Health Foods & Supplements

On 14.02.2019, the MOFCOM suspended the filing and administrative approval of direct selling companies due to unreasonable promises with regards to health foods. In collaboration with the SAMR, MOFCOM is overhauling the health food market in China by optimizing the direct sales regulatory system.

On 28.03.2019, the SAMR (State Administration for Market Regulation) released three major adjustments to health food function claims, which are open to public comments. First, 18 health function claims are being modified because they are deemed imprecise, misleading or exaggerated. For instance, SAMR suggests to replace 减肥 (Fat reduction) with 有助于调节体脂 (Bodyfat Adjustment Support). Second, 21 existing health food function claims might be cancelled. Even though they were considered acceptable in the past, they will not gain approval when reviewed now. For example 促进头发生长 (Promotes hair growth). Third, 6 health care function claims will have to be further studied and proven, as they are easily confused with drug-like disease prevention or treatment. For example 辅助降血压 (Helps Lower Blood Pressure).

On 20.08.2019, the SAMR (State Administration for Market Regulation) announced that the health food regulatory framework will significantly change (No. 13-2019). Companies and individuals will be able to propose to the SAMR to add ingredients to the directory of health food raw materials and to increase the list of approved functional claims. These measures will take effect on 01.10.2019. The procedure under the old regulatory framework led to stagnation and did not produce major changes to the list of approved functional claims or health food raw materials.As reported before, on 28.03.2019, the SAMR had requested public feedback on three major adjustments to health food function claims. The proposed modification of 18, cancellation of 21 and analysis of 6 health function claims.

From October 25^th to November 1^st, China SAMR publicly solicited opinions upon its release of the third draft on the measures of advertising review management for health food, FSMP, drug products and medical devices.SAMR had been open to public feedback from March 13^th to April 13^th and June 6^th to June 26^th followed by adjustments made to the first and second draft.As revealed in the previous announcement and drafts, SAMR aims to formulate a major regulatory reference in future by requiring compliance for advertising health food, FSMP, drug products and medical devices including, but not limited to, the following conditions:Content (e.g. name, application scope, composition):

• Must match the details in NMPA registration documents, certificate and IFU
• Must be legal and truthful
• Must not mislead or deceive users

Disclaimers necessary:

• Personal use devices:g. ‘Please read the instructions before using the device’ or ‘Please seek the advice of a healthcare professional when buying and using this device’
• If safety instructions & precautions are mentioned in NMPA certificate, they must be displayed clearly in the advertisement

e.g. ‘Please read carefully the precautions before using the device’Approval number of the advertisement:

• Must be clearly indicated in the advertisement

For further information on the above topic, please contact us.