March 2004

FDA warns manufacturers to stop distributing andro supplements

The federal government has announced a crackdown on companies that manufacture, market and distribute products containing androstenedione, (andro), which acts like a steroid once it is metabolized by the body. According the Food and Drug Administration, andro can pose similar kinds of health risks as steroids.

Andro products are generally advertised as dietary supplements that enhance athletic performance based on their claimed anabolic and androgenic properties to stimulate muscle growth and increase production of testosterone.

"Young people, athletes and other consumers should steer clear of andro because there are serious, substantial concerns about its safety," HHS Secretary Tommy Thompson said. "Young people should understand that there are no short cuts to a stronger body and that the best way to get faster and stronger is through good diet, nutrition and exercise."

As part of the crackdown, the FDA has sent warning letters to 23 companies asking them to cease distributing products sold as dietary supplements that contain androstenedione and warning them that they could face enforcement actions if they do not take appropriate actions.

Thompson also encouraged Congress to pass legislation sponsored by Sens. Orrin Hatch and Joe Biden in the Senate and Reps. James Sensenbrenner, John Sweeney and John Conyers, Jr. in the House that would classify andro-containing products as a controlled substance. Such legislation would enable the U.S. Drug Enforcement Agency (DEA) to regulate these types of products as anabolic steroids under the Controlled Substances Act.

Since December 2002, FDA has issued about 75 letters to firms making misleading claims about their products for treatment of life-threatening diseases such as cancer, lupus and heart disease. FDA has also seized approximately $9 million worth of dietary supplement products which were promoted to treat a variety of serious medical conditions.

Androstenedione is produced naturally in humans during the production of testosterone and estrogen. It is considered an anabolic steroid precursor because it can be converted in the body to testosterone

Each of the warning letters states that FDA assumes that the firm has a basis to conclude that androstenedione is a dietary ingredient. If androstenedione is a dietary ingredient, FDA believes that it is also a new dietary ingredient for which a premarket safety notification is required.

FDA will determine whether further actions are necessary if firms refuse to cease distribution of these products. Such actions could include seizing violative product as well as pursuing injunctions or seeking criminal sanctions against persons who violate the law.

The National Collegiate Athletics Association, the National Football League and the International Olympic Committee have all banned use of androstenedione. The American Academy of Pediatrics, the Endocrine Society, the American Medical Association, and other health professional groups have cautioned against the use of androgenic and anabolic steroids and their precursors, like androstenedione, because of their potential long-term adverse health consequences.

More information about the announcement, including copies of the FDA warning letters, is available at http://www.cfsan.fda.gov/~dms/andrlist.html.

Source: Department of Health and Human Services

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