U.S. exporters of dairy products to China are subject to importing country listing requirements for manufacturers or processors as a precondition of market access.  Recently, the U.S. Food and Drug Administration (FDA) has signed a Memorandum of Understanding (MOU) with the Certification and Accreditation Administration of the People’s Republic of China (CNCA), formally establishing a registration process for U.S. food manufacturers who export certain foods to China.  FDA also issued guidance for industry on how to establish and maintain a list of U.S. milk and milk products, infant formula, and formulas for young children manufacturers or processors.

In this post we summarize the key legal requirements for exporting dairy products to China.

Read more.

Partner Roy Zou and Senior Associate Jessie Xie from our Beijing office contributed to this post. 

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Photo of Joe Levitt Joe Levitt

Partner, Washington, DC

As the FDA’s former top food regulator, Joe Levitt brings a true insider’s knowledge to helping food industry clients deal effectively with the FDA. Whether influencing policy making or confronting a threatened compliance action, Joe’s 25 years of FDA experience puts clients in the best position to succeed.  In the private sector, Joe was on the ground floor when Congress developed the landmark FDA Food Safety Modernization Act (FSMA). Joe was also a leading voice for the food industry when the FDA developed regulations that all food companies must now follow. No one can help navigate the labyrinth of FDA’s FSMA regulations better than Joe and his team, and no one can better put your company in the driver’s seat when the FDA inspector knocks on your door for your first FSMA inspection.

Joe adeptly handles high visibility recalls and compliance actions. If a company finds itself in trouble with the FDA, they need someone with a deep insider’s understanding of what works and what doesn’t. Joe knows what the agency expects in the compliance arena, and the bar clients will be expected to meet. He can communicate his client’s position calmly and effectively to the FDA so the matter gets put behind them. His record of “helping startups and multinational companies… survive Food and Drug Administration investigations and avoid import bans that could shutter the companies,” led to Joe being named a Law360 Food & Beverage MVP (2016).

Joe is among the most decorated officials in FDA history, with his achievements being recognized by multiple U.S. presidents, cabinet secretaries, and FDA Commissioners. He maintains close working relationships with senior FDA officials and has served as the Board Chair of the FDA Alumni Association.

Photo of Xin Tao Xin Tao

Senior Associate, Washington, DC

With a working knowledge of regulatory requirements and a strong understanding of life science, Xin Tao works closely with clients in the food and drug industry to navigate the evolving federal and state regulatory environments and develop innovative regulatory strategies to commercialize products made with emerging technologies.  Xin’s background in life science (biochemistry and biophysics) assists him in his science-based food and drug law practices. Xin advises clients on food and drug law with a particular focus on novel food and dietary ingredients, biotechnology, FDA cGMP compliance, ingredient labeling, and California’s Proposition 65.  Xin’s unique ability in understanding and interpreting the complex scientific issues as they relate to the governing regulatory requirements helps clients with all phases of the product development, manufacturing, and marketing.  He is also increasingly expanding his expertise of USDA’s organic regulatory regime as it pertains to his clients.

Xin has helped numerous food, dietary supplement, and pharmaceutical companies evaluate the need for marketing approval from the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA). He also pursues clearance or pre-market approval (e.g., food additive petition, GRAS notice, NDI notification) when necessary and responds to FDA enforcement activities including Warning Letters and Import Alerts. Xin has advised numerous companies on issues relating to the advertising and promoting of products including the Federal Trade Commission (FTC)’s claim substantiation standards . Xin also has vast experience with FDA and USDA due diligence investigations for companies subject to takeover or merger activity.

Xin is very actively involved in a number of organizations that serve Chinese legal and life science professionals in the Washington region, including the Sino-American Pharmaceutical Professionals Association and Washington DC Chinese Legal Association.  Xin is a frequent speaker and contributor to industry publications both in the U.S. and China.  He is adept at assisting both Chinese food and drug companies doing business in the U.S. and U.S. clients doing business in China.

During law school, Xin worked as a regulatory food scientist and also served as an executive editor of the Georgetown Environmental Law Review.