SAMR Issued the Draft on Adjusting the Health Function of Health Food

In order to strengthen the management of health function claim, SAMR issued a draft on ‘adjusting the health function of health food’ for public comment on 28 March 2019. Opinions and advices shall be given before 28 April 2019.

1. Health functions proposed to be adjusted

I. Please refer to table 1 for the health functions proposed to be adjusted.

II. After the health functions are officially adjusted, the function expression on the labels and instructions can be modified directly without applying for registration change. The listed products can be sold until the expiration of the shelf life. For products in the process of review, the review body will directly adjust their functions so that the applicants do not need to make corrections by themselves.

Table 1 Health functions proposed to be adjusted

2. Health functions proposed to be cancelled

I. Please refer to table 2 and table 3 for the health functions proposed to be cancelled.

II. When the following health functions are officially cancelled, the production of relevant products shall be immediately stopped. The health food which was already produced, can be sold until the end of the shelf life if they do not involve quality and safety problems. Furthermore, SAMR shall no longer accept the application of these health functions.

Table 2 Existing health functions proposed to be cancelled

Table 3 Health functions which were approved in the past but no longer accepted currently and proposed to be cancelled (Include but not limited to the following functions)

3. Health functions need to be further studied

Please refer to table 4 for the health functions need to be further studied.

Table 4 Health functions need to be further studied

CIRS comments

SAMR pays more and more attention to the publicity of health food. We think it is very likely that Chinese authority will not change the final decision on the functions listed in table 1, 2 and 3. In addition, please note that once the functions listed in table 2 and table 3 are formally cancelled, all the registration certificates with such functions will be invalid, which means that the enterprises cannot produce or sell the health food again on Chinese market, even the products had been approved before.

Table 4 includes several common functions, such as assisting blood lipids reduction, assisting blood sugar reduction and assisting blood pressure reduction, etc. The main reason for why these functions are listed to be further studied is that, they are similar to disease treatment, and it is easy to make false propaganda. Therefore, before being officially announced, enterprises preparing new products are advised to avoid the application of the functions listed in table 4.

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Reference:

SAMR news