Guan Cha Zhe Wang·2025-10-10 13:25Core Insights - The FDA has officially confirmed that β-nicotinamide mononucleotide (NMN) can be legally sold as a dietary supplement, marking a significant regulatory shift in the U.S. market [1][2] - This regulatory relaxation highlights a deeper industrial competition between China and the U.S., as Chinese companies, which control 90% of global NMN raw material production, face challenges in exporting raw materials while struggling to sell finished products domestically due to stricter regulations [1][5] - Scientific controversies surrounding NMN's efficacy and safety cast a shadow over its commercial potential, with limited clinical trials and high costs limiting its market appeal primarily to high-net-worth individuals [1][9] Regulatory Landscape - The FDA's change in stance is attributed to a revision of the "drug preemption" clause, allowing NMN to be classified as a dietary supplement without requiring proof of health benefits, only safety assessments [2][4] - In contrast, China's regulatory framework remains cautious, with no formal approval for NMN as a food additive or health supplement, reflecting a more stringent approach to food safety standards [4][5] Market Dynamics - Chinese companies like Ginkgo BioWorks and Aibin Chemical are leveraging their technological capabilities in the production of NMN, but they primarily export raw materials or sell through cross-border e-commerce platforms due to domestic regulatory hurdles [5][7] - Despite having a strong position in raw material supply, Chinese firms lag in brand recognition and market presence compared to international giants, with limited sales of NMN products in domestic markets [5][7] Scientific and Commercial Challenges - The scientific basis for NMN's anti-aging claims is rooted in NAD+ metabolism, but the transition from animal studies to human applications remains uncertain, with only 19 registered clinical trials globally [7][9] - The high cost of NMN supplementation, which can reach thousands of yuan annually, raises questions about its value proposition compared to lifestyle interventions that can also enhance NAD+ levels at a lower cost [9]