Cathie Chen counsels clients on domestic and global regulatory and compliance requirements related to food additives, food packaging materials, drug and medical device packaging, pharmaceuticals, and cosmetics. She assists companies in obtaining regulatory clearances for food contact materials in the United States (U.S.) and international jurisdictions, including China, Japan, Thailand, and the European Union (EU).
Cathie prepares regulatory submissions and legal opinions regarding the status of packaging components (e.g., printing inks, adhesives, polymer components, and color additives). With an undergraduate degree in International Health, she is well-versed in various global requirements for establishing the safety of chemical substances. Cathie also advises clients on good manufacturing practice (GMP) matters related to the manufacture of food and drug packaging and on recycled materials intended for use in food contact applications.
While attending George Washington University Law School, Cathie served as Senior Managing Editor of the Public Contract Law Journal. She also helped develop the health law initiative as a Fellow in the Kahan Health/FDA Law Fellowship, and mentored law students interested in health and FDA law as President of the Student Health Law Association. In 2021, she won 1st Place in the University of Maryland’s Health Law Regulatory & Compliance Competition, highlighting her passion for helping clients navigate a complex regulatory landscape. Cathie previously served as a Legal Intern in the Office for Civil Rights, U.S. Department of Health and Human Services; a Judicial Intern for the Honorable Jonathan Biran, Court of Appeals of Maryland; and a Judicial Intern for the Honorable Jason Park, Superior Court of the District of Columbia.
(Admitted to practice in Maryland only. Practice limited to matters before the FDA and matters ancillary thereto.)
- Counseled and supported Food Contact Notifications (FCNs) for new food contact substances
- Assisted clients in securing no objection letters for plastic recycling processes
- Performed legal analysis of legislation and policy to assist multinational companies in assessing compliance with food contact laws and regulations in the EU, China, and Japan
- Asian Pacific American Bar Association of the Greater Washington, DC Area (APABA-DC)