Global Regulatory Progress of NMN in the United States, Australia and European Union

Nicotinamide Mononucleotide (NMN) is currently undergoing regulatory authorization processes in multiple major global markets. To help companies clearly understand the international compliance status of NMN, CIRS has summarized recent regulatory developments in the United States, Australia, and the European Union for reference.

United States

In May 2022, NMN produced by SyncoZymes (Shanghai) Co., Ltd. became the first NMN ingredient to receive the notification from U.S. New Dietary Ingredient (NDI No. 1247). However, in October 2022, the U.S. FDA rejected the NDI notification submitted by Inner Mongolia Kingdomway Pharmaceutical Limited (NDI No. 1259), stating that “NMN is excluded from the dietary supplements definition under the Federal Food, Drug and Cosmetic Act (the FD&C Act)”. At the same time, FDA withdrew the previously granted NDI acknowledgement for SyncoZymes’ NMN.

Following nearly three years of continuous petitions and legal challenges by industry associations and companies, the FDA formally confirmed on December 2, 2025, the restoration of SyncoZymes’ NMN NDI status, explicitly recognizing NMN as a lawful dietary supplement ingredient. Subsequently, on December 9, 2025, the FDA published official response letters regarding the NDI submissions from both SyncoZymes and Kingdomway on its website.

As a result, NMN is now clearly recognized in the United States as an approved NDI, and may be legally marketed and sold as an ingredient in dietary supplements.

Australia

The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority responsible for overseeing medicines, medical devices, and other therapeutic goods, ensuring their quality, safety, and efficacy. In Australia, all medicinal products must obtain TGA approval, comply with Good Manufacturing Practice (GMP) requirements, and complete pre-market evaluation and registration before entering the market. Products not approved by the TGA are prohibited from sale and may be subject to destruction and legal penalties.

On December 10, 2025, the TGA officially approved SyncoZymes’ NMN for inclusion in the list of permitted ingredients for listed complementary medicines. According to the approval, SyncoZymes’ NMN is granted a two-year period of market exclusivity in Australia (from December 10, 2025 to December 10, 2027). During this period, NMN may be used as an active ingredient with a maximum recommended daily intake of 500 mg, restricted to adult use only (excluding pregnant and breastfeeding women).

Note: In Australia, “complementary medicines” are not classified as prescription or over-the-counter medicines. They include vitamins, minerals, and herbal products, and are more comparable to “health foods” in China or “dietary supplements” in the United States.

European Union

In the European Union, NMN is classified as a Novel Food, and its commercialization requires a comprehensive safety assessment by the EFSA. According to information published on the EU’s official public database OpenEFSA, as of December 24, 2025, the EU has received six Novel Food applications for NMN. At present, applications submitted by two Chinese companies have entered EFSA’s safety evaluation phase. However, no NMN product has yet been officially approved in the EU. Detailed information on the current application status is summarized in Table 1 below.

Table 1. Overview of NMN Novel Food Applications in the European Union

Conclusion

As of December 2025, NMN has reached major milestones in its global regulatory journey in the United States and Australia, these developments represent a critical step forward, significantly lowering regulatory barriers for NMN products to enter mainstream consumer markets. At the same time, the EU Novel Food approval process is progressing steadily. Companies seeking to establish a presence in international NMN markets should maintain close attention to jurisdiction-specific regulatory updates and adopt a compliance-driven strategy supported by comprehensive scientific data and well-prepared regulatory submissions, in order to capture early-mover advantages in a rapidly evolving market.

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