Enforcement News
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 Letters Highlight Differences Between Cosmetics and Medical Devices October 8, 2008
- 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
Import Surveillance
- Imported Cosmetics
- Import Alerts for Cosmetics
- Import Refusals for Cosmetics (updated monthly). For your convenience, links to recent Import Refusal Activities are listed below. For reports from previous years in addition to those listed here, see Import Refusal Reports for OASIS.
Recalls
- Recall Policy for Cosmetics
- FDA Enforcement Report
- Recalls of cosmetic products that involve health risks are featured on FDA's Cosmetics home page, in the "Highlights" column, for 60 days after they occur.
*PDF Readers are available for free from the Adobe Acrobat web site.