Functional Foods in a New Era of FDA Enforcement
Thursday, March 25, 2010
9:15 – 10:15 a.m.
- Anthony Pavel, J.D., Attorney, K&L Gates
- Shanon Trueman, M.S., Analyst, Nerac, Inc.
Functional foods continue to be a rapidly growing segment of the consumer food market. The sale of these products must be approached with increased caution, however, because under the new administration, the FDA has sharply increased its enforcement activities. Moreover, the FDA does not specifically recognize functional foods because they straddle several FDA classifications, and can involve numerous regulations. Through practical examples of currently marketed products, you’ll learn about the application of FDA regulations to these foods, as well as applicable advertising law principles. In addition, you’ll gain a firm grasp of FDA’s increased focus on enforcement, and get a better sense of the types of data needed to support health claims for functional foods.
About the Speakers: 
Anthony Pavel is an attorney in the Food and Drug Practice of K&L Gates LLP, providing regulatory counseling to clients on food, drug, cosmetic, and medical device products. His practice focuses on food law, and he has a broad range of experience with issues in food safety compliance related to Hazard Analysis Critical Control Points (HACCP), food security measures under the BioTerrorism Act, and Generally Recognized As Safe (GRAS) self-affirmations and notifications. He also assists clients with novel food and color additive petitions, product claims in labeling, advertising and other promotional material, as well as clinical research and substantiation issues. Mr. Pavel worked for a HACCP consulting business during his undergraduate and legal education.
Shanon Trueman is an analyst at Nerac, Inc., a research and advisory firm for companies developing innovative projects and technologies. She has been with Nerac for more than ten years, and holds a bachelor’s degree in Agronomy from the University of Connecticut, as well as a master’s degree in Microbiology from the University of Massachusetts. Ms. Truenan works on projects involving food science and agriculture, specifically food safety, food production, organic and natural foods, and regulations.