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FDA Excludes NMN From the List of Supplements

UPDATE February 2023:

Amazon have taken a more definitive stance on NMN supplements. As of today US Amazon has officially banned the sale of NMN (nicotinamide mononucleotide) supplements on its platform. 

NMN is a popular anti-aging supplement that is believed to boost NAD+ levels in the body, which can have various health benefits. 

In the email from Amazon we read that the “FDA decision “that NMN is no longer considered a dietary supplement” but a drug ingredient that requires FDA approval.” Products that contain NMN as an ingredient can no longer be sold or distributed as a dietary supplement by manufacturers or retailers in the United States,” the email from Amazon Services stated. “If you want to sell NMN on Amazon, you must show that you are approved by the FDA for over-the-counter sales.”

Amazon sellers can continue to offer NMN-containing products until March 13, 2023. 

UPDATE:

Meetings were held between the FDA and NMN manufacturers and retailers, led by Dan Fabricant of the Natural Products Association (NPA) and Matt Anania of Cellmark.

New information was presented to the FDA regarding the history of NMN, clinical trials, and sales, but there’s no current resolution.

NMN, an anti-aging ingredient, has been disallowed by FDA because of its prior investigation as a drug.

This action can raise ethical questions of fairness and transparency for individuals and the supplement industry.

It appears to favor the pharmaceutical industry over dietary supplements.

But, unfortunately, it may also look like the FDA doesn’t represent the best interest of consumers.

It’s unclear how that decision will impact access to NMN supplements, which are still available. Under one scenario, it is possible NMN would be available only through a doctor’s prescription.

It does not look like the FDA will inform retailers to stop selling NMN products at this time, although we can’t be sure.

The process could be quick or long and drawn out.

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In the USA, NMN products might soon be sold only with a prescription. The FDA stated their reason for excluding NMN from being classified as a dietary supplement is due to it being investigated as a drug.

Dr. David Sinclair is a co-founder of Metro International Biotech, a pharmaceutical company trying to get MIB-626 classified as a drug.

MIB-626 is a proprietary formulation and a version of β-NMN Beta-Nicotinamide Mononucleotide (Beta NMN). Beta NMN is the form of NMN commonly sold by companies in the U.S. and abroad.

NMN Was Approved As a Dietary Supplement & Then It Was Revoked. 

FDA_ban_nmn

The FDA previously approved an NDI for NMN, allowing it to be sold as a dietary supplement.

But, in an unprecedented action, they revoked the NDI on October 11, 2022.

We hope this is only a temporary hiccup and everyone will continue benefiting from NMN products.

You can read more on the website of Natural Product Insider FDA says ingredient studied as drug—β-NMN—is excluded from supplement.

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