March 11, 2004
Q: What action did FDA?
A: As part of the Department of Health and Human Services crackdown on companies that manufacture, market and distribute products containing androstenedione, or, "andro," the FDA 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 action if they do not take appropriate actions.
Q: Why did FDA take this action?
A: FDA concluded that there is inadequate information to establish that a dietary supplement containing androstenedione will reasonably be expected to be safe. In fact, FDA believes that these products may increase the risk of serious health problems because they are converted in the body to testosterone which is an androgenic and anabolic steroid.
Q: What do you mean by androgenic?
A: Androstenedione is converted to testosterone and estrogen, and when taken in sufficient quantities androstenedione can cause masculinizing and feminizing effects. Androstenedione is considered an androgenic steroid precursor because testosterone is an androgen or male hormone.
Q: What is an anabolic steroid precursor?
A: An anabolic steroid is a steroid, such as testosterone, that induces muscle growth. An anabolic steroid precursor is a steroid that does not itself cause muscle growth, but can be converted by the body into such a steroid. Androstenedione is an anabolic steroid precursor because it is converted to testosterone in the body.
Q: How are these dietary supplements marketed?
A: Androstenedione-containing supplements are widely advertised for anabolic effects (building muscles) and for enhancing athletic performance.
Q: What makes FDA believe these products are not safe?
A: Based on a limited number of studies of androstenedione's actions in humans and existing knowledge about steroid hormone metabolism and action in the body, FDA believes that the use of dietary supplements containing androstenedione may increase the risk of serious health problems because of their conversion in the body to active hormones with androgenic and estrogenic properties.
Q: When androstenedione is sold as a dietary supplement, it doesn't require FDA approval. On what basis can FDA take this action?
A: Under the Dietary Supplement Health and Education Act of 1994, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
In addition, there are certain requirements that must be met in order for dietary supplements containing new dietary ingredients (dietary ingredients that were not marketed in the United States before October 15, 1994), not to be deemed adulterated under the act. These requirements have not been met for androstenedione, and therefore, androstenedione cannot be lawfully marketed in dietary supplements.
Furthermore, FDA is not aware of the existence of adequate information to establish that a dietary supplement containing androstenedione will reasonably be expected to be safe. In fact, FDA believes that these products may increase the risk of serious health problems because of their androgenic properties.
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.
Q: How did FDA learn about these firms?
A: FDA learned of the firms that are receiving warning letters by monitoring the dietary supplement industry. FDA focused on these selected firms because the agency determined that these firms were actively manufacturing, marketing, and/or distributing androstenedione as a dietary supplement.
Q: What if the companies do not cease distribution of these products?
A: 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.
Q: Does this action indicate that FDA believes that androstenedione is a dietary ingredient and not a new drug?
A: The letters note that because the products are labeled as dietary supplements, FDA assumes that the firm has a basis to conclude that androstenedione is a dietary ingredient. However, FDA is still considering the legal status of androstenedione-containing products. At this time, the Agency has not reached any final conclusion as to whether products containing steroid hormones not scheduled under the Controlled Substances Act may be lawfully marketed.