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Unique status of NMN – Issue

The dietary supplement industry feels like the U.S. Food and Drug Administration (FDA) has been playing cat and mouse with its members. Although the FDA had initially allowed one company to market NMN (nicotinamide mononucleotide) as a dietary supplement, in late 2022 the FDA banned NMN from being sold as a dietary supplement because it was studied as a drug first. However, this ban is not being enforced.

Research indicates that NMN is a precursor for nicotinamide adenine dinucleotide (NAD+), thus a key player in supporting many cell processes, including brain health, anti-aging, and the cardiovascular system, to name a few. So NMN is of major interest to many health conscious individuals.

Because of the unique situation with the FDA, NMN products are more challenging to evaluate and to obtain.

ISSUE: Do I wish to expand my research of NMN products?

AHHA strives to maintain a neutral position and views knowledge as power. For those interested in this month’s Issue, we offer you the following background articles and encourage you to make the effort to better understand how to evaluate NMN products. You may also wish to research options for protecting the public’s ability to have access to NMN products.

FDA Halts NMN Supplement Approval, Citing Pharmaceutical Potential (11/29/22)
by Brett J. Weiss
NMN.com
“The Food and Drug Administration (FDA) withdraws new dietary supplement (NDI) status of nicotinamide mononucleotide (NMN) under pharmaceutical industry pressure. This development is a reversal of the FDA’s previous decision to allow its sale as a new dietary supplement (NDI). Although many vitamin and supplement companies that sell NMN remain concerned with this news, banning NMN’s sale is not currently being enforced.”

NMN is precluded in supplements, says pharma company to FDA (1/2/24)
by Josh Long
Natural Products Insider
“A clinical-stage pharmaceutical company that has been investigating the use of nicotinamide mononucleotide (NMN) to treat medical conditions, including Alzheimer’s, has requested the Food and Drug Administration uphold its determination that the ingredient is excluded from the definition of a dietary supplement product and cannot be marketed in such products.”

FDA Bans NMN as a Dietary Supplement: Why and What Happened? (2/13/24)
by Kimberly Drake
Healthnews
“…timeline of events leading up to and after the FDA banned NMN. 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.

FDA sticking to its guns on NMN in dietary supplements (4/11/24)
by Josh Long
Natural Products Insider
“In letters that were made public in late March on the government docket, FDA reiterated its view that β-NMN (beta-nicotinamide mononucleotide) is excluded from the definition of a dietary supplement.”

Longevity Supplement in Peril (6/28/24)
Alliance for Natural Health USA
“The FDA claimed in 2022 that NMN was illegal because it was studied as a drug first. But instead of enforcing a ban, it has continued to allow NMN supplements to remain in a legal grey area. This discourages reputable companies from investing in NMN products, while shady businesses may sell fraudulent versions, ultimately reducing the quality and choice of supplements for consumers”

You are also encouraged to post your comments.

To review past ISSUES, visit the Special Updates Archives.

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