Undisclosed Allergen, Caffeine Claims Prompt Supplement Recalls
This article was originally published in The Rose Sheet
Firms marketing supplements found to contain steroid ingredients also are recalling products.
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"Despite repeated promises to fix the problems, Defendants have not done so. Accordingly, the United States now seeks a permanent injunction to bring Defendants’ operations into compliance with the law," US attorneys say in a complaint. Global Marketing Enterprises enters consent decree with FDA requiring that before resuming manufacturing and distributing supplements, it implement remedial measures to brings its operations into compliance.
Warning letters state that ingredients listed on labels for AndroPharm and Hardcore Formulations brand products "are synthetic steroids and do not constitute dietary ingredients" under FDA regulations.
Serving amounts such as one-sixteenth of a teaspoon indicated on product labels “cannot be accurately measured using common household measuring tools,” FDA says. NPA, however, suggests the agency gives too little credit to consumers’ measuring skills.