This article was written by Mark Schaub (International Partner) and Chen Bing (Partner).
schaub_m1On April 28, 2017, China Food and Drug Administration (“CFDA”) released for public comment a draft Opinion on the Further Strengthening of the Supervision of Health Food (“Draft Opinion”).
The Draft Opinion leans heavily on principles already set out in the new Food Safety Law and the Administration Measures on Registration and Filing of Health Food (“Administration Measures”) of 26 February 2016 but also does give a hint as to their current thinking in relation to health food registration and filing:
More Filings; Less Registrations
The Draft Opinion proposes that going forward more health food products would require only filing and less would be subjected to the more onerous registration requirements.
This is important as it shows that CFDA is signaling a willingness to overhaul the supervision system in an open manner. In order to achieve this the CFDA will likely expand permitted health food material and ingredient lists so that health food only using permitted ingredients included in the list will require a simple filing and not registration.
What is health food?
The Draft Opinion specifies that health food is a special type of food that can be differentiated from both medicine but also normal food. The definition includes dietary supplements and food claiming functions to promote human health.
Health food will need to provide clear edible dosages and also specify which groups are suitable or unsuitable for taking the product. Health food products are not to be a substitute for normal dietary needs or claim that they can be used to treat disease or as a substitute for medicine. It should also be noted that normal food should not claim any health function.
Strengthen the management of raw materials of health food
CFDA intends to formulate health food materials lists. These lists will form the foundation in order to expand a system that will allow many more products to require a simple filing rather than the more onerous registration process. These lists will include details as to specifying the ingredients, dosage, corresponding function, production technology and other technical requirements. Importantly, these raw materials will only be able to be used in health food – if a normal food has such ingredients it will be considered a health food.
The CFDA Opinion stresses that a review and examination of the scientific basis for function claims needs to be improved. In principle, function claims made by health food should be verified by way of human testing. Consumers should be able to properly rely on such function claims and this should be evidenced by scientific consensus, solid scientific basis and verification through human testing. Foods other than health food should not make function claims.
Health food advertisement and labelling
The content on the label and packaging of the product must be consistent with the contents in the registration certificate or filing information. Health food labels and packaging must provide proper functional information to guide consumers and cannot include misleading information. In the future it is intended that health food will be labeled with a special symbol. The label, packaging and advertisements for health food must emphasize the product is not a substitute for medicine and also the products should not be named after a function claim.
This Draft Opinion will be welcome news to many companies confronted with onerous registration requirements for their health food products as well as consumers that need better information to guide their purchases. In addition the Draft Opinion indicates the authority’s determination to fully implement the principles and provisions provided in the Food Safety Law and the Administrative Measures. Naturally time will tell but the “More filings, Less Registration” principle does indicate a more open minded health food registration and filing system.