Xin Tao

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 pharmaceutical, medical device, food, and cosmetic applications that require FDA pre-market approval or clearance 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 cell therapy, software as a medical device (SaMD), cell-cultured meat, and AI-empowered digital health devices. He has represented many life science companies during US 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.

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

• Successfully helped a global pharmaceutical company in resolving FDA Warning Letter for drug cGMP violations and delisting from Import Alert.*

• Successfully helped a global food and beverage 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.*

• 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