FDA’s Proposal for Increasing Color Certification Fees

FDA’s Proposed Rule for Amending Color Certification Fees: Written Comments due by January 3, 2023

FDA recently issued a proposed rule to amend the color additive regulations, proposing to increase fees for certification services by 10 cents per pound. As the first proposed increase since 2005, the proposal is being made to cover increased operating costs (purchase and maintenance of critical equipment, facility charges, and staffing) of FDA’s color certification program.

FDA requires that certain color additives be certified by FDA for use in foods, drugs, cosmetics and medical devices. As part of the certification process, manufacturers submit samples from each batch of color additives to FDA so the agency can verify that the color additive meets composition and purity specifications. This certification process is conducted before the color additives are allowed to be used in U.S. marketed products. In support of FDA’s color certification program, manufacturers pay fees which are based on the weight of each batch.

Any party interested in submitting electronic or written comments to the proposed rule should do so by January 3, 2023. If you are interested in submitting formal comments, please contact us at info@garg-law.com to discuss further.

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