INFORM January 2024

inform January 2024, Vol. 35 (1) • 15

from policy disparities, laying the foundation for the country to refine and improve related policies. The third phase (post-2009) signifies a period of policy refinement. In the new Food Safety Law, FSMP were explicitly designated as ‘foods,’ a departure from their previous classifi cation under the Drug Administration Law. This shift influenced the development of these foods within China and restricted the entry of foreign products into the market. To address concerns related to product development and clinical demand, the National Health Commission introduced a ‘2+1’ standard management scheme. Concurrently, the China Food and Drug Administration issued the Regulations on the Registration and Management of FSMP (Trial), providing com prehensive regulatory framework and technical support. These policies layout legal stipulations, along with practical require ments for regulatory authorities and manufacturers to safe guard FSMP quality. REGULATORY PROCESS FOR FSMP DESIGNATION Recognizing the unique position of FSMP within the food industry, in April 2017, China established the Special Food Registration and Management Division under the China Food and Drug Administration. The primary role of this division was to develop and oversee the regulatory framework and asso ciated standards for registering special foods. These special foods include health foods, infant formula products, and FSMP. Additionally, in August 2018, a Special Food Safety Supervision and Management Division was established under the State Administration for Market Regulation. As part of the broader institutional reforms, China’s regulatory system for FSMP has undergone steady evolution. This regulatory framework relies on government-led oversight, supported by industry self-regulation and enterprise independent action. Together, these elements work to shape a new mechanism aimed at promoting the long-term and healthy development of the FSMP sector in China. As the food safety management system continues to evolve, regulatory agencies have intensified their oversight. This comprehensive regulatory approach spans the entire life cycle of FSMP, as outlined in Table 2. Government authorities

have played a crucial role in facilitating the steady growth of the FSMP industry. Consequently, certain brands have either voluntarily exited or been compelled to withdraw from the market, contributing to further market consolidation.

FUTURE DIRECTIONS FOR CHINA’S FSMP INDUSTRY

Despite the existence of a regulatory framework for over five years, certain categories within complete nutritional formula foods and non-complete formula foods lack approved prod ucts, and the specialized medical foods market faces several challenges: 1. FSMP are categorized as food, not pharmaceuticals, leading to higher prices compared to standard medica tions and limiting the possibility of reimbursement. 2. Stringent registration requirements, requiring approval from relevant authorities and clinical trial reports, result in high costs and lengthy timelines. 3. Advancements are needed in manufacturing processes, nutritional preparation stability, safety, efficacy, and clinical formulations. China lacks technical personnel and research funding in this field, with a limited variety of products, mostly imported. 4. FSMP require medical supervision, but the distribution network is inadequate, hindering access. 5. The FSMP industry in China is in its early stages, with challenges in understanding national policies and regis tration requirements. To promote growth and address these challenges, the industry needs proactive government policiesl. Recent invest ments in technological innovation within the nutrition and health-focused food industry, along with policy developments related to FSMP, are expected to drive significant demand within healthcare institutions. New standards for various med ical conditions are in the pipeline, enhancing the compre hensiveness of specialized medical purpose formula foods in China. Liang Song is an associate professor in the School of Food Science and Technology at Dalian Polytechnic University. He can be reached at ryo.song@foxmail.com. AOCS EVENTS WATCH April 28-May 1, 2024. AOCS Annual Meeting & Expo, Montréal, Québec, Canada. https://annualmeeting.aocs. org/about/save-the-date-for-2024 April 28-May 1, 2024. Sustainable Protein Forum, Montréal, Québec, Canada. https://sustainableprotein. aocs.org/ To advance your career and learn new skills, visit https:// www.aocs.org/education and register for our latest Continuing Education Program or contact us at general@ aocs.org, +1 217-359-2344.