monitor the FDA’s development of regulations required by the new law. 29

                                                            
Letter from Sens. John McCain and Byron Dorgan to Sens. Orrin G. Hatch, Tom Harkin and Michael B. Enzi, March 10, 2010, available at http://mccain.senate.gov/public/index.cfm?FuseAction=PressOffice.PressReleases&ContentRecord_id=6358dbb50dde-6cd0-28b3-3680d8d31be2&Region_id=&Issue_id=. 20 Id. 21 Dietary Supplement Safety Act of 2010, S. 3002, Feb. 4, 2010, see “All Congressional Actions” available at http://thomas.loc.gov/. 22 FDA Food Safety Modernization Act of 2010, Public Law 111-353, 111th Congress, January 4, 2011. 23 FDA Food Safety Modernization Act, H.R. 2751, June 8, 2009, see “All Congressional Actions” available at http://thomas.loc.gov/. 24 Id. 25 Alliance for Natural Health-USA, Food Safety Bill Update, November 30, 2010, available at http://www.anhusa.org/senate-food-safety-update/; http://www.anh-usa.org/main-menu/about/. 26 Id. 27 Id.; Alliance for Natural Health-USA, ANH-USA Victory! Supplements Are Exempted From Codex Language in Food Safety Bill, April 13, 2010, available at http://www.anh-usa.org/anh-usa-victory-supplements-are-exemptedfrom-codex-language-in-food-safety-bill/. 28 Id.; FDA Food Safety Modernization Act of 2010, Public Law 111-353, Jan. 4, 2011. 29 Alliance for Natural Health-USA, The “Food Safety” Saga: Our Job Is Just Beginning, January 4, 2011, available at http://www.anh-usa.org/the-food-safety-saga-our-job-is-just-beginning/.
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Also in 2010, ANH-USA accused Rep. Henry Waxman (D-CA) of introducing a provision into the financial regulatory reform bill that would have increased Federal Trade Commission (FTC) regulatory and enforcement authority, a broad change supplement industry participants said was aimed at restricting access to nutritional supplements. 30 Rep. Waxman has called the FTC’s jurisdiction “limited” and “hampered by a slow and burdensome rulemaking process.” 31 After the November 2010 midterm election, the Natural Products Association (NPA), an industry trade group, said it was watching the lame duck session carefully to make sure legislation granting additional enforcement power to the FTC wasn’t resurrected. 32 NPA Executive Director and CEO John Gay said “the shift in leadership in the House may help as Representative Henry Waxman must now give up the chairmanship of the Energy and Commerce Committee, although he remains in Congress.” 33 Lobbying The dietary supplement industry has steadily increased its lobbying spending over the past six years, going from roughly $3.5 million during the 109th Congress (2005-2006) to more than $6.4 million during the 111th Congress (2009-2010), an increase of approximately 86%. 34 Lobbying Total Amount 109th Congress (2005-2006) $3,471,032 110th Congress (2007-2008) $5,303,175 111th Congress (2009-2010) $ 6,446,189

                                                            
Press Release, Alliance for Natural Health-USA, Victory! The Anti-Supplement FTC Expansion Provision is Defeated—At Least for Now, June 29, 2010. 31 Silla Brush, Tough Fight for FTC to Gain More Regulatory Authority, The Hill, March 18, 2010. 32 Press Release, Natural Products Association, Election Brings Changes to Congress that Will Impact the Natural Products Industry, April 21, 2010. 33 Id. 34 Raw data for this section was compiled from searches of the Senate Office of Public Records, Lobbying Disclosure Act Database on January 12, 2011. Data for fourth quarter 2010 was compiled on January 20, 2010. CREW searched for all lobbying disclosures filed from 2005 through 2010 listing Alliance for Natural Health-USA (formerly American Association for Health Freedom), Alticor Inc., American Herbal Products Association, Coalition to Preserve Dietary Supplement Health and Education Act, Council for Responsible Nutrition, Embria Health Sciences, General Nutrition Centers Inc., Herbalife International of America Inc., Hippocrates Health Institute, Iovate Health Sciences Inc., Jarrow Formulas, Natural Products Association, Neways International, Pharmavite LLC, Sunshine Health Freedom Foundation or United Natural Products Alliance (formerly Utah Natural Products Alliance) as a client. We excluded from the study some large companies that manufacture dietary supplements and lobby on issues related to the industry, but have such broad legislative agendas that including them would have artificially inflated the industry’s lobbying and campaign contribution totals. The companies excluded include Pfizer, which in 2009 acquired Wyeth, maker of Centrum products and GlaxoSmithKline, maker of Beano and other dietary supplement products. As a result, totals represent the low end of the industry’s spending. In cases where those companies and groups lobby directly, CREW tallied only the lobbying expenses reported by their internal reports, to avoid double-counting lobbying spending. In cases where the companies and groups lobby only through external firms, CREW tallied lobbying expenses reported by the external reports. In some cases, companies had underreported lobbying expenses because external firms reported receiving more in lobbying fees than the clients reported spending on lobbying. In those cases, CREW tallied lobbying expenses reported by both internal and external lobbying reports.
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Dietary supplement companies strengthened their outside lobbying rosters in 2010, as legislation aimed at the industry moved through Congress. Right after Sens. McCain and Dorgan filed S. 3002, General Nutrition Centers, Inc. (GNC) hired law firm Brownstein Hyatt Farber Schreck to lobby on the legislation. 35 The Brownstein Hyatt lobbyists registered to advocate for GNC include former Rep. Larry LaRocco (D-ID). 36 Hippocrates Health Institute hired Capitol Strategy Consultants, Inc., also in February, to lobby on dietary supplement regulation and the food safety bill. 37 Jarrow Formulas Inc. hired Wexler & Walker Public Policy Associates in January 2010 to lobby on food safety legislation affecting dietary supplements. 38 In addition, the Coalition to Preserve DSHEA and the NPA are both represented by Walker, Martin & Hatch, a lobbying firm where Scott Hatch, Sen. Hatch’s son, is a partner. 39 In 2010, the firm lobbied for those clients on several bills, including efforts to derail Sen. McCain’s S. 3002 , and to pass S. 3414, the Dietary Supplement Full Implementation and Enforcement Act, a bill co-sponsored by Sen. Hatch. 40 The legislation, introduced in May 2010, would have authorized funds for enforcement of the DSHEA. 41 At the time, Sen. Hatch said the FDA did not need new regulatory authority, and “the laws already on the books are sufficient if the FDA has the resources and the will to fully enforce them.” 42 Sen. McCain credited Sen. Hatch with persuading him to withdraw his support of S. 3002. Lobbying reports from 2010 show that while Scott Hatch did not personally lobby on behalf of the Coalition to Preserve DSHEA or the NPA, both clients were represented by another partner at the firm, Jack Martin, a former aide to Sen. Hatch. 43 Walker, Martin & Hatch collected $125,600 from those clients in 2010. 44 Senate rules prohibit immediate family members from lobbying the office of their relatives.45 In the past, Sen. Hatch has addressed his son’s lobbying by saying, “My son, Scott, does not lobby me or anyone in my office. He is a very moral and ethical person.” 46
                                                            
Brownstein Hyatt Farber Schreck, Lobbying Registration 2010 on behalf of General Nutrition Centers, Inc., Secretary of the Senate, Office of Public Records; Brownstein Hyatt Farber Schreck filed a termination of its lobbying registration on behalf of General Nutrition Centers, Inc., on January 18, 2011. 36 Id.; http://www.bhfs.com/People/llarocco. 37 Capitol Strategy Consultants, Inc., Lobbying Registration 2010 on behalf of Hippocrates Health Institute, Secretary of the Senate, Office of Public Records. 38 Wexler & Walker Public Policy Associates, Lobbying Registration 2010 on behalf of Jarrow Formulas, Inc., Secretary of the Senate, Office of Public Records. 39 Walker, Martin & Hatch, LLC, Fourth Quarter 2010 on behalf of Parry Romani DeConcini & Symms (On Behalf of Coalition to Preserve DSHEA), Secretary of the Senate, Office of Public Records; Walker, Martin & Hatch, LLC, Fourth Quarter 2010 on behalf of Natural Products Association, Secretary of the Senate, Office of Public Records; Jim McElhatton and Jerry Seper, Sen. Hatch’s Secret Drug Firm Links, The Washington Times, March 2, 2009. 40 Dietary Supplement Full Implementation and Enforcement Act of 2010, S. 3414, 111th Congress, May 25, 2010. 41 Dietary Supplement Full Implementation and Enforcement Act of 2010, S. 3414, May 25, 2010. 42 Sen. Orrin Hatch, Remarks on S. 3414, Congressional Record, 111th Congress, May 25, 2010. 43 McElhatton and Seper, The Washington Times, March 2, 2009; Walker, Martin & Hatch, LLC, Fourth Quarter 2010 on behalf of Parry Romani DeConcini & Symms (On Behalf of Coalition to Preserve DSHEA), Secretary of the Senate, Office of Public Records; Walker, Martin & Hatch, LLC, Fourth Quarter 2010 on behalf of Natural Products Association, Secretary of the Senate, Office of Public Records. 44 Id. 45 Honest Leadership and Open Government Act of 2007, Public Law 110-81, 110th Congress, September 14, 2007. 46 McElhatton and Seper, The Washington Times, March 2, 2009.
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Campaign Donations 47 Total federal campaign donations by the employees and political action committees (PACs) of the 16 companies, trade associations and industry groups represented here ticked upward in the 2008 presidential election cycle, but fell back down during the 2010 cycle. However, donations from six industry PACs now make up a larger percentage of the industry’s total donations compared to donations from employees: 64% in the 2010 cycle compared to 45% in the 2008 cycle and 55% in the 2006 cycle. The trend towards giving through PACs indicates the dietary supplement industry is directing its donations more strategically. Campaign Contributions to Federal Candidates Company Employees and PACs Employees PACs 2006 Election Cycle $403,686 $183,650 $220,036 2008 Election Cycle $460,772 $254,838 $205,934 2010 Election Cycle $419,775 $150,495 $269,280

The growth in PAC contributions during the 2010 election cycle was fueled by increased contributions from three PACs. Alticor PAC’s contributions went up 65%, from $63,477 during the 2006 election cycle to $104,500 during the 2010 election cycle. The Council for Responsible Nutrition’s PAC contributions rose by 75%, from $17,708 during the 2006 election cycle to $31,000 during the 2010 election cycle. Pharmavite’s PAC more than doubled its political contributions, from $21,230 during the 2006 election cycle to $44,000 during the 2010 election cycle. Herbalife International’s PAC posted a 38% decrease, falling from $101,040 in contributions during the 2006 election cycle to $63,080 during the 2010 election cycle. The NPA’s PAC fell by 19%, from $16,581 in the 2006 election cycle to $13,500 during the 2010 election cycle. Finally, GNC’s PAC launched in 2009, and contributed $13,200 to federal candidates during the 2010 election cycle. 48

                                                            
Raw data for this section was taken from the Center for Responsive Politics on January 19, 2011 and CQ MoneyLine.com on January 18, 2011. CREW aggregated campaign donations from the past three campaign cycles from all donors listing Alliance for Natural Health-USA (formerly American Association for Health Freedom), Alticor Inc., American Herbal Products Association, Coalition to Preserve Dietary Supplement Health and Education Act, Council for Responsible Nutrition, Embria Health Sciences, General Nutrition Centers Inc., Herbalife International of America Inc., Hippocrates Health Institute, Iovate Health Sciences Inc., Jarrow Formulas, Natural Products Association, Neways International, Pharmavite LLC, Sunshine Health Freedom Foundation or United Natural Products Alliance (formerly Utah Natural Products Alliance) as their employer and all donations made by PACs of those companies to create our totals. 48 General Nutrition Centers, Inc. Political Action Committee, FEC Form 1, Statement of Organization, December 28, 2009.
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Top Recipients of Campaign Contributions – 2010 Cycle 49 Sen. Hatch was, by far, the largest recipient of donations from the dietary supplement industry, taking in $45,780 during the last election cycle, even though he was not up for re-election. Nutritional supplements are the third-largest industry in Sen. Hatch’s home state of Utah, with business revenues ranging from $2.5 to $4 billion per year. 50 The next largest recipient of supplement industry donations is newly elected Rep. Justin Amash (R-MI), who received $18,750 in the 2010 election cycle. Alticor’s world headquarters is located in Rep. Amash’s district, in Ada, Michigan. 51 Rep. Amash’s supplement industry donations were exclusively from Alticor’s PAC and employees. Sen. Harkin, who chairs the Senate Committee on Health, Education, Labor, & Pensions, was third, receiving $12,750 in donations from the dietary supplement industry. Fourth place goes to Rep. Frank Pallone, Jr. (D-NJ), who, during the 111th Congress, chaired the House Energy and Commerce Committee’s Subcommittee on Health, which has jurisdiction over the FDA. 52 He received $12,000. Rep. Jason Chaffetz (R-UT), a co-chair of the Dietary Supplement Caucus during the 111th Congress, reaped $11,000 in contributions, putting him in fifth place. 53

                                                            
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The raw data for this section was taken from the Center for Responsive Politics on January 19, 2011, and CQ MoneyLine on January 18, 2011. CREW aggregated campaign donations from the 2010 cycle from all donors listing Alliance for Natural Health-USA (formerly American Association for Health Freedom), Alticor Inc., American Herbal Products Association, Coalition to Preserve Dietary Supplement Health and Education Act, Council for Responsible Nutrition, Embria Health Sciences, General Nutrition Centers Inc., Herbalife International of America Inc., Hippocrates Health Institute, Iovate Health Sciences Inc., Jarrow Formulas, Natural Products Association, Neways International, Pharmavite LLC, Sunshine Health Freedom Foundation or United Natural Products Alliance (formerly Utah Natural Products Alliance) as their employer and all donations made by PACs of those companies to create the ranking. 50 Economic Development Corporation of Utah, Utah Nutritional Products Industry Profile, 2009. 51 http://www.alticor.com/resource-center/company-information/alticor.aspx; http://amashforcongress.com/map. 52 http://house.gov/pallone/biography.shtml. 53 http://cha.house.gov/index.php?option=com_content&view=article&id=181%3Acongressionalorganizations&catid=1%3Amember-services&Itemid=1.