FDA Issues Warning to Manufacturers and Distributors of Unapproved Drugs Containing Steroids

The Food and Drug Administration (FDA) has again issued a stern warning to several makers and distributors of unapproved drugs containing steroids that continuing to distribute and sell these products without the approval of the FDA could result in regulatory action including seizure of the offending products and an injunction prohibiting their sale.

The FDA warns that these products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may lead to serious long-term adverse health affects in men, women, and children.

These products claim to be anabolic. Anabolic steroids are linked to many adverse health consequences, such as liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and an increased risk of heart attack and stroke.

“FDA takes its responsibility to protect Americans from dangerous unapproved drugs seriously. Today’s action is indicative of our resolve,” said Margaret O’K. Glavin, FDA’s Associate Commissioner for Regulatory Affairs.

Consumers who have any of the products listed below should stop taking them immediately and return them to their place of purchase. The FDA issued warning letters for the following so-called dietary supplement products:

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, Michigan, and distributed by Affordable Supplements, Wichita, Kansas.

Copies of the warning letters can be accessed at the following links:

Affordable Supplements
http://www.fda.gov/foi/warning_letters/g5739d.pdf
http://www.fda.gov/foi/warning_letters/g5739d.htm

Anabolic Resources LLC
http://www.fda.gov/foi/warning_letters/g5736d.pdf
http://www.fda.gov/foi/warning_letters/g5736d.htm

Legal Gear
http://www.fda.gov/foi/warning_letters/g5738d.pdf
http://www.fda.gov/foi/warning_letters/g5738d.htm

Supplementstogo.com, LLC
http://www.fda.gov/foi/warning_letters/g5737d.pdf
http://www.fda.gov/foi/warning_letters/g5737d.htm

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