Xin Tao is a member of Baker McKenzie's North America Steering Committee for Healthcare & Life Sciences, and currently heads our US Food and Drug Law Practice. A former research biochemist, Xin brings a deep understanding of the complex scientific issues that relate to the US FDA's legal and regulatory requirements, enabling him to help clients with all phases of product development, manufacturing, and marketing.
As the science and technology continues to evolve, Xin supports our clients to constantly innovate and push the boundaries of what's possible in the world of life science. Xin is a frequent speaker and writer on US FDA legal developments related to emerging technology, and he has been selected to serve on the 2023 Law360 Life Sciences Editorial Advisory Board.
Xin's practice focuses on empowering global scientific innovation through legal compliance. As a seasoned FDA regulatory counsel, Xin works closely with companies with novel food, cosmetic, and medical device applications that require FDA pre-market review and FDA Current Good Manufacturing Practices (cGMP) compliance.
Xin has extensive experience advising both emerging and established companies on the launching and promoting innovative products such as plant-based proteins, cell-cultured meat, and wearable digital health devices. He has represented many pharmaceutical companies during FDA on-site inspections around the world and helped respond to FDA enforcement actions including Form 483 observations, Warning Letters, and Import Alert.
Xin also has a strong track record in FDA product recall matters, and with a deep understanding of the intricacies involved in navigating the complex and interrelated legal and scientific issues, Xin can creatively and effectively represent companies in these bet-the-company cases.
Born and raised in China, Xin is also well-equipped to assist global companies in adapting to the evolving regulatory regime of China's National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA). Working closely with our China team, Xin also advises pharmaceutical companies on the compliance strategy with the human genetic resource (HGR) regulatory regime in China.
Representative Legal Matters
Xin handled the following matters (*prior to joining the Firm):
Successfully helped a global food company in obtaining FDA's concurrence for conducting a voluntary market withdrawal than a product recall.
Successfully obtained FDA's favorable review of intended uses of novel food additives, generally recognized as safe substances (GRAS), and food contact substances (FCS) in foods and beverages.*
Successfully helped food and pharmaceutical companies delisted from FDA's Import Alert and effectively responded to FDA Form 483 Observations/Warning Letters to avoid further enforcement actions.*
Developed legal strategies in helping consumer products companies and trade associations establish compliance with California's Proposition 65 warning and federal and state laws and regulations involving heavy metals and PFAS.
Successfully helped global life sciences companies in developing response to NMPA (China) enforcement actions to narrow the scope of follow-up actions; developed premarket strategy of new drug products and advised on one of the first drug recalls in China conducted by a global pharmaceutical company.*
- Rising Star, Washington, DC Food and Drug Law, Super Lawyers, 2020-2023
- Law360 Life Sciences Editorial Advisory Board, 2023
- District of Columbia~United States
- Georgetown University Law Center (JD) (2012)
- Texas A&M University (MS) (2009)
- Shanghai Jiao Tong University (BS) (2006)
Co-author. "Assuring the Food Safety of Crops Developed through Breeding," ACS Agricultural Science & Technology, 2022
Co-author, "FDA completes first pre-market consultation for human food made with animal cell culture technology," JD Supra, 21 November 2022
Co-author, "FDA Cites Five Companies for Illegally Selling Delta-8 THC and CBD Products," JD Supra, 18 May 2022
Co-author, " What To Do As PFAS Food Packaging Phaseouts Approach," Law360, 21 January 2022
Speaker, "Intro to Food Law," Food and Drug Law Institute, 21 September 2022