FDA Warning on Androstenedione (Andro)

The U.S. Food and Drug Administration (FDA) has announced a crackdown on products containing androstenedione, commonly known as "andro." The products are marketed over the counter as dietary supplements that enhance athletic performance. In the body, androstenedione is converted into testosterone and estrogen.

While ads claim that andro-containing supplements promote increased muscle mass, research has not shown this to be the case. In addition, studies have shown side effects and potential long-term risks; androstenedione poses the same kinds of health risks as anabolic steroids. Given the lack of proven benefits and the risks, the FDA is requesting companies to stop distributing dietary supplements containing androstenedione. The FDA is also encouraging Congress to consider legislation to classify these products as a controlled substance.

Potential Long-Term Risks

• For men—shrinkage of testicles, growth of breast tissue, impotence
• For women—male pattern baldness, increased facial hair, increased risk for breast cancer and endometrial cancer, blood clots
• For youth—acne, early start of puberty, stunted growth

Advice to Consumers

Consumers should understand that there are risks for serious side effects. Do not take supplements with andro.

More Information

• FDA Press Release: www.fda.gov/bbs/topics/news/2004/hhs_031104.html (3/11/2004)
• FDA Androstenedione Questions and Answers: www.cfsan.fda.gov/~dms/androqa.html (3/11/2004)
• FDA White Paper, "Health Effects of Androstenedione": www.fda.gov/oc/whitepapers/andro.html (3/11/2004)
• CAM on PubMed: nccam.nih.gov/research/camonpubmed
  Search for published research articles about androstenedione.

Date Reviewed: March 2004
Editorial Changes Made: December 2004

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