The FDA under Commissioner Makary’s leadership has backed down from its attempt to block NMN, a powerful anti-aging supplement, marking a major victory for health freedom and consumer access. This is a major step for health freedom—while the broader fight over drug preclusion continues.
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THE TOPLINE
- In response to a Citizen Petition filed in 2023 by ANH and the Natural Products Association, the FDA has just reversed its position and acknowledged that NMN was legally marketed as a dietary supplement before drug trials began—blocking an attempted drug monopoly and securing consumer access.
- This decision represents a major victory for health freedom and the supplement industry, ensuring NMN, a key precursor to NAD+ with strong anti-aging potential, remains available at reasonable prices.
- Despite the win, the FDA continues to defend its broad, pro-Pharma interpretation of the drug preclusion clause, meaning further reforms are still needed to protect access to natural compounds.
We have some great news to share on our fight to protect access to NMN, a critical anti-aging supplement. In response to a Citizen Petition we filed alongside the Natural Products Association (NPA), the FDA has conceded that it was wrong to exclude NMN from the definition of a dietary supplement—a position that had threatened to hand a monopoly to a drug company.
NMN, or nicotinamide mononucleotide, is becoming widely recognized for its potential to reverse aging, likely because NMN is one of the most effective precursors to NAD+ , which is critical to longevity, healthy neurological function and energy production in the body. NMN is on the cutting edge of anti-aging, so we’re thrilled with this legal victory allowing us to have access to this compound at reasonable prices.
Under the previous administration, the FDA argued that, even though NMN supplements have been on the market for years, NMN was not “legally” marketed as a supplement before drug trials began because no New Dietary Ingredient notification had been accepted on the ingredient. But the law (as it applies to the drug preclusion clause) does not allow FDA to make that determination. In the agency’s own words: “Congress did not intend for FDA to examine whether the first marketing of the article as a dietary supplement or as a food was lawful.”
The upshot is this: the FDA under the leadership of Dr. Marty Makary has just responded to our petition acknowledging that NMN was marketed as a supplement in the U.S. as early as 2017, before drug investigations began, and therefore is not excluded from the definition of a dietary supplement. This is a major win for health freedom and consumer access.
We should note that, while this is a major win for NMN access, there are still major problems with how the FDA is interpreting the drug preclusion clause—or what we have called the FDA back-channel by which Big Pharma can turn natural compounds into drugs. Our petition raised several of these issues, and on many of them the FDA doubled down on its pro-Pharma interpretation. We will continue to fight for structural reforms to protect consumer access to affordable natural compounds.
Speaking to this, Jonathan Emord, ANH’s General Counsel, said: “We are grateful that our alliance with NPA yielded a positive outcome to keep NMN available as a dietary supplement and avoid a drug monopoly on that B vitamin. The battle is far from over, however, as CRN explains, we still need FDA to reform its interpretation of the drug exclusion provision to mirror the plain statutory language and legislative intent.”
Rob Verkerk, PhD, ANH executive and scientific director, said, “This is a real win for American health, longevity, research, and innovation. There’s ample scientific data showing that NMN reliably boosts NAD⁺ levels in humans and improves some metabolic or vascular markers. Now NMN is once again safe as a supplement, there’s a strong incentive for companies to invest in more research to see if humans respond the same way as lab animals where NMN has been shown to improve multiple markers linked to longevity.”
Share this win with your network—and help prove, again, that people power protects health freedom when we stay proactive.
