Navigating the Regulatory Landscape for Protein Claims
Session Track: Protein Enhancement: Labeling & Regulatory Considerations
Session Date: Friday, March 21, 2014; 9:00 - 10:00 a.m.
As more high protein foods enter the marketplace and companies look to leverage the latest research findings on the benefits of high protein diets, there are a number of regulatory considerations to navigate to minimize the regulatory risk in product label and advertising claims. This session will present the food-related regulatory authorities to which protein claims are subject, review the substantiation requirements for protein claims in advertising, and examine some regulatory actions against companies for protein claims. Finally, with a renewed focus by FDA and FTC on weight loss claims, this session will examine the potential impact of the agencies’ joint initiative on protein-enhanced products.
Julie Tibbets, Alston + Bird, LLP
Julie Tibbets is a partner in the firm's Food, Drug & Device/FDA Group. Julie focuses her practice on assessing regulatory advantages and risks and advising clients on compliance with various laws and regulations, including those administered by FDA, DEA, FTC, USDA and related state authorities. She counsels manufacturers and distributors of FDA-regulated products, including drugs, biologics, medical devices, in vitro diagnostics, foods, dietary supplements and cosmetics in addition to counseling marketers of these products and health care providers. Her areas of expertise include advising clients on: product labeling, advertising, marketing claims and employee training materials; company interactions with health care professionals; continuing medical education programs; Sunshine Act compliance; product recall strategies; adverse event reporting; product formulations/ingredients; the resolution of establishment inspection deficiencies; and controlled substance diversion/loss reporting. Julie has been selected by Super Lawyers as a 2013 Washington, D.C. “Rising Star.”