China's FSMP Industry: How Special Medical Foods Become a New Pillar of Healthy Consumption

Strategic Guidance, Precision Empowerment for Healthy Consumption

FSMP refers to formulated foods that are specially processed and prepared to meet the special nutritional or dietary needs of individuals with conditions such as dietary restrictions, digestive or absorption disorders, metabolic disturbances, or specific disease states. With the continuous improvement of the policy and regulatory framework, this industry has grown into a key specialized segment within the food sector — characterized by high technological intensity and strong economic performance.

Data shows that China records approximately 220 million inpatient hospitalizations annually. Standardized use of FSMP for nutritional support can significantly improve survival rates and markedly shorten hospital stays for inpatients. Notably, among the first batch of diseases listed in China's catalog of rare diseases, 32 conditions require FSMP intervention, with 18 of these requiring lifelong and adequate use. As China enters an era of an aging population, FSMP are increasingly becoming an important source of nutritional support for patients with chronic diseases.

As a vital component of the Healthy China initiative, FSMP hold significant importance for the development of China's health consumption system and the improvement of public health. According to an official from the Department of Special Foods of the State Administration for Market Regulation, as an essential part of precision nutrition, the scientifically designed formulations of FSMP have played a key role in multiple clinical scenarios, including oncology treatment, post-operative rehabilitation, rare disease intervention, and metabolic regulation. Clinical data show that the use of FSMP can reduce the incidence of malnutrition in cancer patients. For rare diseases such as phenylketonuria and methylmalonic acidemia, FSMP represent an effective therapeutic strategy. For perioperative patients, the use of FSMP, such as electrolyte formulas, can help maintain electrolyte balance, reduce insulin resistance, and promote post-operative recovery.

Furthermore, the widespread application of FSMP helps optimize the allocation of medical resources and reduce the burden of diagnosis and treatment. Data show that through effective nutritional intervention, patient hospital stays are significantly shortened, and medical costs are subsequently reduced. Internationally, some countries have included certain FSMP in their health insurance systems, achieving favorable social benefits.

At the industrial level, FSMP are driving the transformation of the general health consumer market from "broad-spectrum wellness" toward "precision nutrition." Currently, 249 FSMP products have been approved for registration in China, covering all age groups and various disease types. Policies encourage enterprises to develop clinically needed, disease-specific formulas such as those for oncology and nephrology, and to accelerate the translation of research and development outcomes into products through optimized review and approval processes.

In light of the population aging trend, the value of FSMP in the chronic disease management of the elderly has become increasingly prominent. For common age-related conditions such as sarcopenia and dysphagia, FSMP can provide easily absorbable nutritional support and reduce the risk of complications. Promoting FSMP in settings such as elderly care institutions and community hospitals can enhance the capacity of primary healthcare services and bridge the urban-rural gap in health resources.

Confronting Challenges, Removing Development Bottlenecks

The FSMP industry has developed rapidly. However, in terms of practical application, challenges such as insufficient product accessibility, low public awareness, and inadequate supply capacity still remain.

According to a relevant official from the Department of Special Foods of the State Administration for Market Regulation, the primary consumption scenarios for FSMP remain concentrated within hospitals, while their use and consumption in communities, pharmacies, and elderly care institutions are significantly insufficient. Furthermore, FSMP are only available in hospital information systems (HIS) under temporary codes, which makes it inconvenient for physicians to prescribe them for patients. There is also a lack of FSMP products suitable for rare diseases and clinically urgent needs, leaving patients with limited options. Most of the available products are imported, and the substitution rate with domestically produced alternatives remains low.

In addition, the level of awareness of FSMP among both the general public and professional groups still needs to be improved. Given the relatively short period of FSMP development in China, this emerging category still faces an "awareness gap" at the societal level. In particular, outside the hospital system, both merchants and consumers have a limited understanding of FSMP, which hinders their broader application and promotion in a wider range of settings.

On the supply side, the number of high-quality products remains insufficient. FSMP enterprises in China generally have weak research and development foundations, leading to product homogenization among registered products. There is an urgent need to strengthen innovative research and development and optimize market supply for the following categories:

• Complete nutrition formula products for specific diseases, including diabetes, respiratory diseases, kidney disease, liver disease, sarcopenia, inflammatory bowel disease, gastrointestinal absorption disorders, and fatty acid metabolism disorders;

• And FSMP for rare diseases with urgent clinical needs, such as amino acid metabolism disorders, fatty acid oxidation disorders, and refractory epilepsy.

In response to the existing challenges, the State Administration for Market Regulation has stated that it will further optimize the registration of FSMP. While strictly implementing the registration review and approval process, the Administration will promote the issuance of priority registration guidelines for certain clinically needed products, organize research and publication of clinical technical guidelines for specific complete nutrition formula foods, and encourage enterprises to actively apply for registration, thereby supporting the prompt approval and market launch of qualified products. In addition, further efforts will be made to remove bottlenecks in the operational and usage stages. These include researching and optimizing reform measures for the regulatory requirements concerning online sales of specific complete nutrition formula foods; actively promoting relevant authorities to issue clinical use guidelines for FSMP; and continuing to organize public welfare awareness campaigns to steadily enhance public understanding of FSMP.

Innovative Regulation to Forge a Synergistic Driving Mechanism

To achieve a dynamic balance between food safety regulation and industrial development, the State Administration for Market Regulation has been continuously promoting the standardized and institutionalized development of the FSMP industry by establishing a tripartite governance model centered on "safety as the foundation, innovation as the driver, and efficiency as the enabler."

According to the relevant official, in terms of access management, the State Administration for Market Regulation, guided by the "Four Strictest" requirements (the strictest standards, strictest regulation, strictest penalties, and strictest accountability), has strictly implemented a dual-access control system consisting of "product registration + production licensing." The Administration has revised the Measures for Registration of Foods for Special Medical Purposes, further emphasizing the conditions, capabilities, legal responsibilities, and obligations that applicants must meet, and specifying seven circumstances under which registration will not be granted. Meanwhile, the Administration is currently revising the Detailed Rules on Examination of Production Licensing for Formula Foods for Special Medical Purposes to further tighten production licensing requirements and ensure the quality and safety of FSMP.

To stimulate innovation momentum in the industry, the State Administration for Market Regulation has strengthened policy support. It has established a classification-based registration system for FSMP, issued registration guidelines for various product categories such as electrolyte formulas, and streamlined application documentation, effectively reducing research and development costs for enterprises. A priority review channel has been set up to significantly shorten the review timeline for clinically needed FSMP, including those for rare diseases. This has led to a breakthrough in achieving zero domestic production of two types of FSMP for metabolic disorders in China. Furthermore, the Administration has successively issued guidelines such as the Clinical Trial Quality Management Standard for Foods for Special Medical Purpose and the Technical Guidelines for Clinical Trials of Specific Complete Nutritional Formula Foods for Liver Disease, actively facilitating the application and market approval of clinically needed products.

In terms of institutional innovation, the State Administration for Market Regulation, in collaboration with relevant departments, has introduced a series of new institutional arrangements and supporting measures, creating policy synergy through multi-agency coordination. The Department of Special Foods of the State Administration for Market Regulation and the Department of Food Safety Standards, Risk Surveillance and Assessment of the National Health Commission have established a "technical collaboration and joint expert review" mechanism for FSMP registration and approval. The two departments have set up a multidisciplinary expert review team and implemented a dual-track system combining "regular review" and "priority channel." For clinically needed products such as FSMP for rare diseases and specific complete nutrition formula foods, review resources are prioritized. Through category-based management, resource allocation is optimized to accelerate the filling of supply gaps in FSMP.

Multisectoral collaboration is also steadily advancing. The Ministry of Commerce, the National Health Commission, the State Administration for Market Regulation, and nine other departments jointly issued the Action Plan for Promoting Healthy Consumption, which encourages enterprises to strengthen process research and development, product innovation, and quality control, with a focus on advancing FSMP. Through enhanced regulation, optimized approval processes, incentives for research and development, and multisectoral coordination, the State Administration for Market Regulation guides FSMP production and operating enterprises to proactively provide more high-quality choices for healthy consumption.

At the practical level, the Hainan Lecheng International Medical Tourism Pilot Zone has taken the lead in piloting a policy for the temporary importation of FSMP. The first imported product indicated for Crohn's disease has already been put into clinical use. At the same time, the State Administration for Market Regulation, in collaboration with multiple departments, has guided local pilot areas in carrying out special campaigns to promote FSMP into communities, elderly care institutions, schools, and pharmacies. Starting from the goal of enhancing public scientific awareness of FSMP, these initiatives aim to increase understanding of FSMP among relevant institutions, organizations, and key population groups, while exploring ways to expand distribution channels for FSMP.

As the policy system becomes increasingly well-established, the regulatory mechanism continues to improve, and industry innovation steadily advances, the FSMP industry is accelerating its entry onto a track of high-quality development. The State Administration for Market Regulation has stated that it will continue to uphold the bottom line of safety, strengthen institutional guidance, and promote multisectoral coordination, so as to continuously improve the accessibility and professional standards of FSMP and better serve new demands in health consumption.

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