The "Administrative Measures for the License and Filing of Food Business" that came into effect on December 1, 2023 has added the scope of filing management, especially involving formula food for special medical purposes. There are many details that need to be noticed in the process of operating and selling these special foods. So, let's explore the relevant regulations and precautions with Foodmate.

1.Definition of Formula Food for Special Medical Purposes

The formula food for special medical purposes (hereinafter referred to as the FSMP) refers to the processed and formulated food products that are specifically designed to meet the special needs of nutrients or diets for people with restricted eating, digestive absorption disorders, metabolic disorders, or specific diseases. This includes the formula food for special medical purposes for infants from 0 to 12 months old and the formula food for special medical purposes for people over 1 year old. These products must be consumed either alone or in combination with other foods under the guidance of a doctor or clinical nutritionist.

2.The regulations on the operation and sale of FSMP

2.1The qualification requirements for the operation and sale of FSMP

The "Food Safety Law of the People's Republic of China" (amended in 2021) stipulates that the state implements a licensing system for food production and operation. If only prepackaged foods are sold, they shall be reported to the local food safety supervision and management department at or above the county level for record. FSMP belong to prepackaged foods, so when selling prepackaged foods containing FSMP, attention should be paid to the relevant regulations and requirements for the record of business license.

The "Measures for the Administration of Food Business License and Record Filing" stipulates that medical institutions and drug retail enterprises do not need to apply for record filing when selling specific full-nutrition formula foods in FSMP, but the business enterprises that sell specific full-nutrition formula foods to medical institutions and drug retail enterprises should obtain a food business license or apply for filing.

The "Regulations on the Implementation of the Food Safety Law of the People's Republic of China" (revised in 2019) stipulates that specific full-nutrition formula foods in special medical foods shall be sold to consumers through medical institutions or drug retail enterprises. Medical institutions and drug retail enterprises that sell specific full-nutrition formula foods do not need to obtain a food business license, but they shall comply with the provisions of the Food Safety Law and the Regulations on food sales.

For the sale of other categories of special medical foods, the "18 Questions on Special Medical Foods" compiled by the China Health Care Food Association mentions that other categories of FSMP(including full-nutrition formula foods and non-full-nutrition formula foods) can be sold by non-medical institutions and drug retail enterprises, but they cannot be mixed and sold with ordinary foods or drugs, and it is also prohibited to make false publicity of foods through meetings, lectures, health consultations, and other ways. based on the above, a brief summary of the requirements for obtaining business licenses and filings for the sale of special medical foods is shown in Table 1.

Table 1: Requirements for the sale of FSMP

2.2 The online operation and sale of special medical food

Nowadays, the share of online sales in various industries is gradually increasing, and the online operation and sales of special medical food need to pay attention to the "Measures for Investigating and Punishing Illegal Activities in online Food Safety" (2021 revised edition), which stipulates that in addition to general requirements such as food production and operation licenses, food producers and operators who sell special medical food online should also legally publicize product registration certificates. Those holding advertising review and approval numbers should also publicize the advertising review and approval numbers, and provide links to the corresponding data query page on the website of the market supervision and administration department. In addition, specific complete nutritional formula food in special medical food shall not be traded online.

There are also review requirements for advertising in online sales: "Interim Measures for the Administration of Internet Advertising" stipulates that special medical formula food must be reviewed by the advertising review authority for special goods advertising, and cannot be released without review. Summarize the requirements for online sales of special medical food in Table 2.

Table 2 Requirements for online sales of special medical food

Summary

With the continuous development of the market, the demand for special medical food is increasing. To further regulate and promote the progress of this industry, relevant regulations will be continuously improved to provide consumers with more suitable and safer product choices. As a professional service platform in the industry, Foodmate will continue to follow the latest trends in special medical food regulations and share relevant information with you in a timely manner.