Hair Smoothing Products That Could Release Formaldehyde - Background
In October 2010, OSHA became aware of the emerging issue of formaldehyde gas being released from keratin-based hair smoothing products. Federal OSHA and State OSHA programs continue to investigate complaints from stylists and hair salon owners about exposure to formaldehyde while products such as: Brazilian Blowout (Acai Professional Smoothing Solution, Professional Brazilian Blowout Solution), Brasil Cacau Cadiveu, Keratin Complex Smoothing Therapy (Natural Keratin Smoothing Treatment, Express Blow Out, Natural Keratin Smoothing Treatment Blonde), and Marcia Teixeira (Advanced Brazilian Keratin Treatment, Extreme De-Frizzing Treatment). OSHA has conducted air sampling at multiple salons and found formaldehyde in the air when stylists were using hair smoothing products. Some of these products were labeled "formaldehyde free" or did not list formaldehyde on the product label or in the Material Safety Data Sheet (MSDS). In most cases, where the label did not state that the product had formaldehyde in it, OSHA found that hair salon owners using those products did not know that hair smoothing products contain or could expose workers to formaldehyde because manufacturers, importers, and distributors did not include the correct hazard warnings on the product's label or MSDS.
During Federal OSHA investigations, air tests showed formaldehyde at levels above OSHA's limits in salons using Brazilian Blowout Acai Professional Smoothing Solution, labeled "formaldehyde free," and Brasil Cacau Cadiveu. Both Federal and State OSHA have found violations at several manufacturers, importers, and distributors (GIB LLC dba Brazilian Blowout, Keratronics Inc., Pro Skin Solutions, M&M International Inc., Copomon, INOVA Professional). Some of violations include failing to list formaldehyde as a hazardous ingredient on the MSDS provided to downstream users (e.g., salon owners, stylists), failing to include proper hazard warnings on product labels, and failing to list the health effects of formaldehyde exposure on the MSDS. Labels must include ingredient and hazard warning information and the MSDS must provide users with information about the chemicals in a product, the hazards to workers, and how to use a product safely.
On August 22, 2011 the Food and Drug Administration issued a warning letter to GIB LLC dba Brazilian Blowout, a Florida-based importer and distributor of the hair straightening product Brazilian Blowout. The warning letter states that the product “Brazilian Blowout” is an adulterated cosmetic because it contains a hazardous substance that may adversely affect users when it is used as described in the labeling. FDA found that Brazilian Blowout contains methylene glycol, the liquid form of formaldehyde, which releases formaldehyde when hair treated with the product is heated with a blow dryer and then with a hot flat iron. The FDA warning letter also identifies this product as a misbranded cosmetic because its label and labeling (including instructions for use) make misleading statements regarding the product's ingredients and fail to warn users about any problems that may result from the use of the product. Specifically, Brazilian Blowout contains the liquid form of formaldehyde, methylene glycol, but the product label states that the product contains "No Formaldehyde" or is "Formaldehyde Free."
NIOSH published a health hazard evaluation in May 2011 summarizing an investigation conducted in December 2010 at a salon in Ohio during a single hair smoothing treatment with Brazilian Blowout Acai Professional Smoothing Solution. During the investigation, NIOSH tested both the air and the products used during the hair smoothing process. Air tests were done in the breathing zone of the stylist doing the process and an adjacent stylist, and in several locations throughout the salon. Test results for the stylist using the product showed formaldehyde at levels above the NIOSH ceiling limit of 0.1 parts per million parts (ppm) of air during all of the steps of the process (initial hair wash, products application, blow dry, flat ironing, mask application/hair wash, blow dry post hair wash) except the initial hair wash. All of the test results were below OSHA's limits. NIOSH also found formaldehyde at lower levels in the breathing zone of the adjacent stylist and at the areas tested throughout the salon, indicating that workers other than the stylist doing the process could be exposed to formaldehyde. NIOSH's test results for the products being used during the process showed that the Brazilian Blowout Acai Professional Smoothing Solution (labeled "Formaldehyde Free") contained 11% formaldehyde. The MSDS for this product did not list formaldehyde as a hazardous material. NIOSH also tested the Anti-Residue Shampoo and the Deep Conditioning Masque. NIOSH found formaldehyde in these products, but at levels below 0.1%.
NIOSH recommended that the salon stop using Brazilian Blowout Acai Professional Smoothing Solution - Formaldehyde Free Formula. If the salon continued to use the solution, NIOSH recommended that the salon follow the requirements of the OSHA formaldehyde standard, collect additional air tests, and use controls and respirators if the levels were found to be above the OSHA, NIOSH, or other occupational limits. NIOSH also recommended the use of gloves during the process. For additional information, see the NIOSH Health Hazard Report.
In July 2010, a stylist at a Portland area salon contacted the Center for Research in Occupational and Environmental Toxicology (CROET) at the Oregon Health Sciences University (OHSU) because she was having difficulty breathing, eye irritation, and nose bleeds when she used a keratin-based hair smoothing product. CROET investigated and found that the product's material safety data sheet (MSDS) did not state that any ingredients in the product were hazardous or give any related warnings. CROET asked for Oregon OSHA's help in finding what in the product could cause the stylist's symptoms. Oregon OSHA's laboratory found that the product was made of 6.3 to 10.6 percent dissolved formaldehyde. A second sample of the product, which was labeled as "formaldehyde free", was made of approximately 8.5 percent dissolved formaldehyde. Based on stylists' known exposures and symptoms, CROET gave a public alert and Oregon OSHA began a more complete investigation of keratin-based hair smoothing products. Oregon OSHA found that several different products were made of different amounts of dissolved formaldehyde, and sometimes, they threatened worker health and safety.
On April 13, 2011, Cal/OSHA reported that the testing of Brazilian Blowout's Acai Professional Smoothing and Brazilian Blowout Professional Smoothing Solutions found that formaldehyde was present in these products, and testing performed by federal OSHA found that use of these products caused workers to be overexposed to formaldehyde in the air they were breathing. Cal/OSHA further found that the company that distributes Brazilian Blowout did not list formaldehyde as an ingredient on the products' labels, and in fact Acai Professional Smoothing Solution was labeled as "Formaldehyde Free." They also did not list formaldehyde on the Material Safety Data Sheets (MSDS) that are required to accompany the products when sold. These are violations of California's Hazardous Substances Information and Training Act and occupational safety and health standards and have resulted in the issuance of citations to Brazilian Blowout.
In addition, the California Department of Public Health (CDPH) operates a Safe Cosmetics program that is required by law and orders cosmetic and beauty product makers to report when specific hazardous chemicals, like formaldehyde, are above certain levels in their products. The CDPH never received information from the company that makes the product. On November 10, 2010, the California Attorney General filed a lawsuit against the company for failure to warn consumers about the presence of formaldehyde in its products. On April 5, 2011, the state filed a preliminary injunction against the distributor of Brazilian Blowout. As of June 2, 2011, the case is ongoing.
The Cosmetic Ingredient Review was established in 1976 to provide an independent review process for the industry. The CIR's Expert Panel met in June, 2011 and revised its Tentative Amended Safety Assessment for formaldehyde and methylene glycol. The revised Tentative Amended Safety Assessment states, in part, that "formaldehyde and methylene glycol are unsafe for use in hair smoothing products, the use of which involves application of high temperatures."
A more thorough time line linking to documents concerning keratin-based hair smoothing product can be found on a separate page.
- Federal OSHA Formaldehyde Safety and Health Page
- Federal OSHA letter to Brazilian Blowout distributor seeking corrections of misleading statements
- Food and Drug Administration Warning letter issued to importer and distributor of Brazilian Blowout Hair Straightening Product
- California Department of Health Q&A on Keratin-based Hair Smoothing Products
- Cal/OSHA Update on Products that May Release Formaldehyde
- California Attorney General Memorandum of the Preliminary Injunction on the Distributors of Brazilian Blowout
- Connecticut Department of Public Health Health Advisory Cautioning About the Presence of Formaldehyde in Keratin-based Hair Smoothing Products
- Health Canada Keratin-based Hair Smoothing Products Advisory
- National Institute of Occupational Safety and Health Health Hazard Evaluation of Formaldehyde in Hair Smoothing Products at Salons
- New York State Health Department Consumer Health Alert: Hair Straightening Products and Formaldehyde
- Oregon OSHA Keratin-based Smoothing Product and the Release of Formaldehyde Report
- Oregon OSHA Hazard Alert
- Washington Department of Labor and Industries EBulletin for Stylists and Cosmetology Schools
- 9/22/11 OSHA issues updated hazard alert on formaldehyde dangers to hair salon owners, workers after new agency findings and FDA warning letter
- 9/08/11 OSHA cites Florida manufacturers and distributors of hair products containing formaldehyde for health violations
- 8/22/11 FDA issues Warning Letter to importer and distributor of Brazilian Blowout
- 5/10/11 Select Members of Congress Letter to FDA to act on Brazilian Blowout
- 4/13/11 Cal/OSHA Brazilian Blowout investigation completed
- 4/11/11 OSHA OSHA issues press release announcing Hazard Alert
- 03/14/11 Cosmetic Ingredient Review Board Reaffirmed 2005 Statement on Formaldehyde in Cosmetics
- 02/11/11 Oregon OSHA Reaffirms its Stance on Formaldehyde in Keratin-based Hair Smoothing Products
- 12/09/10 American Chemistry Council Decides in Favor of Oregon OSHA's Interpretation of Formaldehyde in Solution
- 11/13/10 California Attorney General's Office Files Suit Against Supplier of a Keratin-based Hair Smoothing Product
- 10/29/10 Oregon OSHA Reiteration of Caution When Using Keratin-based Hair Smoothing Products
- 10/05/10 Oregon OSHA Develops Local Emphasis Program for Keratin-based Hair Smoothing Products