Attorney General Files Lawsuit Against Dietary Supplement ‘Andro’ Manufacturers

Attorney General Bill Lockyer (D) has filed a lawsuit against 35 makers of androstenedione, or "andro," arguing that the dietary supplement is "akin" to steroids and "should be covered" under Proposition 65, the San Francisco Chronicle reports. In 1986, voters approved Proposition 65 -- known as the Safe Drinking Water and Toxic Enforcement Act -- which requires manufacturers to warn consumers about the "stunted growth, liver damage, acne, personality changes and fertility problems associated with steroids." The suit, filed in Alameda County Superior Court, seeks fines of $2,500 per day for each "violation" of the law, which could amount to "millions of dollars" in penalties for "selling the products without warnings." Lockyer also has asked stores that sell andro to post "consumer alerts" about the supplements. According to the Chronicle, the lawsuit names 35 makers of the supplement, including Met-RX Nutrition, Weider Nutritional, Sportpharma and Champion Nutrition. The Chronicle reports that the lawsuit does not target other supplements, such as ephedra and creatine, which "cannot be considered steroids."

According to Kim Smith, legislative director of the National Nutritional Foods Association, under federal law, the FDA considers andro supplements a food product, not a drug. However, agency officials could withdraw andro from the market "if they conclude it presents an unreasonable risk of injury or illness." Researchers have conducted few studies on andro, but a Harvard University study last year found that testosterone levels increased 34% and estrogen levels 128% when about 24 "healthy men" took varying amounts of the supplement, which can lead to enlarged breasts in men, premature baldness, greater risk of heart disease and facial hair in women (Salladay, San Francisco Chronicle, 8/17). Medical experts from the U.S. Anti-Doping Agency, the American Academy of Pediatrics and the American College of Sports Medicine have urged the FDA to ban over-the-counter sales of andro and reclassify the dietary supplement as a steroid (California Healthline, 12/6/00).