China’s State Administration for Market Regulation (“SAMR”) is seeking public comment on its proposed amendment to the country’s Food Safety Law.  The amendment is intended to include ready-to-drink liquid infant formula in the current regulatory regime for powder infant formula, as part of the implementation of the “Four Strictest” principles for food safety (i.e., the most stringent standards, the most rigorous supervision, the most severe punishment, and the most serious accountability). 

Under the current law, manufacturers and importers of infant formula powder products are required to register the formulas of their products with SAMR.  The registration submission must include a research and development report on the formula, and materials that prove the formula’s safety and “scientific rigor.”  Manufacturers cannot repackage infant formula powder purchased in bulk, nor can they produce powder products for different brands with the same formula.  The current law does not address liquid infant formula products.

The proposed amendment, if enacted, would impose the current requirements for powder infant formula on liquid infant formula.  The explanation that is posted along with the proposed amendment notes that liquid infant formula products currently on the market in China are all imported.  It also notes that, because liquid infant formula needs to have higher quality control procedures for microbial levels, stability, and packaging, it is necessary to institute a regulatory regime that is at least as strict as, or perhaps even stricter than, that for powder products. 

Manufacturers of liquid infant formula products and other stakeholders may submit comments by February 19, 2024.

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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Annie Wang, Kaixin Fan, and Kexin Yang.

Photo of Kaixin Fan Kaixin Fan

Kaixin Fan is an associate in the firm’s London office, where she is a member of the Dispute Resolution Practice Group. Prior to joining the London office, Kaixin was resident in the firm’s San Francisco office, where she was a member of the…

Kaixin Fan is an associate in the firm’s London office, where she is a member of the Dispute Resolution Practice Group. Prior to joining the London office, Kaixin was resident in the firm’s San Francisco office, where she was a member of the Food, Drug, and Device and the Litigation and Investigations Practice Groups. Kaixin also maintains an active pro bono practice.

Photo of John Balzano John Balzano

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with…

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, and implementing product recalls. John also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

John has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.

Photo of Julia Post Julia Post

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act…

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Julia has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

Prior to joining the Food and Drug practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.