New Regulations from the Korean FDA: Starting in 2024, Health Food Approval May Fall into the Double Strike Trap, Companies Need to Be Alert!

The Ministry of Food and Drug Safety (MFDS) issued Notice No. 2024-386 on August 21, 2024, announcing plans to revise the current Regulations on Functional Raw Materials and Certification of Standards and Specifications for Health Functional Food. The main contents of this revision include the following aspects:

1. New regulations on the return and handling of application materials: In order to simplify the review procedures for those raw materials that have been reviewed, for application materials that are returned or withdrawn within two years, only the subsequent information can be supplemented and improved in the future. The move aims to reduce the cumbersome process of repeated audits and improve audit efficiency.

2. It specifically stipulates the treatment of returned application materials: for the application materials that are returned within the specified time, the relevant departments will no longer re-examine all the materials, but focus on the completed information part after the return. Such provisions help speed up the audit process and shorten the waiting time for enterprises.

3. Public Comment: This revised announcement will be open for public comment until October 21, 2024. Through extensive consultation with all parties, we will ensure that the revised content is more scientific and reasonable and meets the actual needs of the industry.

4. Expected effect: After the completion of the revision, it is expected to greatly improve the efficiency of health functional food management in South Korea and further optimize the relevant regulatory system. This will help improve the management level of the entire industry and promote the healthy development of the healthy functional food market.

5. Industry impact: Relevant people in the food industry said that the policy adjustment will effectively shorten the audit time, reduce the burden on enterprises, and help enhance the vitality of the Korean health food market. Enterprises should pay close attention to the follow-up policy trends, timely adjust the declaration strategy, in order to make full use of the convenience brought by the policy.

Through this revision, the South Korean government hopes to further regulate the health functional food market, improve management efficiency, and create a more favorable development environment for related enterprises.