In order to further standardize the substitution of health food-related excipients and clarify related work requirements, a few days ago, the SFDA issued a notice reaffirming the requirements for alternative food replacement of health food products.

The notice emphasized that the applicant should stop production and sales of related products within the time stipulated by the SFDA. At the same time, the applicant may apply for replacement of other related materials or apply for removal of relevant auxiliary materials. Replacement or removal of excipients should have no impact on product quality and safety, and comply with relevant standards for health food products. The applicant should provide an application form for the change of health food, and refer to the “Notice on Substitution of Supplementary Materials Containing Phthalate Esters” to provide relevant information.

The notification requires that food and drug supervision and administration departments at all levels should strengthen supervision and discover that enterprises that have not stopped the production and sales of related products within the prescribed time limit should be handled according to law and report the relevant information to the SFDA. After further verification, SFDA cancels the relevant product approval number and announces it.

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