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.
Areas of Focus
Obtained FDA and FSIS authorization for a novel food contact substance used for collecting and removing gases and liquid impurities during the meat aging process.
Helped companies respond effectively and on time to Form FDA 483 observations and Warning Letters challenging the manufacturing and labeling practices.
Developed legal strategies in helping companies establishing compliance with Proposition 65 warning for BPA.
Developed legal and scientific support for the advertising of novel food and dietary supplement products under FTC's claim substantiation standards.
Excellent Service Award
Sino-American Pharmaceutical Association
Latest thinking and events
Hogan Lovells Events
October 31, 2016: Beijing
November 3, 2016: Shanghai
Sponsorships and Speaking Engagements
17 September 2016