Yes. Color additives for food, drug, or cosmetic use are subject to FDA pre-market approval or listing requirements under the Federal Food, Drug, and Cosmetic Act. Importers must confirm that the specific colorant is either exempt from certification or holds an approved color additive petition before entry into commerce. Consult a licensed customs broker or regulatory counsel familiar with FDA color additive rules.

A dyeing extract is a concentrated product obtained directly from a plant or animal source with minimal processing, retaining the natural colorant in a semi-crude form. A preparation is a formulated product where the natural colorant has been blended with carriers, standardizing agents, or other ingredients to achieve a specific hue strength or application profile — a distinction that can affect both classification and end-use labeling requirements.