FDA Warning on Androstenedione (Andro)

Q: These products have been on the market for a while. What prompted FDA to take action now?
A: As part of its public health mission, FDA is committed to removing unsafe products from the market. When the agency becomes aware of potential safety concerns with a marketed product, we will investigate and take appropriate steps to ensure that unsafe products do not continue to be marketed. In taking this action, the Department of Health and Human Services and FDA are, in part, responding to concerns about the safety of androstenedione-containing dietary supplements that have been raised by consumers, medical organizations, and members of Congress.

Q: Is FDA planning to take actions against other steroids or steroid precursors that may be marketed as dietary supplements?
A: FDA is aware that other steroid precursors are being marketed as dietary supplements. The agency intends to continue to examine information about these different substances being marketed as dietary supplements and evaluate their status under the Act. Depending on the results of these deliberations, FDA may take further enforcement actions if any are found to violate the Act.

FDA is particularly concerned about other steroid precursors that are promoted to help build muscle mass or improve sports performance. If they have powerful enough androgenic properties to have these effects, then they may also be more likely to cause the serious health risks that accompany these effects.

Q: Are there other groups that support FDA's position?
A: Yes. Organizations such as the National Collegiate Athletics Association, the National Football League and the International Olympic Committee have 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 potential long-term adverse health consequences.

Q: How do these products work in the body?
A: Widely marketed as "performance enhancers," androstenedione and other steroid precursors have been advertised to promote muscle growth, improve muscular strength, reduce fat, and slow aging. Some studies suggest that androstenedione can raise the levels of testosterone and estrogen. Taken over time and in sufficient quantities, androstenedione may have serious adverse health consequences.

Q: What are the side effects of dietary supplements containing androstenedione?
A: Potential long-term adverse health consequences 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, increased facial hair, and enlargement of the clitoris, as well as abnormal menstrual cycle and abnormal bleeding, and blood clots. Women may also be at increased risk for breast cancer and endometrial cancer. Children and adolescents are at risk for androgenic and estrogenic effects as in adults, for early onset of puberty, and for premature cessation of growth, such that they will be short as adults.