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GAO Calls for More Dietary Supplement Regulation
GAO Calls for More Dietary Supplement Regulation In March 2009, a Government Accountability Office (GAO) report was released to the public that called for the US Food and Drug Administration (FDA) to have more authoritative oversight of the dietary supplement industry.1 The 77-page report, titled �Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding,� stemmed from a request of the House Energy and Commerce Committee, particularly Representatives Henry A. Waxman (D-CA) and Bart Stupak (D-MI), as well as Assistant Senate Majority Leader Richard J. Durbin (D-IL). For just over one year, GAO conducted a performance audit of FDA�s relationship and past actions with dietary supplements. Among several conclusions, GAO found that the agency cannot adequately identify safety concerns, dedicates relatively few resources to dietary supplement oversight, and has limited ability to efficiently and effectively remove what the agency might deem a contaminated or otherwise unsafe product from the market. An article in the New York Times, for example, noted that because FDA cannot require manufacturers to remove tainted supplements from stores, only 3 out of 69 brands of weight-loss products deemed as harmful in a recent FDA report had been voluntarily recalled (as of early March 2009).2 Based on its findings, GAO recommended that the FDA commissioner seek additional authority to oversee dietary supplements and improve consumer understanding of such products. It specifically called for the commissioner to require facilities and companies to provide more information about themselves and their products, such as a list of products and copies of their labels. It also suggested that FDA issue a guidance to clarify what is considered a new dietary ingredient (NDI) and explain the difference between dietary supplements and foods with added dietary ingredients. Furthermore, GAO called for the FDA commissioner to require reports of all adverse events, not just those that are serious. Though GAO recognized that the number of adverse event reports has tripled since mandatory reporting for serious adverse events went into effect in December 2007, it said underreporting remains a concern and noted that FDA has estimated that a total of more than 50,000 mild, moderate, and serious adverse events occur each year. In response to GAO�s recommendations, some industry organizations have voiced their opposition, with most disagreement surrounding the controversial recommendation that all dietary supplement-related adverse events be reported. �While we supported legislation to establish mandatory adverse event reporting for dietary supplements and over-the-counter drugs, we still believe that reporting should be limited to incidents that are serious,� said David Seckman, executive director and CEO of the Natural Products Association (NPA) at that time, in a press release.3 �If the FDA�s resources are already stretched, as the report indicates, then adding to this burden by mandating that any complaint be dealt with by the agency does not make sense,� he continued. NPA additionally disagreed that FDA doesn�t have enough information about individual dietary supplement products, citing that the industry has registered all manufacturing facilities under bioterrorism regulations enacted 5 years ago. Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), stated in a press release that requiring all adverse events to be reported would create more bureaucratic paperwork and would not result in true benefits for consumer safety.4 �The adverse event reporting law was carefully considered and supported by numerous stakeholders, including consumer groups, and there is no need to revise a law that only recently went into effect and appears to be working,� said Mister. FDA also recognized this potential problem in its response to GAO.1 The agency said that receiving an increased number of reports on all adverse events could make it more difficult to recognize signals of potential toxicity generated by reports of serious adverse events. This could delay the identification of safety concerns, FDA said. Not all of the response, however, was in disaccord with GAO. FDA generally agreed with most recommendations, and NPA and CRN also supported guidance that clarifies how the FDA determines NDIs and what evidence is needed to document safety of NDIs. The Center for Science in the Public Interest (CSPI) agreed with the overall report, claiming in a press release that the supplement industry operates in a gray area where the law doesn�t always reign supreme.5 �Congress should close those loopholes by requiring that ingredients be reviewed for safety and effectiveness and that cautionary information appear on product labels,� said CSPI Legal Affairs Director Bruce Silverglade, in a press release. Representatives Waxman, Stupak, and John D. Dingell (D-MI), as well as Senator Durbin, said in response to the report that they will work with other lawmakers to ensure FDA has the regulatory authority and resources that it needs.6 Two weeks after the report�s release, President Barack Obama nominated Margaret Hamburg, MD, to be the new FDA commissioner and Joshua Sharfstein, MD, to be deputy commissioner.7 (Dr. Hamburg was approved for the position on May 18 after a Senate voice vote8 and Dr. Sharfstein was appointed in March with no Senate confirmation necessary.) Obama�s choices for FDA leadership, as well as increasing criticism of FDA�s performance on a number of food safety issues, initially caused speculation that the agency might be separated into 2 entities�one focusing solely on foods and the other focusing primarily on medicines and medical devices. Dr. Hamburg went through her Senate hearings in May, during which she denied that any possible severing of the agency would take place and called reports of such �simply untrue.�9 Also during her hearing, Senator Orrin Hatch (R-UT) asked Dr. Hamburg if she thought the Dietary Supplement Health and Education Act (DSHEA) and the Dietary Supplement and Non-prescription Drug Consumer Protection Act are adequate at regulating the dietary supplement industry and protecting consumers, to which she responded that she currently lacks experience with these topics. �This is really a complex issue and one that I haven�t been deeply involved in my other professional experiences�one that I want to take time to study and examine and work with you and others,� she said. Dr. Hamburg also recognized the GAO report and its recommendations, though she did not indicate if she would or would not implement any of its suggested changes. She ended her response by saying FDA oversight of the industry is important to ensure safety for the many American consumers who use these products. Several other recent incidents have also occurred that could potentially spur changes at FDA, including a recall of Hydroxycut® weight loss supplements in May that initiated numerous calls for a review and overhaul of alleged weaknesses of DSHEA,10 as well as the proposed 2010 fiscal year budget for FDA of .2 billion (a 19% increase, the largest in FDA history).11 These events� influence on FDA�s relationship with the dietary supplements industry remains to be seen. If Congress or Dr. Hamburg do take the GAO�s advice, the dietary supplement and natural products industries could encounter some big changes. Some observers, however, say FDA currently has bigger issues on its plate.12 �Lindsay Stafford References United States Government Accountability Office. Dietary Supplements: FDA should take further actions to improve oversight and consumer understanding. GAO-09-250; January 2009. Available at: Accessed March 26, 2009. Singer N. Study urges more oversight of dietary items. New York Times. March 3, 2009;B3. Natural Products Association comments on new GAO report on regulation of dietary supplements [press release]. Washington, DC: Natural Products Association; March 2, 2009. CRN responds to GAO report on dietary supplements [press release]. Washington, DC: Council for Responsible Nutrition; March 2, 2009. FDA can�t protect Americans from dangerous dietary supplements, GAO says [press release]. Washington, DC: Center for Science in the Public Interest; March 2, 2009. Schiff D. Congress says GAO report supports increasing supplement oversight. The Tan Sheet: 17(10):10. March 9, 2009. Harris G. President promises to bolster food safety. New York Times. March 15, 2009;A24. Alonso-Zaldivar R. Senate confirms Obama�s pick for FDA chief. The Associated Press. May 18, 2009. Hearing on the Nomination of Margaret A. Hamburg for Commissioner of the Food and Drug Administration before the Senate Committee on Health, Education, Labor, and Pensions; May 7, 2009; Washington, DC. Fiore K. Group calls for review of DSHEA in light of Hydroxycut. Medpage Today. May 7, 2009. Scott-Thomas C. Record FDA budget proposed as Hamburg clears Senate. May 12, 2009. Editorial: Tighten up laws on diet supplements. Minneapolis-St. Paul Star Tribune. May 5, 2009. Available at: opinion/editorials/44325417.html?elr=KArksUUUU. Accessed May 6, 2009.