Lawsuits Against FDA's NMN Ban Could Be Coming Soon

Natural health and product advocates are contemplating suing the FDA to reverse its determination that NMN is not a legal dietary supplement.

Key takeaways:

Nicotinamide mononucleotide (NMN) is a precursor to NAD+ and NADH, which are metabolic compounds that decrease as a person ages. Supplements containing NMN may help boost mitochondrial function and insulin sensitivity by increasing NAD+ levels, which could promote healthy aging. While this appears promising, research has produced conflicting evidence on whether NMN lives up to these claims.

The FDA had previously accepted NMN as a New Dietary Ingredient (NDI), which allowed supplement manufacturers to market it. But in 2022, the agency revoked the NDI so companies could no longer sell NMN in the United States.

This decision has caused outrage among those in the dietary supplement community and organizations who advocate for consumer access to natural vitamins, herbs, and supplements.

Why is NMN banned?

When a supplement company wants to market a new ingredient, it must voluntarily submit an NDI form to the FDA. In July 2022, Mongolia Kingdomway Pharmaceutical Limited submitted an NDI for NMN because the company wanted to include it in a new dietary supplement.

In October of that year, the FDA denied Kingdomway's NDI, stating that NMN could not be marketed in the U.S. because it had been authorized for investigation as a new drug.

However, because the FDA previously accepted NMN as a new dietary ingredient, Kingdomway and others questioned the agency's decision.

The FDA explained its stance, saying NDIs submitted for NMN in the past occurred after pharmaceutical companies began investigating the compound as a potential new drug.

An FDA spokesperson tells Healthnews, "The FDA has previously communicated to several firms who submitted new dietary ingredient (NDI) notifications that NMN appears to be excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B)(ii) and therefore may not be marketed as or in a dietary supplement in the United States."

However, the FDA does not disclose when a pharmaceutical firm submits an Investigational New Drug (IND) application. So, it's unclear whether pharmaceutical companies had an IND for NMN before companies like Kingdomway submitted an NDI for the same ingredient.

"This is a massive problem because it creates a stacked deck in favor of Big Pharma monopolies," Robert Verkerk, Ph.D., founder and executive and scientific director with Alliance for Natural Health, explains to Healthnews. "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 NDI 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."

Verkerk says that until someone closes this loophole, pharmaceutical companies will use these rules to take valuable natural compounds and create expensive drugs, leaving them out of reach of consumers who could benefit from them.

Dr. Brad Stanfield, a primary care physician in Auckland, Australia, tells Healthnews, "While the FDA has a duty to protect consumers from potentially dangerous supplements, the NMN ban unfortunately centers around money."

Stanfield says a company called Metro-Biotech, co-founded by Dr. David Sinclair, lobbied the FDA to ban NMN so they could sell their own patented version of NMN called MIB-626.

"From the multiple human studies we have available, there are no significant safety concerns," Stanfield explains. "This ban is purely about money and greed."

NMN ban impacts the supplement industry

A global 2022 research report estimated the value of the U.S. NMN market to be $280.2 million, with a projected value of $496.4 million by 2028. Therefore, the FDA's decision to ban the ingredient has undoubtedly affected the supplement industry. For example, in March 2023, Amazon prohibited retailers from selling NMN products.

However, the NMN ban may have a more significant impact on consumers.

"If the FDA doesn't change course, or if Congress doesn't step in to change the law to protect NMN supplements, we could see these products disappear," Verkerk says. "This has already happened to the naturally occurring pyridoxamine form of vitamin B6. A drug company went to the FDA claiming it had started investigating pyridoxamine as a drug before it was sold as a supplement. The FDA agreed, and pyridoxamine supplements were banned. Note that no pyridoxamine drug ever came to market, so consumer access was completely lost — and remains so to this day."

Verkerk says this cannot happen to NMN.

"NMN is one of the most effective precursors to NAD, which is critical to longevity and consequent disease-risk reduction in later age. […] Studies have shown that boosting NAD levels increases insulin sensitivity, reverses mitochondrial dysfunction, and extends lifespan. NAD itself is not absorbed well by cells, so we benefit from ingesting precursors like NMN to raise blood levels of NAD," Verkerk explains.

FDA fails to resolve a citizen petition

On March 7, 2023, the Natural Products Association (NPA) and the Alliance for Natural Health sent a citizen petition to the FDA regarding NMN. Federal regulations require the FDA to respond to a citizen petition within 180 days.

"ANH-USA submitted the Petition with our allies at the Natural Products Association to urge the FDA to reverse its determination that NMN is not a legal dietary supplement," Verkerk explains. "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."

Verkerk says submitting a petition on NMN is critical because it lays the groundwork for a legal challenge if the FDA maintains that NMN can't be a supplement.

In response to the NMN citizen petition, the FDA sent a letter to both organizations stating it did not reach a decision but is evaluating the petition. According to an agency spokesperson, the FDA "did not take any position on the regulatory status of NMN under the dietary supplement definition because this same issue is under consideration in another proceeding."

The spokesperson adds, "Our decision on this pending citizen petition will directly affect our position regarding the use of NMN as or in a dietary supplement."

Verkerk tells Healthnews that this is common practice at the FDA. For example, the Office of Inspector General noted that the FDA doesn't have an effective process for dealing with citizen positions in a timely manner.

"This kind of delay can also be a tactic. It's harder to do business in a climate of uncertainty," Verkerk says. "The FDA is probably hoping that more companies follow Amazon's example by voluntarily banning NMN supplements from their stores. When major distributors withdraw products prior to any formal ban, it allows the FDA to be less liable to public criticism."

The NPA previously submitted a citizen petition to the FDA and subsequently filed a lawsuit over N-acetylcysteine (NAC), another dietary ingredient banned by the agency. The organization withdrew the lawsuit after the FDA issued final guidance on NAC, allowing dietary supplement makers to market and sell the compound.

Will the FDA face an NMN lawsuit?

Daniel Fabricant, Ph.D., president and CEO of the NPA, told NutraIngredients-USA in September that the NMN situation will likely approach a convergence point in the courts.

Verkerk says they are well aware of the looming lawsuit and have agreed to be a co-claimant on the case.

Yet, whether the FDA will face a lawsuit is only part of the big picture.

Verkerk concludes, "We need to protect access to NMN, but we also need to fix the bigger issue, which is that the law, as it is currently set up, allows drug companies to ransack natural compounds and turn them into a monopoly for the drug companies."

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