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FDA Issues Warning About Body-Building Products Labeled to Contain Steroid and Steroid Like Substances

Tuesday, June 20, 2017

[6/20/17] The U.S. Food and Drug Administration today posted warning letters to Flex Fitness/Big Dan’s Fitness, AndroPharm, and Hardcore Formulations for illegally marketed products labeled to contain steroid and steroid-like substances and promoted to increase muscle mass and strength.

Although the products that are the subject of these warning letters are marketed as dietary supplements, they are not dietary supplements. Instead, these products are unapproved drugs that FDA has not reviewed for safety and effectiveness.

FDA recommends consumers immediately stop using over-the-counter body-building products labeled or promoted to contain steroid and steroid-like substances due to the risk of serious liver injury and other adverse health consequences including kidney injury, increased risk of heart attack and stroke, and shrinkage of the testes and male infertility.

The agency reviewed more than seven years of adverse event reports and found 35 patients who suffered liver injuries, many requiring hospitalization, that were associated with these types of products.

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Source: U.S. Food & Drug Administration