NDI Notifications Take Center Stage In FDA's Evaluation Of DSHEA

FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.

Vitamins

Improving compliance with the US Food and Drug Administration's premarket notification requirement for dietary ingredients is the focal point of the agency's discussion on strengthening its dietary supplement industry oversight.

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Some New Tools, More Old For Supplement Sector Enforcement During Trump’s Second Term

 

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.

Availability Of Counterfeit Supplements Ringing Up Impact On Brand Sales And Consumer Safety

 

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.

US FDA Reorganization Set Stage To Improve Food Programs, But Slim Budget Grabs Spotlight

 

“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.

US Supplement Industry Needs Relief From ‘Drug Preclusion’ Policy, CRN Reminds FDA

 

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.

More from Policy & Regulation

Traceability Rule Compliance Extended For Providers Of Herbals, Other Food Ingredients

 

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.”

Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
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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.

US Supplement Industry Needs Relief From ‘Drug Preclusion’ Policy, CRN Reminds FDA

 

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.