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.
NMN (nicotinamide mononucleotide) has been the subject of extensive research due to its potential pharmacological activities beyond its role as an intermediate in NAD+ biosynthesis. In vivo studies have investigated the link between NMN and various conditions such as Alzheimer’s disease, obesity, cerebral and cardiac ischemia, and type 2 diabetes. While NMN was initially studied for its role in NAD+ synthesis, recent attention has focused on its anti-aging properties and other pharmacological and therapeutic uses.
Numerous studies, including cell culture experiments, animal models, and human clinical trials, have explored the potential benefits of NMN as an anti-aging health product and its ability to prevent age-related diseases. This review aims to provide an overview of the latest advancements and current understanding of NMN, including its promises, safety concerns, and mechanism of action in relation to anti-aging properties. The goal is to stimulate further research and shed light on the potential translation of successful preclinical and clinical outcomes into effective treatments for aging and age-related diseases.
Nicotinamide mononucleotide (NMN) is a compound that exists in two forms: α and β anomers. It is also known by various names, including nicotinamide ribotide, nicotinamide-1-ium-1-β-D-ribofuranoside 5′-phosphate, β-nicotinamide ribose monophosphate, and 3-carbamoyl-1-[5-O-(hydroxyphosphinato)-β-D-ribofuranosyl] pyridinium. The β form is the active form of NMN. It is naturally synthesized through a reaction catalyzed by the enzyme nicotinamide phosphoribosyltransferase, which involves the combination of a phosphate group and a nucleoside containing nicotinamide (a form of vitamin B3) and ribose.
NMN is a bioactive nucleotide with a pyridine base and has a molecular weight of 334.22 g/mol. It is soluble in water and has a reported solubility of 1.8 mg/mL.
Overall, NMN holds significant potential for its pharmacological activities, particularly in the context of anti-aging effects and the prevention and treatment of age-related diseases. Continued research and exploration of NMN’s mechanisms of action are essential to further understand its therapeutic applications.
NMN is primarily found in the nucleus, mitochondria, and cytoplasm of cells. In the human body, it can be found in tissues such as the placenta, as well as in body fluids like blood and urine. NMN is naturally present in various fruits and vegetables, including soybean pods, cabbage, cucumber, broccoli, tomato, mushroom, and avocado. It is also found in raw beef and shrimp, although at lower levels compared to plant-based foods. The NMN content in these foods ranges from 0.25 to 1.88 mg/100 g for vegetables and fruits, and 0.06 to 0.42 mg/100 g for raw beef and shrimp. The absorption of NMN from these food sources is believed to contribute to the physiological levels required for NAD+ biosynthesis and various physiological functions.
NMN is an intermediate in the biosynthesis of NAD+. NAD+ is an essential coenzyme involved in numerous enzymatic reactions and plays a critical role in various biological processes, including cell death, aging, gene expression, neuroinflammation, and DNA repair. Maintaining adequate levels of NAD+ is important for longevity and overall health. NMN supplementation has been shown to compensate for NAD+ deficiency and has demonstrated a range of pharmacological activities in different disease conditions.
Various methods have been employed to prepare and purify NMN, including enzymatic reactions and chemical synthesis. However, these methods have limitations in terms of efficiency and yield, resulting in the high cost of NMN production. Currently, microbial biotechnologies are being used to produce NMN in a more cost-effective manner. Continued research and optimization of production and purification methods are necessary to address the cost and purity challenges associated with NMN production.
While NMN was initially viewed as a cellular energy source and an intermediate in NAD+ biosynthesis, recent scientific focus has shifted towards its anti-aging activity and its potential health benefits and pharmacological activities related to NAD+ restoration. NMN has shown therapeutic effects in various diseases, including age-induced type 2 diabetes, obesity, cerebral and cardiac ischemia, heart failure, Alzheimer’s disease and other neurodegenerative disorders, corneal injury, macular degeneration, retinal degeneration, acute kidney injury, and alcoholic liver disease.