FDA Warns Manufacturers To Stop Distributing Products Containing 'Andro'

“Young people, athletes and other consumers should steer clear of andro because there are serious, substantial concern about its safety,” Secretary 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. ”

“Athletics benefit young people's health and give them a lesson in the value of hard work,” said John Walters, Director of National Drug Control Policy. “Androstenedione and other performance-enhancing drugs undercut these benefits by endangering our children's healthy development and teaching them that cheating is an acceptable component of pursuing excellence.”

As part of the crackdown, HHS' Food and Drug Administration (FDA) today 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.

“While andro products may seem to have short-term benefits, the science shows that these same properties create real and significant health risks,” said FDA Commissioner Mark B. McClellan, Ph.D., M.D. “While the products are advertised to athletes, they have the potential to get into the hands of our impressionable youth who may believe these products will help their development. Anyone who takes these products in sufficient quantities to build muscle or improve performance is putting himself or herself at risk for serious long-term and potentially irreversible health consequences. There is no proven safe substitute for hard work and training when it comes to improving athletic skill; we will do all we can to protect Americans against companies that seek to profit by trying to convince consumers otherwise.”

Secretary 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. HHS and DEA are providing technical assistance to the Senators and Congressmen as they pursue such legislation.

About one out of 40 high-school seniors reported that they had used andro in the past year, according to HHS' 2002 Monitoring the Future survey, which tracks drug use among students. The survey, conducted by HHS' National Institute on Drug Abuse, also found that about one out of 50 10 th graders had taken andro in the previous year.

Today's actions represent the most recent steps in HHS' broader effort to ensure that dietary supplements are safe for the consumers who use them. In December, Secretary Thompson announced that the FDA would prohibit sales of dietary supplements containing ephedrine alkaloids due to the risks of illness and injury that consumers would face. The FDA has also increased enforcement actions against fraudulently marketed dietary supplements. 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. Scientific evidence shows that when androstenedione is taken over time and in sufficient quantities, it may increase the risk of serious and life-threatening diseases.

Potential long-term consequences of these products in men include testicular atrophy, impotence, and the development of female characteristics such as breast enlargement. Women who use these products may develop male characteristics such as male pattern baldness, deepening of the voice, and increased facial hair. In addition, women may also develop enlargement of the clitoris, as well as abnormal menstrual cycles, abnormal menstrual bleeding, and blood clots. Women who use these products may also be at increased risk for breast cancer and endometrial cancer. Children who use these products are at risk of early onset of puberty and of premature cessation of bone growth.

Each of today's 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. Because no such notification has been submitted by any manufacturer or distributor who has received a warning letter, these products are adulterated and their marketing is prohibited under the Federal Food, Drug, and Cosmetic Act.

The letters further state that FDA is, based on what it knows now, aware of no history of use or other information establishing that a dietary supplement containing androstenedione will reasonably be expected to be safe. In the absence of such information, these products would be adulterated even if the required premarket safety notification were submitted. There is also evidence that the use of androgenic steroids such as androstenedione may have long-term adverse health consequences. If a manufacturer files a new dietary ingredient notification to the FDA, the FDA will evaluate whether specific products are adulterated or are fraudulent.

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