Since 2010, the beauty and cosmetic business was afire with the news that the “Brazilian Blowout” hair treatment released the known carcinogen formaldehyde when used. (Brazilian Blowout is the trademark of GIB, LLC (GIB) but is commonly used generically to describe keratin-based hair straightening 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).) It was a story that created a media blitz and caused consumer backlash. The treatment was exposing consumers to carcinogens and further, the Brazilian Blowout treatment was labeled “formaldehyde free,” when it was not.
In the midst of the media frenzy and for the first time, the cosmetics industry officially declared formaldehyde unsafe at any level in chemical hair straightening products, commonly referred to as keratin-based or the Brazilian Blowout. On September 21, 2011, the Cosmetic Ingredient Review (CIR), an unbiased advisory board established by the leading cosmetic manufacturers, declared that formaldehyde and methyl glycol are unsafe for use in the Brazilian Blowout and similar hair straightening or smoothing products. This came in the aftermath of several state and federal investigations, including the federal Occupational Safety and Health Administration (OSHA) and Food and Drug Administration (FDA) into the safety of these products to salon workers and consumers.
After a comprehensive review of the safety data, CIR scientists, dermatologists, pharmacologists and toxicologists evaluated the safety of methylene glycol and formaldehyde in hair straightening products on a number of factors, including the concentration of formaldehyde and methylene glycol, the amount of product applied, the temperature used during the application process, and the ventilation provide at the point of use. CIR concluded that under present practices of use and concentration, formaldehyde and methylene glycol are unsafe in hair straightening or smoothing products.
In early 2010, Brazilian Blowout and similar keratin-based hair straightening products initially came under fire when Oregon OSHA investigated a complaint from a salon worker who had nosebleeds, eye irritation, and trouble breathing while using a Brazilian Blowout product labeled “Formaldehyde-free.” After testing 100 samples of keratin-based hair straightening or smoothing products, including Brazilian Blowout, Oregon OSHA determined that many contained formaldehyde, a chemical associated with the salon worker’s complaints. Specifically, the products contain the chemical compound methylene glycol, an aqueous solution that is created when formaldehyde is hydrated. OSHA reported that when methylene glycol is heated during the product application, it reverts back into gas formaldehyde.
On October 8, 2010, Oregon OSHA published a hazard alert and alerted federal OSHA finding the hazard information listed on the products were incorrect and failed to meet federal OSHA requirements. FDA was also alerted and called into action to determine whether the products were unsafe and improperly labeled by failing to include formaldehyde as one of the products’ ingredients. Additionally, FDA acknowledged consumer complaints on its website and stated it was working with federal OSHA to determine the composition of the products and whether the products or ingredients would be likely to cause health problems. Studies by the Department of Health and Human Services, OSHA, FDA and several action groups, including the Environmental Working Group and the American Chemistry Council, began investigating the safety concerns and practices in salons.
FDA set the task of assessing the safety of formaldehyde and methylene glycol ingredients to the CIR Expert Panel, under the aegis of the U.S. Personal Care Products Council. The CIR had previously reviewed the use of formaldehyde as a preservative agent in cosmetic products in 2005 and concluded it safe in levels not to exceed 0.2 percent. However, it did not evaluate formaldehyde safety in cosmetic products intended to be aerosolized – which is precisely what occurs during the application of the hair straightening or smoothing product. The application process requires the hair to be heated and dried at high temperatures which thereby causes the product to emit formaldehyde gas into the air. The hair straightening product fumes may be inhaled by the customer or salon worker and cause harm.
Despite complaints, investigations and media attention, Brazilian Blowout and other manufacturers continued to tout their products as “formaldehyde-free.” (Initially in 2010, Brazilian Blowout asserted that the products were formaldehyde-free since they contained methylene glycol, an organic compound wholly distinct from formaldehyde. After researchers pointed out that methylene glycol is simply formaldehyde mixed with water, Brazilian Blowout changed its position. Brazilian Blowout revised its position stating their products contained less than 0.2 percent formaldehyde, levels deemed safe for cosmetic use—a statement in line with the 2005 formaldehyde evaluation.) Called into action by consumer complaints to address concerns, FDA conducted a sample analysis of Brazilian Blowout. The results revealed contradictory information and confirmed the presence of methylene glycol at levels ranging from 8.7 to 10.4 percent.
On August 22, 2011, FDA sent an official Warning Letter to the Brazilian Blowout manufacturer GIB citing violations of adulteration and misbranding for failing to include the presence of a “deleterious substance,” methylene glycol. Specifically, FDA cited the product adulterated by containing methylene glycol, a liquid form of formaldehyde, and misbranded by stating on its label that it does not contain formaldehyde.
Specifically, FDA noted that the product is adulterated within the meaning of Section 601 (a) of the Federal Food, Drug and Cosmetic Act [21 U.S.C. § 361 (a)] for containing a poisonous or deleterious substance that may render it injurious to users. That substance methylene glycol was found by the FDA at 8.7–10.4 percent in an analysis of 50 mg samples.
According to the Warning Letter, formaldehyde is released into the air when the product is applied to the hair and heated by a blow dryer and a flat iron, as directed on the product's packaging. The inhalation of formaldehyde reacts with biological tissues, particularly the mucous tissues lining the respiratory tract and the eyes, which can cause a number of adverse events, including eye irritation, nervous system disorders and respiratory problems.
The product was found to be misbranded within the meaning of Section 602(a) of the act [21 U.S.C. § 362(a)]. Specifically, the product was considered misbranded for declaring on its label that it contains "No Formaldehyde and is "Formaldehyde Free." FDA found this to be a false and misleading statement, given that the product contains methylene glycol. FDA also noted that the product also is misbranded for not disclosing information on the product's label about the release of formaldehyde as a result of heating the product.
The Warning Letter gave the manufacturer, GIB, 15 days to advise the agency of steps to correct labeling and content violation, specifically the “Formaldehyde Free” claim and the unacceptable formaldehyde levels. FDA also demanded assurance of future regulatory compliance and documentation that the corrections have been achieved.
GIB broadcasted a public response to the FDA’s warning letter. On August 24, 2011, GIB sent salon owners a letter and issued a statement on its website indicating that the company would be working directly with the FDA to clear up the controversy. The statement also included GIB’s own testing analysis, which differed from the FDA sample analysis. GIB suggested that possibly the media inaccurately reported that its product contained 8–10 percent formaldehyde when “the measure of potential formaldehyde released at that level never occurs in a real world application.” GIB further stated that federal OSHA was aware of the only accurate testing method for formaldehyde exposure— “controlled air monitoring”—and that its product fell beneath even the most stringent OSHA safety standards when measured in this way.
OSHA promptly sent a letter on September 22, 2011, to GIB refuting the manufacturer’s safety assertions as misleading. GIB’s statement was completely contrary to OSHA’s previous findings that workers using the Brazilian Blowout “were exposed to formaldehyde levels that exceeded OSHA’s 15 minute short term exposure limits of 2 ppm.” OSHA followed up and issued a revised hazard alert to hair salon owners and workers about potential formaldehyde exposure from working with certain hair straightening products, including Brazilian Blowout. The OSHA news release stated that the revised alert was prompted by the agency investigation results, FDA warning letter, and factually incorrect information sent to salons by the Brazilian Blowout manufacturer. According to the revised alert, OSHA air tests revealed formaldehyde levels above OSHA’s limits in salons using Brazilian Blowout. The revised alert further listed the various health hazards of formaldehyde and how salon workers could protect themselves while using hair straightening or smoothing products that contain or release formaldehyde.
Bolstering FDA and OSHA warnings, the CIR concluded its intensive study and made its official findings available on September 26, 2011, deeming the hair straightening products unsafe. Brazilian Blowout and other hair straightening products containing formaldehyde continue to be available in salons across the country, despite FDA warnings. FDA typically urges such manufacturers to initiate a voluntary recall, and if they do not comply, FDA has other measures at its disposal to force a recall. In order to prompt a mandatory recall, FDA must pursue action through the Department of Justice in federal court to remove the adulterated and misbranded products from the market. In addition, FDA can request a federal district court to issue a restraining order against the manufacturer to prevent further shipment of the product. However, there is no indication that this has or will occur.
Brazilian Blowout and FDA are at a stalemate with neither side making any moves towards removal of the unsafe products. Formidable cosmetic action groups such as the Campaign for Safe Cosmetics and the National Healthy Nail and Beauty Salon Alliance urged FDA to take action and initiate a mandatory recall of the Brazilian Blowout’s products. Congressional members Jan Schakowsky (D–IL), Ed Markey (D–MA) and Earl Blumenauer (D–OR) also have demanded that GIB voluntarily remove its product from the market, to no avail. Nonetheless, GIB refused to recall its product, stating “We’re going to continue to offer a product that gives people the hair of their life . . . .”
In addition to the FDA warning letter, GIB also was sued by the state of California, where the company is headquartered. In February 2012, GIB settled and agreed to cease advertising two of its products as formaldehyde free and safe. The company also agreed to make changes to its website and pay $600,000 in fees, penalties and costs.
To date, FDA has taken no action against Brazilian Blowout. FDA neither requested a voluntary recall of the products, nor made steps to initiate judicial intervention to remove the products from the market. Respecting its limited authority over the cosmetics industry, FDA continues to provide consumers updated safety information to reduce health risks associated with formaldehyde hair treatment products, suggesting consumers limit exposure and products labels with formaldehyde, formalin and methylene glycol. Likewise, GIB revised its product use materials to include the updated safety information.
On March 27, 2012, the Congressional Subcommittee on Health held a hearing—Examining the Current State of Cosmetics—gathering FDA, industry trade groups and other organizations to debate whether there is a need for a national standard, preemption of state legislation and an overall renewal of FDA’s regulatory authority over the personal care and cosmetic industry. This ongoing debate comes on the heels of the proposed “Safe Cosmetics Act of 2011,” which sought to give FDA authority to demand pre-market safety assessments of cosmetics ingredients, issue recalls of unsafe products and ban the use of ingredients linked to cancer and birth defects. It also would mandate ingredient labels on cosmetics and post-marketing testing, and would allow individual states to pass their own regulatory laws. The Safe Cosmetics Act was initially proposed in 2010. It was revised and resubmitted in 2011, but has yet to be approved by Congress. The cosmetics industry would see more benefits with a nationwide safety standard for their products that would preempt state laws that could vary from state to state. It would be difficult for cosmetic companies to formulate innovative products if different standards apply in different states.
Yet, while the proposed legislation appears reasonable on its face, it arguably would impose costly and unnecessary restrictions on the cosmetics industry. There is a legislative mechanism already in place regulating cosmetics. Cosmetic companies are already bound by the existing “Food, Drugs and Cosmetics Act of 1938,” which requires manufacturers to list most of the ingredients on product labels, and to substantiate the safety of their products before marketing.
While the Brazilian Blowout battle may seem trivial to most cosmetic manufacturers, those who already make great efforts to ensure product safety, it could have broad implications to the cosmetics industry. The obligation to assure cosmetic safety lies squarely on the shoulders of the cosmetic companies. The cosmetic industry remains largely self-regulated. In order to be effective, cosmetic companies must try to be transparent and forthcoming in providing consumers with specific information as to what their safety testing entails and standards utilized in testing. From a pragmatic perspective, cosmetic products that use known, safe ingredients will be less likely to face difficulties like those facing Brazilian Blowout. In keeping up with cutting-edge trends and science, companies may want to consider extra safety precautions when introducing innovative ingredients to their products. But most importantly, cosmetic product labeling should be comprehensive and conspicuous to allow consumers to consider the ingredients before using the product.
For hair straightening manufacturers, many companies have considered the risks and are looking to distance themselves from their “Brazilian” roots. Many have altered their product lines to be formaldehyde free—removing methylene glycol, formol, formalin or any other substance that produces formaldehyde from their products. Some other companies have gone as far as changing their packaging to include a “Proven Safe by OSHA” stamp to verify product safety. Then again, the Brazilian Blowout treatment containing formaldehyde remains popular because consumers simply like the treatment—even with the knowledge that it contains a carcinogen. At the end of the day, consumers have the right to use any products they choose, and should be allowed to buy those products, provided they understand any potential risks.