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CRN’s Mister, Olsen discuss beta-NMN, drug exclusion – videoCRN’s Mister, Olsen discuss beta-NMN, drug exclusion – video

CRN executives weigh in on FDA’s determination that an anti-aging ingredient can't be marketed in a dietary supplement, as well as the broader challenges of drug preclusion.

Josh Long

November 16, 2022

FDA’s conclusion, as reported last week by Natural Products Insider, is based on its finding that β-NMN was authorized for investigation as a drug before it was lawfully marketed as a dietary supplement.

Drug preclusion is affecting many ingredients, including hemp-derived CBD, NAC (N-acetyl-L-cysteine) and now NMN, noted Olsen, senior vice president and general counsel with CRN.

“We’re finding that it’s not just about the individual ingredients but the precedent that FDA is setting,” Olsen said. “We made that very clear when CRN challenged FDA’s statements in 2020 about NAC being an appropriate dietary ingredient because we don’t want to have to just fight these [FDA determinations] on an ingredient-by-ingredient basis. We want the precedent to be set as to how the statute should be interpreted in a manner that provides a path [to market] for safe and effective dietary supplements … as Congress intended.”

CRN’s CEO and president, Mister, cited the need to consider a legislative fix to change the drug exclusion provision in the law, which essentially prohibits an ingredient from being marketed in dietary supplements if it was first studied or approved as a drug.

“I think there’s a much bigger issue here that’s going to lead us to really peel back the drug preclusion provision and ask what needs to be done to fix this,” Mister said. “That will take the involvement of Congress. FDA’s not going to change the statute on its own. But all of these issues keep pointing to the fact that we have a problem as the research keeps getting better and we know more about these ingredients, and we have drug companies that pop up and say, ‘Well, I studied it first. I should get a monopoly over it.’”

Related:Trade groups react to FDA decision on β-NMN in supplements

During the webinar, Olsen and Mister also addressed related issues in response to questions, including:

  • Considerations for NMN brands selling the ingredient.

  • Challenges in bringing a lawsuit against FDA.

  • And the opportunity for compromise with FDA on a legislative package.

To watch the entire Washington Watercooler webinar focused on NMN, the midterm elections and an economic study released by the CRN Foundation, go here: https://www.linkedin.com/video/event/urn:li:ugcPost:6998322132707373058/


About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long has been a journalist since 1997, holds a J.D. from the University of Wyoming College of Law, and was admitted to practice law in Colorado in 2008. Josh is the legal and regulatory editor with Informa's Health and Nutrition Network, specializing on matters related to Natural Products Insider. Ping him with story ideas at [email protected].

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