[author: Krysten Thomas*]
On June 13, the Biden Administration released its Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which announced its plan to propose a rule that would ban the inclusion of formaldehyde and other formaldehyde-releasing chemicals in hair smoothing or hair straightening products that are marketed in the United States. According to the announcement, the proposed rule would be promulgated by the Food and Drug Administration (FDA), which is expected to issue a Notice of Proposed Rulemaking in April 2024. The announcement is notable because it represents the first time that an administration has expressed its intent to ban the inclusion of formaldehyde in hair products, but it is not the first time that the government has explored the negative effects of formaldehyde in hair products.
As the administration states in the announcement, the use of hair products with formaldehyde and formaldehyde-releasing chemicals has been linked to an increased risk of certain cancers, in addition to short-term adverse health effects including sensitization reactions and breathing problems. For example, in December 2017, the National Institutes of Health (NIH) released a study in the Environmental Health Perspectives Journal, which showed that there was an association between the use of hair products and ovarian cancer, among women in the United States. The study specifically revealed that higher rates of ovarian cancer were associated with adult use of hair straighteners. This study also indicated that higher rates of breast cancer were associated with adolescent and adult use of hair products, but those hair products were not identified in more detail.
Then, in October 2022, the NIH released a study in the Journal of the National Cancer Institute, which presented the first epidemiologic evidence of association between the use of hair straightening products and uterine cancer, among women in the United States. This study demonstrated that there was a higher rate of uterine cancer among study participants who used hair straighteners, relaxers, or pressing products than among study participants who did not. The study also established that the association between the use of hair straighteners, relaxers, or pressing products and uterine cancer was stronger for those who used the products more frequently. As the NIH notes in the introduction of the October 2022 study, other research has shown a connection between hair product use and cancer development, as well.
The administration cites 21 U.S.C. 361 and 21 U.S.C. 371 as its legal authority for the regulation. 21 U.S.C. 361 is the section of the code that defines adulterated cosmetics as a cosmetic that is, in whole or in part, unsafe based on its intended use, which is significant because 21 U.S.C. 331 prohibits the introduction, delivery, and receipt of adulterated products in interstate commerce. 21 U.S.C. 371 provides the FDA with the authority to promulgate regulations and details the steps that the FDA must take to promulgate regulations.
Once the Notice of Proposed Rulemaking is issued in the Federal Register, the FDA will accept comments from the public here for a period that will likely span 60 days. If the regulation becomes final, the citation for it in the Code of Federal Regulations will be found in this section. Federal action on hair products with formaldehyde and formaldehyde-releasing chemicals has support from members of Congress.
It is important to prepare your organization now for the upcoming Notice of Proposed Rulemaking.
*Krysten Thomas is a law clerk in the firm’s Washington, D.C. office.
