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.
- Rising Star, Washington, DC Food and Drug Law, Super Lawyers, 2020-2023
- District of Columbia~United States (2013)
- Georgetown University Law Center (JD) (2012)
- Texas A&M University (MS) (2009)
- Shanghai Jiao Tong University (BS) (2006)
Publications and Presentations
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