China SAMR Consults on Health Food, FSMP, Drug and Medical Devices Advertising Administrative Measures

On Mar. 13, 2019, China SAMR opened the draft of Administrative Measures for Advertisement of Drug, Medical Devices, Health Food, and Food for Special Medical Purposes (FSMP) to public feedback. The public consultation period will end on Apr. 12, 2019.

Advertising requirements

The draft stipulates that the advertising content is limited to the information certified in product registration/filing certificate and product specification. Apart from the advertisement approval No., following items shall be clearly indicated in health food and FSMP advertisement:

Health food

• health food logo

• suitable and unsuitable consumer groups

• Statement that “this product cannot replace drugs”.

FSMP

• suitable consumer

• statement that “this product is not applicable to non-target groups” and “please use under the guidance of doctor or clinical dietitian”

*All these indications shall be obviously presented in the full advertising video.

Besides, health food, FSMP, drug and medical devices advertisements cannot use the following methods:

• Use endorsements or recommendations from influencers, KOLs or famous people

• Use the name of medical research unit, academic institution, industry association, medical institutions, experts, doctors or patients.

• Use the name of army units or military personnel

• Promote the products in the form of news report or program introducing health maintenance knowledge and medical service.

• Other cases that are prohibited by relevant laws and regulations.

The specific complete nutrition formula is regulated as prescription drugs in terms of advertising, and their advertisements could only be published on medical and pharmaceutical journals designated by both health administration and drug regulatory agency under the State Council. Additionally, the advertisement of FSMP products targeted at infants of 0 to 12 months old is prohibited.

Advertisement review procedure

The advertisement applicant must be a health food or FSMP registrant, and they shall bear the responsibility of content authenticity. The overseas advertisement applicants can submit the application through its representative institution in China or the local advertisement examination organization of the entrusted agency in China.

The advertisement approval No. remains valid for 1 year.

Please click here to download Administrative Measures for Advertisement of Drug, Medical Devices, Health Food, and Food for Special Medical Purposes (draft)