FDA Proposes Increase in Color Certification Fees
What's New
May 24, 2024
The U.S. Food and Drug Administration (FDA) is extending the comment period on May 28, 2024, for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services that appeared in the Federal Register on November 2, 2022. On April 26, 2024, the FDA reopened the comment period for 30 days to provide for comment on supporting information added to the administrative record. The FDA received a request for a 90-day extension of the comment period. The agency is extending the comment period by 30 days, until June 27, 2024. The FDA believes that a 30-day extension is reasonable and allows adequate time for interested parties to review the supporting information added to the administrative record and to develop and submit additional comments to the proposed rule. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-1635.
April 25, 2024
The U.S. Food and Drug Administration (FDA) is reopening the comment period on April 25, 2024 for 30 days for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services that appeared in the Federal Register on November 2, 2022. We are taking this action to add supporting information to the administrative record and to adjust the record to reflect the same cost and benefits figures that were published in the preliminary regulatory impact analysis. We are reopening the comment period specifically to invite public comments on the new information being added to the administrative record. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-1635.
January 23, 2023
The U.S. Food and Drug Administration (FDA) is reopening the comment period on January 24, 2023 for 45 days for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services that appeared in the Federal Register on November 2, 2022. The FDA is reopening the comment period in response to a recent request from stakeholders to allow additional time for interested persons to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-1635.
Original Constituent Update
November 1, 2022
The U.S. Food and Drug Administration (FDA) today issued a proposed rule to amend the color additive regulations to increase the fees for certification services. If finalized, the proposed rule will implement a 10 cent per pound increase in color certification fees. This is the first increase proposed since 2005 when the current schedule became effective.
An 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 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 U.S. consumers. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.
Comments on the proposed rule should be submitted within 60 days after publication in the Federal Register. Submit electronic comments to http://www.regulations.gov. Submit 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.
Any final rule resulting from this rulemaking will be effective 30 days after the final rule’s date of publication in the Federal Register, to provide industry sufficient time to prepare for and adjust to the change in fees.
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