Expertise in all things FDA
Menu
Expertise in all things FDA
Overview
Diane Barber McColl works with chemical and ingredient supplier companies, providing counsel on the regulation of their products and biomaterials intended for use in human foods, medical foods, dietary supplements, food contact articles, animal foods, medical devices, cosmetics, and pharmaceuticals. She has advised clients on FDA and USDA regulatory issues for over 30 years, helping manage products throughout their lifecycle. Ms. McColl’s scientific and technical knowledge gained from her former career as a pharmacist enhances her work with research and development teams. In particular, she is an expert on issues related to the development of new food ingredients. Because of her extensive industry knowledge of foods, dietary supplements, animal foods, OTC drugs and cosmetics, Ms. McColl often conducts due diligence for mergers and acquisitions.
Ms. McColl provides guidance on U.S. aspects of global regulatory strategies for novel food ingredients, including sweeteners, functional ingredients, processing aids, color additives, fermenting agents, and flavor modifiers. She also helps clients evaluate, develop, and defend product labeling and advertising, reviewing health and “structure/function” claims.
Ms. McColl joined Hyman, Phelps & McNamara in 1989, and today is one of the food and chemical industry’s foremost experts on FDA and USDA regulatory issues. She served on the Food Ingredient Expert Committee of United States Pharmacopoeia (USP) from 2010-2020. Ms. McColl also served as President of the International Society for Regulatory Toxicology and Pharmacology (ISRTP). Ms. McColl is currently a member of the ISRTP Council. Since 2010, Chambers USA has recognized Ms. McColl each year on its list of attorneys for “Food & Beverage: Litigation & Regulatory.” In addition, she has repeatedly received the “Highest Possible Rating in Both Legal Ability and Ethical Standards” awarded by Martindale-Hubbell.