HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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)
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

RS009307

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel