The Legal Battle Over NMN Supplements: Is NMN a Supplement or a Drug?

Key Takeaways

• NMN's Legal Status in the U.S. Is Uncertain: The FDA is currently deciding whether NMN should be classified as a supplement or a drug, leaving its future in limbo for consumers.
• NPA Challenges FDA: The Natural Products Association is fighting to keep NMN available as a supplement, potentially following the path of NAC.
• International Differences: While NMN faces potential restrictions in the U.S., it could remain available in Canada and other countries with more lenient supplement regulations.

FDA Regulation and Legal Context of NMN

In December 2021, when Metrobiotech, a company founded by Dr. David Sinclair, requested that the FDA prohibit NMN from being sold as a supplement. Metrobiotech argued that because NMN was being developed as a drug, it should not be sold as a dietary supplement.

Interestingly, back in 2018, the FDA approved NMN as "Generally Recognized As Safe (GRAS)," allowing it to be marketed as a supplement. In 2022, NMN was also approved as a New Dietary Ingredient (NDI). However, in the same year, the FDA reversed its decision, leading major retailers like Amazon to remove NMN products from their stores.

Recent Events: NPA vs. FDA

In March 2023, the Natural Products Association (NPA) submitted a petition to the FDA, requesting that NMN be allowed to be sold as a supplement. Under U.S. law, the FDA was given 180 days to respond, with a deadline of September 7, 2023. On that day, the FDA announced that it had not yet reached a decision on NMN's status.

Further escalating the issue, on August 13, 2023, the FDA blocked a shipment of 5 kg of NMN, claiming it violated New Drug Application regulations. This action raised concerns within the supplement industry. In response, on August 27, 2023, the NPA filed a lawsuit against the FDA and the Department of Health and Human Services, arguing that NMN should continue to be available as a dietary supplement.

Legal Changes and Future Implications

One key legal development that may impact NMN's future is the overturning of the Chevron Defense by the U.S. Supreme Court in June 2023. In the past, courts could rely on government agencies like the FDA to help clarify unclear laws. Now, courts must exercise independent judgment, which could weaken the FDA's position in cases like NMN's classification.

What Happens if NMN is Classified as a Drug?

If the FDA ultimately classifies NMN as a drug, consumers will only be able to access it through a doctor’s prescription after successful clinical trials. Currently, Metrobiotech is in Phase 2 of its clinical trials. Even if these trials succeed, Phase 3 trials will likely be required, meaning it could take several more years before NMN is approved as a drug.

Additionally, if NMN is classified as a drug, its price is expected to rise significantly compared to its current cost as a supplement.

What This Means for Consumers

For now, the future of NMN as a supplement in the U.S. remains uncertain. A similar situation occurred with NAC (N-acetylcysteine), where the FDA allowed it to be sold both as a drug and a supplement. There is hope that NMN could follow a similar path, allowing it to remain available at reasonable prices.

The ongoing legal battle between the NPA and the FDA will ultimately determine whether NMN will continue to be sold as an affordable supplement or be restricted to prescription use at a much higher cost.

NMN’s Status in Other Countries

While NMN faces regulatory challenges in the U.S., the situation may differ in other countries, including Canada. In the case of NAC, while the U.S. imposed restrictions, Canada allowed it to remain available as a dietary supplement. This difference in regulatory frameworks suggests that NMN could remain available in Canada, even if it is restricted in the U.S.

Right now, the FDA is closely looking at NMN in the U.S., and it could face similar rules. However, Canada’s more relaxed regulations on supplements could allow NMN to stay on the market there.

Conclusion

As the legal battle over NMN continues, its future as a supplement remains uncertain. Consumers in the U.S. may face more restrictions, while those in Canada and other countries might still have access to NMN as a supplement. Keep an eye on this evolving situation to stay informed about the availability and pricing of NMN products.

The NPA has filed a lawsuit against the FDA over its actions regarding NMN. If NMN is classified as a drug in the U.S., other countries, like Canada, may continue to handle it differently, allowing it to remain available as a dietary supplement. This case echoes what happened with NAC, which faced restrictions in the U.S. but stayed available in Canada.

For now, whether NMN will remain on the market as an affordable supplement or be restricted to a prescription-only drug is still up in the air. If you’re considering taking NMN, it’s important to stay updated on the latest legal developments, and Just Glow will continue to offer high-quality NMN supplements