Color Additives

Background

Color additives play a multifaceted and pivotal role in consumer healthcare products, serving both functional and aesthetic purposes. In pharmaceuticals and dietary supplements, these additives are employed to distinguish between various medications, dosages, or formulations, aiding in accurate identification and administration — an imperative aspect in self-care settings. Simultaneously, color additives contribute to the overall visual appeal of these products, enhancing recognition and patient acceptance. Beyond these functions, color additives are increasingly recognized for their capacity to deter harmful ultraviolet (UV) rays in tablets. UV protection is paramount in preserving the efficacy and stability of certain healthcare products, shielding them from light-induced degradation. This dual role of color additives, both as identifiers and protective agents, underscores their critical importance in consumer healthcare product design and manufacturing. Adherence to rigorous regulatory standards ensures the responsible and safe integration of colors, addressing both aesthetic and functional requirements in the ever-evolving landscape of healthcare.

The Issue

Some states and localities are considering restrictions on FDA-approved color additives, unnecessarily complicating the regulatory ecosystem for these ingredients.

CHPA’s Position

CHPA opposes state and local government attempts to restrict the use of FDA-approved color additives as doing so is vital for maintaining a cohesive regulatory framework. FDA approval signifies a thorough evaluation of safety and efficacy, and unnecessary restrictions could hinder innovation and create inconsistencies in product availability across regions. A standardized, nationwide approach ensures that healthcare products benefit from the full spectrum of FDA-approved color additives, supporting both functional and aesthetic aspects without compromising safety.