Diane B. McColl
Diane B. McColl works with chemical and ingredient supplies companies, providing counsel on the regulation of their products in foods, dietary supplements, food contact articles, medical devices, cosmetics, and pharmaceuticals. She has advised clients on FDA and USDA regulatory issues for 30 years, helping manage products throughout their lifecycle. Ms. McColl's scientific and technical background 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 drugs and feeds, and 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 serves on the Food Ingredient Expert Committee of United States Pharmacopoeia (USP), and past President of the International Society for Regulatory Toxicology and Pharmacy (ISRTP). Since 2010, Chambers USA has recognized Ms. McColl each year on its list of attorneys for "Food & Beverage: Litigation & Regulatory." In addition, she received a peer review rating of "AV Preeminent" by Martindale-Hubbell.
Foods and Dietary Supplements
• Helps clients develop lifecycle strategies for FDA-regulated products; specifically, GRAS food ingredients, medical foods and dietary supplements, food and color additives, and food contact substances.
• Provides guidance on FSMA and FDA's interpretation and implementation of its statutory and regulatory requirements.
• Helps clients prepare for and respond to FDA inspections, addressing health hazard evaluations, recalls, and reportable food registry reports.
• Provides crisis management counsel, responding to allegations of safety concerns, questionable data, and lack of scientific grounds.
Human and Animal Foods
• Assists with the development of USDA-regulated products, including those ingredients intended for use in meats, poultry, and organic products.
• Helps clients establish AAFCO Official Definitions for the use of new ingredients in animal feed and pet foods.
• Provides counsel on submission categories for food and feed ingredients, including GRN, NDIN, AGRN, and food additive petitions.
• Advises on FCNs and requests for Threshold of Regulation (TOR) exemptions.
OTC Drugs and Cosmetics
• Assists with regulatory strategies to introduce and market ingredients for OTC drugs and cosmetics, advising clients on the use of color additives in cosmetics, and on safe and suitable excipients in OTC drugs.
Food Ingredient Expert Committee, USP
Past President, ISRTP
Professional Member, Institute of Food Technology (IFT)
Longest standing non-European member, European Food Law Association (EFLA)
Pharmacy Law Association
Awards & Recognition
Chambers and Partners, Nationwide: Leaders in their Field - Food and Beverages: Regulatory & Litigation, 2013
Chambers & Partners, Nationwide, Band 3, 2012
• The International Who's Who of Business Lawyers (Life Sciences), 2016
Articles / Publications
see more articles
• USP Recognizes Work of Food Ingredients Expert Committee,
• FDA'S Implementation of FDAAA'S Food-Related Provisions: A Work in Progress,
• Surprise!...That Food Is Now a Drug,
• FDAAA § 912 - A Fundamental Shift in the Dividing Line Between Foods and Drugs,
• Nutrition Labeling - A Look at FDA's Proposed Requirements,
see more speaking engagements
• EFLA EU-US Food Law Conference 2017, September 28, 2017
• GMA Webinar Series, PHO Compliance: An Update Webinar, June 20, 2017
• GRAS Final Rule Webinar, September 15, 2016
• National Restaurant Association’s Nutrition Executive Study Group Annual Meeting, DBM 3/16: PHO: GRAS list removal and its impact on the restaurant industry, March 16-17, 2016
• Food Law for In-House Counsel and Regulatory Professionals, Diane McColl 10/7 Speech TBD, October 7, 2015
• FDA Files GMA Petition for Partially Hydrogenated Oils,
November 2, 2015