Q&A: FDA must ‘do right’ by explaining delayed ban of formaldehyde in hair products

Key takeaways:

• The FDA has missed its self-assigned deadline to address proposed rule banning formaldehyde in hair smoothing, straightening products.
• Chris G. Adigun, MD, FAAD, discussed the importance of this issue.

The FDA has missed its action date to address its proposed rule banning formaldehyde and formaldehyde-releasing chemicals from hair smoothing and straightening products.

In October 2023, the FDA proposed a ban on the use of formaldehyde and other formaldehyde-releasing chemicals as ingredients in hair smoothing or hair straightening products marketed in the U.S.

The proposed rule was catapulted by a letter penned by Reps. Ayanna Pressley and Shontel Brown, who emphasized the chemical’s connection to an increased risk for uterine cancer as well as the fact that these hair products are primarily marketed to Black women.

The FDA set a notice of proposed rulemaking date for April 2024, which has since come and gone, leaving policymakers and clinicians stumped at the lack of action.

Healio spoke with Chris G. Adigun, MD, FAAD, the owner and medical director of Dermatology & Laser Center of Chapel Hill, about the importance of this issue.

Healio: What are the dangers of formaldehyde?

Adigun: Formaldehyde is a preservative that is colorless and has a very distinct smell. Sometimes it is put into products in very, very small amounts for antimicrobial purposes. However, it can be hazardous when it’s in gas form and breathed into the lungs or if it gets into the eyes or onto the skin.

Additionally, over time, products with formaldehyde that are exposed to heat will release formaldehyde as it breaks down, and even those very small amounts can cause reactions such as burning eyes and upper respiratory symptoms such as coughing and wheezing. Some people are very sensitive to it and some people are not, so there’s a spectrum of sensitivity to formaldehyde.

Formaldehyde is also a known carcinogen, so there is typically a minimum amount of formaldehyde that is permitted to be used as a preservative in different products.

Healio: Who is at risk for formaldehyde exposure?

Adigun: When it comes to the presence of formaldehyde in hair relaxers or hair straighteners, the symptoms can occur not just to the person receiving the hair treatment, but also to the person administering it.

If you are receiving a hair relaxing or straightening treatment, which spans from “keratin” treatments to hair relaxers that are used to turn very tightly coiled hair into straight hair, you’re having a heightened exposure. But if you’re administering that treatment to client after client after client over the course of a day, weeks and years, then that presents even more of an exposure. In fact, there are hairstylists that are reporting symptoms when they have this exposure, and that has been well documented.

Healio: What about formaldehyde-free products? Are there any dangers associated with those?

Adigun: The problem is that something can be formaldehyde-free, but not formaldehyde-releaser-free. There are some common preservatives that are used in different products that are not formaldehyde, such as DMDM hydantoin and imidazolidinyl urea, that over time can release formaldehyde. Those products include baby lotions, shampoos, conditioners and other types of personal care products.

Now, the whole point of formaldehyde in these types of products is to inhibit fungal and bacterial growth and the amount of formaldehyde that’s released is low, but it is still there.

Unfortunately, this gives consumers an extra step when they are looking for formaldehyde-free or formaldehyde-releasing-agent-free products, because a product that says formaldehyde-free may not be enough.

Healio: Do you think the FDA should ban the use of formaldehyde in personal care products?

Adigun: We know formaldehyde causes problems even in very, very small amounts. It can cause problems to especially sensitive patients. And the fact that we can make products without formaldehyde or formaldehyde-releasing agents that are still safe and effective just supports the notion that it is not needed.

Healio: Hair relaxers and straightener products are often marketed to women with skin of color. How does the FDA’s inaction affect them?

Adigun: I think that whenever our governing body that is supposed to keep us safe overlooks issues and products that can be potentially dangerous, especially at a disproportionate rate to African Americans, we have a problem. Because there is a pattern of that, this only feeds future distrust, which is founded.

Ultimately, the FDA is not taking the proper action to keep everyone safe. I think the FDA does need to do right here and if they are delaying this ban then they need to explain why. If the FDA’s job truly is to protect all of us, all Americans, then they need to do exactly that.

Healio: In light of this conversation, what else should dermatologists know to care for their patients moving forward?

Adigun: Don’t miss early presentations of formaldehyde sensitivity, because we are going to see those patients. Those patients come to us. They may have allergic contact dermatitis on their hands and fingers from nail products with formaldehyde or on their scalp and neck from hair products with formaldehyde. As dermatologists, we need to help patients identify this, diagnose it and help them move to safe products.

For more information:

Chris G. Adigun, MD, FAAD, is active on @dlcofchapelhill on Instagram and X and @dlc_chapelhill on TikTok.

References:

• Pressley, Velázquez, Brown seek information from FDA on delay of ban on formaldehyde in hair products. https://pressley.house.gov/2024/08/28/pressley-velazquez-brown-seek-information-from-fda-on-delay-of-ban-on-formaldehyde-in-hair-products/. Published Aug. 28, 2024. Accessed Sept. 16, 2024.
• Use of formaldehyde and formaldehyde-releasing chemicals as an ingredient in hair smoothing products or hair straightening products. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202304&RIN=0910-AI83. Published spring 2023. Accessed Sept. 16, 2024.