The NMN Regulatory Battle: Is NMN a Supplement or a Drug?

Key Takeaways

• NMN Benefits: Boosts NAD+ levels, supports cellular health, and may promote longevity.
• Current Regulatory Issues: NMN's classification as a supplement or drug is under debate due to FDA actions and a lawsuit by the NPA.
• Future of NMN: If classified as a drug, NMN may be unavailable in the U.S. for years and sold only by prescription at a higher price.
• Legal Shifts: A Supreme Court ruling may weaken the FDA’s position and give courts more power to decide NMN’s fate.

Understanding NMN and Its Health Benefits

NMN is a compound that supports the production of NAD+ (Nicotinamide Adenine Dinucleotide), which plays a key role in energy production, DNA repair, and overall cellular health. As we age, NAD+ levels naturally decline, which has been linked to various age-related health issues. Many people take NMN supplements to boost NAD+ levels, potentially improving longevity, metabolic health, and immune function.

Why Is NMN Facing Regulatory Scrutiny?

In 2021, MetroBiotech, a company associated with renowned longevity researcher Dr. David Sinclair, informed the FDA that they were investigating NMN as a drug. This is where the issue begins. According to U.S. law, a substance cannot be classified as both a drug and a dietary supplement. Once MetroBiotech filed its investigation, the FDA began reassessing NMN's status.

Although NMN was previously classified as "Generally Regarded as Safe" (GRAS) in 2018 and approved as a dietary ingredient in 2022, the FDA reversed its position later that year, leading to confusion.

Recent FDA Actions on NMN Imports

In August 2023, the FDA intercepted a shipment of NMN, citing its status as an investigational drug. This action suggested a potential crackdown on NMN sales in the U.S. While the FDA had previously been lenient on enforcing the NMN ban, this interception indicates they may be tightening regulations.

The Natural Products Association's Lawsuit Against the FDA

To address the uncertainty, the Natural Products Association (NPA), which represents supplement manufacturers, filed a lawsuit against the FDA and the U.S. Department of Health and Human Services (HHS). The NPA’s main request is that NMN should not be excluded from being sold as a dietary supplement.

The lawsuit also points out that the FDA has not clearly defined its position on NMN, leaving businesses and consumers in a state of confusion. The NPA argues that this regulatory uncertainty has harmed businesses, as companies have lost revenue due to the mixed messaging on NMN’s legal status.

Legal Shifts That Could Affect the Outcome

In June 2023, the U.S. Supreme Court overturned a legal precedent known as the Chevron Defense. This doctrine previously required courts to defer to government agencies like the FDA when there was ambiguity in the law. However, with this ruling overturned, courts now have more power to interpret ambiguous legislation themselves. This could potentially weaken the FDA’s position in the NMN case and give the courts more room to rule in favor of the supplement industry.

What Happens if NMN Is Classified as a Drug?

If the FDA officially declares NMN a drug, it will likely be removed from the U.S. market until it completes the FDA’s drug approval process, which could take years. Even if NMN is approved as a drug, it would only be available by prescription and would likely be far more expensive due to MetroBiotech’s monopoly on the product.

For consumers, this could mean limited access to NMN supplements for the foreseeable future, as well as significantly higher prices when it eventually becomes available again.

A Possible Compromise?

There is hope that a compromise can be reached, similar to what happened with NAC (N-Acetyl Cysteine). NAC was allowed to be sold as both a drug and a dietary supplement under FDA enforcement discretion. If a similar arrangement is made for NMN, it could remain available to consumers as a supplement while still being investigated as a drug.

What’s Next for NMN in the U.S.?

The legal battle over NMN is still ongoing, and the outcome is uncertain. However, the recent lawsuit by the NPA, combined with changes in the legal landscape, may create an opportunity for NMN to continue being sold as a supplement. Consumers and businesses alike are eagerly awaiting a clear ruling from the FDA, which could come in the next few months.

In the meantime, it’s important for NMN users to stay informed and consult healthcare professionals about alternatives or next steps if NMN becomes less accessible.

Conclusion

The future of NMN in the U.S. is at a crossroads. With regulatory challenges and legal battles in full swing, the availability of NMN as a supplement could be in jeopardy. As the situation unfolds, Just Glow will continue to monitor developments and keep you informed, ensuring access to high-quality NMN supplements.