The US Food and Drug Administration (FDA) has issued a Public Health Advisory (PHA) warning against using body-building products that are represented as containing steroids or steroid-like substances.
According to the FDA, many of these products are marketed as dietary supplements but are actually unapproved or misbranded drugs not recognised as being safe or effective.
The FDA has also issued a warning letter to American Cellular Laboratories for marketing and distributing body-building products containing synthetic steroid substances.
The letter was based on five adverse event reports submitted to the agency, which documented acute liver injury in men taking American Cellular Laboratories’ TREN-Xtreme and MASS Xtreme products that contain anabolic steroids. Some of the cases resulted in hospitalisation but no deaths have been reported.
The warning issued to consumers and healthcare professionals advises against body-building products from any manufacturer that are claimed to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.
Reports of serious side effects from these products include cases of serious liver injury, stroke, kidney failure and pulmonary embolism.
FDA Commissioner of Food and Drugs Margaret Hamburg said that products marketed for body building claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous.