FDA issues warning about over-the-counter skin lightening products

The FDA has issued warning letters to 12 companies for selling over-the-counter skin lightening products containing hydroquinone, according to a press release.

“FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products,” the release said.

Serious side effects have been reported with these products including skin rashes, facial swelling and skin discoloration, and the FDA is warning the public not to use any OTC skin lightening products.

Hydroquinone is not approved in any OTC products, as its only indication is for Tri-Luma, a prescription product for the short-term treatment of dark spots associated with melasma.

While some of the companies involved have already removed their products from shelves, the FDA plans to take action against those who continue to sell or market these products.

The organization has asked each company to respond within 15 days detailing how these violations to the CARES act are being addressed.

“FDA reminds manufacturers and distributors it is their responsibility to comply with all requirements of federal law and FDA regulations, and to ensure their drugs meet federal standards for safety and effectiveness,” the release said.

Adverse reactions to these products should be reported to MedWatch, the FDA’s safety information and adverse event reporting program, by completing and submitting the form found here.