CIR "Insufficient Data" Ingredients Subject Of Upcoming FDA Warning Letters
This article was originally published in The Rose Sheet
Executive Summary
FDA is establishing a system to send warning letters to manufacturers using ingredients the Cosmetic Ingredient Review panel has determined do not have sufficient data to establish safety.
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"Insufficient Data" Labeling "Framework" Should Be CFSAN Priority - CTFA
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Insufficent data labeling
Guidance outlining FDA's decision to send warning letters to cosmetic manufacturers based on Cosmetic Ingredient Review Expert Panel findings will be published in Federal Register notice by "late summer," FDA Office of Cosmetics and Colors Acting Director Adele Dennis says during panel meeting June 4-5 in Washington, D.C. Warning letters likely will be issued to manufacturers using ingredients determined by CIR to have insufficient data to establish safety and will require manufacturers to place warning labels on products. Action, which was placed on FDA's Cosmetics & Colors "A" lists of priorities, is expected to encourage companies to submit more data to CIR to prevent insufficient data rulings. Regulation is "first step in the process of determining whether or not the safety of cosmetic products is being compromised" by businesses, she says. Agency has authority to impose warning statements on cosmetics that lack safety data under Section 740.10 of FD&C Act (1"The Rose Sheet" May 29, 2000, p. 3)