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Fourth Time’s A Charm? President’s FY 2016 Budget Includes Cosmetic Fees

This article was originally published in The Rose Sheet

Executive Summary

Continuing what has become a familiar refrain, the Obama administration’s fiscal 2016 budget request for FDA includes cosmetics user fees, marking the fourth consecutive year that such a system has been proposed. Legislation would need to be introduced – and passed – in order to establish cosmetics user fees.

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FDA Seeks $17.7m In User Fees For Mandatory Cosmetic Registration

Again in its budget justification, FDA signals that a Mandatory Cosmetic Registration Program does not come cheap. Legislation would be needed to implement the program, as well as the industry user fees required to support it, but only one cosmetics safety bill currently in play includes a user-fee mechanism to fund proposed facility and product registration with the agency.

Congress Proposes Public-Private Partnership For CIR

In reports accompanying draft fiscal 2016 funding bills, both House and Senate committees recommend that FDA work with industry to explore formalizing the Cosmetic Ingredient Review via a public-private partnership similar to that in place with the U.S. Pharmacopeial Convention.

FDA Looking At Over $20 Million Annually In Proposed Cosmetics Fees

“The Rose Sheet” offers an interactive bar graph depicting the fee schedule proposed for cosmetic registration under the Personal Care Products Safety Act for 2016, based on average gross annual sales for the preceding three-year period, as well as the percentage of targeted fee revenue for which each industry tier would be responsible in subsequent years.

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