On March 11th, Secretary of Health & Human Services (HHS), Tommy Thompson, announced the department’s intention to crack down on companies manufacturing, marketing and distributing products containing androstenedione (“andro”), which, the agency claims, acts like a steroid once it is metabolized by the body and therefore can pose similar kinds of health risks as steroids. Secretary Thompson said, “Young people, athletes and other consumers should steer clear of andro because there are serious, substantial concerns about its safety.” As part of the crackdown, FDA sent warning letters to 23 companies asking them to cease distributing products sold as dietary supplements that contain androstenedione, warning them that they could face enforcement actions if they do not take appropriate actions. Secretary Thompson also encouraged Congress to pass legislation sponsored by Sens. Orrin Hatch (R-UT) and Joseph Biden (D-DE) in the Senate and Reps. James Sensenbrenner (R-WI), John Sweeney (R-NY) and John Conyers, Jr. (D-MI) in the House that would classify andro-containing products as controlled substances. Such legislation would enable the Drug Enforcement Agency (DEA) to regulate these types of products as anabolic steroids under the Controlled Substances Act. Each of the warning letters sent out by 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 considered by the agency to be 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, it will evaluate whether specific products are adulterated or are fraudulent. FDA will also determine if 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.