Enhancing the Safety and Accessibility of FSMP (Micro Perspective)

Compared to conventional foods, Foods for Special Medical Purposes (FSMP) face greater challenges in research and development, higher quality requirements, and narrower sales channels, necessitating strengthened policy support to stimulate the enthusiasm of relevant business entities.

Today, Foods for Special Medical Purposes (hereinafter referred to as "FSMP") are receiving increasing attention. Infants with protein allergies, adults with gastrointestinal issues, and patients recovering from surgery all rely on them.

FSMP are specially formulated foods designed to meet the nutritional or dietary needs of individuals with specific disease conditions, playing a crucial role in disease treatment, recovery, and bodily function maintenance. Among China's first catalog of rare diseases, 32 require the use of FSMP, with 18 needing timely, lifelong, and adequate FSMP consumption.

FSMP are not pharmaceuticals, yet they are pivotal in clinical nutrition therapy—not merely serving as "meals" for certain populations but also as "life-saving treatments" for patients with rare diseases. In China, newborns undergo heel blood testing to screen for conditions such as phenylketonuria (PKU). Without timely intervention, PKU can lead to intellectual disabilities, microcephaly, epilepsy, and other symptoms. Early screening combined with lifelong dietary therapy now enables patients to achieve normal intelligence, health, and lifespan.

China's FSMP industry started relatively late. While approved products are safe and reliable, the variety remains limited. In recent years, relevant authorities have optimized processes, accelerated registration and approval, and promoted comprehensive product coverage. Recently, the State Administration for Market Regulation issued guidelines refining the priority review and approval procedures for FSMP registration, further speeding up market entry. As of October this year, China has approved 208 FSMP products, with registrations in 2023 alone surpassing the total of the previous six years.

Despite growing supply and market expansion, FSMP still face challenges such as high costs and limited sales channels, failing to meet diverse clinical needs. Many patients still resort to overseas purchases or third-party sourcing. Enhancing accessibility is both an industry imperative and a public expectation.

Compared to conventional foods, FSMP entail more complex R&D, stricter quality standards, and narrower distribution channels, calling for stronger policy incentives to motivate businesses. During a visit to an FSMP production facility in Jiangsu, the author observed that pharmaceutical production lines for enteral nutrition were operating at full capacity, while FSMP lines with identical functions were underutilized. Low market awareness and acceptance have dampened corporate enthusiasm for FSMP production and innovation. Breaking this cycle requires addressing challenges across the entire product lifecycle—registration, R&D, clinical trials, production, and testing—with targeted support.

One effective way to improve FSMP accessibility is integrating them into the healthcare system. Some provinces have already included PKU-specific FSMP in local medical insurance, significantly reducing patient burdens. Moreover, as strictly regulated products, incorporating FSMP into insurance frameworks facilitates traceability, quality oversight, and public awareness. By optimizing supervision, expanding sales channels, and increasing education, FSMP can overcome the challenges of limited availability, high costs, and procurement difficulties, achieving broader development and benefiting more patients.

Advancing public health requires not only steady improvements in basic medical security but also ensuring that special groups—such as rare disease patients and those with chronic or severe conditions—receive adequate care and support. It is hoped that regions and departments will further refine policies and regulations, combining policy and market measures to incentivize corporate R&D, enhance FSMP safety and accessibility, and ensure that those in need can access affordable, reliable products—ultimately improving public health and well-being.