Washington, DCOn the heels of the Hydroxycut recall comes another diet supplement scare. The FDA has now issued a warning concerning body building products that claim to contain steroids or steroid-like substances and the risk for serious adverse health effects.
Specifically, the warning relates to TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme, products which are made by American Cellular Laboratories Inc.
The FDA has so far 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.
According to the FDA, 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, the FDA claims, because the label is misleading and fails to provide adequate directions for use.
"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."
The FDA is recommending that people stop using these, and any other products that claim to contain steroid like substances immediately.
Symptoms of adverse reactions include nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine. The FDA is recommending that anyone who experiences side effects contact their health care professional immediately.
These types of products are sold primarily through gyms, the internet and mail order catalogues and are used by body builders who want to increase muscle mass, or lose weight.
The FDA sent a warning letter to American Cellular Laboratories, for marketing and distributing body building products containing synthetic steroid substances.