Skin lightening products are a 'regulatory black hole,' and the FDA is warning against using them

Skin lightening products are a 'regulatory black hole,' and the FDA is warning against using them

The FDA has launched an initiative warning about over-the-counter skin lightening products after receiving reports of side effects.

The agency's Skin Facts! Initiative, announced last week, is aimed at promoting safe use of skin care products, urging people to be aware of non-prescription products marketed to lighten or bleach the skin.

It warned consumers that such products may contain mercury, which poses serious health risks, and hydroquinone, an ingredient that should only be used by prescription. Dermatologists safely prescribe hydroquinone-based creams to help with hyperpigmentation, or dark spots.

The FDA banned the sale of over-the-counter hydroquinone products in 2020 and ordered removal from shelves, but many remain on the market online and in shops.

The agency issued warning letters to 12 companies in the spring after receiving reports of side effects including exogenous ochronosis – or worsening discoloration of skin that can become permanent – as well as facial swelling and rashes.

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Doctors and other experts say people of color are most at risk, and may also be using these products to lighten their skin color, an issue rooted in colorism.

Dr. Neelam Vashi, a dermatologist and associate professor at Boston University School of Medicine, directs the Center for Ethnic Skin. Patients who come to her after developing side effects used hydroquinone products from overseas, where they could purchase them over the counter, she said.

Dr. Neelam Vashi
Dr. Neelam Vashi

She cautioned that hydroquinone should only be used under a doctor’s supervision and that the ingredient shouldn’t be used long-term. Dark spots should be treated by a doctor.

“We will know how to properly stop it. We can prescribe other products, too,” she said.

Dr. Valerie Harvey, a dermatologist, is president of the Skin of Color Society and codirects the Hampton University Skin of Color Research Institute. She also emphasized oversight for the use of hydroquinone.

“It's really an important part of our toolbox in treating these pigmentary conditions, which tend to occur in minority, skin-of-color patients,” she said.

Dr. Valerie Harvey
Dr. Valerie Harvey

She also noted people with discoloration, and other conditions like eczema, often first try to use over-the-counter products as an “accessible” option before going to the doctor.

“Sometimes people just dismiss hyperpigmentation as a cosmetic concern,” Vashi said. But “it is a health concern,” and studies show it affects quality of life.

To better understand use of skin-lightening products for hyperpigmentation, the most common skin complaint from people of color, the Reagan-Udall Foundation, a research group under the FDA, conducted listening sessions with Black, Asian and American Indian and Alaska Native communities, and consulted experts.

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Joanne Rondilla, a San Jose State University sociologist, expert on colorism and former cosmetic industry worker, was among them. She said colorism is also at play among those reaching for skin-lightening products.

Rondilla, who grew up in Guam and is Filipina, studies Filipina and Pacific Islander communities’ perceptions of beauty. In many cultures, she said, lighter skin signifies wealth, status and beauty and has strong roots in colonialism.

“When you look at the literature on colorism in the Black community, or the Latinx community, oftentimes it's messages from other people in the family,” she said. “It's skin tone discrimination, or looks-based system of discrimination, that occurs within the same racial or ethnic group.”

Joanne Rondilla
Joanne Rondilla

Her own experiences led her to research the issue. Growing up, she was darker than her sisters. Her mother forbade her from swimming so she wouldn’t get darker. Television often featured lighter-skinned actresses, and relatives made comments. In her research, she found these experiences in other women’s lives, too.

“In a lot of my interviews, so much harm was generated just within the family: the circulation of skin-lightening products, being told not to play outdoor sports, because you're going to get too dark,” she said.

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In one study, a Filipina interviewee told Rondilla her mother would scrub her skin with lemon to “lighten” it. Women in her studies said they use skin care products to “look better.”

“When I would dive deeper and ask, ‘Well, what does this look like, descriptively?’ It would be, ‘lighter skin’ or 'clearer skin,'” she said.

Environmental health scientist Ami Zota, a professor at Columbia University's Mailman School of Public Health, researches chemical exposures from personal care products among women of color, coining a framework called “the environmental injustice of beauty.”

In an analysis published in the American Journal of Obstetrics and Gynecology, Zota noted several studies suggesting U.S. women of color have higher levels of hormone-disrupting chemicals compared to white women.

While many communities around the world use different forms of “skin-whitening” creams, in the U.S., she said these are predominantly used by communities of color.

“There are mercury-containing skin-lightening creams that you can still find on these online commerce sites, and it's sort of a regulatory black hole in terms of the accountability there,” she said.

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Mercury is considered the most toxic heavy metal. If a woman is pregnant, mercury can be transferred to the fetus causing developmental problems, said Zota, an expert in maternal and reproductive health issues.

One study found 6% of more than 500 skin-lightening products purchased online globally contained high levels of mercury. Close to half of that sample had levels of mercury more than 10,000 parts per million.

“This unregulated global industry is being driven by a demand for lighter skin because of the pervasive social norms that are rooted in racism and colonialism,” Zota said. “There's a power hierarchy and white femininity, Eurocentric beauty norms are at the top of that hierarchy.”

Margaret Hunter, a sociologist and scholar on colorism at Santa Clara University in California, said it’s important to “see the subtlety of colorism” throughout different contexts.

“The ideals of beauty that are marketed around the globe aren’t necessarily white beauty, but they are anglicized beauty,” she said. “People use them because light skin is a real benefit and it is a privilege status.”

Reach Nada Hassanein at or on Twitter @nhassanein_.

This article originally appeared on USA TODAY: FDA Skin Facts! Initiative targets lightening products. Here's why.