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In US, Does NDI Indicate ‘Not Delivering Innovation’ Rather Than ‘New Dietary Ingredient’?

Reasons Clear For Gridlock On FDA’s Notification Requirement, Solution Remains Murky

 
• By Malcolm Spicer

Why stakeholders have many questions and why so many ingredients that weren’t cleared by FDA are rampant in the US are questions at the heart of resolving disagreement between the industry and the agency over regulation both sides acknowledge is biggest impediment to market growth.

Gap (cherezoff/Shutterstock.com)

The number of questions the US Food and Drug Administration’s new dietary ingredient notification generates is large and growing but is dwarfed by the number of new ingredients added to dietary supplements since the rule was established, most without being notified.

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More from Policy & Regulation

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• By Malcolm Spicer

Changes established in West Virginia and proposed in numerous other states gained momentum after Trump was elected to his second term as president and nominated Kennedy to head HHS.

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

 
• By Malcolm Spicer

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

 
• By Malcolm Spicer

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.