The Codex Alimentarius Commission (CAC) issued the Code of Infant Formulations and Special Medical Infant Formulas (Codex Stan 72-1981) in 1981. Appendix B of this standard is specific to infant formulas for special medical uses. based on the requirements of normal infant formula, the nutrition compositon adjust according to the disease condition. In addition, CAC issued the Codex Standard for Labeling and Claiming of Formulas for Special Medical Uses (Codex Stan 180-1991) in 1991, mainly for the definition and labeling of Foods for Special Medical Purpose (FSMP). Detailed regulations were made.

CAC defines a FSMP as “FSMP refers to a type of food specially processed or formulated for special diets that is used for dietary management of patients and can only be used under the supervision of a doctor. FSMP is for those patients who are restricted or have difficulty in eating, digesting, absorbing or metabolizing certain foods or certain nutrients, or those who have other special nutritional needs due to their medical condition, or whose diet cannot be improved only by improving the normal diet. A type of food that must be used with a special diet or a combination of both." The definition defines the product as a type of food, as well as its target population, role and method of use.
 

In 1999, the European Union officially promulgated the Standard for Formulation of Special Medical Uses (1999/21/EC), which defines FSMP as “process or formula for special dietary use for patient diet management, which needs to be used under the supervision of a doctor. ", and the products are divided into three categories: full-nutrition standard formulas, full-nutrient-specific formulas for certain diseases or clinical requirements, and non-nutrition standard formulas or specific formulas. In addition, the EU has issued a series of documents stipulating food additive standards, microbial limits and corresponding labeling specifications for FSMP.
 

In the United States, FSMP uses are called Medical Foods. In 1988, the United States first explicitly defined medical foods in the Orphan Drug Act Amendments, which are “Meal management for specific diseases or conditions, for the specific nutritional needs, based on recognized scientific principles and based on medical assessments for the formulation of the intestines, the use of the food needs to be under the supervision of a doctor.
 

In June 2012, the Australian Food Standards Agency (FSANZ) issued a standard for the FSMP(Standard 2.9.5), which was officially implemented in June 2014. The standard mainly defines the definition, sales, nutrient content and label identification of FSMP. The product definition is basically equivalent to the definition in the CAC standard. The label identification also emphasizes the nutrition of the product to be identified. Ingredients and content, osmotic pressure, use under the guidance of a doctor or dietitian.
 

In Japan, FSMP are called Food for Sick. In 2002, Article 26 of the Japanese Health Promotion Act (Law No. 103) established the legal status of FSMP, and patients with special foods need to be approved by the Japanese Ministry of Health and Welfare before going public. For using the standard formula foods for patients, the Ministry of Health and Welfare of Japan has reviewed and approved the formula of the declared products according to the permissible standards for each type of patient. The limits of various nutrients in the licensing standards are clearly defined, and the time is short and the procedure is simple. For foods that require individual approval, the Ministry of Health and Welfare conducts a comprehensive technical review and approval of the declared products for a long period of time and the approval process is complicated.
 

In China, the national earliest policy document on FSMP is the General Principles of Ingredients for Special Medical Uses (GB25596-2010). The national food safety standard was officially established by the former Ministry of Health on December 21, 2010. It was released on January 1, 2012, and has launched the button for the rapid development of China's FSMP industry. On December 26, 2013, the National Health and Family Planning Commission (NHFPC) also issued three national food safety standards for FSMP, namely the General Principles of Formulations for Special Medical Uses (GB29922-2013) and Good Manufacturing Practices for FSMP (GB29923-2013) and "Food Labels of the Prepackaged FSMP" (GB13432-2013). Since then, China has established a food safety standard management mode with one production specification and two product rules in line with international standards.

FSMP are included in the new Food Safety Law, with clear legal status. The newly revised "Food Safety Law of the People's Republic of China", which was officially implemented on October 1, 2015, incorporates health foods, special medical formulas and infant formula into "special foods" to implement strict supervision and management. In addition, the legal status of the FSMP is  clarified and the establish the registration system for special foods by the food and drug supervision and administration department of the State Council. The product formulations, manufacturing processes, labels, instructions, and the materials safety report of the product, nutritional adequacy, and clinical effects of FSMP should be submitted upon registration.