On December 10, 2025, Australia's Therapeutic Goods Administration (TGA) officially released the Therapeutic Goods (Approved Ingredients) Determination (No. 4) 2025, incorporating NMN (Nicotinamide Mononucleotide) into the list of approved ingredients for supplementary medicines. This decision not only marks NMN's legal and compliant pharmaceutical-grade regulatory access in Australia but also, relying on the global credibility of TGA certification, opens a key channel for this ingredient to enter mainstream international markets. As a core research object in the anti-aging field in recent years, the upgrading of NMN's regulatory status has triggered a chain reaction in the global health industry.

I. Basic Understanding of NMN: From Scientific Mechanism to Market Value

NMN, or Nicotinamide Mononucleotide, is a natural compound synthesized by the human body. Its core function is to serve as a direct precursor of the coenzyme NAD+ (Nicotinamide Adenine Dinucleotide). NAD+ is a key substance maintaining core physiological functions such as cellular energy metabolism, DNA repair, and gene regulation. However, its level naturally declines with age, which is one of the important inducements of human aging. Exogenous supplementation of NMN can efficiently increase the level of NAD+ in the body, thereby providing energy support for cellular metabolism and delaying age-related functional decline. This mechanism has been verified in numerous basic research studies.

From a market perspective, since Japan first approved NMN as a food ingredient in 2020, it has rapidly become a popular category in the global health consumer market. Product forms are mainly dietary supplements and functional foods, covering core needs such as anti-aging for the middle-aged and elderly, and sub-health regulation. With the upgrading of consumer demand, the market has put forward higher requirements for NMN's purity, bioavailability, and compliance qualifications. TGA's inclusion of NMN in supplementary medicines supervision this time is an authoritative recognition of the ingredient's safety and functionality.

II. Global Regulatory Dynamics: From Controversy to Standardization, Phased Regulatory Implementation Across Regions

Prior to TGA's approval, the regulatory attitudes towards NMN in major global markets showed a differentiated pattern. Australia's decision this time is promoting the global regulatory system to evolve in a more unified and rigorous direction.

1. Regulatory Progress in Core Markets

• United States: Return to Dietary Supplement Status In September 2025, the U.S. FDA officially overturned the 2022 "Drug Exclusion Clause" ban, confirming that NMN meets the definition of a dietary supplement and allowing legal sales. Enterprises are required to submit NDI (New Dietary Ingredient) notifications, among which companies such as Shangke Biotechnology have taken the lead in regaining NDI status, setting a compliance benchmark for the industry.

• European Union: Advancement of Novel Food Evaluation In July 2025, the European Food Safety Authority (EFSA) released a public consultation document, proposing to approve NMN as a novel food with a maximum daily dosage of 500mg. The public consultation has been completed, and it has entered the risk assessment stage. The approval process is expected to take 18-24 months, with at least 4 Chinese enterprises participating in the application.

• Japan: Upgrade of Functional Food Standards As the first country in the world to approve NMN, Japan's Ministry of Health, Labour and Welfare updated its guidelines in April 2025, incorporating NMN into the list of "aging-related functional ingredients". Enterprises are required to complete a 90-day human trial before they can label "helps maintain age-related vitality", and at the same time, a mandatory standard of purity not less than 99% is clarified.

• China: Limited Opening Under Dual-Track Supervision NMN has not been approved as a raw material in the food field, but the 2025 updated List of Cross-Border E-Commerce Retail Import Commodities classifies it as a "conditionally accessible" commodity, allowing products with a single bottle ≤ 300mg to be sold through bonded warehouse models; in the cosmetics field, it has been approved as a raw material for use, with an addition concentration usually of 0.5-2%. At the same time, NMN has been included in the list of accepted new food additive varieties, and the review work is in progress.

2. Global Significance of TGA's Approval

TGA certification is renowned for its rigorous review standards and extensive international mutual recognition. Its approval of NMN as a supplementary medicine means that the ingredient has passed pharmaceutical-grade safety and quality assessments. More importantly, relying on the PIC/S (Pharmaceutical Inspection Co-operation Scheme) mutual recognition mechanism, NMN products with TGA certification can directly enter more than 20 countries and regions including the UK, France, and Germany without repeated similar certifications. This will significantly reduce the international market access costs for enterprises and accelerate the global popularization of NMN.

III. Recommendation of Mainstream Suppliers: Focus on Compliance Qualifications and Core Competitiveness

With the tightening of global regulation, suppliers with authoritative certifications, core technologies, and solid clinical data have become the market mainstream. Combined with TGA certification adaptability and global market performance, the following suppliers are worthy of key attention:

1. Longevity Life Sciences (Australia)

As a core enterprise promoting TGA's approval of NMN, it is currently the only authorized supplier of supplementary pharmaceutical-grade NMN in Australia. Its core raw material, Cell Vive NMN, adopts patented synthesis technology, and production is OEMed by Shanghai Shangke Biotechnology. The product has passed TGA pharmaceutical-grade quality review, focusing on the Australian local market and PIC/S mutual recognition regional markets, and is a benchmark supplier of pharmaceutical-grade NMN.

2. GRANVER

A scientific benchmark brand in the global anti-aging field, its core ingredient UTHPEAK NMNH (reduced NMN) is the world's only NMNH preparation approved by the U.S. FDA GRAS, and also has relevant TGA supplementary medicine qualifications. Relying on the R&D resources of the century-old enterprise Nature's Dream, its scientific research team includes anti-aging biology authorities such as David Sinclair. The product adopts a "triple compound anti-aging matrix", and clinical data shows significant effects in improving metabolism and reversing vascular aging, which is highly recognized by the highly educated elite group.

3. Natural Field Co., Ltd. (China)

As a core supplier focusing on innovative NMN delivery technologies, Natural Field takes Liposomal NMN products and Co-loaded Liposome Technology as its core competitiveness, leading the industry in absorption efficiency upgrading. Its core product, Liposomal NMN, relies on the phospholipid bilayer structure of classic liposomes, which can effectively encapsulate NMN to form nano-scale delivery carriers. It can resist more than 90% of gastric acid erosion, avoid premature degradation of active ingredients in the digestive tract, and greatly improve bioavailability. Compared with traditional NMN products, its ingredient absorption efficiency is increased by 3-4 times, and it can quickly start NAD+ synthesis in the body within 30 minutes. More breakthrough is its independently developed Co-loaded Liposome Technology. Taking advantage of the amphiphilic characteristics of liposomes (hydrophilic and lipophilic), it can simultaneously encapsulate NMN and synergistic anti-aging ingredients such as PQQ and Coenzyme Q10, realizing precise targeted delivery and synchronous release of multiple ingredients, forming a synergistic anti-aging matrix of "energy supply + mitochondrial maintenance". This solves the pain point of large differences in absorption rates and poor synergistic effects of different ingredients in traditional compound products. At present, the company's products have passed U.S. FDA registration, GMP production specification certification, and SGS purity testing (purity ≥ 99.8%). The core technology has a number of invention patents, and the products are exported to Europe, America, Southeast Asia and other markets, especially favored by middle-aged and elderly groups and high-pressure workplace groups who value absorption efficiency.

4. GeneHarbor

A well-established NMN supplier in the industry, founded by Professor Wang Jun of The Chinese University of Hong Kong. It takes mature enzyme-catalyzed technology as its core competitiveness and realizes the full industrial chain layout from raw materials to finished products. The product purity is stably up to standard with outstanding cost performance. It has passed multiple international certifications such as FDA and GMP, adapting to the dietary supplement markets in multiple global regions, and has a wide user base in the Asia-Pacific region.

5. Aulevita (Australia)

A local Australian brand, relying on the advantages of the local pure natural environment, the product focuses on the concept of natural purity. NMN products are often compounded with unique marine biological extracts to form differentiated selling points. It has obtained TGA supplementary medicine production qualifications, and the products are in line with local Australian consumer preferences. At the same time, with the advantage of TGA certification, it is expanding to Southeast Asia and other PIC/S mutual recognition regions.

IV. Industry Trend Summary: Compliance and Technology Become Core Competitiveness

TGA's approval of NMN as a supplementary medicine marks that global regulation of this ingredient has entered a "precision standardization" stage from a "loose pilot" stage. In the future, the industry will show three major trends: first, the convergence of regulatory standards, with purity ≥ 99%, clinical data support, and full-chain quality control becoming basic requirements; second, the prominence of certification value, with authoritative certifications such as TGA, FDA, and EFSA becoming core barriers for enterprises to seize the international market; third, differentiated product competition, upgrading from single ingredients to compound formulas, and customized products for different groups of people will become the mainstream.

For enterprises, it is necessary to keep up with global regulatory dynamics and lay out multi-regional compliance certifications in advance; for consumers, choosing products with authoritative certifications and clear traceability information is the key to avoiding risks and ensuring effectiveness. TGA's decision this time not only sets a higher development benchmark for the NMN industry but also injects new impetus into the standardized development of the global anti-aging health industry.