Nicholas Prust advises domestic and foreign clients on regulatory requirements for food, dietary supplements, pharmaceuticals, and food and drug packaging under federal, state, and foreign laws and regulations. In the food regulatory area, Nicholas works with clients to meet their needs and establish an appropriate regulatory status for their product or process in the most efficient way possible, e.g., through the filing of a Generally Recognized as Safe (GRAS) notification or Food Contact Notification (FCN), a Keller and Heckman opinion letter, or a letter of no objection.
Nicholas also has experience in counseling clients on anticipating and responding to enforcement actions, including Proposition 65 matters and Food and Drug Administration (FDA) Warning Letters. Nicholas has counseled clients on a variety of other issues, such as import and export issues, and all manner of marketing and labeling claims, including nutrition labeling, labeling under the National Organic Program, and both mandatory and voluntary bioengineered (BE) food disclosures.
Prior to joining Keller and Heckman, Nicholas was an associate in private practice, focusing on corporate litigation. As a corporate litigator, Nicholas worked primarily with clients to defend against shareholder derivative claims and breach of contract claims in the Delaware Court of Chancery. Nicholas has also worked on the plaintiff side and assisted clients in filing similar claims. Additionally, he has worked on cases in front of the U.S. District Court of Delaware and the Delaware Family Court, including pro bono work on a child custody case. Nicholas’ litigation background assists him as he analyzes and advises clients on the litigation risks that they may face.
While in law school, Nicholas served as a senior staff editor on Georgetown’s The Food and Drug Law Journal. He was also a member of the Center for Applied Legal Studies, where he successfully obtained asylum for an Afghan refugee. Additionally, he interned for the Department of Homeland Security and was a summer law clerk for the Department of Justice. As an undergraduate student, Nicholas received an Honors Bachelor of Science in Pre-Veterinary Medicine and Animal Biosciences and was a summer research intern at the National Institutes of Health, where he studied opportunistic pathogens associated with HIV. His varied legal background and his scientific training help him to counsel clients on a variety of complex matters, which often involve scientific issues.
(Admitted to practice in Delaware only. Practice limited to matters before the FDA and matters ancillary thereto.)
- Reviewed food labeling and marketing materials to assess regulatory compliance under FDA and USDA standards and counsel client on risk levels where alternative approaches are available
- Assisted client in obtaining Keller and Heckman opinion letter regarding suitable regulatory status of food additives
- Assisted client in filing GRAS and FCN submissions for food additives whose intended uses are not cleared under existing regulations
- Assisted client in obtaining an FDA letter of no objection for their recycling process