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HerbalEGram: Volume 6, Number 4, April 2009
GAO Calls for More Dietary Supplement Regulation
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Last month a Government Accountability Office (GAO) report was released to the public that called for the Food and Drug Administration (FDA) to have more authoritative oversight of the dietary supplement industry.1 The 77-page report “Dietary Supplements: FDA should take further actions to improve oversight and consumer understanding,” stemmed from a request from 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 a limited ability to efficiently and effectively remove what the agency might deem a contaminated or otherwise unsafe product from the market. Though FDA has mandatory recall power over dietary supplements, the agency first has to go through an administrative hearing and receive a court order, said Rakesh Amin, senior partner of Amin Hallihan, LLC (e-mail, March 31, 2009). For this reason, mandatory recalls do not happen often and about 98% of recalls of foods, supplements, and drugs are voluntary, he added.
Based on its findings, GAO recommended that the FDA commissioner seek additional authority to oversee dietary supplements and improve consumer understanding of such products.1 It specifically called for the commissioner to require facilities and companies to provide more information on 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.
GAO also 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 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 a total of more than 50,000 mild, moderate, and serious adverse events each year.
In response to GAO’s recommendations, some industry organizations have voiced their opposition, with the 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), in a press release.2 “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.3
“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.4
“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 and Stupak and Senator Dingell 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.5
Two weeks after the report’s release, President Barack Obama nominated Margaret Hamburg and Joshua Sharfstein to lead the FDA.6 These agency picks, as well as what many critics view as FDA’s flawed performance on a number of food safety issues, have caused speculation that the agency might be separated into 2 entities. If FDA is split and the agency’s new leaders and those in Congress take GAO’s advice, the dietary supplement and natural products industries could encounter some big changes. Many observers, however, say FDA currently has bigger issues on its plate.
—Lindsay Stafford
References
1. 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: http://www.gao.gov/new.items/d09250.pdf. Accessed March 26, 2009.
2. Natural Products Association comments on new GAO report on regulation of dietary supplements [press release]. Washington, DC: Natural Products Association; March 2, 2009.
3. CRN responds to GAO report on dietary supplements [press release]. Washington, DC: Council for Responsible Nutrition; March 2, 2009.
4. 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.
5. Schiff D. Congress says GAO report supports increasing supplement oversight. The Tan Sheet: 17(10):10. March 9. 2009.
6. Harris G. President promises to bolster food safety. New York Times. March 15, 2009. Available at: http://www.nytimes.com/2009/03/15/us/politics/15address.html?scp=3&sq=hamburg&st=Search. Accessed March 16, 2009.
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