[4/19/2022] FDA issued warning letters to 12 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).
FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis (discoloration of skin) from the use of skin lightening products containing hydroquinone. FDA advises consumers not to use these products due to the potential harm they may cause, including ochronosis which may be permanent. Consumers should talk to their health care professional about treatment options for certain skin conditions including aged or dark spots.
FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products. Some manufacturers and distributors have already removed their OTC skin lightening products from the marketplace, and FDA plans to take action against those continuing to market these potentially harmful and illegal OTC products.
Currently, Tri-Luma is the only FDA-approved drug containing hydroquinone. Tri-Luma is a prescription product approved for the short-term treatment of dark spots associated with moderate-to-severe melasma of the face. Tri-Luma should only be used under the supervision of a licensed health care professional.
In addition to the COVID-19 response efforts, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) included important reforms that modernized the way certain OTC drugs are regulated. This reform finalized the legal status of products with certain active ingredients or other conditions that had been pending under the previous rulemaking framework, including finalizing the status of OTC skin lightening products. As a result, since enactment of the CARES Act, OTC skin lightening products containing hydroquinone are deemed to be new drugs and are misbranded. All OTC skin lightening products require an FDA approved new drug application before they can be legally marketed.
As a result of CARES Act, effective September 23, 2020, manufacturers and distributors of OTC skin lightening products that do not have FDA approval must remove the products from the marketplace. The warning letters FDA issued today are to companies still marketing OTC skin lightening products containing hydroquinone without an FDA approved new drug application.
FDA has asked the companies receiving warning letters to take prompt action to correct any violations outlined in the respective warning letters and respond to FDA within 15 days with what they have done to address any violations and prevent their recurrence.
FDA is taking a comprehensive approach to protect consumers from the risks posed by skin lightening products containing hydroquinone. The agency is notifying companies that have listed these drugs with FDA, but may not actively be distributing them, of the current legal status of these drugs to prevent companies from distributing these illegal products. FDA is also adding certain skin lightening product manufacturers to an import alert to help stop their products from entering the U.S. Many of FDA’s safety concerns regarding the use of hydroquinone in OTC skin lightening drug products also apply to the use of hydroquinone in cosmetic products.
FDA reminds manufacturers and distributors it is their responsibility to comply with all requirements of federal law and FDA regulations, and to ensure their drugs meet federal standards for safety and effectiveness. Those who fail to comply with the law are subject to FDA action.
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: