Congress Says GAO Report Supports Increasing Supplement Oversight

Key congressional leaders want to give FDA tighter control over dietary supplements, saying a Government Accountability Office report critical of the agency's enforcement supports granting additional authority.

The March 2 GAO ¹ report recommends that FDA require firms to report all supplement adverse events, register annually specifically as dietary supplement companies and maintain records of current products and labeling.

The report also calls on FDA to draw a brighter line between supplements and foods formulated with added dietary ingredients and to complete its planned guidance on the new dietary ingredient notification process.

"I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements," House Energy and Commerce Committee Chairman Henry Waxman says in a same-day release.

Waxman, D-Calif., along with Michigan Democrats John Dingell and Bart Stupak and Senate Assistant Majority Leader Dick Durbin, D-Ill., a frequent supplement industry critic, released the report. The report responds to a 2007 request from the committee to examine FDA's ability to monitor and address supplement AERs and safety concerns.

The lawmakers say they intend to work with Capitol Hill colleagues to grant FDA necessary authorities and allocate additional resources.

In previous sessions, Waxman, Dingell and Durbin sought to amend the Dietary Supplement Health and Education Act to make certain product categories subject to pre-market approval.

Although the lawmakers stop short of saying they will create specific authorities through legislation, their comments suggest that the GAO report could renew a drive for mandatory pre-market approval of NDIs - something industry opposes (² (Also see "Firms Need To Commit More Time, Money To Industry Cause – DSEA’s Balbert" - Pink Sheet, 12 Mar, 2007.), p. 12).

FDA "should have the regulatory authority it needs to protect the American consumer," says Durbin, whose influence on food and drug regulation is expected to grow through his ties to the president.

AERing On The Side Of Caution

GAO recommends that FDA require firms to report all adverse events related to their products - not only "serious" events as current law requires - to counter what it sees as widespread underreporting of AEs and to improve the agency's safety data.

At a March 3 briefing on food safety, Durbin said FDA should have authority to collect all AERs.

The report notes that FDA received 596 serious dietary supplement AERs from December 2007 through October 2008 - compared to more than 50,000 annual AEs linked to supplements, as estimated by FDA in September 2008.

Supplement firms previously were required to keep track of all AEs they receive, but since December 2007 the firms must submit to the agency information on reports of serious events (³ (Also see "Set Serious Threshold For AERs" - Pink Sheet, 28 Jul, 2008.), p. 12).

By comparison, drug firms must report to FDA all serious adverse events linked to prescription products no later than 15 calendar days after receiving the information. The Center for Drug Evaluation and Research says firms also must submit follow-up reports after receiving additional information on a serious AE.

Information on non-serious AEs linked to Rx drugs must be submitted in quarterly or annual reports.

GAO suggests supplement AEs frequently are unreported because many consumers assume the products are safe, do not report their use to physicians and are hindered by a "cumbersome reporting process."

The development of FDA's Web-based MedWatch Plus system to receive AERs for all agency- regulated products will facilitate more reporting, GAO says.

FDA, however, questions the feasibility of handling reports on all levels of dietary supplement adverse events (⁴ (Also see "“MedWatch Plus” Will Create Single Adverse Event Reporting Venue" - Pink Sheet, 10 Jul, 2006.), p. 8).

In a Jan. 22 response to GAO included with the report, FDA says the resulting influx of information "might make it more difficult to filter out signals of potential toxicity generated by reports of serious adverse events."

However, Durbin said supplement AERs are essential in providing "more statistical information [on which] to base any additional changes in the law" for how FDA regulates the industry.

Committee Calls For More Guidance

The Energy and Commerce Committee refers to the long-awaited NDI guidance as a key element for improving FDA's regulation of supplements (⁵ (Also see "NDI Notification Guidance To Assist Puzzled Industry Could Emerge In 2009" - Pink Sheet, 12 Jan, 2009.), p. 3).

The committee says the guidance in part would "clarify" that firms have to "submit evidence of safety before [NDIs] can be marketed."

But legislation, rather than an NDI guidance, would be required to impose pre-market approval on supplement products. DSHEA requires firms to submit NDI notifications to FDA within 75 days of launching a product containing an ingredient new to the market since DSHEA was enacted in 1994.

GAO says the guidance is "critical for dietary supplement safety," since firms may not realize, for example, that nano-sized versions or certain extracts of grandfathered ingredients still may require NDI notifications.

FDA says it is reviewing internally the guidance, but does not state a timetable for completion.

Along with the NDI guidance, GAO asks FDA to provide a guidance on when a product should be marketed as a conventional food rather than a supplement. Both guidances were recommended by GAO in its previous dietary supplement report in July 2000 (⁶ (Also see "Dietary Supplement, Functional Food Regulatory Harmonization Urged By GAO" - Pink Sheet, 17 Jul, 2000.), p. 14).

Finally, GAO recommends FDA collect information on manufacturing facilities through annual registration procedures, maintain a database of all marketed supplement products and their labels, and educate consumers through enhanced outreach programs and coordination with stakeholders.

The agency says it will consider the feasibility of the conventional food/supplement guidance in light of its "limited resources and competing priorities," according to the comments.

As for outreach, FDA says the Office of Dietary Supplements in the National Institutes of Health appears better suited to educate consumers, but expects the agency's recently launched outreach collaboration with WebMD will include supplement information (⁷ (Also see "FDA Links With WebMD To Help Distribute Public Health Information" - Pink Sheet, 8 Dec, 2008.), p. 13).

In a March 2 release, the Center for Science in the Public Interest says GAO's findings support the idea that "the supplement industry operates in a gray area where the loopholes loom larger than the law" and warrant congressional action.

Report Shows Progress, Say Stakeholders

Industry stakeholders disagree, pointing out the progress made in serious AE reporting and good manufacturing practices since GAO's 2000 report.

"Where we are still dealing with some of the consumer press that talk about this being an unregulated industry, this report demonstrates that we are not that at all," said Steve Mister, president and CEO of the Council for Responsible Nutrition.

Mister pointed out that FDA's failure to bring enforcement actions against companies flaunting the NDI notification requirement is as much a result of insufficient resources as it is of a lack of guidance.

Requiring that all AEs be reported would create "more bureaucratic paperwork that would not result in true benefits for consumer safety," Mister added.

Natural Products Association Executive Director and CEO David Seckman sees little reason for concern about a push for additional FDA authority since everything GAO requests is doable under current laws and regulations.

"We've always maintained that DSHEA had the authority to take unsafe products off the shelves. I think if the GAO thought otherwise, they would've issued some sort of recommendation to that point."

Seckman noted supplement firms already register their facilities under bioterrorism regulations, so pursuing a separate registration process could result in FDA receiving duplicate information.

Additionally, both Seckman and Mister pointed out voluntary activities that address some of GAO's concerns. NPA compiling and organizing supplement product information with ODS, and CRN reaches out to consumers through its "Life...supplemented" campaign.

- Dan Schiff ([email protected])