Healthnews has compiled the timeline of events leading up to and after the FDA banned NMN. We detailed the twists, turns, and unexpected roadblocks for consumers and companies hoping to market the anti-aging compound.
Nicotinamide mononucleotide (NMN) is a precursor to nicotinamide adenine dinucleotide (NAD+) — a compound involved in cellular repair and protection. Reports suggest supplementing with NMN may reduce age-related inflammation, boost cardiovascular and brain health, and support the body's metabolic processes.
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However, the U.S. Food and Drug Administration (FDA) banned NMN in 2022 from being sold as a dietary supplement after initially allowing one company to market it as a dietary supplement, sending shockwaves through the supplement industry and organizations that support natural health products.
In addition, the events leading up to and following the ban have left many unanswered questions about what's happening with this anti-aging supplement.
NMN creeps into the retail market
According to one report, in 2016, Shinkowa Pharmaceutical Co. announced its new NMN supplement was available on Amazon in the United States. However, it's unclear how that was possible, as NMN had yet to go through the FDA's supplement regulatory process.
The FDA oversees dietary supplements differently than conventional food or drug products. Per FDA regulations under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug, and Cosmetic Act, supplement manufacturers must submit a New Dietary Ingredient (NDI) notification to the FDA when they plan to market a supplement that contains a new ingredient.
The submitted document must include information demonstrating that the dietary supplement, which incorporates the new ingredient, can be reasonably deemed safe for use under recommended conditions or as instructed on the label.
Still, the FDA does not approve dietary supplements for safety and effectiveness before the products are allowed to enter the market. Instead, the agency approves or denies the manufacturer's NDI notifications.
However, the FDA has the authority to act if a supplement product is misbranded or adulterated, or the agency receives reports of adverse health events related to the product after it enters the market.
FDA green lights NMN for the first time
Before 2022, several manufacturers submitted NDI notifications for NMN, but none gained FDA approval until May 16, 2022. That's when the agency accepted an NMN NDI notification from SyncoZymes, a Shanghai-based pharmaceutical firm, which allowed the company to market NMN in the United States.
Other NMN supplement companies follow suit
On July 28, 2022, Inner Mongolia Kingdomway Pharmaceutical Limited decided to get in on the action and submit its NDI notification for NMN. The manufacturer planned to market their NMN-containing supplement, like SyncoZymes, in the U.S.
FDA bans NMN marketing as a dietary supplement
On October 11, 2022, Kingdomway hit a significant roadblock when the FDA responded to the NDI notification, stating that NMN is under investigation as a new drug and, therefore, cannot be marketed in the U.S. as a dietary supplement.
The NDI denial was based on a preclusion provision of Section 201(ff) of the Federal Food, Drug, and Cosmetic Act, which is designed to protect pharmaceutical companies' interests as they develop new drugs and prevent companies from bypassing the drug approval process. The FDA claimed another pharmaceutical company had submitted an Investigational New Drug (IND) application for NMN.
However, the FDA does not disclose when a pharmaceutical company submits an IND. In its response to Kingdomway, the FDA said that NMN was not marketed as a dietary supplement, except unlawfully without an NDI notification, or as a food before the agency authorized it for investigation as a new drug.
Because the agency does not reveal details about an IND, supplement manufacturers and the public must accept the FDA's claim that the IND application occurred before the supplement companies submitted their NDI notifications.
Can you still buy NMN supplements in the U.S.?
While the FDA has strongly advised against marketing NMN as a dietary supplement, NMN supplements are still available for purchase in the United States from various manufacturers. Despite the regulatory stance, consumers can find NMN supplements on the market until further notice. Many individuals seek NMN for its potential health benefits, including its role in cellular energy production and potential anti-aging properties.
As with any supplement, it's essential to research top NMN brands and consult with a healthcare professional before incorporating NMN into your regimen.
SyncoZymes loses its NDI approval
After the Kingdomway NDI denial, other companies continued to submit NDI notifications for NMN but were met with the same response from the FDA. Then, on November 4, 2022, the FDA revoked SyncoZyme's previously approved NDI.
Supplement advocates submit a citizen's petition
On March 7, 2023, The Natural Products Association (NPA) and Alliance for Natural Health USA, two organizations that advocate for access to natural health-related products, sent a citizen petition to the FDA asking the agency to reverse its decision that NMN is not a legal dietary supplement. If the FDA refused, the petition requested that the agency allow NMN to be sold as a supplement regardless of its decision.
The FDA remains unmoved
On August 30, 2023, the FDA responded to the citizen petition, reiterating that NMN is under investigation as a new drug and cannot be marketed as a dietary supplement. An agency spokesperson said 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."
What could happen with NMN?
The FDA's ban on NMN incited debate among many experts in the supplement industry. For example, Metro-Biotech, co-founded by Dr. David Sinclair, is developing an NMN-based drug called MIB-626. Yet some health influencers say the drug is different from NMN therefore, it should be allowed in the supplement marketplace.
However, because of the FDA's flat response to the citizen petition, the issue will likely end up in court. Robert Verkerk, Ph.D., founder, executive, and scientific director of the Alliance for Natural Health, said in a previous interview with Healthnews that they know of a potential lawsuit and have agreed to be a co-claimant on the case.
A similar lawsuit occurred in 2021 when the FDA banned N-acetylcysteine (NAC). The National Products Association filed suit but eventually withdrew the lawsuit after the FDA issued final guidance and allowed manufacturers to market the ingredient.
- Businesswire. Shinkowa Pharmaceutical: The world's first NMN dietary supplement specialized for anti-aging, the top sales in the new product rankings and the best seller in the resveratrol dietary supplement on Japan Amazon, now available on the US Amazon.
- FDA. New dietary ingredient (NDI) notification process.
- FDA. Dietary supplements.
- SyncoZymes. SyncoZymes (Shanghai) Co., Ltd, the world's first NMN raw material passed FDA NDI certification.
- FDA. CFR - Code of Federal Regulations Title 21.
- Natural Products Association and the Alliance for Natural Health USA. Citizen petition regarding regulatory status of β-nicotinamide mononucleotide.
- Natural Products Association. FDA response to NMN citizen petition.
- The Journals of Gerontology. MIB-626, an oral formulation of a microcrystalline unique polymorph of β-nicotinamide mononucleotide, increases circulating nicotinamide adenine dinucleotide and its metabolome in middle-aged and older adults.
- Natural Products Association. Following final NAC guidance and marketplace stabilization, NPA withdraws FDA lawsuit.