FDA issues warning to companies selling illegal skin lightening products

USA – The Food and Drug Administration (FDA) has issued warning letters to twelve companies for selling certain over-the-counter (OTC) skin lightening products that have not been approved by the agency and pose safety risks.

Hydroquinone, a depigmentation agent used in skin lightening creams that has come under FDA scrutiny due to safety concerns, is present in products from companies such as M & M Beauty and Wellness, Ultimark Products, and Genomma Lab USA.

The FDA stated that it has received reports of serious side effects such as skin rashes and facial swelling from hydroquinone-containing skin lightening products.

It has warned people not to use such products because they can cause conditions like ochronosis, a bluish-black or grey-blue discoloration of the skin that can be permanent.

The FDA said consumers should not use these products due to the potential risks. Instead, they should talk to their health care provider about treatment options for certain skin conditions, including dark or age spots.

According to the FDA, OTC drugs containing skin lightening products containing hydroquinone must be FDA approved before they can be legally sold, as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act reforms.

Companies that received warning letters were instructed to correct their violations as soon as possible. They were given 15 days to inform the FDA of the steps they had taken to address the violations and prevent them from occurring again.

There are no over-the-counter (OTC) skin lightening products that are FDA-approved or otherwise legally marketed.

Some manufacturers and distributors have already removed such products from the market in the United States, and the FDA has stated that it will take action against businesses that continue to market “potentially harmful and illegal” products.

Currently, the only FDA-approved hydroquinone therapy is Tri-Luma, a prescription product. Tri-Luma is approved for the treatment of dark spots associated with moderate-to-severe melasma, a pigmentation disorder in the short term.

According to the FDA, Tri-Luma should be used only under the supervision of a licensed health care professional.

The FDA is asking consumers and health care providers to report any problems with over-the-counter skin lightening products.