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

 
• By Malcolm Spicer

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.

(Source: Shutterstock/Citeline)
Key Takeaways
  • “We thought it was a good time to sort of crystallize for FDA what it is that the industry wants to get out of this process and remind them of what were the key issues in our petition,” says CRN CEO Steve Mister.
  • CRN’s points in supplement to citizen petition include: “evidence of marketing as a food or dietary supplement should be dispositive, unless FDA has met its statutory burden of demonstrating that the marketing was unlawful.”
  • Preclusion is “a race to market, and it's a race to market that we have criticized because it gives drug companies, right now, a very broad monopoly,” says CRN general counsel Megan Olsen.

The Council for Responsible Nutrition suggests the US Food and Drug Administration give attention to the trade group’s suggestion that the agency reconsider its policy prohibiting substances studied or approved...

The CRN and the Natural Products Association in 2023 filed separate citizen petitions suggesting the FDA adjust its policy on the “drug preclusion” provision in its supplement regulation framework, established...

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