Benjamin E. James
Benjamin (Ben) James counsels domestic and international clients on regulatory and compliance matters in food and drug law, with an emphasis on food packaging, food manufacturing, and recycling. He assists clients in obtaining regulatory clearances for food-contact materials from the U.S. Food and Drug Administration (FDA) and other comparable international agencies.
Ben prepares legal opinion letters regarding the FDA status of food packaging components, such as monomers, polymers, adhesives, printing inks, and color additives, and advises clients on establishing self-determined Generally Recognized as Safe (GRAS) positions. In the area of sustainability, Ben advises clients on regulatory requirements applicable to recycling processes and recycled materials intended for use in food-contact applications. He also counsels clients on good manufacturing practice (GMP) issues and helps clients comply with state and local laws regarding food packaging, food service, and environmental responsibility.
Prior to joining Keller and Heckman as an attorney, Ben was a Legal Intern for the Office of the County Attorney, Montgomery County, MD, and a Fellow for The American Constitution Society for Law and Policy. While in law school, Ben was President of the Student Chapter of the American Constitution Society and a Senior Staff Member of the American University International Law Review. He also worked for Keller and Heckman as a summer associate and a law clerk, during which time he conducted regulatory research, drafted proposed legislation on environmental marketing claims, and tracked state and local laws for clients.
- Assisted clients in preparing and submitting Food Contact Notifications (FCNs) to FDA to obtain regulatory clearances for food-contact substances
- Prepared legal opinion letters and submissions to FDA establishing the capability of their recycling processes to produce post-consumer recycled material that is suitable for food-contact use
- Provided guidance and developed comments on new legislation and policies affecting food-contact materials and recycling in the United States and European Union
- Reviewed clients’ food labeling and promotional materials and provided advice regarding environmental marketing claims