McCollum Applauds New FDA Warning About Harmful Skin-Lightening Products

Congresswoman Betty McCollum (MN-04) reacted today after the U.S. Food and Drug Administration (FDA) announced it has issued warning letters to 12 companies for selling over-the-counter (OTC) skin-lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs. Additionally, the FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin-lightening products.

Rep. McCollum, as a member of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, has partnered with the Beautywell Project in Saint Paul to secure provisions within recent federal funding bills requiring the FDA to engage in public education activities about the harms of skin-lightening products, which contain unsafe levels of ingredients like hydroquinone, and to combat the sale of these products.

"I have worked with the FDA on the issue of harmful skin-lightening products for several years, and am proud to have secured provisions directing the agency to educate the public about the dangers as well as stop the illegal sales of these products," Rep. McCollum said. "These new warnings from the FDA will better protect consumers and send a strong message to companies that the FDA is watching and will take decisive action against companies that continue to market these illegal products. These products have gone unchecked for too long, and are a growing safety concern for consumers. Skin-lightening cosmetics disproportionately impact women of color, which is why I'm pleased to partner with advocates like Amira and the Beautywell Project to help shine a light on the health implications and change the narrative around damaging beauty standards. I am committed to continuing this important work to improve our federal regulations and protect public health."

"These skin-lightening products expose communities of color to intense levels of mercury, hydroquinone, and other toxic chemicals and impact their health outcomes, especially women and children," said Amira Adawe, founder and executive director of the Beautywell Project. "This practice was inherited from colonization – where historically people were taught to dislike their skin color. This is a racial equity issue, a gender issue, and a health issue that requires a multi-faceted approach to combat it. I'm glad that FDA took action to regulate these skin-lightening products that contain hydroquinone sold over-the-counter. A special thanks to Congresswoman Betty McCollum for securing funding for FDA to address this issue. This would not have been possible without her leadership and support!"

McCollum-secured language in the last two fiscal year Appropriations bills is as follows:

FY 21 bill report (p. 94):
Skin Lightening.—The Committee is concerned about the availability of illegal skin lightening products containing dangerous levels of mercury and hydroquinone that are available to consumers, particularly through online retailers. With the passage of the CARES Act, FDA has new authorities to address the safety and effectiveness of OTC drug products, including those containing hydroquinone. The Committee encourages the Office of Cosmetics and Colors, within CFSAN and the Office of Non-Prescription Drugs within CDER to collaborate to combat online sales of illegal skin lightening products, including testing to determine compliance with FDA content limits. The Committee provides an increase of $1,000,000 to FDA's Office of Minority Health and Health Equity to educate the public on the dangers of cosmetics containing these ingredients, including partnering with community-based organizations with records of reaching out to communities. The FDA should coordinate with the National Institute of Health's National Institute on Minority Health and Health Disparities to ensure any potential interventions or educational efforts are complementary and not duplicative.

FY 22 bill report (p. 104):
Skin Lightening Products.—The Committee is concerned about the dangers of mercury and hydroquinone in skin lightening products, particularly those that are disproportionately targeted towards and used by minority men and women and girls of color. Regular application of creams containing mercury can lead to skin damage, while long-term exposure to high levels of mercury in cosmetic products can cause serious health consequences, including damage to the eyes, lungs, kidneys, digestive, immune, and nervous systems. Hydroquinone has been linked to ochronosis and other significant health risks. The Committee continues to provide $4,700,000 to the Office of Minority Health and Health Equity to educate the public on the dangers of skin lightening products containing these ingredients, including partnering with community based organizations with records of reaching out to impacted communities. The FDA is directed to report back to the Committee within 120 days of enactment of this Act detailing how the funds provided for this work in 2021 were spent, including the outreach they did to community-based organizations, what organizations they partnered with and how that determination was made, what vulnerable communities were reached out to and how that determination was made, the specific actions taken to educate the public about these products, how they are evaluating the impact and success of this public education, and any lessons learned that should be given to the Committee. Further, the Committee has concerns about the overall safety of imported cosmetic products and directs the FDA to report back to Congress within 180 days of enactment of this Act on the staffing and budget resources it needs to enforce the physical inspection process, as well as the most up to date information on the number and kinds of personal care products imported each year, the number of imported products that were inspected, and the number of contaminated products that were intercepted.

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