FDA Cracks Down on OTC HQ Products
The FDA issued warning letters to 12 companies explaining that all OTC skin lightening products require an FDA-approved new drug application before they can be legally marketed.
The US Food and Drug Administration is cracking down on over-the-counter (OTC) skin lightening products containing hydroquinone (HQ) that do not meet the requirements to be legally sold as OTC drugs.
The group issued warning letters to 12 companies explaining that all OTC skin lightening products require an FDA-approved new drug application before they can be legally marketed. These products not generally recognized as safe and effective (not GRASE). The FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis from the use of skin lightening products containing HQ.
The companies were given 15 days to fix any violations outlined in the warning letters and tell the FDA what actions they've taken to address violations and prevent them from happening again.
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.
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.
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.
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. The 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.