FDA Ruling on NMN Means it Can Be Lawfully Used as a Dietary Supplement in the US Again
A statement from the FDA regarding the status of NMN means it can once again be lawfully available for sale in the USA.
Supplements that may contribute to longevity and quality of life in our later years are big business these days.
One of the most closely followed is nicotinamide mononucleotide (NMN) and its availability status changed in the US in 2022, causing frustration for consumers.
The background to NMN
Some scientists believe it’s possible to boost our levels of NAD, a coenzyme that’s present in every cell in our bodies, using NMN.
NAD provides fuel for our mitochondria to function, and mitochondria are often referred to as the powerhouse of our cells and are essential to our health, energy and longevity.
But our levels of NAD decline with age and the theory is by boosting it we can improve our cell function and reduce some of the negative effects of aging.
NMN is derived from vitamin B3 and there are other vitamin B3 related supplements out there including nicotinamide riboside (or NR) and niacin.
As a group of supplements there is quite a bit of debate in the scientific community about which one most readily converts to NAD in the body, with some suggesting one is better over another, others saying they do much the same thing, and others questioning whether supplementing with a B3 derivative would have much of a beneficial effect at all.
While it is available to buy as a dietary supplement in many parts of the world, the situation was different in the US where it is being investigated for licensing as a potential prescription drug.
While the Food and Drug Administration considered its status it was precluded from being defined as a dietary supplement which prevented it from being sold as such.
for cell power-houses called mitochondria.
FDA’s New Ruling on NMN Status
Until today, technically speaking any business in the US selling NMN as a dietary supplement was violating the FDA ruling and could be subject to fines if enforced.
But the FDA came under pressure from representative bodies including the Natural Products Association to clarify the position regarding regulatory status.
It has now done that, in a letter which said: “We now conclude that NMN is not excluded from the definition of dietary supplement.”
The ruling means NMN is likely to become more widely available again in the US.
NMN evidence
Proponents of NMN cite a multitude of studies, but they’re mainly on mice or rats.
The studies concluded that boosting NAD levels with NMN led to improved insulin sensitivity in diabetic mice, restored gene expression linked to circadian rhythm which in other words improves our sleep, and found a reduction in inflammation and oxidative stress, both cornerstones of aging.
It was also shown to suppress age-related weight gain in mice, protect older organs and improve cognitive function, and increase their endurance levels in exercise.
And it was found to have restored the number of blood capillaries and capillary density to those seen in younger mice and resulted in increased blood flow to the muscles and significantly greater exercise capacity in the treated mice compared to untreated mice.
But in general the human clinical trial results have not been as dramatic as those seen in mice to date.
Together with my parents (who are in their 80s) we have taken third-party-tested NMN for over two years now because we have all experienced improvements in energy, and my parents feel it has greatly helped their arthritic pain.
