In a significant move, the Biden Administration unveiled its Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions on June 13, revealing plans to propose a rule prohibiting the use of formaldehyde and formaldehyde-releasing chemicals in hair smoothing and straightening products marketed in the United States. The proposed rule is set to be issued by the Food and Drug Administration (FDA), with a Notice of Proposed Rulemaking expected in April 2024. This announcement marks a historic step, as it is the first time an administration has expressed its intent to ban formaldehyde from hair products. However, it is not the first instance of the government investigating the detrimental effects of formaldehyde in these products.
The administration’s announcement highlights that the use of hair products containing formaldehyde has been linked to an increased risk of certain cancers and short-term adverse health effects, including sensitization reactions and respiratory problems. A significant study conducted by the National Institutes of Health (NIH) in December 2017 found an association between the use of hair products and ovarian cancer in women in the United States. This study specifically indicated that higher rates of ovarian cancer were linked to adult use of hair straighteners. While it also suggested a connection between higher rates of breast cancer and adolescent and adult use of hair products, the specific products were not identified.
In October 2022, the NIH presented epidemiologic evidence of an association between the use of hair straightening products and uterine cancer among American women. This study revealed a higher incidence of uterine cancer in participants who used hair straighteners, relaxers, or pressing products compared to those who did not use such products. The study further emphasized that the association between the use of these products and uterine cancer was stronger among those who used them more frequently. Additionally, prior research had already highlighted the connection between hair product usage and cancer development.
The administration draws its legal authority for this regulation from 21 U.S.C. 361 and 21 U.S.C. 371. 21 U.S.C. 361 defines adulterated cosmetics as those that are unsafe for their intended use, which is significant because 21 U.S.C. 331 prohibits the introduction, delivery, and receipt of adulterated products in interstate commerce. Meanwhile, 21 U.S.C. 371 empowers the FDA to create regulations and outlines the steps necessary for the FDA to promulgate these regulations.
Upon the issuance of the Notice of Proposed Rulemaking in the Federal Register, the FDA will open a public comment period, likely lasting for approximately 60 days. Should the regulation ultimately be enacted, its citation in the Code of Federal Regulations will be located in the appropriate section. Importantly, federal efforts to regulate hair products containing formaldehyde and formaldehyde-releasing chemicals have garnered support from members of Congress.
It is imperative for your organization to proactively prepare for the forthcoming Notice of Proposed Rulemaking.
