Establishing specialized nutrition in China

January 2024

Food as medicine is an idea starting to gain traction in the Western world, but in China providing patients with clinical nutritional support has been practiced since the 1970s. Foods for Special Medical Purposes (FSMP), as they are called, have shown potential to enhance survival rates by reducing hospitalization length and decreasing complications, hence minimizing readmission rates which lowers associated healthcare costs. China has adjusted policies, in recent years, to systematize medical foods and potentially reduce national healthcare spending while improving the physical well-being and quality of life of its citizens.

Distinct from pharmaceuticals, FSMP cannot prevent, treat, or substitute for medication in managing disease or clinical disorders. However, FSMP do require medical prescriptions or advisors, so they occupy a unique position between pharmaceuticals and health supplements. They do not claim health-related benefits or nutrient supplementation properties which differentiate them from health supplements. Due to increased government attention and improved policies, FSMP are being used more among the elderly, patients with chronic ailments, and those undergoing surgery.

China has implemented their policies in accordance with the trajectory of the medical food industry. Over four decades, the government has developed and refined the regulatory framework for retail pharmacy sales of FSMP. Regulations governing the display, promotion, and sale (including online commerce) of FSMP are now explicitly outlined for multiple geographic regions within the country. Here we discuss those policies and the future of FSMP in China.

FOOD-BASED MEDICINE

The application of food as medicine varies according to a patient’s needs. However, there are some common ingredients worth discussing.

Fat is one of the three essential nutrients for the human body. In FSMP, different functional fats are chosen as raw materials based on the metabolic characteristics of patients. For instance, in full-nutrient specialized medical foods designed for liver disease patients, medium-chain triglycerides (MCT) may be used as a fat source due to their unique metabolic pathway, which alleviates the burden on the liver.

Proteins are large molecules that cannot be directly absorbed by the human body. They are valuable only after enzymatic hydrolysis that breaks them down into peptides and amino acids. Consequently, FSMP products include protein sources derived from plants and animals, as well as peptides or amino acids obtained from animal or plant protein hydrolysates.

Carbohydrates are the primary energy source required to maintain vital bodily functions. Common carbohydrate sources in FSMP include glucose, lactose, maltodextrin, cornstarch, and dietary fiber sources such as soy fiber, soy polysaccharides, soy oligosaccharides.

Vitamins are essential micronutrients. Both the FSMP Regulation (GB 29922-2013) and the Standards for the Use of Food Nutritional Enhancers (GB 14880-2012) specify the permissible range and sources of vitamins. Similarly, GB 29922 outlines limited standards for minerals, including sodium, potassium, copper, magnesium, iron, and others. In addition to essential nutrients, the standard permits the addition of optional nutrients to full-nutrient formula foods. While these nutrients are not mandatory, they contribute to human growth and development.

Currently, in China, six optional nutrients have been added to registered products, including chromium, molybdenum, choline, taurine, L-carnitine, and dietary fiber. However, fluoride, inositol, and nucleotides have not yet been incorporated. This opens new avenues for future research and development of FSMP.

MEDICAL CONDITIONS AND DISTINCTIONS

Foods for Special Medical Purposes are categorized into two main groups: Infant FSMP and Non-Infant FSMP. Infant FSMP in China are designed for patients aged 0-12 months and encompass a variety of formulations. Examples include lactose-free or low-lactose options, partially hydrolyzed protein formulations, premature or low birth weight infant formulas, breast milk supplements, and formula for amino acid metabolic disorder. On the other hand, Non-Infant FSMP are tailored for individuals over one year with specific nutritional requirements, digestive absorption disorders, metabolic disorders, or other medical conditions.

The General Guidelines for FSMP outlines 13 full-nutrient formula foods intended for patients with diverse medical conditions. These include:

• diabetes
• chronic obstructive pulmonary disease (COPD)
• kidney disease, malignant tumors (cachexia)
• inflammatory bowel disease
• food protein allergies
• refractory epilepsy
• obesity
• weight-loss surgery
• liver disease
• muscle wasting syndrome
• stress-related conditions (trauma, infection, surgery, and others)
• fatty acid metabolism disorders
• gastrointestinal absorption disorders

In addition, there are non-full-nutrient formula foods designed for individuals requiring specific or partial nutrient supplementation (Table 1), those with metabolic disorders, or those with distinct dietary needs. Whether they are full-nutrient or non-full-nutrient formulas, the key distinction in FSMP lies in the composition and content of the product.

IMPLEMENTATION METHODS

The Chinese government developed and refined the regulatory framework for retail pharmacy sales of FSMP over many years. Presently, the distribution of FSMP in China happens through both in-hospital and external channels. Within the hospital premises, FSMP are retailed through on-site pharmacies, often affiliated with chain drugstores. Hospitals procure these products through bidding and purchasing mechanisms, typically upon recommendations or prescriptions from clinical nutritionists. FSMP are also available externally through various outlets such as pharmacies, supermarkets, and maternity stores.

Another approach to FSMP distribution involves collaborative ventures between distribution enterprises or manufacturers and medical institutions, sometimes engaging all three parties. These collaborations leverage the financial strengths of distribution enterprises or manufacturers and aim to cre-ate holistic solutions that encompass science, nutrition, and health.

FSMP CASE STUDIES

Chinese researchers have predominantly concentrated their efforts on developing disease-specific FSMP, notably for conditions like diabetes, respiratory disorders, and inflammatory bowel diseases. Products meant to treat these ailments have successfully entered the domestic market.

Diabetes, a prevalent metabolic disorder characterized by elevated blood glucose levels, has been a prominent area of research. For instance, Bao-quan Jiang, professor of Nutrition and Food Hygiene at the Third Military Medical University, used biotechnological fermentation to create a specialized medical yogurt designed to protect pancreatic function, improve sugar metabolism, and lower blood glucose and lip-ids. The findings laid a strong theoretical foundation for diabetes-specific medical foods.

Gestational Diabetes Mellitus (GDM), a condition caused by prolonged high blood sugar levels during pregnancy, poses substantial risks to both mother and fetus. Jin-feng Ji, deputy chief physician at Xiaolan Hospital, affiliated with Southern Medical University, conducted a study involving 103 GDM patients. The study integrated dietary management, education, and diabetic nutritional supplements. The results suggested that this comprehensive approach effectively managed and controlled GDM, consequently reducing pregnancy complications.

Respiratory disorders, such as chronic obstructive pulmonary disease (COPD), acute respiratory distress syndrome (ARDS), and acute lung injury (ALI), have received significant attention. FSMP for COPD often include high-fat, low-carbohydrate formulations containing medium-chain triglycerides (MCTs) and omega-3 unsaturated fatty acids to preserve lung function and alleviate inflammation. Yan-li An, chief physician at Zhengzhou People’s Hospital, conducted research showcasing the benefits of enteral nutritional support in reducing clinical symptoms and markers in ARDS patients. The results underscored the positive impact of early nutritional support for ARDS patients after mechanical ventilation, leading to better patient conditions and reduced mortality rates.

Inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease, have also been a target of research. FSMP for IBD aims to mitigate inflammatory lesions by adjusting dietary composition, often using easily digestible proteins and low fiber content. Lactose intolerance is common among enteritis patients, necessitating lactose-free products. Xiu-fang Wang, chief physician at Xinhua Hospital of Hubei Provinces, conducted a study involving 131 ulcerative colitis patients, which emphasized the advantages of enteral nutrition in improving body weight, albumin, and total protein levels.

In summary, the development of disease-specific FSMP in China, particularly for diabetes, respiratory disorders, and inflammatory bowel diseases, has shown promise in improving patient outcomes and addressing unique dietary needs associated with these conditions.

HISTORY OF FSMP IN CHINA

The first phase in the evolution of China’s FSMP policy began between 1970 and 2000. During this period, as clinical nutrition advanced, the potential societal value of FSMP emerged. Reports of their clinical application first appeared in Beijing as early as 1974. In the 1980s, the Chinese healthcare system started recognizing the specialization of nutrition disciplines.

Formal policies to regulate the use of clinical nutrition took hold in the early 2000s. In 2002, the Chinese Medical Association classified FSMP as a category, while government bodies indicated their relevance by including them on medical insurance policies. In 2006, the China Nutrition Improvement Action Plan emphasized proper nutrition for sustaining health. Comprehensive guidelines were established for enteral and parenteral nutrition to assist physicians in devising suitable nutritional support regimens and outline operational protocols. This era established China’s specific technical and functional requirements for FSMP. It also identified issues arising 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 classification 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 comprehensive regulatory framework and technical support. These policies layout legal stipulations, along with practical requirements for regulatory authorities and manufacturers to safeguard 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 associated 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 lifecycle 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 products, and the specialized medical foods market faces several challenges:

1. FSMP are categorized as food, not pharmaceuticals, leading to higher prices compared to standard medications 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 registration requirements.

To promote growth and address these challenges, the industry needs proactive government policiesl. Recent investments 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 medical conditions are in the pipeline, enhancing the comprehensiveness of specialized medical purpose formula foods in China.