FDA: Halt Unapproved Steroid Drugs

Agency Considers Action Against Makers of Some 'Dietary Supplements'

Reviewed by Louise Chang, MD on March 09, 2006
From the WebMD Archives

March 9, 2006 -- The FDA is warning that it may crack down on several companies that make and distribute unapproved drugs containing steroids.

If those firms keep making and selling the drugs, the FDA could start regulatory action, including seizing the drugs.

The FDA issued warning letters for the following so-called dietary supplement products:

  • Anabolic Xtreme Superdrol, manufactured for Anabolic Resources and distributed by Supplements To Go
  • Methyl-1-P, manufactured for Legal Gear and distributed by Affordable Supplements

Consumers who have any of those products should stop taking them and return them to their place of purchase, the FDA advises in a news release.

Potential Health Risks

The drugs are marketed as dietary supplements and promoted for building muscle and increasing strength. In its news release, the FDA expresses concern that the drugs "may cause serious long-term adverse health consequences in men, women, and children."

These products claim to be "anabolic," states the FDA, listing problems associated with anabolic steroids including:

  • Liver toxicity
  • Testicular atrophy and male infertility
  • Masculinization of women
  • Breast enlargement in males
  • Short stature in children
  • Adverse effects on blood lipid (fat) levels
  • A potential to increase the risk of heart attack and stroke

The FDA "takes its responsibility to protect Americans from dangerous unapproved drugs seriously. Today's action is indicative of our resolve," says Margaret Glavin, the FDA's associate commissioner for regulatory affairs, in the news release.

The warning letters are part of the FDA's continued efforts to protect consumers from dangerous steroid products. In March 2004, the FDA sent warning letters to 23 manufacturers and distributors of products containing androstenedione, commonly called "andro."