FDA has received inquiries from consumers and salon professionals concerning the safety of hair-smoothing products containing formaldehyde or related ingredients, which may release formaldehyde gas into the air when heated.
The U.S. Occupational Safety and Health Administration (OSHA) issued a Hazard Alert to hair salon owners and workers about potential formaldehyde exposure from working with these products. FDA has issued warning letters to GIB, LLC dba Brazilian Blowout and to Van Tibolli Beauty Corp., citing safety and labeling violations.
FDA continues to evaluate hair products that release formaldehyde when heated. The following information is intended to answer questions people may have on this subject.
FDA's Role in Regulating These Products
FDA regulates cosmetics, including hair-smoothing products, under the authority of the Federal Food, Drug, and Cosmetic Act and, if they are marketed on a retail basis to consumers, under the Fair Packaging and Labeling Act. Under these laws, cosmetics do not have to be approved by FDA before being marketed.
However, cosmetics must be safe and properly labeled, and companies and individuals who manufacture or market them have a legal responsibility for the safety and labeling of their products and ingredients. FDA can take action against cosmetics on the market that do not comply with the law. To learn more, see FDA Authority Over Cosmetics.
What the Warning Letters Say About These Products
FDA issues warning letters to notify firms or individuals that they have been found to be in violation of the laws FDA enforces. A warning letter also tells what violations need to be corrected in order to comply with the law.
The warning letters issued by FDA address products that contain methylene glycol, which, when heated, releases formaldehyde into the air. Because these products must be applied with heat, formaldehyde is released when people use them following directions on the label.
Both of these warning letters cite safety and labeling violations. In addressing safety, the letters note that hair-smoothing products containing formaldehyde have been associated with reactions such as eye problems, nervous system problems (for example, headaches and dizziness), respiratory tract problems, nausea, chest pain, vomiting, and rash. Labeling violations include, for example, failure to warn consumers of potential health risks.
Regulation of Salon Safety
Workplace safety in general, including air quality issues, is regulated by OSHA. Salons are also generally subject to state and local authorities, which may specify safety practices such as assuring proper ventilation. FDA does not have authority over the operation of salons or the practice of cosmetology.
What OSHA Says About These Products
OSHA states that formaldehyde presents a health hazard if workers are exposed. It can irritate the eyes and nose; cause allergic reactions of the skin, eyes, and lungs; and is linked to nose and lung cancer.
For OSHA's complete statement, see Hazard Alert: Hair-Smoothing Products That Could Release Formaldehyde.
Similar Products That Use Formaldehyde-related Ingredients
These warning letters should not be interpreted as a broad evaluation of the safety of hair-smoothing products in general. Other hair-smoothing products may vary with respect to composition, intended conditions of use, and other factors. FDA continues to evaluate these products for safety and labeling on a case-by-case basis.
FDA's Advice to Consumers
Skin sensitivity can develop after repeated contact with formaldehyde-related ingredients. When formaldehyde is released into the air it can cause serious irritation of your eyes, nose, and lungs. The greater the exposure, in terms of both duration and concentration, to products that contain formaldehyde-related ingredients, the higher the health risks.
For example, studies of workers exposed to high levels of formaldehyde, such as industrial workers and embalmers, found that formaldehyde causes myeloid leukemia, and rare cancers including sinonasal and nasopharyngeal cancer. (See “Formaldehyde,” on the National Institute for Environmental Safety and Health website.)
Read the label. If you're purchasing a product on a retail basis, whether at a store or by mail order, including on the Internet, the product is required to have a list of the ingredients. If it doesn't, please let FDA know. The list of ingredients is required under the Fair Packaging and Labeling Act. Here are some ingredients to look for:
- Formaldehyde
- Formalin
- Methylene glycol
Ask your salon professional. Products that are marketed only to salon professionals may not have a list of ingredients, because the Fair Packaging and Labeling Act applies only to products marketed on a retail basis to consumers. Professional use products, however, are required to have directions for safe use and any necessary warning statements, and OSHA requires them to have an SDS (also called an MSDS). You can ask salon professionals if they know whether a product contains formaldehyde-related ingredients or other ingredients you may wish to avoid.
Report bad reactions. Consumers are one of FDA's most important sources of information. To report a reaction to a cosmetic product, use one of these contacts:
1) Reporting by phone to the Consumer Complaint Coordinator at your nearest FDA district office. Phone numbers are posted on FDA's Web page, Consumer Complaint Coordinators. 2) Reporting online to FDA's MedWatch adverse event reporting system. You also may call MedWatch at 1-800-332-1088 to request a reporting form by mail.
Salon workers also can file complaints about unsafe workplaces with OSHA, as stated in OSHA’s Hazard Alert.
Where to Learn More
For information on workplace exposure to formaldehyde, see Formaldehyde on OSHA’s website. The National Institute for Occupational Safety and Health (NIOSH) at the Centers for Disease Control and Prevention also has published resources on formaldehyde on its website under Formaldehyde: NIOSH Resources.
FDA will continue to monitor safety issues regarding hair-smoothing products and will report on any new developments.
