FDA Commissioner Emphasizes Enforcement in Guidance to Supplement Industry
by Millard Baker
FDA Commissioner Margaret Hamburg identified “enforcement of the law” as the overriding objective of the FDA under her leadership at a presentation for the Food and Drug Law Institute in Washington, D.C. on August 6, 2009.
Hamburg cited the FDA raid of American Cellular Labs and the FDA public health advisory regarding steroids in supplements as examples of the increased enforcement activity by the agency; Hamburg promised additional efforts targeting the “illegal sale of anabolic steroids” sold “under the guise of dietary supplements”.
Hamburg did not specifically identify the Dietary Supplement and Health Education Act (DSHEA) by name in her speech. Nonetheless, her comments may provide some guidance to sports nutrition companies recently affected by increased FDA enforcement and provide clues to the future of DSHEA.
The FDA Commissioner admitted that the FDA has failed to adequately enforce the law and fulfill its regulatory duties in the past (”FDA Commissioner Margaret A. Hamburg’s Speech on Effective Enforcement and Benefits to Public Health (as prepared) delivered at the Food and Drug Law Institute“, August 6).
In recent years, the Government Accountability Office and others have suggested that the FDA’s enforcement efforts may not have always lived up to these principles.
Reports have noted that there has been a steep decline in the FDA’s enforcement activity over the past several years. At the same time, many of the enforcement actions that the FDA has undertaken have been hampered by unreasonable delays.
In some cases, serious violations have gone unaddressed for far too long. These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising.
Hamburg promised to devote the increased funding to heightened enforcement actions under the Obama administration.
The FDA is fortunate to have received significant funding increases for the current and next fiscal year that will be devoted to additional inspection and compliance activities that will support the elements of an effective enforcement strategy that I have outlined.
Hamburg’s emphasis on enforcement of the (existing) law is encouraging to supporters of DSHEA. DSHEA advocates claim that problems within the supplement industry are the result of a failure of FDA enforcement rather than symptomatic of problems inherent in DSHEA.
However, Hamburg’s comments at FDLI suggest that DSHEA is not entirely safe. Hamburg reiterated the FDA warning that warned consumers to stay away from bodybuilding supplements that contain “androgen-, estrogen-, and progestin-related active ingredients” regardless of whether they were currently DSHEA-compliant. This suggests DSHEA is very likely to be weakened in the near future.
In addition to sending warning letters, the FDA has posted a Public Health Advisory and other materials urging consumers to stop taking body-building supplements from any manufacturer that are labeled as containing androgen-, estrogen-, and progestin-related active ingredients. By pairing enforcement action with education, we hope to prevent others from being harmed by these products.
Furthermore, Hamburg repeated the assertion that the supplements involved in the raid were legally classified as “anabolic steroids”. The assertion was first articulated by FDA Special Agent Jeff Novitzky in the affidavit for a search warrant involving American Cellular Labs. Novitzky identified “Tren” (aka “4-estra”, 19-Norandrosta-4,9-diene-3,17-dione and Estra-4,9-diene-3,17-dione) and “Madol” (aka desoxymethyltestosterone, “DMT” and 17a-Methyl-etioallocholan-2-ene-17b-ol) as “anabolic steroids”.
Last week, we took action against companies selling anabolic steroids under the guise of dietary supplements.
One manufacturer, American Cellular Labs, sells eight of these products on its website. The site promotes the products with claims like, “MASS Xtreme is perfect if you are focused on adding muscle mass, power and strength to your physique,” and “ESTRO Xtreme… You get two estrogen blocking effects in one fantastic product!”
It is important to note that “DMT” and “4-estra” were NOT legally defined as an “anabolic steroid” under the Anabolic Steroid Control Act of 1990 and 2004. Supplement industry legal experts disagree with the assertion that “tren” or “Madol” can currently be legally classified as a controlled substance (anabolic steroid).
Supplement legal expert Michael DiMaggio of Collins McDonald and Gann says that the FDA does not have the authority or jurisdiction to make this administrative determination (”Supplements for Athletes Draw Alert From F.D.A.,” July 28).
“The F.D.A. kind of kicked the door in and said ‘we believe they are illegal now,’ ” Mr. DiMaggio said. “This is going to come as a shock to many companies and big distributors.”
FDA Commissioner Margaret Hamburg’s FDLI presentation suggests that DSHEA will likely be weakened and clearly subject to tight enforcement.