FDA warns consumers
against steroid-containing supplements
of Article: http://www.foodproductiondaily.com/Quality-Safety/FDA-warns-consumers-against-steroid-containing-supplements
By Lorraine Heller, 29-Jul-2009
The US Food and Drug Administration
(FDA) has issued a public health advisory warning against the use of body
building products marketed as supplements but found to contain steroids.
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
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
To view the warning letter, click here .
To view FDA’s public health advisory, click here .