Twelve companies have been issued warning letters about selling over-the-counter skin lightening products containing hydroquinone, the U.S. Food and Drug Administration announced Tuesday.
What is hydroquinone?
Hydroquinone is a skin-lightening agent that bleaches the skin by decreasing the number of melanocytes present. Melanocytes make the melanin that produces your skin tone. Hydroquinone can be effective in treating different forms of hyperpigmentation where more melanin is present.
Hydroquinone is typically used to treat skin conditions related to hyperpigmentation. This includes:
- acne scars
- age spots
- post-inflammatory marks from psoriasis and eczema
Hydroquinone can cause you to experience severe side effects depending on your skin type. In fact, it may worsen hyperpigmentation in darker skin tones.
Unapproved skin lightening products
The products are unapproved drugs that are not recognized as safe and effective, according to the FDA, which has received reports of serious side effects including rashes, facial swelling and skin discoloration that may 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.
There are no FDA-approved or otherwise legally marketed over-the-counter (OTC) skin lightening products. Some manufacturers and distributors have already removed such products from the U.S. marketplace, and the FDA said it plans to take action against businesses that continue to market what it called “potentially harmful and illegal” products.
The companies that received warning letters were told to immediately correct their violations. They were given 15 days to tell the FDA what actions they’ve taken to address violations and prevent them from happening again.
Currently, a prescription product called Tri-Luma is the only FDA-approved therapy containing hydroquinone. Tri-Luma is approved for