Warning letters were issued by the Food and Drug Administration (FDA) to 12 companies for illegally selling over-the-counter (OTC) skin lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs.

According to the FDA, the following companies have received warning letters for continuing to illegally sell these OTC skin lightening products containing hydroquinone:

These OTC skin lightening products containing the active ingredient hydroquinone are not approved and are not generally recognized as safe and effective. There have been reports of serious side effects associated with the use of these products including skin rashes, facial swelling, and ochronosis.

The FDA is advising consumers not to use these OTC skin lightening products due to the potential harm they may cause, including ochronosis which may be permanent. Consumers should be aware that there are no FDA-approved or legally marketed OTC skin lightening products. These warning letters have been issued to companies who are still marketing these products without an approved New Drug Application.

The only FDA-approved drug containing hydroquinone is Tri-Luma, which is indicated for the short-term treatment of dark spots associated with moderate to severe melasma of the face. Tri-Luma is available via prescription and should only be used under the supervision of a licensed heath care professional. 

Health care providers and consumers are encouraged to report adverse events related to these unapproved products to the FDA’s MedWatch Adverse Event Reporting program.

Reference

FDA works to protect consumers from potentially harmful OTC skin lightening products. News release. US Food and Drug Administration. Accessed April 19, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-works-protect-consumers-potentially-harmful-otc-skin-lightening-products?utm_medium=email&utm_source=govdelivery