The recent ruling by the Food and Drug Administration (FDA) has excluded NMN (nicotinamide mononucleotide) from the definition of a dietary supplement, effectively banning its sale as a dietary supplement. The FDA has authorized NMN for investigation as a new drug, which has raised concerns among suppliers and consumers. However, there is a possibility that the FDA may choose not to enforce this ruling and exercise “enforcement discretion,” similar to what was done with N-acetyl-L-cysteine (NAC).
Enforcement discretion means that the FDA may decide not to enforce the rules that ban the sale of NMN supplements. This discretion would apply to products containing NMN that are legally marketed as dietary supplements. As of now, NMN supplements are still available for purchase in the US through online retailers without apparent restrictions on shipping.
It’s important to note that the FDA’s ruling only applies within the United States. The FDA has no authority over other countries, so the ban does not affect the sale of NMN supplements outside the US.
The FDA’s interest in regulating NMN stems from its potential as a precursor to NAD+ (nicotinamide adenine dinucleotide), which plays a crucial role in cellular metabolism and energy production. NMN supplements have gained popularity due to their potential anti-aging and health benefits. However, the FDA’s authorization of NMN for investigation as a new drug means that clinical trials and further research are needed to evaluate its safety and efficacy.
The FDA’s ruling is partly driven by the desire to protect the rights of pharmaceutical companies conducting human research on NMN with the intent to seek FDA approval to license it as a drug. Pulling NMN off the supplement shelves would allow these companies to recoup their investment and potential profits from developing NMN as a drug.
NMN is important in the context of longevity because it is a precursor to NAD+, which is involved in cellular energy production and various physiological processes. NAD+ levels naturally decline with age, and NMN supplementation aims to replenish NAD+ levels, potentially improving metabolic function and cellular health.
Human trials on NMN have been conducted, but they have been small-scale and of limited duration. These studies have shown some promising results, such as improved insulin sensitivity and cellular function. However, larger and longer-term studies are needed to fully understand the effects and safety of NMN supplementation in humans.
In conclusion, while the FDA’s ruling has excluded NMN from the definition of a dietary supplement, the actual implications and enforcement of this ruling remain uncertain. NMN supplements are currently still available for purchase, and the FDA may choose not to enforce the ban through enforcement discretion. It’s important to stay informed about regulatory changes and consult with healthcare professionals before starting any new supplement regimen. Further research is needed to determine the long-term effects and safety of NMN supplementation in humans.