Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.
The advisory came five days after FDA investigators raided the California offices of American Cellular Labs, looking for evidence the company sells steroids under the guise of a supplement.
The FDA sent a warning letter to the company, saying it was selling unapproved and misbranded drugs and asking the company what it intended to do with the products in question that were currently on the market.
Those products 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.
The FDA has received 5 reports of serious adverse reactions associated with the use of products with steroids.
Those include 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 from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.
Anyone who thinks they are experiencing problems associated with the products should report them to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.
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