There are some differences in the supervision managements between the formula food for special medical purposes (FSMP) in China and the United States. To enhance the understanding of FSMP, Foodmate compares and analyzes FSMP in China and US from the product category, industry access, advertising, marketing and other aspects for your reference.


In China, FSMP refer to formula foods specially prepared to meet the special needs of nutrients or diets for people with restricted eating, digestive and absorption disorders, metabolic disorders or specific disease states, including those suitable for Infant from 0 months of age to 12 months of age and those for people over 1 year old.

In the United States, FSMP are called Medical food, which are made according to formulas, digested or function in the intestine under the supervision of physicians, and are determined through medical evaluation based on recognized scientific principles. Medical food is special management diet for a disease or condition with special nutritional needs. The formulas provided for infants with genetic metabolic diseases from 0 to 12 months are managed according to Exempt Infant Formulas. Exempted Infant Formulas refer to infants with congenital metabolic defects, low birth weight, other special medical conditions or dietary problems.

1. Are the classifications consistent?

The classification of special medical products in China and the United States is different. For example, diabetes complete nutrition formula food is included in the scope of special food supervision in China. American medical food is provided for patients with limited or impaired ability to ingest, digest, absorb, and metabolize common foods or certain nutrients, as well as patients with other medical conditions requiring special nutrition, which cannot be compensated by adjusting diet. Diabetic patients can adjust their diets to ensure the intake of nutrients, so the FDA has not included nutritional foods for diabetic patients in the scope of medical food supervision. In terms of specific classification, according to the different target groups, the two countries have corresponding product categories.

Because there are certain differences in classification, using Chinese FSMP classification as a benchmark compare with the US classification. The details showed in the table below. It can be seen that the classification of FSMP in Chinese regulations is more specific.


2. What are the industry entry barriers?

In China, obtaining the registration certificate and food production license for FSMP is a necessary condition for domestic enterprises. China implements product formula registration management for special medicine. Whether it is domestically produced or imported products, applicants for formula registration should submit materials to the State Administration for Market Regulation (SAMR) for registration. After obtaining formula food registration certificates, a food production license for the corresponding product is also needed before domestic production enterprises produce FSMP.

There are no relevant audit requirements for medical foods before they are marketed in the United States, but FDA has the right to supervise medical foods after they are marketed, and factories engaged in manufacturing, processing, packaging, or preserving medical foods must register with FDA. Exempt Infant Formulas should implement the relevant requirements of infant formulas in 21 CFR 107 C, that is, before manufacturers of infant formulas generally available at the retail level sell new infant formula food, they should submit information about the production of new infant formula food to the FDA at least 90 days in advance for record filing. Infant formulas not generally available at the retail level shall comply with the relevant provisions of 21 CFR 107.50(c).

3. How to manage product advertising?

In terms of advertising management, China has stricter management. According to the "Regulations on the Implementation of the Food Safety Law of the People's Republic of China", advertisements for specific full nutritional formula foods are managed in accordance with prescription drug advertisements, and advertisements for other types of FSMP are managed in accordance with non-prescription drug advertisements.

In the United States, medical food is not a drug, so it is not subject to any regulatory requirements specifically applicable to drugs. At the same time, there are no specific regulations applicable to medical food advertising in the United States, and medical food needs to meet the requirements of general food advertising.

4. What are the sales channels?

FSMP are different from ordinary foods. In China, specific full nutritional formula foods should be sold to consumers through medical institutions or pharmaceutical retail enterprises. There are no clear regulations on the sales channels of other FSMPs, but a food business license is necessary before they can be sold, and they cannot be mixed with ordinary food or drugs for sale. There are no clear regulations on the sales channels of medical food in the United States, but the Exempt Infant Formulas are divided into two sales channels based on the label declaration and the applicable population. They are "infant formulas generally available at the retail level" and "Infant formulas not generally available at the retail level". Among them, infant formulas generally available at the retail level are generally declared and labeled for dietary conditioning for people with a disease or clinical diagnosis that is not serious and not in a life-threatening state; infant formulas not generally available at the retail level are usually prescribed by a physician and provided at the request of the pharmacist, or distributed directly to institutions such as hospitals, clinics, and state or federal agencies. Such formula foods will indicate on the label that only specific diseases that are clinically diagnosed as serious or life-threatening and require a longer period or dietary management of illness.

Summary

In summary, China has stricter regulations on FSMP and has a clear classification. It can be divided into two categories: FSMP for infants from 0 to 12 months and FSMP for people over 1 year old; The formulas in the United States for infants from 0 to 12 months suffering from genetic and metabolic diseases are managed in accordance with Exempt Infant Formulas and belong to the category of infant formulas.

Regarding the regulatory model, China's FSMP are subject to production licensing and registration management, and advertisements are managed in accordance with drug advertisements. Specific fully nutritional formula foods should be sold to consumers through medical institutions or drug retail enterprises. In the United States, medical food is not a drug and does not apply to the regulatory constraints of drugs. There are no relevant audit requirements before marketing, but manufacturers need to register with the FDA; Exempt Infant Formulas need to be registered according to 21 CFR 107 C.

Recommend Article:
Food for Special Medical Purposes Registration
Summary | Analysis of FSMP registration (Until June 30, 2020)

---

Please note: Original English article of Business Division of Food Safety and Regulatory Compliance of Global Foodmate, please indicate the source from the Global Foodmate if reprint.
Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net