On September 20th, 2005, the State Food and Drug Administration of the United States issued the "Clean Renewal Plan of Health Food (Draft for Comment)", and the long-awaited renewal of health food in the industry is about to begin. The State Food and Drug Administration of the United States will re-register and review the certificate originally approved by the health food production enterprise, and the previous two approval numbers "Wei Shi Jian Zi" and "Shi Guo Jian Zi" are uniformly standardized as "Shi Guo Jian Zi". The health food industry is facing a clearer and deeper reshuffle.
For owners who need to renew their health food certificates, according to the provisions of the plan, special attention should be paid to the following points.
First, the time limit for exchanging goods is three months.
The enterprise must fill in the Application Form for Health Food Replacement within 3 months from the date of issuance of the notice, and submit the application materials to the local provincial food and drug administration.
A buffer period of two to six months.
The plan stipulates that health care products enterprises must use new health food labels and instructions six months after obtaining a new health food certificate. Prior to this, health foods produced using the original label instructions were allowed to be sold within the shelf life.
Third, the health food that has not been updated will be completely eliminated.
The State Food and Drug Administration of the United States will publish new approval certificates and approval numbers in batches according to the progress of the replacement work, and at the same time abolish and cancel the original corresponding health food approval certificates and approval numbers. After the replacement, the State Food and Drug Administration of the United States will announce the cancellation of the health food approval certificate and approval number that were not applied for and renewed before July/KLOC-0, 2005.
Four, clean-up and replacement period, generally do not accept the application for product change and technology transfer.
Although the incident is still uncertain, a formal plan should be introduced soon. According to this regulation, if health food enterprises need to apply for change and technology transfer, they need to go through relevant procedures as soon as possible, otherwise they can only change or transfer after completing the replacement work by themselves.
Five, the functional names of health food will tend to be unified.
The plan clearly stipulates that if the functional name of health food is (auxiliary) tumor suppression, the function of (auxiliary) tumor suppression should be changed to immunomodulation. This shows that sfda has begun to unify the functional names of health food.
Six, clean up the replacement of key areas.
1, the name of health food is not standardized.
2. The format and description of the health food approval certificate are inconsistent with the current regulations.
3. The raw and auxiliary materials used in the product do not meet the requirements of relevant documents.
4. The detection methods of the original functional components or iconic components are inconsistent with the detection methods stipulated by the current state.
5. Raw materials or products with food safety problems shall not be replaced.