In this video excerpt taken from the Nov. 15 Council for Responsible Nutrition (CRN) Washington Watercooler webinar hosted by Informa, which publishes Natural Products Insider, CRN executives Megan Olsen and Steve Mister react to FDA’s determination that another ingredient—the anti-aging hot-shot β-NMN (beta-nicotinamide mononucleotide)—is excluded from the definition of a dietary supplement.
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.’”
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/