NDI Notification Guidance Deadline Included In Senate Draft Bill For FDA User Fee Programs

HELP Committee Chairwoman Patty Murray, and ranking member Richard Burr also include supplement registration requirement in discussion draft for reauthorizing FDA’s user fee programs for prescription, generic and biosimilar drugs and medical devices.

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US dietary supplement industry stakeholders are split on the Food and Drug Administration requiring product registration as a draft Senate bill would authorize, but agreement is likely on a provision ordering the agency to publish a final guidance on new dietary ingredient notifications.

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US Consumer Health Industry Buckles Up For Another Ride As Trump Swings Tariff Tool Again

 

Manufacturers, marketers and other businesses in the industry may be thinking, “Well, this is different” because the president ordered tariffs on a list of countries rather than on his sole first-term target of China.

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.

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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.

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.