NMN Major Breakthrough: EffePharm β-NMN Successfully Passes EFSA Safety Assessment

On May 11, 2026, EFSA released a safety assessment opinion report regarding the novel food application for beta-nicotinamide mononucleotide (β-NMN) submitted by EffePharm (Shanghai) Co., Ltd. The conclusion of the opinion indicates that EffePharm’s NMN has successfully passed the EFSA safety assessment and is about to undergo the final risk management assessment by the European Commission. If it raises no objections, NMN will officially enter the Union market following the US and Australia.

To help companies clearly understand the international compliance status of NMN, CIRS Group will summarize the application approval status of NMN in the EU, the US, and Australia for reference.

EU: EffePharm β-NMN Has Passed EFSA Safety Assessment

According to the public information from the OpenEFSA, EffePharm’s application for β-NMN as a novel food has successfully passed the EFSA safety assessment:

EffePharm β- NMN Application Timeline

Proposed Usage Conditions

According to the currently published assessment report, NMN is intended for use in dietary supplements, with a maximum dosage of 300 mg per day, which corresponds to an equimolar amount of 109.7 mg nicotinamide per day. The target population proposed by the applicant is adults, excluding pregnant and lactating women.

EU NMN Novel Food Application Status

As of May 14, 2026, the EU has received applications for 6 NMN products as novel foods. CIRS has compiled the specific application status, as detailed in the table below.

Table 1: Overview of EU NMN Application Status

The United States: FDA officially restores the legal status of NMN as a dietary supplement ingredient

In May 2022, SyncoZymes (Shanghai) Co. Ltd. received the first NDI (New Dietary Ingredient) notification for its NMN ingredient in the United States (NDI number: 1247). However, in October of the same year, the FDA rejected Inner Mongolia Kingdomway Pharmaceutical Limited’s NDI application for NMN (NDI number: 1259) on the grounds of the drug exclusion clause, stating that NMN does not fall within the definition of dietary supplements, and simultaneously revoked the previous NDI notification for SyncoZymes’ NMN.

After three years of continuous petitions and legal battles by relevant industry associations and companies, the FDA officially confirmed the restoration of SyncoZymes’ NDI notification for NMN on December 2, 2025, clearly recognizing NMN as a legal ingredient for dietary supplements. On December 9, 2025, the FDA published a formal response regarding the NDI applications of both SyncoZymes and Kingdomway on its official website, making it public.

As of now, NMN is clearly recognized in the United States as an NDI, available for sale and market circulation as a dietary supplement.

Australia: NMN approved by TGA for listing as a complementary medicine ingredient

The Therapeutic Goods Administration (TGA) is the regulatory authority for medicines, medical devices, and other therapeutic goods in Australia, responsible for ensuring the quality, safety, and efficacy of relevant products. In Australia, all medicines must be produced and marketed under TGA approval, comply with Good Manufacturing Practice (GMP), and complete pre-market evaluation and registration. Products not approved by the TGA cannot circulate in the market, and violators will face product destruction and legal accountability.

On December 10, 2025, the TGA officially approved the inclusion of SyncoZymes’ NMN in the list of available ingredients for complementary medicines. According to the approval document, SyncoZymes NMN will enjoy a two-year market exclusivity period in Australia (from December 10, 2025, to December 10, 2027), can be used as an active ingredient, and the recommended daily intake should not exceed 500 mg, applicable only to adults (excluding pregnant and breastfeeding women).

*Note: "Complementary medicines" in Australia are not "medicines" in the traditional sense; they encompass traditional nutritional supplements such as vitamins, minerals, and herbs, more akin to "health foods" in China or "dietary supplements" in the United States.

Figure 1: Screenshot of NMN Approval Regulatory Document

Conclusion

From being “restricted” three years ago to the current regulatory turnaround in the United States, market approval in Australia, and promising progress in the European Union, the global compliance landscape for NMN is clearly accelerating. This trend has effectively given the right for NMN products to enter the mainstream consumer market, signaling that overseas market opportunities are rapidly emerging. CIRS recommends that companies planning to expand into the international NMN market closely monitor regulatory developments in their target markets and rely on robust scientific evidence together with compliant regulatory submissions in order to seize market opportunities ahead of competitors.

About CIRS

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, feed and pet food, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of team members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% hold Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including: health food registration and filing in China; Application for “Three New Foods” in China; U.S. GRAS, NDI, and CAP notifications; EU Novel Food, food additives, and food enzymes applications; as well as application for new feed ingredients and feed additives in China, the U.S., and the EU.

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