FDA Issues Warnings to Manufacturers & Distributors of Illegal Steroids Sold as Dietary Supplements
The Food and Drug Administration (FDA) has issued a news release announcing that it has issued warning letters to two manufacturers and two distributors of unapproved drugs containing steroids.
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The FDA states that continued distribution and sale of the following products without FDA approval could result in regulatory action including seizure and injunction:
Anabolic Xtreme Superdrol, manufactured for Anabolic Resources LLC, Gilbert Arizona, and distributed by Supplements To Go, Cincinnati, Ohio, and
Methyl-1-P, manufactured for Legal Gear, Brighton, MI and distributed by Affordable Supplements, Wichita, Kansas.
FDA Concerned About Use of Steroids Marketed as Dietary Supplements
The FDA is concerned that the use of the above-listed products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may cause serious long-term adverse health consequences in men, women, and children.
The FDA notes that these products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, short stature in children, adverse effects on blood lipid levels, potential to increase the risk of heart attack and stroke, etc.
Affected Products are Considered New Drugs
On March 8, 2006, the FDA issued separate warning letters to Anabolic Resources, LLC and Supplements To Go with regard to Anabolic Xtreme Superdrol and also to Legal Gear and Affordable Supplements regarding Methyl-1-P.
The FDA states that both these products are considered new drugs under Section 201(p) of the Federal Food, Drug, and Cosmetic Act (Act) because the products are not generally recognized as safe and effective for the uses claimed in the labeling. The FDA adds that as these products are not the subjects of approved new drug applications (NDAs), they may not be marketed in the U.S. and their continued distribution violates Section 505(a) of the Act.
Among other things, the FDA directs the above-named parties to notify it, within 15 working days of receipt of these letters, as to the specific steps they have taken to correct the violations described in the letters and an explanation of each step taken to assure that similar violations will not recur.
(See ITT's Online Archives or 03/15/04 news, 04031599 2, for BP summary of FDA crackdown on manufacturers, marketers, and distributors of products containing androstenedione ("andro"), which acts like a steroid once metabolized in the body.)
FDA Contact - Sebastian Cianci (301) 827-6242
FDA News Release and Links to Letters (P06-37, dated 03/09/06) available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01332.html