Update on the FDA’s Decision to Reclassify NMN
Update on FDA Decision to Reclassify NMN
On October 11, 2022, the US Food and Drug Administration (FDA) made a decision that caused ripples in the health and wellness community. NMN, or nicotinamide mononucleotide, once classified as a dietary supplement, has been reclassified by the FDA as an investigational prescription drug. It was previously approved by the FDA as a New Dietary Ingredient (NDI), which allowed NMN to be sold freely as a supplement. In an unprecedented move, the FDA reversed this decision due to current clinical trials investigating NMN as a prescription drug. This decision has raised questions about the future of NMN products and their availability on the market. Let’s take a closer look at what this decision means for consumers.
What is Nicotinamide Mononucleotide?
Nicotinamide mononucleotide (NMN) is an enzyme cofactor found naturally in mammals and involved in energy production. It is also thought to have potential to extend lifespan due to its ability to support healthy cellular function and metabolism. As such, it has become increasingly popular among those interested in promoting healthy aging or looking for potential natural remedies for age-related diseases.
Why has NMN been reclassified?
The FDA's decision to reclassify NMN was based on new data that suggested that it may have more than just nutritional value; there may be potential therapeutic effects as well. In other words, it may be able to treat certain diseases or conditions instead of just improving overall health and wellness through nutrition alone. This means that if NMN products are going to continue being sold without any restrictions, they must first meet certain criteria set by the FDA in order to be classified as drugs instead of supplements. This is not wholly a bad thing, since it highlights that NMN may have more tangible benefits on longevity than was previously thought, and is now being taken seriously as a therapeutic agent.
Impact on consumers
Currently, there is no timeline for when the FDA will make its final decision about whether or not NMN products can continue to be sold without restriction. In the meantime, NMN products can still be sold as dietary supplements while the FDA overlooks new data regarding their potential therapeutic effects. This gives consumers the continued opportunity to purchase and use these products legally, and has led to some panic buying in the industry. We strongly discourage panic buying of NMN, since it is likely that we are still a while away from a final ruling by the FDA.
Latest update:
Last week, a meeting between the FDA, NMN manufacturers, and retailers was held to discuss the progress of NMN sales. This meeting, led by Dan Fabricant of NPA and Matt Anania of Cellmark included new information presented to the FDA regarding the history of NMN sales, however it ended without any resolution. While there is no definite answer yet on what changes will come out of last week’s meeting, we do not expect retailers to stop selling NMN products in the near future.
Zest is keeping a close eye on any developments as we wait for more information. We are committed to providing the best NMN supplementation for our customers while we wait on the FDA’s final decision.
Make sure to subscribe to our mailing list to stay on top of future updates!
Sources:
- https://www.regulations.gov/document/FDA-2022-S-0023-0051
- https://www.naturalproductsinsider.com/regulatory/crns-mister-olsen-discuss-β-nmn-drug-exclusionvideo
- https://www.nutritionaloutlook.com/view/nmn-not-a-dietary-ingredient-says-fda-citing-drug-preclusion-clause
- https://longevity.technology/news/fda-says-nmn-cannot-be-sold-as-a-dietary-supplement-in-the-usa/
- https://www.naturalproductsinsider.com/regulatory/fda-says-ingredient-studied-drugβ-nmnis-excluded-supplements
- https://renuebyscience.com/nmn-ban-details/?gclid=CjwKCAiAjs2bBhACEiwALTBWZeYVBtSaEVK9Uhu-oDwHTiiwh4bLXB9cycXqobKRSzktNU1i5nbrzRoCeh8QAvD_BwE
