FDA warns consumers against steroid-containing supplements
The advisory comes after the agency sent a warning letter this week to supplement manufacturer American Cellular Laboratories for selling body building products containing synthetic steroid substances.
“The FDA has received reports of serious adverse events associated with the use of these products and other similar products,” wrote FDA in its health advisory.
“Although products containing synthetic steroids are frequently marketed as dietary supplements, they are NOT dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.”
Serious health impacts
FDA’s serious adverse event reporting system identified a number of negative health effects associated with body building products that claim to contain steroids or steroid-like substances. These included serious liver injury, stroke, kidney failure and pulmonary embolism, it said.
The agency advised consumers to stop taking any body building products that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.
These products are often marketed as alternatives to anabolic steroids for increasing muscle mass and strength, and are promoted to athletes to improve sports performance and to aid in recovery from training and sporting events.
Supplement products for sports performance have been under increased scrutiny of late, after a number of high-profile cases where supplements were blamed for failed anti-doping tests.
Doping concerns are a major bane for the dietary supplements industry, which bears the brunt of blame as a whole even when the contamination issues are linked only to certain irresponsible firms.
After a string of negative media reports published earlier this year and pointing the finger at sports supplements in general, the supplements trade group Natural Products Association (NPA) tried to set the record straight.
NPA commended increased scrutiny by professional sports leagues on steroid usage, but said this has also led to unsubstantiated allegations that a ‘tainted’ or mislabeled dietary supplement is to blame when an athlete tests positive for a banned substance.
“As the Dietary Supplement Health and Education Act of 1994 (DSHEA) mandates, all ingredients must be listed on product labels and product claims must be substantiated,” said Seckman.
“If this is not the case, the U.S. Food and Drug Administration (FDA) - along with the Federal Trade Commission (FTC) – have the authority under DSHEA to act promptly. These federal enforcement powers include, but are not limited to, removing any dietary supplements deemed adulterated from the marketplace and imposing substantial penalties on those who violate the law.”
FDA flexed its enforcement might earlier this week when it informed American Cellular Laboratories its body-building products were unapproved and misbranded as drugs.
FDA required the firm to respond with details of steps taken to correct the noted violations within the next 15 days. Failure to do so could result in further action without notice, including injunctions and product seizure.
To view the warning letter, click here.
To view FDA’s public health advisory, click here.