Follow us on :

FDA Commissioner Hamburg’s Speech and the Potential Impact on the Supplement Industry

FDA

Recently Rick Collins and Alan Feldstein gave a speech at the ISSN conference in New Orleans on the effect the new Administration will have on our industry. They spoke about their belief that there will be greater regulatory scrutiny and more enforcement of dietary supplements, especially in the sports nutrition category.They emphasized the need to strictly comply with the law and to make sure that all dietary supplement products are substantiated, manufactured and marketed appropriately, and in fact actually fall within the definitional requirements for dietary supplement products as enunciated in DSHEA.

Those thoughts and opinions have now been echoed Margaret Hamburg, M.D., the newly appointed FDA Commissioner, during a recent speech at an industry sponsored conference.

Dr. Hamburg listed several major changes to be more aggressive, more responsive and more timely in enforcing FDA’s rules and regulations. In outlining these changes she provided two examples – one dealing with bogus H1N1 virus products and the other “against companies selling anabolic steroids under the guise of dietary supplements.”

In her comments Dr. Hamburg stated “over-the-counter body-building products have been associated with serious and life-threatening adverse events, including liver injury, stroke, kidney failure, and pulmonary embolism. These are unproven and unapproved drugs, not dietary supplements.”

She went on to further state that “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.”

Of equal significance is her statement that “this action is not the end of our efforts on the illegal sale of anabolic steroids…”

In the past, many within the industry have listened to our advice and thought that although they were “pushing the envelope” or perhaps even slightly crossing the line, they were still relatively at little risk. Clearly, recent enforcement actions and Dr. Hamburg’s comments show that is not the case. The FDA is going to be more aggressive, and the scrutiny will likely come not only from federal authorities but from state regulators as well. In fact, Dr. Hamburg specifically mentioned in her speech that the FDA will work more closely with their regulatory partners. When this happens, civil litigation from plaintiff lawyers may also not be far behind.

Therefore, we urge you, as we have done in the past, to review your products to ensure that they are well researched, well substantiated, and clearly meet the applicable definitional requirements for dietary supplement products.

Share This :