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HHS/FDA RIN: 0910-AI83 Publication ID: Spring 2024 
Title: Use of Formaldehyde and Formaldehyde-Releasing Chemicals as an Ingredient in Hair Smoothing Products or Hair Straightening Products 
Abstract:

This proposed rule would ban formaldehyde (FA) and other FA-releasing chemicals (e.g., methylene glycol) as an ingredient in hair smoothing or hair straightening products marketed in the United States. These chemicals are used in certain cosmetic products that are applied to human hair as part of a combination of chemical and heating tool treatment intended to smooth or straighten the hair. Use of hair smoothing products containing FA and FA-releasing chemicals is linked to short-term adverse health effects, such as sensitization reactions and breathing problems, and long-term adverse health effects, including an increased risk of certain cancers. As hair smoothing products increased in popularity in the late 2000’s, FDA began receiving inquiries from consumers and salon professionals about the safety of products containing formaldehyde or related ingredients. In response to these concerns, in 2010, the Agency began communicating with the public to provide information about the potential health effects of these products and how to recognize products containing formaldehyde or its liquid forms. Since then, FDA has engaged in additional public outreach, including a series of focus groups with salon owners, salon stylists, and salon customers.  In 2021, FDA received a citizen petition from the Environmental Working Group and Women’s Voices for the Earth requesting that FDA take regulatory action to ban formaldehyde, formaldehyde equivalents, and other chemicals that emit high levels of formaldehyde in hair smoothing products and hair straightening products.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 700   
Legal Authority: 21 U.S.C. 361    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2024 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Elizabeth Anderson
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
4300 University Station, River Road,
College Park, MD 20740
Phone:240 402-4565
Email: elizabeth.anderson@fda.hhs.gov