A Letter to the Office of Budget and Management on the FDA’s proposed rule on formaldehyde

December 18th, 2024

The Honorable Shalanda Young
Director
Office of Management and Budget
Executive Office of the President
Washington, DC 20503

The Honorable Richard Revesz
Administrator
Office of Information and Regulatory Affairs
Office of Management and Budget
Executive Office of the President
Washington, DC 20503

Dear Director Young and Administrator Revesz,

On behalf of our organizational partners who are deeply concerned about the serious health and environmental risks posed by formaldehyde exposure, we urge you to prioritize the swift release of the FDA’s proposed rule on formaldehyde in hair straighteners. This proposed rule, which has been introduced for review with the Office of Management and Budget (OMB), is a critical step toward protecting public health and ensuring the safety of consumers and salon workers who use these products daily.

Formaldehyde is a known carcinogen and a potent sensitizer, yet it continues to be used in the formulation of many hair straightening products, such as those commonly referred to as “Brazilian blowouts.” The toxic effects of formaldehyde are well-documented, with exposure linked to cancer, respiratory issues, reproductive harm, and other serious health conditions. Despite these risks, as well as numerous complaints about health effects from hair straighteners first brought to FDA’s attention over 15 years ago, the FDA has not yet enacted adequate regulations to limit the presence of formaldehyde in these widely used consumer products.

The need for regulatory action has been further underscored by data from the CFSAN Adverse Event Reporting System (CAERS), which tracks consumer complaints related to adverse reactions to cosmetics including formaldehyde and/or formaldehyde releasing hair straighteners. Between 2010 and 2023, FDA received over 250 reports of adverse health events linked to the use of formaldehyde-containing hair smoothing treatments, including breathing difficulties, skin irritation, and eye damage often requiring medical attention or even hospitalization. (See attached chart of CAERS data.) The persistence of these adverse events highlights the urgency for the FDA to take immediate action to safeguard consumers and, particularly, salon workers who are at an even greater risk due to repeated and prolonged exposure.

For years, FDA has been aware that consumers have been exposed to unsafe levels of formaldehyde in products marketed as safe and effective. It is crucial that the FDA take immediate action to reduce these dangers and protect vulnerable populations from further harm. A strong, enforceable rule is needed to ban the use of formaldehyde in hair smoothing products and to ensure that these products are accurately labeled to inform consumers about potential risks.

We recognize the importance of balancing industry innovation and public health, but the need for action is urgent and well overdue. The lack of federal standards and oversight has allowed this hazardous chemical to remain in products that continue to be marketed to consumers. Communities—especially those who work in salons—have waited long enough for meaningful regulatory action.

Therefore, we urge you to release the EPA’s proposed rule creating discharge limits on manufacturers and formulators of toxic PFAS chemicals by the end of this year.

We urge you to review the FDA’s proposed rule to provide clarity to manufacturers, consumers, and regulators that formaldehyde-containing hair straighteners are unsafe and unlawful. This rule would not only protect public health but also create an equitable framework for manufacturers to operate within, ensuring that safer alternatives are brought to market.

It is also important to note that a growing number of manufacturers have already started to reformulate their products to eliminate formaldehyde . The proposed rule would build on these voluntary efforts, ensuring that all products are held to the same high safety standards and that consumers can make informed decisions.

This proposed rule is long overdue, and it is imperative that the FDA release it without further delay. The health and well-being of workers and consumers depend on it. We urge you to prioritize the timely release of the FDA’s proposed rule on formaldehyde in cosmetics and personal care products before the end of this year.

Sincerely,

Women’s Voices for the Earth
Alaska Community Action on Toxics
Black Women For Wellness
Breast Cancer Prevention Partners
Breastfeeding + Things
Center for Environmental Health
City of Minneapolis Health Department
Clean Air Coalition of North Whittier and Avocado Heights
Clearya
Defend Our Health
Earthjustice
Environmental & Public Health Consulting
Environmental Working Group
Ethical And Respectful Treatment of Humans
Families Advocating for Chemical and Toxics Safety
Heal By Dawn
Healthy Babies Bright Futures
Keep A Breast
Moms for a Nontoxic New York (MNNY)
My Style Matters, Inc.
National Council for Occupational Safety and Health (COSH)
Non-Toxic Neighborhoods
Northeast NY Coalition for Occupational Safety and Health
Parker Morrison Productions
Salon FiG
Science and Environmental Health Network
Seventh Generation
The Forbes Funds
Toxic Free NC
Upstate Medical University Occupational Health Clinical Center
Young, Gifted & Green