China’s State Administration for Market Regulation (“SAMR”) recently issued Measures for the Administration of Lists of Serious Illegal and Dishonest Acts (the “Measures”). These Measures, which took effect on September 1, 2021,[1] were promulgated to standardize the management of lists maintained by market regulation authorities of parties that have committed serious violations of law in the areas of food safety, drugs, medical devices, and cosmetics, among others.

With respect to food safety, the Measures lay out a number of serious unlawful acts that could cause a party to be included in publicized lists on the National Enterprise Credit Information Publicity System. Such illegal acts include:

  • engaging in food production or distribution activities without obtaining a food production and operation permit;
  • producing food using non-food grade raw materials;
  • adding chemical substances, other than food additives, or other substances to food that may harm human health;
  • producing food designed specifically for infants, young children, or other specific populations with nutritional ingredients that do not conform to food safety standards;
  • producing health foods, formula foods for special medical purposes, or infant formula that have not been registered in accordance with regulations, or that have not been manufactured in accordance with the technical requirements of registered product formulas and production processes;
  • producing or distributing food or food additives containing pathogenic micro-organisms, residues of pesticides, veterinary medicines, biotoxin, heavy metals, or pollutants and other substances harmful to human health that exceed the limits set out in food safety standards;
  • other illegal acts that violate food safety laws and administrative regulations that seriously endanger the health and safety of human health and life.

Parties included in such lists are subject to severe administrative penalties, including heavy fines, revocation of permits (e.g., product and facility licenses) and business licenses, and suspension or closure of businesses.

The Measures also include provisions for notification of parties and hearing and objection procedures, as well as procedures for application for administrative reconsideration and removal from the lists.

For further information or inquiries relating to this post, please email APACRegBlog@cov.com.

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

John Balzano, Julia Post, Muyun Hu, and Kaixin Fan

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[1] Available at http://gkml.samr.gov.cn/nsjg/fgs/202108/t20210801_333255.html.

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.

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Photo of Julia Post Julia Post

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development…

Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development matters, including informed consent requirements, biospecimen procurement and research use, and other good clinical practice. She advises clients regularly on product life-cycle management issues, including patent linkage frameworks and marketing exclusivity in the U.S. and China.

Julia works with pharmaceutical, medical device, food, and cosmetics clients on complex regulatory compliance matters and helps them develop their advocacy strategies before U.S. and China regulators, at both national and local levels. She regularly assists companies and trade associations on policy issues, including the development and submission of comments on legislative and regulatory proposals. Julia works closely with local counsel throughout the Asia-Pacific region to assist clients with their marketing approval and compliance strategies.

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

Julia has an active pro bono practice at Covington, with a particular focus on reproductive justice matters and representation of third-party caregivers and children in custody cases.

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