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Senators Push Park Doctrine Prosecution For Spiked Supplement ‘Criminal Endeavors’

This article was originally published in The Tan Sheet

Executive Summary

Key industry allies say they are “deeply concerned” about “blatant criminal activity” in products marketed as supplements but containing anabolic steroids or other drugs. “Bring a few of these actions and you scare people into the idea that … you could actually go to jail,” says attorney Frederick Stearns.

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Four groups say drug identified as “phenibut” is being used in products fraudulently labeled as supplements. The drug, reportedly developed in the former Soviet Union for brain-enhancing properties, has been found in products typically marketed for cognitive benefit and mood enhancement."We're not going to wait for someone to tell us this is not a dietary ingredient," says CRN executive Duffy MacKay.

FDA Regulatory Oversight No Impediment To Drug-Spiked Supplements, Study Finds

Products marketed for sexual enhancement or weight loss remain the most common types that contain undeclared drug ingredients,but drugs are showing up less in a third type that had been frequently found with drugs, bodybuilding supplements, says study in Journal of the American Medical Association. Researchers analyzing FDA database of tainted products marketed as supplements, say the trend didn't slow as FDA increased its GMP inspections and issued numerous warning letters.

FDA May Clarify When Responsibility Prompts Park Doctrine Prosecutions

FDA is considering whether a breach of duty to act or correct violations under the FDCA must occur before criminal charges are brought, Chief Counsel Rebecca Wood says. Clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.

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