FDA Seeks Fee Increase for Color Additive Certification

FDA issued a proposed rule today to increase fees for color additive certification services. If finalized, it will implement a 10-cent-per-pound increase in color certification fees and revise the minimum fee from the current $224 to $288.

FDA notes that this is the first increase proposed since 2005, when the current schedule became effective. It 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, said the agency.

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

Comments on the proposed rule should be submitted within 60 days after publication in the Federal Register, which is scheduled for Nov. 2, 2022. Electronic comments can be submitted to http://www.regulations.gov. Written comments can be sent to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2022-N-1635.

The proposed rule can be viewed here.