FDA issues Warning Letters to let companies know that they have violated the laws we enforce and to tell them what corrective action they need to take.
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 would like to obtain available additional information on the current status of an issue in a particular Warning Letter on this website, please contact FDA 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 Cite Cosmetics as Adulterated Due to Microbial Contamination
- Warning Letters Highlight Differences Between Cosmetics and Medical Devices
- Warning Letter Cites Brazilian Blowout for Safety and Labeling Violations
- Warning Letter to Black Henna Ink, Inc. Cites Illegal Use of Color Additive
- Warning Letter to Parnell Pharmaceuticals, Inc. Cites Oral Moisturizer as Adulterated and Misbranded Medical Device
- Warning Letters Cite Cosmetics as Adulterated Due to Violative Use of Canthaxanthin
- Recalls & Alerts
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
- FDA Authority Over Cosmetics
- Key Legal Concepts: "Interstate Commerce," "Adulterated," and "Misbranded"