FDA Warning on Androstenedione (Andro)
On March 11, 2004, the U.S. Food and Drug Administration (FDA) 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.
Q: What action did FDA take?
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.
Source: Food and Drug Administration