FDA reopens comment period for proposed increase in color certification fees

In an update published on April 25, 2024, the U.S. Food and Drug Administration (FDA) declared the reopening of the comment period for the proposed rule titled “Color Additive Certification; Increase in Fees for Certification Services,” which was initially announced in the Federal Register on November 2, 2022. This reopening, slated for a 30-day duration, will provide the FDA’s administrative record with supporting information and assist in aligning cost and benefit figures with the preliminary regulatory impact analysis.

About the original rule

The original proposed rule, which garnered attention when it was first introduced, seeks to address the escalating costs associated with regulatory oversight and compliance in color additives, which play a key role in cosmetics and personal care product formulations, where they are extensively utilized to enhance the visual appeal of products including makeup, hair dyes, and skincare formulations. According to the FDA’s original constituent update published November 1 last year, “if finalized, the proposed rule​ will implement a ten cent per pound increase in color certification fees,” which is “the first increase proposed since 2005 when the current schedule became effective.” 

As further detailed in the FDA’s original constituent update, “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,” as “manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.” 

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