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.
FDA Commissioner Margaret Hamburg misled the public in an FDA news release by suggesting that ALL steroids sold as dietary supplements are illegal. This is not true.
“Products marketed for body building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “The FDA is taking enforcement action today to protect the public.”
William Llewellyn, author of the authoritative anabolic steroid reference manual “Anabolics“, provides a more accurate clarification of the conditions under which natural steroid ingredients that can be legally sold over the counter (”War on Steroids in the Supplement Industry,” March 19).
If a steroid is found in the food supply naturally, and not regulated as a controlled substance, it may be legal to sell as a dietary supplement. The Dietary Supplement Health & Education Act (DSHEA) is intended to protect ingredients that are natural and already consumed by the public
The FDA warning only identified products manufactured by American Cellular Labs (ACL) including “Tren Xtreme” and “Mass Xtreme“. ACL was the target of an FDA raid led by Special Agent Jeff Novitzky on July 23, 2009. In the search warrant affidavit, Agent Novitzky made the assertion that “tren” aka “4-estra” and “Madol” aka “DMT” could be legally classified as a controlled substance (anabolic steroid).
Supplement legal expert Michael DiMaggio of Collins McDonald and Gann strongly disputed FDA Agent Novitzky’s assertion that the supplements are controlled substances (anabolic steroids) (”Supplements for Athletes Draw Alert From F.D.A.,” July 28).
But a law firm that represents sports nutrition companies said the F.D.A.’s action left consumers and manufacturers in the dark as to what specific products the agency considered to be problematic. Moreover, the agency seems to be taking action against some steroid ingredients that the Drug Enforcement Agency, which has jurisdiction over controlled substances, has not yet declared to be illegal unless prescribed by a physician, said Michael J. DiMaggio, a lawyer in Mineola, N.Y.
“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.”
The FDA stopped short of legally identifying any bodybuilding supplements as “anabolic steroids” in their July 28, 2009 public health advisory and July 27, 2009 warning letter to American Cellular Labs and VMG Global. The agency only suggested that the products were illegal, “misbranded” and “unapproved new drugs”.
Unfortunately, the Food and Drug Administration (FDA) has failed miserably at regulating the dietary supplement industry. Unscrupulous supplement companies have marketed synthetic steroids illegally as dietary supplements. These products are not compliant with DSHEA.
The FDA campaign against steroids in supplements is more reflective of a public relations campaign to divert attention from their failure at regulating the supplement industry under DSHEA. Hopefully, the FDA will start enforcing DSHEA consistently rather than continue to demonize the entire sports nutrition market.