In China, the concept of “Health Food” encompasses both functional food and dietary supplement. It refers to any food with claimed health beneficial functions or those that can supplement vitamins and minerals, and is intended to be consumed by specific population groups. Health food can modulate body functions, is not aimed to cure any disease, nor expected to cause any harm to the body.
In the New Food Safety Law enacted in October 2015 in China, there is a section addressing food categories other than conventional food, including health food, infant formula and food formulated for specific medical use. It is mandated by the law that a Health Food Function Inventory and a Health Food Ingredient Inventory must be established. To be designated as “health food”, a dual-path procedure was proposed, one being the conventional Health Food Registration process, the more vigorous of the two processes; and the other being the Health Food Notification process, which saves much time for eligible products. In February 2016, the China Food and Drug Administration (CFDA) released rules on the Health Food Registration and Notification processes, effective July 1st 2016. In late May, CFDA asked for public comments on the first draft of Health Food Ingredient Inventory with some vitamins and mineral ingredients included, for the second time.
Below is a synopsis on the registration and notification of health food and requirements from CFDA, with comparisons to the New Dietary Ingredient Notification (NDIN) in the U.S. included.
What is the Health Food Registration process and which department has the authority to regulate?
Health Food Registration refers to the process for a food and drug authoritative agency to systematically review, comment and decide to approve or not, on the safety, health functions and quality properties of health food applications from submitters, based on procedures required by the law. CFDA is responsible for processing health food registrations, including selecting and gathering experts to review and recommend to CFDA of whether or not to approve a submission.1
What is the Health Food Notification process and which department has the authority to regulate?
Health Food Notification refers to the process for a health food manufacturer, according to procedures required by the law, to submit materials and information to demonstrate the safety, health functions and quality properties of their product to food and drug authoritative agencies, so that submitted information will be publically accessible and documented for future inspection purposes.1
Eligible products1:
Products with ingredients in the Health Food Ingredient Inventory
Nutrient supplement products of vitamins and minerals imported for the first time, the nutrients of which are in the Health Food Ingredient Inventory
Notifications for vitamin and mineral supplements imported for the first time (the second category of “eligible products” above) should be submitted to CFDA. FDAs on the provincial level[1] are responsible for health food notifications in their territory and conducting inspections on site if needed; local food and drug authoritative agencies on the city and township level perform other regulatory duties, if necessary, to oversee registered and notified manufacturers.1
What are the general procedures and timelines for the registration and notification processes, respectively?
Experts are selected and requested by CFDA to review health food registration submissions; if needed, inspections on site and tests for examinations and verifications can be conducted by relevant departments, respectively. The expert review should be completed within 60 working days[2] (Figure 1). Health food notification, on the other hand, is effective at once with a complete package.1
Figure 1. Administrative procedure for health food registration
If the review process by the expert committee needs to be lengthened, another 20 working days is allowed only if permitted by review committee.
If certain information is found missing from the submission, the submitter has three months to submit any missing data for once, and the 60-day clock would restart after resubmission is received.
If on-site inspection is requested by CFDA, it should be conducted within 30 working days, and inspection report should be submitted to the review committee.
If verification and examination of the and practicality of analytical methods or implementation of these methods are needed, the deficiencies should be verified or examined by relevant departments within 60 working days, and reports should be submitted to the review committee.
If the review committee concludes that it will not recommend the submission for approval to CFDA, the submitter will be notified. The submitter, if not agreeing with their conclusion, can appeal to the committee for a second review within 20 working days, with reasons specified. 1
What is required in the registration process, the notification process, respectively, and how do they compare with the NDIN?
An NDIN is for a New Dietary Ingredient (NDI) incorporated into a dietary supplement product, while the registration and notification processes discussed above in China are for any finished product claimed as health food, there are certain similarities in these applications (Table 1).
Similar elements required in both applications include the identity, description, specification, manufacturing information of the ingredient, as well as safety data. However, the health food registration/notification documents in China is focused on the finished product, and requires evidence and support for any health function(s) claimed; while an NDIN is more focused on the ingredient itself. Another big difference between an NDIN and the Health Food Registration process in China is the extent to which safety and toxicity evidence is required and evaluated. With health function data not needed if no claims are made, the NDIN heavily emphasizes evidence of safety and toxicology which is not focused that much as in the Chinese counterpart.
If you want to learn more about the health food registration/notification in China, such as the criteria for the experts to review a health food registration submission, please reach out to Burdock Group for a detailed consultation.
[1] Including provinces, autonomous regions as well as several large cities designated as direct-controlled municipalities which share the same political status as a province in China, including Beijing, Shanghai, Tianjin and Chongqing
[2] Any time for on-site inspection, testing and verification examinations is not included in the 60 work days.
References:
CFDA. Rules and methods to regulate health food registration and notification (in Chinese). 2016:1-10.
FDA. 21CFR Part 190 Dietary Supplements, Subpart B New Dietary Ingredient Notification, Sec. 190.6 Requirement for premarket notification. Code of Federal Regulations. 2016.
FDA. Dietary supplements: New dietary ingredient notifications and related issues: Guidance for industry (draft guidance). 2016:1-102.
Table 1. Comparison of materials needed for health food registration and notification in China with NDIN in the U.S.
