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Shuttered US Supplement Firm Meets Recall Deadline, But Schumer Says FDA Late Cleaning Up Industry

Executive Summary

While contract manufacturer ABH Nature' complied with consent decree, Sen. Chuck Schumer says FDA is late in enforcing against noncompliant firms across the supplement sector. Other recent consumer health recalls include more OTC ranitidine tablets due to the potential carcinogen NDMA found in the heartburn ingredient and four versions of Sure 48HR Anti-Perspirant & Deodorant with labeling errors.

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New York Supplement Firm Shut Down On GMP Violations Repeated Since 2010

ABH Nature’s and its owner, Mohammed Jahirul Islam, agree to a consent decree recently barring them from distributing adulterated and misbranded supplements and unapproved and misbranded drugs and requiring remedial action before restarting production. FDA records indicate its s inspections of the facilities began in 2010 and at least one GMP violation found in later inspections was noted in the first.

FDA Suggests Legislation To Streamline Enforcement In Supplement Market

Congress should consider legislation authorizing agency to conduct enforcement more directly, says Associate Commissioner Schiller. In FDLI conference keynote, he discussed compliance with FDA regulations across markets it regulates, but made specific example of saying FDA is comparatively hamstrung in regulating businesses marketing products labeled as supplements.

GSK Leaving Pennsylvania Emergen-C Plant, Adding Voltaren To US OTC Line

UK pharma announced that in 2021 it will close its manufacturing facility in Carlisle, PA, where around 260 people are employed making the Emergen-C line. It will move the manufacturing to its Guayama, PR, facility.

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