ANH and the Natural Products Association (NPA) are teaming up to fight the FDA to protect access to NMN supplements. Action Alert!
ANH-USA and NPA have submitted a Citizen’s Petition to the FDA urging the agency to reverse its determination that NMN is not a legal dietary supplement. If the agency won’t change course, then the petition asks the FDA to issue a regulation specifically allowing NMN to be sold as a supplement. This petition is crucial because it lays the groundwork for a legal challenge if the FDA maintains that NMN can’t be a supplement. We need to keep up the pressure on the FDA and Congress if want to win this battle.
The petition lays out many of the arguments that we’ve covered in previous articles relating to NMN. To briefly recap the issue at hand, NMN is a NAD-boosting supplement that helps promote longevity. Last year, the FDA said that NMN can no longer be a supplement. Why?
It all has to do with the backchannel at the FDA that allows drug companies to take natural ingredients and turn them into drugs while banning the supplement versions.
For supplements that are considered “new” under the law—that is, they weren’t sold “in or as a supplement” before 1994—companies must submit a notification to the FDA with studies to prove that it is safe before that ingredient can be marketed. This is the deeply problematic “new dietary ingredient” (NDI) notification process that we have written about extensively over the years. But here’s the issue: if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives an NDI notification on it from a supplement company, it can no longer be sold as a supplement.
This is a massive problem because it creates a stacked deck in favor of Big Pharma monopolies. IND applications are confidential. A drug company can file an IND on an ingredient and sit on it for years. Meanwhile, an innovative supplement company could develop that nutrient into a great product, do the studies to comply with the FDA’s ridiculous notification process, and then create a market for that product—and then the drug company can swoop in with their IND, kick the supplements out of the market, and create a monopoly.
What makes the case of NMN so infuriating is that a supplement company filed an NDI on NMN in 2022, and the acknowledgement letter from the FDA contained no objections. As far as the law is concerned, at that point NMN is a legal dietary supplement. Just a few months later, though, the FDA reversed course, saying that “new information came to light” and that NMN is not a legal supplement. MetroBiotech, a pharmaceutical company, had sent a letter to the FDA late in 2021 asking the agency to remove all NMN supplements because it had submitted an IND on NMN which the FDA says predated any NDI’s the agency had received.
You can read our petition for the detailed legal arguments to support NMN’s status as a dietary supplement. The key point is that there is clear and compelling evidence that NMN was marketed both as a supplement and as a food from as early as 2016. But the FDA has discounted this evidence on specious grounds. For example, NMN was sold in Japan as a supplement in 2016, but the FDA claims, contrary to a plain reading of the law, that that doesn’t count because it is outside the US. This shows the extent to which the FDA is bending over backwards to block NMN supplements.
There are also important questions as to the legality of the FDA reversing its acknowledgement of the NDI on NMN. According to the law, the FDA can’t remove a supplement once it’s on the market unless that product is adulterated or misbranded. That the FDA seems to have made a mistake in its own protocols is not a reason to remove what became a legal supplement. Indeed, such a move sets a dangerous precedent: why should companies go through the trouble and expense of submitting NDI notifications if the agency can reverse course on a whim, based on INDs that the supplement industry has no way of being aware of until it’s too late?
It’s also worth remembering that the company asking for the NMN ban, MetroBiotech, was co-founded by David Sinclair, PhD, an anti-aging guru who has touted the benefits of NMN supplementation for years. Sinclair proselytizes about the benefits of NMN, while the company he co-founded is working to ban the supplement form so they can turn a profit on their NMN drug—a drug that isn’t even on the market yet and is not guaranteed to ever be on the market. You can read more about Dr. Sinclair’s comments on the NMN ban here. Help us draw attention to our Citizen’s Petition by writing to Congress in support of NMN remaining an affordable dietary supplement.
Action Alert! Write to Congress and urge them to protect access to affordable NMN supplements. Please send your message immediately.
