Warning Letters to Industry on Cosmetic-Related Issues

Matters described in FDA Warning Letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter. If you wish to obtain available additional information on the current status of an issue in a particular Warning Letter on this website, please contact the Agency or the recipient of the letter directly. Inquiries to FDA should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Instructions for submitting an FOI request are available online.

• Warning Letters Address Drug Claims Made for Products Marketed as Cosmetics
• Warning Letter to Black Henna Ink, Inc. Cites Illegal Use of Color Additive August 14, 2006 (also available in PDF*, 98 kB)
• Warning Letter to Parnell Pharmaceuticals, Inc. Cites Oral Moisturizer as Adulterated and Misbranded Medical Device July 10, 2006 (also available in PDF*)
• Warning Letters Cite Cosmetics as Adulterated Due to Microbial Contamination December 20, 2005
• Warning Letters Cite Cosmetics as Adulterated Due to Violative Use of the Color Additive Canthaxanthin April 5, 2005
• Hair Removal and Microdermabrasion Device Firms Receive Warning Letters February 19, 2002; Revised October 4, 2004

*PDF Readers are available for free from the Adobe Acrobat web site.