On November 1, the FDA issued a proposed rule to amend the color additive regulations with a 10 cent per pound increase in color certification fees. If the rule is finalized, this would be the first increase since 2005 when the current schedule became effective.

In its announcement of the proposed rule, the FDA said the increase in fees is necessary to cover increased operating costs “in order to ensure the color certification program continues operating at the high level of quality and efficiency that industry expects.”

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA for use in food, drugs, cosmetics and medical devices. The FDA analyzes samples from each batch of color additive received from a manufacturer to verify that it meets composition and purity specifications. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.

Stakeholders can submit electronic comments on the proposed rule at http://www.regulations.gov or send written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2022-N-1635.