PHO Compliance: An Update Webinar

FACULTY

Diane B. McColl
Director
Hyman, Phelps & McNamara, P.C.

Diane B. McColl is a principal at Hyman, Phelps & McNamara P.C., a law firm that specializes in the regulation of foods, drugs, medical devices and cosmetics. She received a B.S. in Pharmacy cum laude from the University of South Carolina in 1976. Ms. McColl practiced pharmacy in Tennessee and South Carolina until 1984, when she earned a law degree from the University of Carolina. Ms. McColl was a member of the Order of Wig and Robe and associate editor-in-chief of the South Carolina Law Review. She joined Hyman, Phelps & McNamara in 1989. Ms. McColl is admitted to the bars of Texas and the District of Columbia. Ms. McColl is a member of the USP Food Ingredient Expert Committee since 2010. She is a past President and current member of the International Society of Regulatory Toxicology and Pharmacology.

In 30 years of legal practice, Ms. McColl has advised ingredient suppliers, manufacturers and marketers of conventional foods, medical foods, dietary supplements, food and color additives, and new food ingredients on compliance with the regulatory requirements for these products and their components. She has helped develop global regulatory strategies for numerous novel food ingredients. She also has assisted with the preparation of food additive petitions, notifications for “generally recognized as safe” (GRAS) food ingredients, notifications for new dietary ingredients for dietary supplements, and requests for “threshold of regulation” exemptions for substances used in productions of food packaging materials. In addition, Ms. McColl has assisted in evaluating, developing, and defending the labeling and advertising materials for such products, and provided guidance on issues such as health claims, nutrient content claims, nutrition labeling, and “structure/functions” claims.