There has been a lot of coverage in the media of late about nicotinamide mononucleotide (NMN) and its legal status in the US. While many can be quick to jump to conclusions based on the headlines alone, it’s important to understand the full story. In this guide, we do just that, unpicking the truth behind whether or not NMN is banned in the United States.
We’ll also take a look at which organisations have suspended the sale of NMN, when the laws may change and the current legal status in other countries where it’s possible to buy NMN.
First, let’s take a deeper look at NMN, how it works, its potential benefits, and the safety behind it.
What Is NMN And How Does It Work?
NMN stands for nicotinamide mononucleotide. It’s a tiny molecule within our bodies that keeps things like our metabolism in order, as well as helping our DNA repair itself. Recent studies, some conducted by the brightest minds around, including Harvard University’s David Sinclar, suggest that supplementing NMN in our bodies can help us look and feel younger.
The science behind this is a little complex, but it’s best to think of it as a cycle. NMN is one stage of that cycle, and an important one. Preceding NMN in the chain is a molecule called nicotinamide riboside (NR). This is converted into NMN, and NMN is then converted into something called NAD+, or nicotinamide adenine dinucleotide.
NAD+ is a key component in helping keep our cells filled with energy and our bodies young. As we age, the amount of NAD+ reduces. The theory behind NMN supplements then is to boost your body's supply so that it produces more NAD+, thereby giving your cells more energy to help you stay younger and fresh.
Let’s look at the potential benefits in more detail.
Are There Benefits To Taking NMN?
Many people make grand claims about the benefits of taking NMN, like it can reverse aging. However, as we’ve explained above, the idea behind NMN is to try and help slow the deterioration of our cells.
There are other benefits that are said to come with taking the supplement. They include:
- Help With Diabetes - some mice-based studies found that NMN helped regulate insulin and glucose levels in test subjects that had induced diabetic conditions.
- Improved Cognitive Function - several studies into NMN suggest it could help protect brain cells and improve overall cognitive health.
- Benefits To The Heart - some studies suggest that NMN can boost blood vessel functions and reduce oxidative stress.
- The Repairing Of DNA - NMN has been found to improve the DNA repair process. This can help lead to better skin, for example.
The Science Behind NMN
We mentioned studies in the section above and here we expand upon them. Having a clearer idea of the science behind NMN is useful when considering the current situation over its legal status.
A good place to begin is with the studies conducted and currently ongoing by Harvard University researcher, David Sinclair.
David Sinclair’s Experiments And Studies
Professor David Sinclair has enjoyed a decorated academic career, finding himself at one of the world’s leading educational institutions pursuing research in a field he is truly passionate about.
Sinclair has devoted a lot of his time to understanding why we age and how we can slow the process down. His work at The Sinclar Lab at Harvard led to the discovery of NAD+, as well as resveratrol and sirtuins. It’s led to him developing an international reputation, one that may be further enhanced when he completes his human trials into the compounds.
While the results of his ongoing human studies are yet to be published, in a recent interview, Sinclair revealed that he took supplements to boost his NAD+ levels and reputedly has the lipid profile and blood profile of someone half his age.
Other Studies Into NMN
Professor Sinclair isn’t the only researcher looking into NMN and NAD+. Early research has been conducted on mice. For example, one study by Wang X, et al (2016) found that NMN helped to slow the cognitive deterioration of a model of Alzheimer’s disease in mice.
A significant body of other research has built up around the supplement, which was reviewed in-depth by Dr Christpher Shade here.
With all of these studies either ongoing or completed, it makes you wonder why the Food and Drug Administration (FDA) made the decision to ban NMN. Let’s dive into the heart of the issue.
Is NMN Banned In The US?
At the time of writing, NMN is banned in the US as a dietary supplement, though the picture isn’t that clear.
NMN has been caught up in a complex and at times contradictory battle for its legal status in the US.
When the product first came to market, it was classed by manufacturers as a dietary supplement. The US Food and Drug Administration acknowledged the product as a “New Dietary Ingredient” (NDI). This gave permission to supplement companies to market it.
However, that changed on October 11 2022 when the FDA revoked that NDI.
It all came to light when a company called Inner Mongolia Kingdomway Pharmaceutical Limited submitted an NDI to sell an NMN supplement.
However, that application was rejected. In its response, the FDA declared that NMN is now being investigated as a new drug and can no longer be marketed as either food or a dietary supplement.
To add a spanner in the works, it appears as if pharmaceutical companies may have had some involvement. Some firms, such as Metro International Biotech, have been conducting studies into NMN. It was reported that the firm had requested that the FDA consider a ban and investigation into the compound as a drug, a move no doubt inspired to protect their own financial interests, with some business leaders accusing the FDA of showing bias against natural products. These products can be sold more cheaply than products sold by pharmaceuticals.
The impact on the growing NMN industry will be significant. In just a few years, the market developed a worth of just under $300 million (as of 2022). Growth was forecast to continue at a rate of 10% annually, but that has now ground to a halt.
Why Is NMN Banned By The FDA?
The NMN has cited numerous reasons for the decision to suspend the marketing of NMN as a dietary supplement. Here’s a breakdown:
- Safety Concerns - The FDA seeks to ensure that all potential side effects are investigated in full. We explain the safety surrounding NMN further below.
- Scientific Evidence - The FDA’s move to recategorize NMN as a drug means there is a higher demand for scientific evidence.
- Quality Control - The FDA seeks to ensure greater consistency with products offered in the market.
There are other reasons that people within the NMN industry have cited, such as bias against dietary supplement companies. However, evidence of this as a basis for the ban is limited.
Which Organizations Have Banned NMN?
The FDA’s ban on NMN being marketed as a dietary supplement has forced a number of organizations to prohibit its sale on their platforms.
One of the main firms to have taken action is Amazon. In an email sent to the President and CEO of the Natural Products Association, Dan Fabricant, Amazon cited the FDA’s decision. They went on to say that products containing NMN as an ingredient in dietary supplement products cannot be sold in the US. Any products must have FDA approval.
Other online sales platforms such as Shopify have also followed suit in preventing the sale of NMN products.
Is NMN Banned In Other Countries?
While the US may have banned NMN, it is possible to buy in other countries.
In Japan, for example, NMN products are available to buy over the counter. It enjoys a similar status in both China and India.
In the West, its legal status is more varied. Canada permits its sale as a natural health product, with licensing and labelling requirements required.
It enjoys a similar status in the European Union. In the United Kingdom, for example, NMN is classed as a food supplement and is available to buy.
Is NMN Safe And If So Why Is It Banned?
At the time of writing, there are no known side effects to taking NMN, so it can be considered safe to take. This is in spite of its current status, a complicated legal matter explained above.
Those who take more than the recommended dosage may experience mild gastrointestinal issues like diarrhoea and vomiting.
It’s also advised that pregnant women or those who are breastfeeding should avoid the supplement; studies into any potential effects here are still ongoing.
NMN is still a new supplement. Although the studies conducted so far have shown great promise, research is still ongoing. So if you’re at all unsure, consult your doctor before taking NMN.
Will The Ban Be Overturned?
It’s hard to say whether or not the ban will be overturned. The FDA has not released much information on the matter. Indeed, the ban was itself only first communicated to the wider public via a failed application by a dietary supplement company.
However, there is hope within the industry that it will be reviewed soon. Pressure has been placed on the FDA to change its stance in the form of a Citizen Petition. As of September 2023, the FDA has not provided a substantive response to this.
- The FDA reclassified NMN products from dietary supplements in 2022, meaning that it cannot be sold in this format in the US. This means NMN is banned as a dietary supplement.
- A Citizens Petition has been submitted to reverse the decision. At the time of writing, no response has been provided.
- NMN is still considered a safe product, with research conducted by the likes of Professor David Sinclar of Harvard University proving its potential health benefits