NPA Files Lawsuit Against FDA Over NMN: A Landmark Case for…

The Fight Over NMN: NPA Challenges FDA’s Ruling

The Natural Products Association (NPA) has taken a bold step, filing a lawsuit against the FDA over the classification of β-nicotinamide mononucleotide (NMN). This case is not only pivotal for the dietary supplement industry but could also shape the future of innovation in natural products and pharmaceuticals.

What’s at Stake?

The lawsuit, filed in the U.S. District Court for the District of Columbia, challenges the FDA’s decision to exclude NMN from the definition of a dietary supplement. NMN, widely recognized for its potential anti-aging benefits, has been under scrutiny since the FDA ruled in 2022 that it couldn’t be marketed as a dietary supplement.

The controversy revolves around NMN being investigated as a new drug by Metro International Biotech LLC, co-founded by renowned scientist David Sinclair, Ph.D. This investigation led the FDA to conclude that NMN no longer qualified as a dietary supplement, despite previously acknowledging its marketing potential.

How the FDA’s Decision Has Impacted the Industry

The FDA’s ruling has had significant repercussions:

• Business Setbacks: Major platforms like Amazon stopped selling NMN supplements. Payment processors like PayPal and Shopify have ceased processing NMN-related sales.
• Compliance Issues: Companies like iHerb, Cellmark USA, and Galaxy Nutrition faced challenges, including product detainment and regulatory roadblocks.
• Innovation Stalled: Ingredient suppliers and brands have suffered, with the ruling creating uncertainty in the natural product market.

The Legal Argument

The NPA’s lawsuit primarily challenges the FDA’s interpretation of the “drug exclusion clause” under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This clause prohibits an ingredient from being marketed as a dietary supplement if it was first authorized for investigation as a new drug and has been part of substantial clinical trials made public.

The NPA contends that NMN should not be excluded under this clause, citing that it was marketed lawfully as a supplement before being investigated as a drug. Additionally, the organization highlights the harm caused to its members and the broader industry, pushing for the FDA to revisit its decision.

The Bigger Picture

This case is about more than just NMN. It marks a turning point for the dietary supplement industry, signaling that companies and trade groups are now ready to challenge regulatory decisions in court. As NPA’s legal counsel put it, “This is a new day” for the industry, showing that it will no longer shy away from holding the FDA accountable.

What’s Next?

The lawsuit seeks a declaratory judgment affirming that NMN can be marketed as a dietary supplement. If the court sides with the NPA, it could pave the way for regulatory changes benefiting both the supplement and pharmaceutical industries.

The outcome of this case will likely have far-reaching implications, shaping how the FDA approaches dietary supplement regulations and potentially influencing future innovation in the health and wellness space.