FDA warns 12 companies about unapproved skin lightening products

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FDA Issues Warnings to 12 Companies on Unapproved Skin Lightening Products

The FDA has received reports of serious side effects from unapproved skin lightening products, including rashes, facial swelling and possibly permanent skin discoloration. Photo: AdoreBeautyNZ/Pixabay

The U.S. Food and Drug Administration announced Tuesday that it has issued warning letters to 12 companies warning them about the sale of over-the-counter skin lightening products containing hydroquinone.

The products are unapproved drugs and are not considered safe and effective, according to the FDA, which has received reports of serious side effects, including rashes, facial swelling and possibly permanent skin discoloration.

The FDA says consumers should not use these products because of the potential risks. Instead, they should discuss treatment options for certain skin conditions, including dark spots or age spots, with their health care provider.

There are no FDA-approved or otherwise legally marketed over-the-counter skin lightening products. Some manufacturers and distributors have already pulled such products from the U.S. market, and the FDA said it plans to take action against companies that continue to sell what it calls “potentially harmful and illegal” products.

Companies that received warning letters were told to immediately correct their violations. They have 15 days to tell the FDA what actions they have taken to address the violations and prevent them from happening again.

Currently, a prescription product called Tri-Luma is the only FDA-approved treatment containing hydroquinone. Tri-Luma is approved for the short-term treatment of dark spots associated with moderate to severe melasma (patchy brown discoloration) on the face. The FDA says Tri-Luma should only be used under the supervision of a licensed health care professional.

Consumers or health care providers are required to report problems associated with OTC skin lightening products to the FDA.

To report problems with OTC skin lightening products, visit the FDA’s MedWatch Adverse Event Reporting Program or download the form and submit it by fax to 1-800-FDA-0178.

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