U.S. FDA issues warning to companies selling unapproved skin lightening products

[April 20, 2022]  The U.S. Food and Drug Administration (FDA) said on Tuesday it sent warning letters to twelve companies for selling certain over-the-counter (OTC) skin lightening products which have not been approved by the agency and pose safety risks.

The products from companies including M & M Beauty and Wellness, Ultimark Products and Genomma Lab USA contain hydroquinone, a depigmentation agent used in skin lightening creams which has come under the FDA's scrutiny over safety concerns.

There is currently only one drug, Tri-Luma, approved by the FDA which contains hydroquinone, the agency said. The Tri-Luma cream is a prescription product for the treatment of moderate-to-severe melasma, a pigmentation disorder.

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.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

The agency also said OTC drugs skin lightening products containing 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.

(Reporting by Amruta Khandekar; Editing by Krishna Chandra Eluri)

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