Avoiding Product Adulteration- The Importance of FDA-Certified Color Additives

The FDA Color Certification process ensures that color additives used in foods, drugs, cosmetics, and medical devices meet safety and quality standards under the Federal Food, Drug, and Cosmetic Act. Certified additives must display the manufacturer’s name, the official FDA-recognized color additive name, the certification lot number, and any usage restrictions. Using uncertified versions of regulated color additives is illegal and can result in product adulteration. The certification process is essential for protecting public health and maintaining compliance with regulatory requirements.
The FDA’s latest update, as of March 10, 2025, lists certified manufacturers from the United States (e.g., Sensient Colors LLC, Roha USA LLC, DSM Biomedical, Sun Chemical MI) and international locations (e.g., Ajanta Chemical Industries in India, Heubach Colorants Germany GmbH in Germany, Sensient China in China). This certification ensures that only tested and approved additives are used in regulated products.