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CIR Panel Plans For Lead Acetate Review At FDA’s Request

This article was originally published in The Rose Sheet

Executive Summary

While FDA has gone on record as being leery of proposed legislation that would formalize its relationship with the Cosmetic Ingredient Review, the agency continues to leverage the industry-funded program’s expertise. At FDA’s request, the CIR Expert Panel will review progressive hair dye lead acetate in 2017.

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CIR Panel Looks To Establish Guidelines For Read-Across Use

At its December meeting in Washington, the Cosmetic Ingredient Review Expert Panel finalized safety assessments for eight ingredients and advanced three other reports. In its reviews, the group made selective use of read-across data while agreeing to discuss protocol for employing the predictive approach in future reviews.

FDA Questions Constitutionality Of Proposed CIR Bridge, A Blow To CMA Bill

The Cosmetic Modernization Amendments of 2015 is touted by small business as a more appropriately sized update to the regulatory framework than the front-running PCPSA. However, some provisions seen as vital are absent from the bill, while its call for FDA to accept CIR safety decisions could be deemed unconstitutional, an FDA official suggests in a letter to Senate HELP Committee Chair Lamar Alexander.

FDA: Ingredient Safety Decisions Under PCPSA Could Differ From CIR

Compared with the Cosmetic Ingredient Review, FDA could consider a wider selection of data in its ingredient safety evaluations under the Personal Care Products Safety Act, an FDA official says. Further, industry would have the burden of demonstrating reasonable certainty of no harm, a high bar to clear.

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