Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the US Food and Drug Administration (FDA) for use in cosmetics, food, drugs, and medical devices. The certification process is as follows: FDA analyzes samples from each batch of color additive received from manufacturer and verifies if it meets composition and purity specifications. Certification shall be gained before the color additives are permitted for use in products sold to US consumers. Manufacturers should pay fees based on the weight of each batch, which will be used to support the FDA’s color certification program.
On November 2, 2022, FDA kicked off a 60-day public consultation on the fee increase for color additives certification services. 1 It also pointed out that an increase in fees was necessary to cover increased operating costs and ensure the color certification program continues to operate with the high quality and efficiency expected by the industry.
Rescheduled Comment Period
On January 24, 2023, the FDA issued a notice, reopening the consultation period for the proposed rule “Increase in Fees for Certification Services”, which will close on March 10, 2023. 2 Any comments regarding the proposed rule shall be submitted before March 10, 2023 via the following two ways:
Submit comments online to http://www.regulations.gov;
Submit written/paper comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
The extension of the comment period aims to provide interested parties with more time to collect, analyze, and incorporate data to develop comments.
If finalized, the proposal will raise the cost of color certification services by 10 cents per pound, as detailed below.
The fee for certification services of straight colors including lakes will be increased from $0.35 to $0.45 per pound; the minimum fee will be changed from $224 to $288;
The fee for repacks of certified color additives and color additive mixtures will be increased from $35 for 100 pounds or less to $45;
The fee for repacks of certified color additives and color additive mixtures over 100 pounds, but not over 1,000 pounds, will be increased from $35 plus $0.06 for each pound over 100 pounds to $45 plus $0.08 for each pound over 100 pounds; and
The fee for repacks of certified color additives and color additive mixtures over 1,000 pounds will be increased from $89 plus $0.02 for each pound over 1,000 pounds to $114 plus $0.03 for each pound over 1,000 pounds.