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 strong understanding of life sciences, Xin Tao works closely with clients in the food and drug industries to navigate the evolving regulatory environments and develop innovative strategies to commercialize products made with emerging technologies both in the U.S. and China.

Xin’s previous work experience as a research biochemist informs his science-based food and drug law practices. His unique ability in understanding and interpreting the complex scientific issues as they relate to the governing legal and regulatory requirements helps clients with all phases of product development, manufacturing, and marketing. His practice focuses on novel food and drug applications that require U.S. Food and Drug Administration (FDA) review and FDA current good manufacturing practice (cGMP) compliance for foods, dietary supplements, and pharmaceuticals.  Born and raised in China, Xin is well-equipped to assist global companies to adapt to China’s National Medical Products Administration’s (NMPA, formerly known as China Food and Drug Administration or CFDA) ever-changing regulatory regime.  Xin is increasingly expanding his knowledge of California’s Proposition 65 (Prop 65) as it pertains to his clients.

Xin is actively involved in a number of organizations that serve Chinese legal and life sciences professionals in the Washington, D.C. region, including the Sino-American Pharmaceutical Professionals Association and the Washington, D.C. Chinese Legal Association. Xin is a frequent speaker and contributor to industry publications in both the United States and China.

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