Xin Tao

Xin Tao

Partner
Baker & McKenzie LLP

Biography

Xin Tao is a partner of Baker McKenzie's North American Food and Drug Practice and is a member of our North American Steering Committee for Healthcare & Life Sciences. A former research biochemist, Xin brings a deep understanding of the complex scientific issues that relate to the U.S. FDA's legal and regulatory requirements, enabling him to help clients with all phases of product development, manufacturing, and marketing. Leveraging his scientific background, he has worked extensively on FDA enforcement actions and consumer class action litigations involving environmental contaminants in foods such as heavy metals, PFAS, and California’s Proposition 65- listed chemicals.

Practice Focus

Xin's practice focuses on novel food, drug and medical device applications that require FDA review and FDA Current Good Manufacturing Practices (cGMP) compliance. Xin has extensive experience advising food technology companies and investors on developing and marketing innovative products including cell-cultured meat, protein derived from microbial fermentation and genetic engineering. Xin has also represented pharmaceutical companies during many FDA cGMP on-site inspections around the globe involving all aspects of cGMP regulations including sterile manufacturing and data integrity. 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).

Representative Legal Matters

Xin handled the following matters (*prior to joining the Firm):

  • 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.*
  • Assisted food and pharmaceutical companies develop effective regulatory compliance strategy when responding to FDA firm 483 observations/warning letters.*
  • 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.
  • Assisted global life sciences companies response to NMPA (China) enforcement actions and advised on premarket strategy of new drug products and drug recalls in China.*
  • Advised various private equity funds, investment banks and global food, drug, and medical device companies in conducting FDA and NMPA regulatory compliance due diligence reviews.

Professional Honors

  • Rising Star, Washington, DC Food and Drug Law, Super Lawyers, 2020-2023

Admissions

  • District of Columbia~United States (2013)

Education

  • Georgetown University Law Center (JD) (2012)
  • Texas A&M University (MS) (2009)
  • Shanghai Jiao Tong University (BS) (2006)

Languages

  • English
  • Mandarin

Publications

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

Presentations

Speaker, "Intro to Food Law," Food and Drug Law Institute, 21 September 2022