Xtreme and Other Steroid-like Body Building Products Pose Risk: FDA Warns

The FDA issued a public health advisory yesterday waning consumers not to use certain body building products marketed as dietary supplements that claim to contain steroids or steroid-like substances. The agency also sent a warning letter to one of the leading manufacturers, labeling several of their “Xtreme” body building products as dangerous and unapproved drugs.

In response to increasing reports submitted to the FDA’s Adverse Events Reporting System (AERS), the agency is warning that dietary supplements claiming to contain steroids, steroid-like substances, or alleging to be “anabolic,” most likely contain unregulated drugs and have been connected to serious liver injury, kidney failure, stroke, and pulmonary embolisms.

The products include TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89 Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme and TT-40-Xtreme bodybuilding supplements from American Cellular Labs and as well as body building supplements from other companies. They are marketed as dietary supplements, which would not normally fall under FDA regulations if they are made with natural products. However the FDA says that they actually are unregulated drugs.

The products are sold as body building supplements and are frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength, the FDA said in its warning. Many of the products also claim to reduce the effects of feminine hormones, such as estrogen, on the body. The FDA said not only do the products contain formulas that constitute new, unapproved drugs, but the labeling is often misleading and lack proper directions for use.

The agency singled out American Cellular Labs, also known as Americell Labs or ACL, issuing a warning letter to the company accusing it of marketing and distributing unapproved and misbranded drugs. The agency says it has executed a search warrant and is gathering and reviewing additional data.

The FDA has advised consumers to immediately stop using these products and urged people to talk to their health care professional about any dietary supplements branded as a body building product.

Consumers who have been using these products should also consult a health care professional if they experience nausea, weakness, fever, abdominal pain, chest pain, shortness of breath, yellowing of the skin or the whites of the eyes, or brown or discolored urine.