The U.S. Food and Drug Administration (FDA) has issued warning letters to 12 companies for selling illicit skin brighteners. The products contain the active drug hydroquinone, rendering them unapproved over-the-counter (OTC) drugs rather than cosmetics—and they do not meet the requirements to be legally sold as OTC drugs.
The warning letters highlight that these OTC skin-brightening products are not generally recognized as safe or effective (i.e., not GRASE). In fact, the FDA has received reports of serious side effects including skin rashes, facial swelling and ochronosis (discoloration of skin) from the use of skin-brightening products containing hydroquinone. The FDA advises consumers to not use these products due to the potential harm they could cause.
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