Why Was NMN Banned in USA | Metro International Biotech

Why Was NMN Banned in USA | Metro International Biotech

Why Was NMN Banned in USA

 

NMN (Nicotinamide Mononucleotide) was not technically “banned” in the USA, but the FDA ruled in late 2022 that NMN is not allowed to be sold as a dietary supplement. Here's a breakdown of why and what it means:


🔍 What happened?

  • The FDA (U.S. Food and Drug Administration) determined that NMN cannot be marketed as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA).

  • The reason: NMN was being investigated as a drug before it was marketed as a supplement.


📜 Legal Basis

  • Under 21 U.S.C. § 321(ff)(3)(B), a substance cannot be a dietary supplement if:

    "It has been authorized for investigation as a new drug... and substantial clinical investigations have been instituted and made public."

  • Metro International Biotech, a company associated with David Sinclair, filed an Investigational New Drug (IND) application for NMN.

  • Because this IND happened before NMN was marketed as a supplement, the FDA concluded that NMN qualifies as a drug, not a supplement.


⚠️ What does this mean?

  • NMN supplements are no longer legally allowed to be sold in the U.S. as dietary supplements.

  • However, enforcement has been inconsistent:

    • Some NMN products are still available online.

    • Retailers and manufacturers are pushing back or reformulating.


🧪 Why was NMN under drug investigation?

  • NMN is a precursor to NAD+ (nicotinamide adenine dinucleotide), which is involved in cellular energy production and aging.

  • It gained popularity for potential anti-aging, metabolic, and cognitive health benefits.

  • These effects attracted pharmaceutical interest, leading to drug development.

NMN Supplement to USA 

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