WHAT IS THE CARES ACT?Updated 6 months ago

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.