Table of Contents
Recently, a major piece of news has garnered widespread attention in the global nutrition and health industry: the European Food Safety Authority (EFSA) has initiated the review process for NMN (β-nicotinamide mononucleotide) as a novel food, with the approval status indicated as “intended approval.” This development could mark a major breakthrough in NMN’s global regulatory compliance.
NMN (Nicotinamide Mononucleotide) is a precursor to nicotinamide adenine dinucleotide (NAD⁺) and has been widely studied for its potential in anti-aging, energy metabolism, and mitochondrial function. Studies have shown that NAD⁺ levels in the body gradually decline with aging. By activating the NAD⁺ biosynthesis pathway, NMN has the potential to boost cellular metabolic activity, improve mitochondrial function, and slow down age-related damage.
In the Novel Food Applications database on the European Food Safety Authority (EFSA) official website, the status of the NMN new food application submitted by Herbaland Naturals Inc. (a Canadian nutritional company) has been updated to “Opinion Adopted – Authorization Procedure Started,” indicating that the EFSA Scientific Committee has no objection to its safety [Source: EFSA official website link].
This is the first significant step in the EU’s substantial legalization of NMN as a food ingredient, following the approval of countries like Japan and Thailand for its use as a dietary supplement, marking a significant shift in regulatory attitudes.
Country/Region | Compliance Status | source |
Japan | It can be marketed as a functional ingredient, with multiple brands already on the market. | Ministry of Health, Labor and Welfare Announcement |
Thailand | NMN will be officially listed as a permitted nutritional supplement in 2022. | FDA Thailand |
United States | The FDA will remove its NDI status at the end of 2022, but it can still be marketed for research purposes. | FDA Letter |
China | It has not yet been listed as a new food ingredient and is currently in the research and exploration phase. | National Health Commission |
European Union | Review will begin in 2024, with proposed approval in the first half of 2025. | EFSA Database |
The positive reception of NMN by the EU, which typically maintains a conservative policy stance, will help guide the global market towards compliance and standardization.
Delaying age-related cognitive decline: Mouse studies have shown that long-term NMN supplementation can improve cognitive performance [Science, 2016];
Improving insulin sensitivity and glucose and lipid metabolism: Preclinical studies have shown that it can alleviate metabolic syndrome [Nature Communications, 2019];
Delaying cardiovascular decline: Enhancing myocardial mitochondrial function and improving energy production [Circulation Research, 2018];
Potential target groups: Middle-aged and elderly individuals, those with cognitive fatigue, and those with abnormal glucose and lipid metabolism.
Improved supply chain legitimacy: Compliance barriers to product exports to the EU market are expected to be eliminated;
Brand development opportunity: Early completion of NMN compliance and labeling registrations can seize first-mover advantage;
Strengthening R&D momentum: Encouraging more innovative “NMN + functional ingredient” combinations, such as NMN + PQQ and NMN + resveratrol;
Market education window: Leveraging favorable policies to educate consumers and build trust.
As compliance trends become clearer, raw material standards will become more stringent. Brands or OEMs are advised to consider the following aspects when selecting products:
Index | Recommended Standards |
Purity content | ≥98% |
Heavy metals/dissolved residue | Comply with EU food additive regulations limits |
Traceable source | Clear fermentation/synthesis process, GMP production |
Compliance Documents | Complete COA/MSDS/EFSA channel information |
Application Compatibility | Can be used in various forms such as dietary supplements/solid drinks/soft candies/powders, etc. |
NMN’s regulatory “inflection point” has arrived. Are you ready?
From “the hottest anti-aging ingredient” to “a new food product in the process of gaining EU approval,” NMN is at a critical turning point in its industry development. When regulation ceases to be an obstacle and becomes a signal, a new market cycle is about to begin. If you’re a health supplement brand, a functional food developer, or a cross-border nutritional product operator, now is the perfect time to invest in compliant and high-quality NMN products.
The European Food Safety Authority (EFSA) has begun the approval process for NMN as a novel food, marking a breakthrough in global compliance. This milestone may accelerate NMN’s role in anti-aging, energy metabolism, and health supplements, shaping a new era in nutrition and wellness.
This guide clarifies distinctions between brand-name drugs, generics, and APIs, emphasizing bioequivalence, cost efficiency for chronic conditions, and safety warnings.
Tianming Pharmaceutical Group (Booth 9A02) will exhibit at CPHI Shenzhen 2025 (Sept 1-3, Futian). Visit us for quality-focused supply chain solutions and collaborative opportunities.
Leading provider of high-quality APIs and intermediates. Contact us for innovative solutions and expert support.