FDA培训：药品中色素添加剂的法规要求.pdf

FDA Regulation of Color Additives in Drug Products Bhakti Petigara Harp, Ph.D. Office of Cosmetics and Colors Center for Food Safety and Applied Nutrition Food and Drug Administration November 6, 2018 Learning Objectives • Recognize a color additive • Describe color additive petition process • Identify certification exempt color additives • Identify certified color additives • Summarize certification process for color additives • Identify enforcement tools 2 Definition of Color Additive • A color additive is a substance that imparts color to a food, drug, cosmetic, or medical device • FDA has regulatory responsibilities for all of these products when they are marketed in the U.S. • FDA must pre-approve the color additives used in FDA-regulated products 3 Ideal Properties of Color Additives • Non-toxic and no physiological activity • High coloring power so only small quantity needed • Stable – Not light sensitive – Not temperature sensitive – pH stable • Free from taste or odor • Water or oil soluble depending on formulation 4 Types of Color Additives • Dyes and pigments • Inorganic and mineral compounds • Plant and animal sources • Lakes – insoluble pigments formed from water- soluble dyes, precipitants, and substrata • Mixtures – color additives made by mixing multiple color additives and one or more diluents – Diluents facilitate the use of mixtures in products – Listed for drug use under 21 CFR 73.1001