Functional Foods: US and EU Regulatory and Enforcement Update
Session Track: Health Issues
Date: Wednesday, March 23, 2011, 3:15 p.m. -4:15 p.m.
"Functional" foods continue to be a rapidly growing segment of the consumer food market. On a global level, government regulatory and enforcement bodies are increasingly scrutinizing the claims made in relationship to functional foods. The United States Food and Drug Administration (FDA) and Federal Trade Commission (FTC) have sharply increased their enforcement activities, and private litigation over claims has also escalated in recent years. In the European Union (EU), all health claims, whether made in advertising or labeling, are required to undergo pre-market scientific review and approval, with a large number of claims being rejected in the past year. Examples of currently marketed products in the U.S. and the EU will illustrate the application of pertinent regulations and advertising laws. This session will cover the regulatory oversight of claims in the U.S. and the EU, as well as the expectations for their scientific substantiation.
Anthony Pavel, J.D., Partner, K&L Gates
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 centers 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, Good Manufacturing Practices (GMPs), 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; clinical research and substantiation issues; and regulatory strategies for functional foods and dietary supplements. He is the current Chair of the IFT’s Food Laws and Regulations Division. During Mr. Pavel's undergraduate and legal studies, he worked for a HACCP consulting business.
Kathy Musa-Veloso, Ph.D., Associate Director, Cantox Health Sciences International
Dr. Musa-Veloso, an Associate Director within the Food & Nutrition Group, assists both domestic and international clients with the preparation of regulatory strategies for food additives, foods that are generally recognized as safe (GRAS), novel foods, and natural health products/ dietary supplements. Since joining Cantox in 2003, she additionally conducts expert scientific reviews of clinical and pre-clinical data for those clients interested in health claims. This data is used in support of either a health claim or a structure-function claim (United States) or a product-specific claim (Canada). Dr. Musa-Veloso is also involved in the preparation and review of clinical study protocols, and in pre-qualifying clinical research facilities prior to the placement of clinical studies with a Contract Research Organization (CRO). To further facilitate her clients’ requirements, she performs on-going support of clinical studies, including clinical trial monitoring and auditing, ensuring compliance to Good Clinical Practice (GCP) and adherence to study protocols. With her strong food and nutrition background, Dr. Musa-Veloso has authored several publications and presented at various national and international conferences. Having completed a combined Honours B.Sc. degree in Kinesiology and Health Science at York University, Dr. Musa-Veloso went on to receive her M.Sc. and Ph.D. from the Department of Nutritional Sciences at the University of Toronto.