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 U.S. Food and Drug Administration (FDA) issued a Public Health Advisory (PHA) warning consumers to avoid using bodybuilding supplements claiming to contain “steroids”, “steroid-like substances”, “steroid alternatives” and “hormone products”. The FDA warning failed to give guidance on the specific product ingredients that were problematic. The extremely broad language cast suspicion upon all “body building supplements” marketed for performance enhancement because they might contain synthetic steroids (”FDA recommends that consumers should not use body building products marketed as containing steroids or steroid-like substances,” July 28).
- “marketed as containing steroids or steroid-like substances”
- “marketed for body building and increasing muscle mass”
- “marketed as alternatives to anabolic steroids for increasing muscle mass and strength”
- “promoted to athletes to improve sports performance and to aid in recovery from training and sporting events”
The target was ostensibly illegal synthetic steroids that are not compliant with the Dietary Supplement Health and Education Act (DSHEA). However, the FDA news releases and statements appears to demonize ALL steroid products including those that are legally sold and marketed as dietary supplements under DSHEA. Read more
