ABH Nature’s Products Inc. met the 15 business-day deadline to recall all its dietary supplement products under a consent decree that came 10 years after the US Food and Administration initially found quality-control problems at its facility.
Shuttered US Supplement Firm Meets Recall Deadline, But Schumer Says FDA Late Cleaning Up Industry
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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Kyle Diamantas was a partner with the Jones Day firm when he was tabbed as acting deputy commissioner to lead the FDA’s Human Foods Program, established in the agency’s reorganization which became effective in October.
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Streamlined process for reporting problems is key piece of “unified Human Foods Program” which officially launched on 1 October, as Commissioner Robert Califf says, “a new model for field operations and other modernization efforts.”
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Brands also making market moves as lawmakers consider legislation instructing Transportation Security Administration to provide guidance to minimize risk for contamination of baby formula and related pediatric nutritional products.
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Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
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FDA says “extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements—ultimately providing FDA and consumers with greater transparency and food safety.”
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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
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CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.