The Strictest Regulation on Infant Formula in Chinese History: How does it compare to the U.S.?

On June 6th 2016, the China Food and Drug Administration (CFDA) published the final rule of Administrative Measures for Registration of Recipes for Formula Powder Product for Infants and Young Children (abbreviated as Infant Formula Measures), six months after the draft measures were notified to the World Trade Organization (WTO) for comment. The final rule to register the infant formula in China will come into force on October 1st 2016.1 Compared to the previous infant formula filing system, several significant changes have been added, including the fact that imported infant formulations now fall under the regulation, which will have a huge impact on overseas manufacturers. Infant formula manufacturers who intend to sell their products on the Chinese market will now be required to register with CFDA and provide the agency with sufficient supportive information to demonstrate their capacity to ensure the safety of the final infant formula products. After the final rule is implemented, all infant formula products will have to be approved by CFDA before they can be marketed in China. In this article, we compare and contrast the regulation of infant formula in China versus that in the U.S., and provide insightful information to help manufacturers better understand and comply with the CFDA’s updated policy.

In addition to elaborating on the requirements for labeling and descriptions, the Infant Formula Measures set several specific requirements for infant formula registration.2 The applicant, including the infant formula manufacturer previously allowed to sell products in China, would be required to submit to CFDA a report describing the research and development (R&D) of the product and the manufacturing process, a product testing report, documentation to demonstrate its capacities in R&D, production, and testing, and other materials that support the science and safety of the formula (Table 1). A CFDA authorized panel will then inspect the manufacturing facility, and a government-certified food laboratory would test product samples. Application materials, inspection outcomes, and testing results will be reviewed by an expert panel organized by CFDA. There are proposed timelines for review, including five working days to inform the applicant of acceptance of the application, 20 days for the on-site inspection (no such limit for overseas manufacturers), 30 days for the product inspection report, 60 days for expert review, and 20 days for CFDA to decide whether to approve the application. The domestic manufacturers would expect to receive the conclusion from CFDA in six months if all the materials are appropriately