Functional Foods, Dietary Ingredients, and Health Claims in the EU & U.S.: Are Regulators Closing the Doors on Innovation?
Session Track: Consumer Lifestyles & Demographics
Date: Wednesday, March 28, 2012; 4:30 – 5:30 p.m.
Functional foods, dietary ingredients, and health claims are of great interest to consumers today. On a global level, government regulatory and enforcement bodies are increasingly scrutinizing the claims made regarding functional foods. The U.S. FDA and FTC have increased their enforcement activities, and private litigation over claims also has escalated in recent years. In the EU, all health claims, whether in advertising or labeling, are required to undergo pre-market scientific review and approval, resulting in a large number of claims being rejected in recent years. This session will cover the regulatory oversight of claims in the U.S. and the EU, and will provide strategies for navigating the regulatory morass around functional ingredients and health claims.
Kathy Musa-Veloso, Ph.D., Associate Director, Intertek Cantox
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).
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.