Wellness Market Regulatory News: GMP Crimes, Spiked Product Sentences
Executive Summary
Connecticut man faces criminal charges for producing supplements after agreeing to cease operations due to GMP violations and get FDA's green light before re-starting. Two other defendants sentenced on criminal charges following FDA investigations of supplements containing undeclared drugs.
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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.
Two Years Into Supplement GMPs, Many Firms Remain Ill-Equipped
FDA inspectors find supplement manufacturers improperly maintaining and calibrating production equipment – in some cases, failing to adequately clean machines between running separate products.
Cosmetics Industry Awaits FDA’s Allergen List While Working To Inform GMP Rulemaking
The Independent Beauty Association does not yet have insight into what ingredients will be listed in the US FDA’s proposed rulemaking for cosmetic allergen labeling – due by 29 June – but is optimistic the agency will consult industry when it comes to setting the compliance timeline. Meanwhile, industry stakeholders are pushing for international harmonization in the agency’s cosmetic GMPs rulemaking.