Recalls With Potential For Serious Health Risks Will Identify Points Of Sale

"Certain supply chain information is confidential between the supplier and retailer" and makes it difficult for FDA to release lists of retailers offering recalled supplements and foods, says Commissioner Scott Gottlieb. But a draft guidance says for some Class I cases, which pose reasonable probability of serious adverse health consequences or death, additional information about retailers selling potentially harmful product may be key to protecting consumers.

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Addresses for retailers offering dietary supplements and other food products recalled due to "a reasonable probability" using the product "will cause serious adverse health consequences or death" could be published by FDA, the agency says.

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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.

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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.

HHS Secretary Kennedy Directs FDA To Consider Axing Self-Affirmed GRAS ‘Loophole’

 

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.”