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. 

• Drug Claims Made for Products Marketed as Cosmetics
• Cosmetics as Adulterated Due to Microbial Contamination
• Warning & Untitled Letters to Industry Citing Color Additive Violations
• Differences Between Cosmetics and Medical Devices
• Dollar Tree, Inc (November 2022) 
• LEC Custom Products, Inc. (September 2020) 
• Nature Essence Small Molecule Co., LTD (February 2020) 
• Greenbrier International, Inc dba Dollar Tree (November 2019) 
• Hangzhou Badi Daily Use Chemical Company (August 2019)
• Glint Cosmetics Pvt. Ltd. (May 2019) 
• Van Tibolli Beauty Corp. GK Hair Taming System (September 2015) 
• Brazilian Blowout (August 2011) 
• Black Henna Ink, Inc. Cites Illegal Use of Color Additive (August 2006) 

Resources

• 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"
• Import Alerts Related to Cosmetics