The U.S. Food and Drug Administration today warned several manufacturers and distributors of unapproved drugs containing steroids that continued distribution and sale of these products without FDA approval could result in regulatory action including seizure and injunction. FDA is concerned that the use of these 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. These products claim to be anabolic and problems associated with anabolic steroids include: 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 a potential to increase the 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 and return them to their place of purchase. 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
-- Methyl-1-P, manufactured for Legal Gear, Brighton, MI and distributed by Affordable Supplements, Wichita, Kansas
These warning letters are part of FDA's continued efforts to protect consumers from dangerous steroid products. In March 2004, FDA sent warning letters to 23 manufacturers and distributors of products containing androstenedione.
Warning Letters:
Affordable Supplements
fda/foi/warning_letters/g5739d.pdf
fda/foi/warning_letters/g5739d.htm
Anabolic Resources LLC
fda/foi/warning_letters/g5736d.pdf
fda/foi/warning_letters/g5736d.htm
Legal Gear
fda/foi/warning_letters/g5738d.pdf
fda/foi/warning_letters/g5738d.htm
Supplementstogo, LLC
fda/foi/warning_letters/g5737d.pdf
fda/foi/warning_letters/g5737d.htm