Regulatory Status of NMN (Nicotinamide Mononucleotide) in the European Union: Perspectives and Challenges

Nicotinamide mononucleotide (NMN) is a direct precursor to NAD+ (nicotinamide adenine dinucleotide). NAD+ is an essential coenzyme involved in cellular energy metabolism and DNA repair mechanisms. Although scientific research confirms NMN's potential in decelerating age-related physiological changes, its commercialization in the European Union dietary supplement market faces strict legal barriers.

Novel Food Regulation

Currently, the sale of NMN in the form of dietary supplements is prohibited in the European Union. This prohibition stems from EU Regulation (EU) 2015/2283 on novel foods.

According to this regulation, any substance that was not consumed to a significant degree by humans in the EU before May 15, 1997, is classified as a "novel food." To legalize the use of such a substance, a comprehensive safety assessment conducted by the European Food Safety Authority (EFSA) is required. Only upon receiving a positive opinion from EFSA and official authorization from the European Commission can the substance be added to the Union list of novel foods.

Global Regulatory Context

Unlike the European Union, the regulatory framework for NMN in other international markets is more flexible:

• United States: Following legal discussions, in late 2025, the US Food and Drug Administration (FDA) confirmed NMN as a lawful dietary supplement ingredient (NDI status).
• Australia: The Australian Therapeutic Goods Administration (TGA) has also permitted the use of NMN in dietary supplements, establishing a maximum daily dose of 500 mg for adults.

EFSA Evaluation Process and Forecasts

Currently, EFSA is evaluating several official applications for the recognition of NMN as a novel food. This process requires the submission of comprehensive toxicological, pharmacokinetic, and clinical data proving the substance's safety for long-term consumption.

While it is impossible to predict an exact date of approval, based on the typical duration of EFSA procedures, a positive decision and market opening are anticipated in 2026.

Versus Labs Strategic Preparation

As an innovation-driven laboratory, Versus Labs is actively preparing for the legalization of NMN in the European market. We are conducting preparatory R&D (Research and Development) work focused on stabilizing NMN in formulations and enhancing its bioavailability (including liposomal technologies).

Our objective is to ensure that immediately following official authorization by the European Commission, our B2B partners can offer the market the highest quality, stable, and safe NMN products, manufactured in strict compliance with GMP standards. We continuously monitor the regulatory environment and are prepared to respond promptly to legal developments.