11.06.24
Counsels representing the U.S. Food and Drug Administration (FDA) and theNatural Products Association (NPA) filed a joint motion to stay a lawsuit related to Nicotinamide Mononucleotide (NMN), an ingredient that the agency declared unlawful for use in supplements two years ago.
According to the motion, both parties agreed that FDA’s response to a citizen petition submitted by NPA would likely resolve the case without further litigation, and FDA anticipates that it will respond to the citizen petition by July 31. "A stay of proceedings in this matter until FDA answers the citizen petition thus will conserve time and resources of the court and its parties," the joint motion reads.
NMN is one of several ingredients in recent years to fall under the agency’s scrutiny, due to uncertainty over whether it is precluded from use in supplements because it was previously investigated as a drug, per the Dietary Supplement Health and Education Act (DSHEA). NPA’s petition requested that FDA reverse its position on NMN’s preclusion from use in supplements.
The joint motion indicated that FDA doesn’t intend to prioritize enforcement actions related to NMN-containing products for the time being – this is subject to change if the agency becomes aware of new safety concerns.
“This is a monumental victory for NPA, our members, and American consumers,” said Daniel Fabricant, PhD, president and CEO of NPA. “The court said plainly that FDA vastly exceeded their authorities and need to go back to the enforcement regime that follows the letter of the law. Hopefully, FDA will get the message and start focusing on using the clear and expansive powers that it has instead of constantly seeking additional authorities they don’t need."
“Fundamentally, FDA’s past decisions have weakened the integrity of the New Dietary Ingredient (NDI) Notification process for members of the NPA who want to bring 21st-century consumer health products to the market. While we believe the FDA could have solved this and other similar cases without litigation, we are pleased with the outcome and will continue to hold the FDA accountable when the agency misapplies the law.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said that he anticipates FDA will soon have answers to the uncertainty surrounding the drug preclusion provision of DSHEA, and the agency’s unexpected declarations that certain ingredients like NMN, NAC, CBD, and others are precluded from use in supplements. This includes providing answers to CRN’s own citizen petition, which addresses the issue of drug preclusion more broadly by precisely determining the date referenced in the statute (i.e. the date which applies to the ‘race to market’ between a drug and supplement).
“We said that what we need is clarity around drug preclusion once and for all, and how FDA interprets the provision, rather than with respect to a specific ingredient,” Mister told Nutraceuticals World. “We’ve been told by FDA that because our petition and the NPA petition are both so linked together around the same issue, they could not answer one without answering the other … we’ll be getting an answer by July as well.
Mister said that the response will set some ground rules for how drug preclusion will be applied in future cases, rather than how it applies to the ingredients being argued over today. And should FDA’s interpretation of the law in its response differ from that of CRN’s, Mister noted that the association plans on working with Congress to amend the language surrounding drug preclusion to make the law itself subject to less interpretation.
According to the motion, both parties agreed that FDA’s response to a citizen petition submitted by NPA would likely resolve the case without further litigation, and FDA anticipates that it will respond to the citizen petition by July 31. "A stay of proceedings in this matter until FDA answers the citizen petition thus will conserve time and resources of the court and its parties," the joint motion reads.
NMN is one of several ingredients in recent years to fall under the agency’s scrutiny, due to uncertainty over whether it is precluded from use in supplements because it was previously investigated as a drug, per the Dietary Supplement Health and Education Act (DSHEA). NPA’s petition requested that FDA reverse its position on NMN’s preclusion from use in supplements.
The joint motion indicated that FDA doesn’t intend to prioritize enforcement actions related to NMN-containing products for the time being – this is subject to change if the agency becomes aware of new safety concerns.
“This is a monumental victory for NPA, our members, and American consumers,” said Daniel Fabricant, PhD, president and CEO of NPA. “The court said plainly that FDA vastly exceeded their authorities and need to go back to the enforcement regime that follows the letter of the law. Hopefully, FDA will get the message and start focusing on using the clear and expansive powers that it has instead of constantly seeking additional authorities they don’t need."
“Fundamentally, FDA’s past decisions have weakened the integrity of the New Dietary Ingredient (NDI) Notification process for members of the NPA who want to bring 21st-century consumer health products to the market. While we believe the FDA could have solved this and other similar cases without litigation, we are pleased with the outcome and will continue to hold the FDA accountable when the agency misapplies the law.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said that he anticipates FDA will soon have answers to the uncertainty surrounding the drug preclusion provision of DSHEA, and the agency’s unexpected declarations that certain ingredients like NMN, NAC, CBD, and others are precluded from use in supplements. This includes providing answers to CRN’s own citizen petition, which addresses the issue of drug preclusion more broadly by precisely determining the date referenced in the statute (i.e. the date which applies to the ‘race to market’ between a drug and supplement).
“We said that what we need is clarity around drug preclusion once and for all, and how FDA interprets the provision, rather than with respect to a specific ingredient,” Mister told Nutraceuticals World. “We’ve been told by FDA that because our petition and the NPA petition are both so linked together around the same issue, they could not answer one without answering the other … we’ll be getting an answer by July as well.
Mister said that the response will set some ground rules for how drug preclusion will be applied in future cases, rather than how it applies to the ingredients being argued over today. And should FDA’s interpretation of the law in its response differ from that of CRN’s, Mister noted that the association plans on working with Congress to amend the language surrounding drug preclusion to make the law itself subject to less interpretation.
