China
Regulatory Standards：The national food safety standard "Health Food" (GB 16740-2014) is the fundamental standard for health foods in China, which stipulates the definition, product classification, technical requirements, inspection methods and other contents of health foods. In addition, there is also a series of related inspection and testing standards. For example, the national food safety standard "Determination of Alpha-Linolenic Acid, Eicosapentaenoic Acid, Docosapentaenoic Acid and Docosahexaenoic Acid in Health Foods" (GB 28404-2012) is used to regulate the detection methods for various components in health foods.
Registration and Filing System: Health products need to be managed through registration or filing. Registered health products are required to undergo strict tests and approvals regarding safety, health functions and many other aspects. Although the process for filing health products is relatively simplified, relevant materials such as product formulas and production processes still need to be submitted to ensure product quality and safety.
United States
Regulatory Framework: It mainly relies on the Federal Food, Drug, and Cosmetic Act (FFDCA). This act recognizes the United States Pharmacopeia - National Formulary (USP-NF) as the official compilation of quality standards for dietary supplements, but its enforcement is not mandatory.
USP Standards: They are formulated by the United States Pharmacopeia Convention. The monographs supervise items used as dietary ingredients and dietary supplements and provide public specifications, including quality requirements for ingredients, pollutant control, etc. The general chapters also contain analytical methods such as testing and assay information to help ensure the quality of dietary supplements.
cGMP Requirements: Manufacturers are required to follow the Current Good Manufacturing Practice (cGMP), which covers all aspects of the production process, such as personnel qualifications, plant facilities, production processes, and quality control, to ensure the consistency, purity, strength and composition of products.
Australia
TGA Certification: Australia is the only country in the world that incorporates the production of nutritional health products into drug management. Its Therapeutic Goods Administration (TGA) has very strict supervision over health products. Health products that have obtained TGA certification need to undergo more than 600 quality inspections from raw materials to finished products and have high standards in terms of production processes, quality control and safety.
Ingredient Requirements: There are strict regulations on the ingredients of health products, including the origin, purity and quality of raw materials, to ensure the safety and effectiveness of the ingredients. Meanwhile, it is prohibited to add certain harmful substances and unapproved drug ingredients to health products.
European Union
Framework Directives: The European Union has formulated a series of framework directives on food supplements. Each member state is required to formulate its own specific regulations and standards according to these directives. The directives stipulate the basic principles such as the definition, ingredient requirements and label identification of food supplements.
GMP Standards: Many EU countries require health product manufacturers to follow the Good Manufacturing Practice (GMP) to ensure the hygiene of the production process, quality control and product traceability, so as to ensure the stability and reliability of product quality.
Ingredient Approval: New ingredients used in health products need to undergo strict safety assessment and approval procedures. They are only allowed to be used when their safety and effectiveness are confirmed.
Japan
Related Regulations: Health products are called "health functional foods" in Japan and are regulated by laws and regulations such as the Health Promotion Law. According to differences in functions and safety, health functional foods are divided into categories such as foods for specified health uses and foods with nutrient functions.
Approval System: Foods for specified health uses need to undergo a strict approval process, including scientific assessments of safety and health functions. Enterprises are required to submit detailed research materials and application documents. Foods with nutrient functions are subject to the filing system, but they also need to meet the relevant ingredient specifications and claim requirements.
