FDAnews Drug Daily Bulletin

Manufacturers Receive FDA Warnings on Steroids Masquerading as Supplements

June 23, 2017

The FDA cautioned manufacturers and consumers that a collection of supplements are illegally marketed drugs containing so-called designer steroids, issuing three warning letters to Flex Fitness/Big Dan’s Fitness, AndroPharm and Hardcore Formulations.

The companies’ products claim to increase muscle mass and strength — with names including “D-Zine,” “Super Powers” and “Ultra-Sten” — and are represented as dietary supplements in their labeling, packaging and marketing materials. The FDA classified eight products between the three companies as unapproved drugs.

Some contained compounds such as dymethazine and methylsten, synthetic steroids that are not considered dietary ingredients under the FD&C Act. The eight products have not been reviewed for safety or effectiveness and carry risks for liver and kidney damage, heart attack, stroke and male infertility, the agency said. — Gayle S. Putrich

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