A Senate committee’s legislation would deliver for the US dietary supplement industry on compelling guidance on new dietary ingredient notifications but has too much for its liking about mandatory regulatory registration of all supplements.
No Longer Draft, Senate Mandatory Supplement Registration Bill Gets Flood Of Opposition
Some stakeholders have supported mandatory listing but they join opponents questioning legislation also authorizing FDA to prohibit sales of products compliant with manufacturing and labeling regulations but deficient, incomplete or late with registration information required for the agency.
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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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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.
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Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”