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FDA Bans NMN as a Dietary Supplement: Why and What Happened?

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.


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Comments

Evan Lott
prefix 9 months ago
This should be a wake up call for the citizens of this country. It's time to get off out butts and get seroius about fixing this bloated off the rails government. Learn what is real, despite the tidlewave of BS and vote for people who actually care about this country, not just themselves.
Jim
prefix 1 year ago
It's pretty amazing how many "trusted" agencies have gone off the rails the last decade. This specific decision is highly unusual and offers no public benefit. Follow the FDA members $ received from irregular sources and the lucrative job offers over the next five years, and I think it will be clear quite a few MD's, are in, at least, the grey area for felony charges. A similar pharma lobby has been going on with peptides, essentially seeking to ban that which makes people feel better and lacks a hospital billing code. The result is that us middle aged and older folks who have put the effort in to decide what works,will be disenfranchised. This is the same FDA who omitted the fact that Pfizer's all cause mortality was the same in both C19 Groups and who moved to suppress all the adverse reports for 75 years. Power corrupts....
Robert Colletto
prefix 1 year ago
I continue buying my NMN from a very reputable source and they have told me they won't stop selling it, until the FDA steps in. I think the FDA banning a natural product is absolute insanity and this should not happen.
Alexis Wong
prefix 1 year ago
The focus of the FDA USED to be about SAFETY but how many times over the years have drugs been previously approved recalled (Vioxx for example) that have been harmful, even causing deaths.
It appears they are in the pocket of Big Pharma with their shenanigans over the years.
Bill
prefix 1 year ago
However, regardless of NMN’s fate, Dr. Gladd suggests that although many people take it for its potential role in healthy aging, it’s unclear whether it has significant benefits.
I've been taking NMN, Trans-Resveratrol and Fisetin for several months now and have recorded significant improvement by losing weight, having more energy and better/longer sleep.
“While supplements may provide benefits, they should never be at the top of one's health and healthy aging plan,” he noted. “A heavy focus on whole foods eating, regular exercise, and high-quality sleep are essential and higher priorities.”
I don't disagree with eating healthy and exercise but the amount of mg in foods cannot compare to the amount and potency in the supplements. For example, eating 50 pounds of peanuts or drinking 250 glasses of wine to get the equivalent is highly impractical.
Bill
prefix 1 year ago
NAD injections is not as convenient as NAD in powder form.
If NMN is banned in the US, would consumers be able to purchase NMN outside of the US and would there be any problems receiving the NMN in the USA?
Dan
prefix 1 year ago
The FDA are clowns and tools of the pharmaceutical industry.
ChatСаботаж
prefix 1 year ago
The FDA, headed and staffed by employees of the drug companies, let the drug companies screw us over using powers they shouldn't even have.

Just another day in the fascist land of the "free".
Chekoudjian
prefix 1 year ago
It must work if they want to ban it and resell as a slightly modified prescription drug! IE big drug companies see $$$$$$$$&
Nina
prefix 1 year ago
Exactly 💯
Nina
prefix 1 year ago
I have been taking NMN for quite a while, along with other supplements. I had a very mild case of covid on 2020, when my husband was in bed 2 weeks. 2021 my husband got another strain of covid and was down for a week, all I got was a sniffle for 2 days. My husband got the flu and covid about a month ago I had nothing. At Thanksgiving several of the kids had a cold, while most all the adults got it, I didn't. I am unvaccinated. I don't need it. 12 years ago I couldn't say this, if something was coming, I caught it, if it was going, I caught it. Now, I have always worked out and looked healthy, but something I changed was supplements and less sugar. My husband takes some of the supplements I do,but he doesn't take NMN. Just saying..
Dwayne
prefix 1 year ago
And big pharma don't give a crap about our health! They want us on drugs for life!
Elizabeth Calderon
prefix 1 year ago
FDA is corrupted just like everything else in our government they will always have big pharma best interest and the hell with everyone else. It's all about the money 💰 the government does not care about the American people and the puppets politicians just want to get re-elected.
Lawrence Tate
prefix 1 year ago
This has "CORRUPTION POTENTIAL" written all over it. Wait, it's worse than that!
TE Gospel
prefix 1 year ago
Big Pharma owns the FDA and both are corrupted by greed and a monopolistic price fixing philosophy. Neither care about your health and any interest in your longevity is tied to their desire to suck money from your pockets for as long as possible.
Michelle Moss
prefix 1 year ago
There must be legitimacy to its effectiveness and the FDA *still* doesn't want to admit supplements can be more effective than pharmaceuticals. Everything I've read about it is positive, which means the FDA will reject it.
Leanne Caster
prefix 1 year ago
I find it extremely interesting that the supplement known to help repair DNA is being banned by the FDA which by the way was shown to receive 40 percent or more of its budget from pharmaceutical companies. The Covid vaccines have also been shown to alter the DNA that interferes with our immune system. I wonder if they are banning this supplement because it may have a reversal effect of the Covid vaccines. During and after the pandemic even now the FDA still does not conduct formal studies to endorse natural remedies. I believe due to its profitable relationship with the pharmaceutical companies who bear no legal liability for the covid vaccines till 2024.

Alexandria Biasotti
prefix 1 year ago
It would be interesting to see if a book on holistic health written by a supplement manufacturer listed NMN for sale decades ago.
Just because sometimes certain companies go out of business doesn't mean that a pharmaceutical company can claim patent.
Very interesting issues to be further looked into.
Joe
prefix 1 year ago
So, all a company needs to do to prevent a new dietary supplement going to market is to file an NDI for it? Interesting...
Johnny Lightning
prefix 1 year ago
Big Pharma again taking over the industry. Greed, an American virtue!
Timothy Burt
prefix 1 year ago
There is quite a bit of research showing the benefits. 1.Find popular sipplement many benefit from and declare it causes cancer. But I thought there aren't enough studies...never mind. 2. Develop drugs from it and cash in on the theft. From politics to freedom of use of supplements, the pharmaceuticalgiants rule....and screw you, it's all about our bottom line. As a reminder very little research was done with the COVID vaccine all the animals they tried it on died, but, shhhh. Trust the science, depending of course on what the meaning of is, is. Is we owning a patent on it or is we ain't?😉
Steve
prefix 1 year ago
I despise Big Pharma. There 100's of natural cures & treatments that could cure or treat many illnesses & diseases that Big Pharma keeps from the people. They know nothing about living a healthy lifestyle.
Michelle Moss
prefix 1 year ago
Yes!! Yes!! Yes!!
Amy
prefix 1 year ago
The fda has way too much power over the American people and its disgusting. Our health and safety has never mattered. It's about how much $$they're losing to the supplement industry.
TE Gospel
prefix 1 year ago
Correct.
CRS One
prefix 1 year ago
That was awesome.