Insufficent data labeling
This article was originally published in The Rose Sheet
Executive Summary
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)
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CFSAN
FDA requests comments on development of fiscal year 2002 (beginning Oct. 1) program priorities in July 18 Federal Register notice. Comments are due Sept. 17. Among CFSAN's completed 2001 "A" list goals is initiation of activities to ensure cosmetics, dietary supplements and foods containing bovine materials from BSE-identified countries are restricted from entering U.S., center says in July 10 report card highlighting 53 "A" list accomplishments through June 15. Guidance outlining cosmetic office's plan to send warning letters to manufacturers based on insufficient data findings by Cosmetic Ingredient Review board is expected by late summer (1"The Rose Sheet" June 11, In Brief). Other initiatives left on cosmetic office's "A" list include DEA risk assessment, labeling guidance for alpha hydroxy acid-containing products (2"The Rose Sheet" Jan. 15, p. 10)