Thomas Smith counsels domestic and international clients on regulatory and compliance matters in food and drug law, with an emphasis on food and drug packaging, dietary supplements, and tobacco and e-vapor regulations. He assists clients in obtaining regulatory clearances for food contact materials, food additives, and color 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 with establishing clearances for tobacco products marketed in the United States.

Prior to graduating from law school and joining Keller and Heckman, Thomas was a Regulatory Specialist for several companies in the food and packaging industries. 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.

While in law school, Thomas was a member of the American Agricultural Law Association. As an undergraduate, he was a Teaching Assistant for a course on Food Quality and Regulation and was a Student Trainee with FDA. 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

• Provided counsel and support to clients in establishing compliance with FDA GMP requirements and regulations administered by FDA
• Assisted clients in obtaining letters of no objection from FDA for plastic recycling processes
• 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