Recently, Abbott was fined RMB1,948,071,151,000 for violating the advertising law, and was ordered to stop publishing the involved advertisement and eliminate its influence within the corresponding scope.

The involved advertisement is an advertisement video of Abbott’s food for special medical purposes (FSMP) product, PediaSure.

According to Article 46 of the Advertising Law, the release of medical, drugs, medical devices, pesticides, veterinary drugs and health food advertisements, as well as other advertisements that should be reviewed as stipulated by laws and administrative regulations, shall be reviewed by the relevant departments before release; without review, shall not be released.

According to the Interim Measures for the Examination and Administration of Advertisements for Medicines, Medical Devices, Health Food and Food for Special Medical Purposes, advertisements for FSMP shall not be published without examination.

However, Abbott did not report to advertisement review organization for examine, which is an unreviewed advertisement.

The Interim Measures for the Examination and Administration of Advertisements for Medicines, Medical Devices, Health Food and Formula Food for Special Medical Purposes was officially promulgated on December 27, 2019, and it came into effect on March 1, 2020. The Measures indicates a lot of strict requirements to the advertisements of FSMP. The details are as follows:

The contents of advertisements of FSMP shall be mainly registered and recorded certificates or product labels and instructions, and the corresponding contents in advertisements shall not exceed the sources mentioned above.

The approval number of the advertisement should be clearly marked in the advertisement.

Advertisement of FSMP shall clearly indicate the applicable population, ‘not applicable to non-target population’ and ‘please use under the guidance of doctors or clinical nutritionists’.

The font and color of the content that should be prominently displayed in advertisements should be clearly visible and legible, and should be displayed continuously in video advertisements.

Advertisements of FSMP shall not violate the provisions of article 9, article 16, article 17, article 18 and article 19 of the Advertising Laws. It shall not include using the name or image of scientific research institutions, academic institutions, trade associations or experts, scholars, physicians, pharmacists, clinical nutritionists or patients for recommendation or certification; Contains ‘safe’, ‘safe and non-toxic side effects’ and ‘little toxic side effects’; The express or implied ingredient is ‘natural’ and therefore has a guarantee of safety and so on within other eight cases. That ‘Safe’, ‘natural’ and other words included in the banned list may have a certain impact on the advertising of ordinary food. Companies should use these terms carefully to avoid unnecessary regulatory enforcement and consumer claims.

The period of validity of the approval document for the advertisement of FSMP shall be the same as the shortest period of validity of the product registration certificate, record certificate or production license document. If the validity period is not specified in the above documents, the validity period of the advertising approval number is two years.

Advertisements of FSMP shall not be edited, spliced or modified. If the contents of an advertisement which have been examined and approved need to be modified, a new application for examination of the advertisement shall be filed.

Advertisements of certain whole-nutrition FSMP can only be published in medical and pharmaceutical journals jointly designated by the health administration department under the state council and the drug regulatory department. It is not allowed to use its name as the name of various activities for advertising. It is also not allowed to use trademark or enterprise name with the same name be used for advertising or activity naming in disguise.

Advertisements of infant formula food for special medical purposes should not be published in the mass media or public places.

More details about advertisements of FSMP please click Administration of Advertisements for Health Food and FSMP Issued.