Evangelia (Eve) Pelonis assists clients on U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) matters relating to human food, animal feed, food additives and ingredients, and dietary supplements. She helps clients achieve their marketing goals within the relevant legal frameworks and counsels them in all aspects of food development and marketing, from product formulation and manufacturing considerations to food labeling and advertising.
Eve helps her clients with issues regarding food labeling and promotional materials, product identity statements, ingredient declarations, nutrient content claims, structure function claims, health claims, and allergen, nutrition, bioengineered and organic labeling. Clients seek her advice regarding obtaining appropriate regulatory status for food ingredients including preparing self-determined Generally Recognized as Safe (GRAS) positions or submitting GRAS Notices, New Dietary Ingredient Notifications (NDINs), food additive petitions(FAPs) or color additive petitions (CAPs) to FDA.
Eve guides clients through product recalls and reports to the Reportable Food Registry. She helps clients navigate complex import and export issues regulated by FDA and USDA and assists companies in gaining the release of detained products. She regularly presents on food law matters for various trade associations and food conferences including Keller and Heckman’s Practical Food Law Seminar.
- Assisted clients regarding compliance with Food Safety Modernization Act (FSMA) requirements including hazard analysis and risk-based preventive controls (HARPC) and foreign supplier verification program (FSVP) requirements
- Assisted clients with detailed reviews of substantiation for labeling and advertising claims
- Advised on food safety issues to determine if recalls are necessary and if so how to best communicate recall information to customers, consumers, and the Agency
- Worked with clients to understand how to best position products as conventional foods or dietary supplements
- Worked with clients to obtain removal from FDA Import Alerts to streamline entry of imports and avoid automatic detention at the border
- Advised clients on risk levels associated with various claims and labeling initiatives in light of recent class action lawsuits
- Helped clients respond to FDA Warning Letters
- Negotiated private settlements to threatened litigation over food labeling claims
- Food Drug and Law Institute, Food Advertising Labeling Litigation Conference Committee
- Institute of Food Technologists, Member
- The Best Lawyers in America®: FDA Law, 2021