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.
Notably, some manufacturers and distributors have already removed their OTC skin-brightening products from the market; the FDA plans to take action against those continuing to market these potentially harmful and illegal OTC products.
The companies named include:
- Dr. Thomas Balshi/Intilight
- Skin PS Brands
- Clinical Formula LLC
- Skin Authority, L.L.C.
- AMBI Enterprises LLC
- Genomma Lab USA, Inc.
- M & M Beauty and Wellness, LLC
- True Earth Health Products, LLC
- Elements Brands Inc.
- Ultimark Products and
- Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc.
In relation, the agency explains the Coronavirus Aid, Relief and Economic Security Act (CARES Act) included 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-brightening products.
As a result, since the CARES Act, OTC skin brighteners containing hydroquinone are deemed to be new drugs and are misbranded. All OTC skin-brightening products require an FDA approved new drug application before they can be legally marketed.