FDA Determines Nicotinamide Mononucleotide (NMN) Not Permitted in Dietary Supplements for Sale

FDA Determines Nicotinamide Mononucleotide (NMN) Not Permitted in Dietary Supplements for Sale

 

The U.S. Food and Drug Administration (FDA) recently published responses to several new dietary ingredient (NDI) notifications submitted for nicotinamide mononucleotide (NMN). The FDA concluded that NMN is “an article authorized for investigation as a new drug by the FDA”. Therefore, if the ingredient is considered a drug by the FDA, it is concluded that the ingredient is NOT permitted in dietary supplement products for sale in the USA, per the “Drug Preclusion Clause”.

Dietary Supplements

The “Drug Preclusion Clause” states that ingredients first approved or clinically studied as a drug, are not permitted for use as a food ingredient in dietary supplements.

What is Nicotinamide Mononucleotide?

NMN is short for nicotinamide mononucleotide, a naturally occurring molecule present in all species. NMN is a precursor of nicotinamide adenine dinucleotide (NAD+), a molecule that may be useful in slowing down some aspects of aging. NAD+ serves many critical functions in our cells, such as electron transport, cell signaling, and DNA repair. NMN can be found naturally in foods such as avocado, broccoli, cabbage, cucumber, and edamame.

Regulation of NMN by FDA.

As stated above, the “Drug Preclusion Clause” states that ingredients first approved or clinically studied as a drug, are not permitted for use as a food ingredient in dietary supplements. Because NMN is an article authorized for investigation as a new drug by the FDA, it does not currently qualify for use in dietary supplements.

NMN and the Future.

NMN is currently considered a drug ingredient and therefore cannot be sold in dietary supplements in the USA.

Research shows that NMN may help to prevent cardiovascular disease by reversing oxidative stress damage on blood vessels that can lead to high blood pressure and heart attacks. NMN may also help treat diabetes by helping insulin work better in people who have type 2 diabetes. There are limited studies that firmly conclude that NMN supplements actually work to slow down aging. Fortunately, there are more human trials underway that will hopefully tell us just how useful NMN is in this respect.

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Conclusion

It seems that NMN, the main ingredient in many supplements, is not yet ready for use in the USA. Until we find out more about this ingredient and how it interacts with other drugs in our bodies, we won’t know what the future holds for us all when it comes to taking NMN supplements.

If either you or your ingredient supplier has recently filed an NDI Notification for NMN or want to learn more about this topic contact Quality Smart Solutions at info@qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs, and medical devices in the United States.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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