FDA Office of Minority Health and Health Equity
 FDA Initiative Urges Consumers to Know the Potential Dangers of Using OTC Skin Lightening Products
New Skin Facts! Initiative Promotes Consumer Safety
The Food and Drug Administration’s Office of Minority Health and Health Equity (OMHHE) has announced a new public health education campaign to warn consumers about the dangers of using over-the-counter (OTC) skin lightening products containing hydroquinone or mercury. OMHHE created the Skin Facts! Initiative to help consumers understand the potential risks of using these products and to help identify whether the skin products they purchase contain these harmful ingredients.
FDA has received reports of serious side effects from the use of skin lightening products containing hydroquinone or mercury. In April, FDA issued warning letters to 12 companies for selling OTC skin lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs.
“It is important for anyone who uses over-the-counter skin products with hydroquinone or mercury to understand the potential harm and to avoid these illegal products,” said FDA Associate Commissioner for Minority Health and OMHHE Director, RDML Richardae Araojo. “With the Skin Facts Initiative, we are encouraging consumers to check the labels of skin lightening products and to report any adverse reactions to the FDA.” Reports can be made to the FDA at www.fda.gov/medwatch/report.htm or by calling 1-800-FDA-1088.
The Skin Facts! Initiative was developed following the 2021 Consolidated Appropriations Act becoming law. The Act provided appropriations for the FDA to educate the public on the potential risks of products containing hydroquinone or mercury.
Skin lightening products are often marketed to racial and ethnic minority communities as treatments for uneven skin tone, acne, age spots, freckles, and wrinkles. Products are often sold as creams, lotions, soaps, or powders and can be described as skin bleaching, fading, evening, brightening, or whitening products.
OMHHE advises consumers not to purchase or use skin products with hydroquinone without a prescription from a licensed health care provider. And consumers should not use or purchase skin products with mercury because exposure to mercury may have serious health consequences, and FDA has banned the use of mercury in skin lightening products.
The Skin Facts! initiative includes educational materials, social media messages and other communications to support consumer awareness regarding illegal over-the-counter skin lightening products containing hydroquinone or mercury. Skin Facts! educational materials, including a public service announcement and a partner toolkit with social media messages, can be found at www.fda.gov/SkinFacts.
Visit the FDA OMHHE website and follow us on Twitter at @FDAHealthEquity
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