FDA Orders Companies To No Longer Market, Distribute Products With the Dietary Supplement Andro
FDA on Thursday in a letter ordered 23 manufacturers to immediately stop marketing and distributing products with the dietary supplement androstenedione, or andro, because it can have "irreversible health consequences," FDA Commissioner Mark McClellan said, the Los Angeles Times reports. Small amounts of androstenedione are produced in the adrenal glands, ovaries and testicles, and the body converts it into the steroid hormone testrosterone. In its synthetic dietary supplement form, andro is converted into a steroid after it is absorbed by the body, increasing the body's production of testosterone and estrogen (Kemper, Los Angeles Times, 3/12). The supplement can cause liver disease, increased aggressiveness, and changes in blood coagulation and red blood cell production. Side effects in men include testicular atrophy and impotence. Women who take the drug can develop male-pattern baldness, increased facial hair, abnormal menstrual bleeding and blood clots. In addition, the drug might increase women's risk of breast and endometrial cancer. Children who take the drug are at risk of early onset of puberty and bone growth problems. Several athletic organizations, including the National Football League, the International Olympic Committee and the National Collegiate Athletic Association, have banned andro products (Kaufman, Washington Post, 3/12). HHS Secretary Tommy Thompson said the government's action is necessary to remove andro products from the market, and said, "We're not stopping here." If companies do not comply with FDA's warning, they could face seizure of their inventories and civil and legal action. The government intends to "clamp down" on other body-building supplements, the Times reports. FDA's action might also "give new life" to legislation that would ban andro, designer steroid THG and 25 other anabolic steroid precursors, according to the Times (Los Angeles Times, 3/12).
Many andro manufacturers and distributors have said that it occurs in nature and does not need to be licensed as a drug but rather should be available as a supplement. But FDA stated on Thursday that because the andro being sold was made synthetically and was not on the market before 1994 -- prior to the Dietary Supplement Health and Education Act of 1994 -- makers and distributors must present to FDA test results proving its safety (Washington Post, 3/12). Companies must also give FDA 75 days' notice before marketing new supplements, and andro marketers failed to do so, according to AAC Consulting Group, which tracks agency actions. If companies file notifications for future sales, they will be subject to FDA analysis of andro products' safety, which could provide a basis for an agency challenge based on health risks. Andro industry attorneys said the products are exempt from the 75-day notice rule because the ingredient is already "present in the food supply as an article used for food" and is not chemically altered. Manufacturers and marketers might also be able to challenge FDA by providing evidence that andro products were sold, even on a very limited basis, before 1994 (Wilde Matthews, Wall Street Journal, 3/11). NPR's "All Things Considered" Thursday reported on FDA's order. The segment includes comments from Sen. Orrin Hatch (R-Utah), McClellan and Thompson (Prakash, "All Things Considered," NPR, 3/11). The complete segment is available online in RealPlayer. In addition, CNN Thursday aired Thompson's press conference on andro (Phillips, CNN, 3/11). The complete transcript is available online.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.