Thomas J. Smith

Thomas Smith counsels domestic and international clients on regulatory and compliance matters in food and drug law, with an emphasis on food, food and drug packaging, dietary supplements, and tobacco and e-vapor regulations. He assists clients in obtaining regulatory clearances for a wide range of food additives from the U.S. Food and Drug Administration (FDA) and other comparable international agencies.

Thomas advises companies on establishing self-determined Generally Recognized as Safe (GRAS) positions and 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. He also assists clients in responding to regulatory investigations from state and federal regulatory agencies.

Prior to graduating from law school and joining Keller and Heckman, Thomas was a Regulatory Specialist for several companies in the food industry. He was also a Law Clerk for a Utah-based law firm, where he gained experience with FDA and U.S. Federal Trade Commission (FTC) regulations impacting dietary supplements. Thomas’ undergraduate degree in Food Science and experience working for food manufacturers provided a solid foundation for a career in food and drug law, where he counsels clients on legal and regulatory matters pertaining to all phases of product development, manufacturing, and marketing.

Representative Matters

• Prepared and filed numerous administrative submissions, including FDA Food Contact Notifications (FCNs) and citizen petitions
• Provided counsel and support to clients in establishing compliance with FDA GMP requirements and regulations administered by FDA
• Advised clients on potential recalls, market withdrawals, and potential contamination situations
• Responded to investigative subpoenas related to compliance with state and federal law
• Performed regulatory reviews of food contact materials to assess compliance with FDA, European Union (EU), MERCOSUR, and various other national food contact laws and regulations
• Advised dietary supplement clients on compliance with labeling and advertising laws administered by the FTC and FDA
• Provided counsel regarding compliance with various state and federal laws including the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), National Organic Program (NOP), U.S. state Extended Producer Responsibility (EPR) programs, and state laws regarding per- and polyfluoroalkyl substances (PFAS) in packaging