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Warning Issued by FDA for Certain Body Building Products


The U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory (PHA) warning consumers to stop using body building products that are represented as containing steroids or steroid-like substances. Many of these products are marketed as dietary supplements.

The FDA also issued a Warning Letter to American Cellular Laboratories Inc, for marketing and distributing body building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

Serious adverse events reported to the FDA that are associated with the use of body building products that claim to contain steroids or steroid-like substance include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received 5 adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

The products listed in the Warning Letter to American Cellular Laboratories Inc., include "TREN-Xtreme," "MASS Xtreme," "ESTRO Xtreme," "AH-89-Xtreme," "HMG Xtreme," "MMA-3 Xtreme," "VNS-9 Xtreme," and "TT-40-Xtreme," and are sold on the Internet and in some stores.

These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective. In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

JULY-29-09: FDA Warns Consumers Don't Use Certain Body Building Products [FDA: ISSUES WARNING ABOUT BODY BUILDING PRODUCTS]

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Published on Jul-29-09


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