China Promulgates Interim Administrative Measures for Health Food, FSMP, Drug and Medical Device Advertising

After three rounds of public consultations in 2019, on Dec. 27, 2019, China SAMR unveiled the "Interim Administrative Measures on the Review of Health Food, FSMP, Drug and Medical Devices Advertisements", which will come to effect on Mar. 1, 2020. This regulation clarifies that advertisers are responsible for the authenticity and legality of health foods, FSMP, drug, and medical device advertisements, per requirements specified in "Advertising Law."

Note: "Advertiser" refers to a natural person, legal person, or other organization that designs, produces, and publishes advertisements or an entity that entrusts another party to promote its goods or services.

Advertising requirements for health food

Health food advertisements cannot claim therapeutic/clinical efficacy or utility in the treatment of diseases. The advertised content must be consistent with the information submitted to authorities during registration or filing. Heath food advertisement shall indicate the disclaimer that “health food is not a pharmaceutical drug and cannot replace medicine to treat any disease." Additionally, the health food certification mark should be indicated, as too should the target population and any unsuitable populations.

Advertising requirements for FSMP

The advertising content of FSMP products shall be aligned with the product registration information. Apart from the target population and unsuitable populations, it shall indicate the statement that "please use under the guidance of a doctor or clinical dietician."

Consistent with the requirements specified in "Implementation Rules of Food Safety Law," the advertisement for Specific Full Nutritional Formula Food of FSMP is supervised the same as prescription medicines. FSMPs can only be advertised on professional medical and pharmaceutical journals designated by both the health administrative department and drug supervision department under the State Council. The advertisement of infant formula food for special medical purposes is prohibited.

Advertisement review procedure

The advertisement permission No. has the same validity period as the product registration certificate, filing certificate, or production license document. If the expiration date of product registration/filing is not specified in those documents, the advertisement permission No. will be valid for two years. 

Chronology of the regulation development

2019/03/13 China SAMR Consults on Health Food, FSMP, Drug and Medical Devices Advertising Administrative Measures
2019/06/06 Second Draft of Advertising Measures of Health Food, FSMP, Medicines and Medical Devices under Consultation
2019/10/25 Third Draft of Advertising Measures of Health Food, FSMP, Medicines and Medical Devices under Consultation