It’s known that the US Food and Drug Administration needs more information to determine whether hemp-derived cannabinoids are safe for dietary supplements. It also should be known, says acting Commissioner Janet Woodcock, that the agency needs to evaluate its oversight of all supplement manufacturing and marketing.
Regulation Of US Supplement Industry Needs ‘Really Hard Look’ – FDA's Woodcock
Acting commissioner's comment on supplement industry regulation was her most definitive statement about the agency’s work in consumer health sector at CHPA's regulatory conference. Pandemic, she says, heightened consumer interest in self-care along with demand for OTC drugs and supplements.
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Tariffs on imports from China and look at eliminating self-affirmed GRAS pathway introduced under Trump while DoJ Consumer Protection Branch also continues supplement sector priorities enduring across administrations.
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Sales of Bioventra’s probiotic put inventory at “a critical low” as “parallel rise in unverified listings on third-party marketplaces prompted concern among” customers. DoJ and food and drug industry attorney say counterfeiting remains a problem in supplement sector.
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“It's kind of a free for all,” says longtime FDA funding advocate Steven Grossman. FDA knew funding it requested “was totally inadequate to the needs. So, Food Chemical Safety is stuck there with about six or eight other purposes the money could have been used for.
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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.
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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.