Skin Facts! What You Need to Know About Skin Lightening Products is a new initiative to alert consumers on the use of and potential risks from skin lightening products. The Skin Facts! initiative was informed by listening sessions conducted in partnership with the Reagan-Udall Foundation.

The U.S. Food and Drug Administration (FDA) has issued warning letters to companies for selling over-the-counter (OTC) skin lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs. The warning letters explain that these OTC skin lightening products containing the active drug ingredient hydroquinone are unapproved drugs and are not generally recognized as safe and effective (not GRASE). Visit the FDA works to protect consumers from potentially harmful OTC skin lightening products page to view the full announcement. 

FDA encourages health care professionals and consumers to report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program by:

• Completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
• Downloading and completing the form, then submit it via fax at 1-800-FDA-0178.