FDA Reverses Position on NMN, Declares Supplement Ingredient Lawful After Industry Legal Challenge
核心洞察
The FDA has reversed its 2022 decision and now declares NMN (搜索) (beta-nicotinamide mononucleotide) lawful for use in dietary supplements, citing evidence the ingredient was marketed in the U.S. as early as 2017.
The agency revised its interpretation of the race-to-market clause, stating that prior marketing of NMN (搜索) as a supplement occurred before drug authorization, making it exempt from exclusion.
Industry groups including the Natural Products Association (搜索) and Alliance for Natural Health (搜索) successfully challenged the FDA's original position through citizen petitions and legal action.
The FDA has reversed its controversial 2022 decision banning NMN (搜索) (beta-nicotinamide mononucleotide) from dietary supplements, declaring the anti-aging compound lawful for supplement use after determining it was marketed before drug authorization began.
In a letter signed by Donald Prater, DVM, principal deputy director for human foods, the FDA stated it had revised its interpretation of the race-to-market clause, which prevents ingredients that are first investigated as drugs from becoming dietary ingredients. The agency concluded that "NMN (搜索) is not excluded from the definition of dietary supplement under section 201(ff)(3)(B)."
Regulatory Reversal Based on Marketing Timeline
The FDA's decision hinged on evidence that NMN (搜索) was marketed as a dietary supplement in the United States as early as 2017, before drug authorization occurred. "Although NMN was authorized for investigation as a new drug, and substantial clinical investigations of NMN have been instituted and made public, NMN was marketed as a dietary supplement in the United States before such authorization," the agency stated.
The FDA acknowledged that its prior position requiring lawful marketing before drug approval was not the "best reading" of the statute. The agency announced it would no longer evaluate whether the dietary supplement or food was lawfully marketed when determining its status under the race-to-market framework, though marketing must have occurred in the United States.
Industry Victory After Legal Battle
The decision represents a significant victory for industry groups that challenged the FDA's original ban through citizen petitions and legal action. The Natural Products Association (搜索) (NPA (搜索)) and Alliance for Natural Health (搜索) (ANH (搜索)) filed a citizen petition on March 7, 2023, requesting FDA determine that NMN (搜索) is not excluded from dietary supplement definition.
Daniel Fabricant, PhD, president and CEO of NPA (搜索), welcomed the decision, stating: "FDA's decision today confirms NMN (搜索) is lawful in supplements, and we now call on e-commerce platforms to immediately restore NMN products to the market."
Rob Verkerk, PhD, ANH (搜索) executive & scientific director, called the confirmation "a landmark victory for consumer choice and natural health," adding that the decision ensures "Americans will continue to have access to this important nutrient that supports healthy aging."
Timeline of Regulatory Uncertainty
The regulatory battle began in November 2022 when FDA announced that NMN (搜索) was not allowed as a dietary ingredient due to its prior investigation as a drug. The agency made this determination after becoming aware of recent drug studies on the ingredient.
After FDA stated in September 2023 that it was unable to reach a decision due to "competing agency priorities," NPA (搜索) filed a lawsuit against the agency in August 2024. U.S. District Judge Paul L. Friedman granted a stay of legal proceedings in October 2024 to allow FDA to evaluate the NMN (搜索) citizen petition, accompanied by FDA instituting enforcement discretion for NMN-containing products.
Broader Regulatory Concerns Remain
While the NMN (搜索) decision provides clarity for this specific ingredient, industry groups express concern about the broader race-to-market framework. The Council for Responsible Nutrition (搜索) (CRN (搜索)), which filed a separate citizen petition in May 2023, stated that FDA "missed a pivotal opportunity to bring clarity and balance to the line between pharmaceuticals and dietary supplements."
Steve Mister, president and CEO at CRN (搜索), noted that "at every juncture where FDA had the opportunity to choose between two interpretations of the statute, it chose one that favors pharmaceutical development over supplements."
The FDA response maintains what CRN (搜索) calls a "secretive preclusion date," stating that the relevant date for the race-to-market clause is when an article was authorized for investigation as a new drug, not when investigations were instituted or made public. The agency also indicated it would evaluate exclusion determinations on a case-by-case basis, creating what industry groups describe as ongoing uncertainty for supplement innovators.
NMN's Role in Cellular Health
NMN (搜索) is one of the forms of vitamin B3, or niacin, that has been shown to enhance levels of nicotinamide adenine dinucleotide (NAD+) in body cells. Boosting these levels has demonstrated significant benefits in staving off cellular aging (搜索), making it a popular ingredient in anti-aging supplements before the regulatory uncertainty began.