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)