The U.S. Food and Drug Administration (FDA) sent warning letters to twelve companies today for selling certain over-the-counter (OTC) skin lightening products which have not been approved by the agency and pose safety risks.
 
The companies named in the letters include:
 

• Dr. Thomas Balshi/Intilight
• SkinPro
• 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.

 
The products from these companies contain hydroquinone, a depigmentation agent used in skin lightening creams which has come under the FDA’s scrutiny over safety concerns.
 
The FDA said it has received reports of serious side effects including skin rashes and facial swelling from skin lightening products containing hydroquinone.
 
It has advised people to not use such products as they may result in conditions such as ochronosis, a bluish-black or grey-blue discoloration of the skin, which could be permanent.
 
The agency also said OTC skin lightening products containing hydroquinone need to be FDA approved before they can be legally sold, as per reforms under the Coronavirus Aid, Relief and Economic Security (CARES) Act.
 
The FDA has asked the companies that received the warning letters to take prompt action and respond to the agency within 15 days. Failure to promptly correct any violations may result in legal action without further notice, including, without limitation, seizure and injunction.