Timeline: The FDA’s Failure to Regulate ‘Brazilian Blowout’ Hair Treatments

For more than a decade, the Food and Drug Administration and the cosmetics industry have known that keratin hair-smoothing treatments – commonly called “Brazilian blowout” treatments – release unsafe amounts of formaldehyde into the air, putting consumers and salon workers at risk. Emails obtained by EWG reveal that in 2015 and 2016, FDA scientists urged the agency to move forward with a ban and grew frustrated with the slow pace of regulation. Four years later, the products remain legal.

1984


The Cosmetic Ingredient Review, or CIR, publishes its first safety review of formaldehyde and finds: “It cannot be concluded that formaldehyde is safe in cosmetic products intended to be aerosolized.” CIR was created and funded by the cosmetics industry’s largest trade association, the Personal Care Products Council.

2003


CIR re-reviewed formaldehyde and confirmed its 1984 conclusions. In 2006, the finding was published in the International Journal of Toxicology.

July 7, 2008


Allure magazine runs a story on the dangers of Brazilian blowout. Dr. Linda Katz, director of the FDA’s Office of Cosmetics and Colors, is quoted.

May 18, 2009, or earlier


The FDA receives “adverse event” complaints from salon customers and workers.

June 17, 2009


Brazil bans the use of formaldehyde in hair-smoothing treatments but struggles to enforce the ban.

September 1, 2010


Oregon Health and Sciences University tests Brazilian Blowout and other hair-smoothing product samples. Tests find formaldehyde makes up more than 10 percent of some product samples.

September 27, 2010


The California Division of Occupational Safety and Health, or Cal/OSHA, acting on a referral from Oregon Occupational Safety and Health, or OR-OSHA, inspects GIB, LLC, an importer doing business as Brazilian Blowout. The agency issues 11 citations for violations, including “not communicating hazards to users.”

October 1, 2010


OR-OSHA discusses test findings and risks to salon workers on Good Morning America.

October 7, 2010


Health Canada issues a warning that Brazilian Blowout contains as much as 12 percent formaldehyde.

October 8, 2010


The FDA begins issuing public information about potential health effects and how to recognize products containing formaldehyde or its liquid form.

October 29, 2010


OR-OSHA issues a report that presents its findings from 105 product samples tested from 54 Oregon salons, which showed significant levels of formaldehyde in products labeled “formaldehyde free.” More than one-third of samples with significant formaldehyde levels come from Brazilian Blowout–brand products. OR-OSHA issues a press release reiterating concerns about formaldehyde levels in salons.

November 9, 2010


The Connecticut Department of Public Health cautions hair salon owners and workers about health effects associated with Brazilian Blowout.

November 10, 2010


The California attorney general sues GIB for violating five state laws, including failing to warn customers and stylists the product contains formaldehyde.

December 2010


At the request of the FDA, the CIR agrees to reopen the safety assessment of formaldehyde in cosmetics to address hair-smoothing products.

March 8, 2011


Email from Wendy Good, an FDA microbiologist, to Robert Bronaugh, a former staff director in the Office of Cosmetics and Colors, indicates that the FDA received its first adverse event report on a hair-smoothing treatment in 1993 and received 50 complaints on Brazilian Blowout in particular between May 2009 and November 2010.

April 11, 2011


U.S. OSHA issues its first hazard alert to salon owners and workers on hair-smoothing products that could release formaldehyde.

April 12, 2011


EWG files a citizen petition to the FDA for regulatory action on formaldehyde in keratin hair-straightening products. In the same month, EWG issues “Flat-Out Risky,” a report on what salon owners need to know to protect stylists and clients.

May 16, 2011


The National Institute for Occupational Safety and Health, or NIOSH, releases a Health Hazard Evaluation that shows six of seven short-term air quality tests conducted at a salon during use of Brazilian Blowout products exceeded exposure limits. The test results demonstrate the product is not “formaldehyde free,” as labeled.

June 20, 2011


Email from Beth Meyers, a writer-editor at the FDA, shows that the agency has developed an initial response to complaints from salon workers.

August 22, 2011


The FDA sends a warning letter to GIB finding the product is “adulterated” and “misbranded” in violation of the Federal Food Drug and Cosmetic Act.

September 8, 2011


OSHA issues a news release about issuing 16 health violations for two Florida manufacturers of formaldehyde-based hair-straightening treatments.

September 21, 2011


The FDA sends an interim response to EWG on its citizen petition.

September 22, 2011


OSHA issues a revised hazard alert on “Brazilian Blowout Acai Professional Smoothing Solution” and “Brasil Cacau Cadiveu.”

September 22, 2011


OSHA sends a letter to GIB directing the company to correct a letter to salon owners mischaracterizing the amount of formaldehyde measured in salons using their products.

September 26-27, 2011


The Cosmetic Ingredient Review finds that “formaldehyde and methylene glycol are unsafe for use in hair smoothing products, the use of which involves application of high temperatures.”

September 29, 2011


GIB responds to the FDA, asserting that Brazilian Blowout “is neither misbranded nor adulterated.”

November 2011


NIOSH releases a Health Hazard Evaluation Report documenting use of Brazilian Blowout products in an Ohio salon. NIOSH found that workers were exposed to formaldehyde in concentrations exceeding both the agency’s limit and that of the American Conference of Governmental Industrial Hygienists. NIOSH’s tests of a product by Brazilian Blowout claiming to be “formaldehyde free” contained 11 percent formaldehyde.

2011-2012


The FDA’s Office of Cosmetics and Colors conducts a limited lab survey testing for formaldehyde in hair straighteners.

January 30, 2012


California settles its lawsuit against GIB. The settlement requires GIB to cease deceptive advertising describing its products as formaldehyde free and safe, make changes to its website, and pay $600,000 in fees, penalties, and costs.

March 5, 2012


GIB agrees to a $4.5 million settlement in a private class-action lawsuit. The CEO tells The New York Times the settlement will be paid by his insurance company and they will “get to sell the product forever without reformulation,” which was “the acquittal we’ve been waiting for.”

March 7, 2012


EWG requests an update from the FDA on the status of its citizen petition.

February-March, 2012


Internal FDA emails between Beth Meyers and Don Havery discuss how to respond to incoming letters complaining of adverse reactions to Brazilian blowout treatments (email labeled March 16, 2012).

June 26-27, 2012


The European Union’s Scientific Committee on Consumer Safety adopts an opinion that methylene glycol (a liquid form of formaldehyde) is unsafe in hair-straightening treatments.

November 29, 2012


A court orders GIB to reformulate to comply with its settlement with California. A subsequent EWG analysis of GIB material safety data sheets finds that the company is still using 3 to 7 percent formaldehyde, down from 11.8 percent.

August 14, 2013


An FDA letter to GIB shows that response to its warning letter has been inadequate, so the FDA cannot close the matter.

December 19, 2014


An email from Nakissa Sadrieh, Ph.D., director of the Cosmetics Division of the FDA’s Office of Cosmetics and Colors, to Katz, the office’s director, shows that the office is working on a risk assessment of formaldehyde and retinyl palmitate.

February 13, 2015


The FDA is looking into formaldehyde levels in hair straighteners. In an email to Shontell Wright, an FDA chemist, and Beth Meyers, Sadrieh writes: “I’m glad that OSHA has some requirements. We sure don’t.”

March 10, 2015


Email from Sadrieh to Katz shows that the FDA is still unsatisfied with GIB’s response but will not issue a consumer alert and does not wish to alert the news media.

June 16, 2015


Email between Charles Silver, an attorney in the New York attorney general’s office, and Sadrieh shows that New York is investigating formaldehyde and exchanging information with the FDA.

June 18, 2015


Email from Sadrieh to Robeena Aziz, an FDA toxicologist; Kapal Dewan, another FDA toxicologist; and Katz emphasizes that formaldehyde review is a high priority.

August 7, 2015


Email from Jonathon Hicks, an FDA policy analyst, to Sadrieh says “substantial research” demonstrates that the chemical industry is hiding formaldehyde use.

September 2, 2015


The FDA sends a warning letter to Van Tibolli Beauty Corp. finding its GK hair-taming system products are “adulterated” and “misbranded” in violation of the Federal Food Drug and Cosmetic Act.

September 3, 2015


The FDA sends a response letter to GIB, informing them that Brazilian Blowout is still in violation of the law, despite label changes.

November 12, 2015


Internal FDA emails show the FDA preparing to do an undercover buy of formaldehyde hair-smoothing products.

December 14, 2015


Email from Sadrieh to Katz indicates she is working on a formaldehyde safety assessment to include in the citizens’ petition response.

February 29-March 9, 2016


The FDA inspects Van Tibolli’s facility in Florida.

March 30, 2016


A draft formaldehyde risk assessment is sent from Sadrieh to Katz.

June 2, 2016


Sadrieh sends Katz an updated draft formaldehyde risk assessment.

June 27, 2016


Sadrieh emails Katz with draft review and proposed response to the EWG citizens’ petition, and next steps.

July 15, 2016


Email from Sadrieh indicates that an internal briefing has been scheduled and that she will make the case for restrictions.

July 21, 2016


Email from Sadrieh to Katz demonstrates frustration over the agency’s approach to regulating cosmetics: “I find it amazing that when the [communications office] people are excited about cosmetics, then things get going. But when the scientists speak, nobody cares. Bloody amazing.”

July 26, 2016


Email from Sadrieh confirms that an internal briefing between FDA departments was held on formaldehyde that day and that the Center for Food Safety and Applied Nutrition “is proposing to develop regulations to ban the use of formaldehyde in hair smoothing products.”

August 3, 2016


An email from Katz to Bill Correll, director of the Office of Compliance in the Center for Food Safety and Applied Nutrition, and Mike Roosevelt, that office’s deputy director, about an upcoming warning letter campaign to support the regulation of formaldehyde.

August 3, 2016


An email exchange between Sadrieh, Katz and Carie Jasperse, an FDA attorney, discusses warning letters and whether they are being sent to support eventual regulation.

August 5, 2016


The FDA asks for an inspection of Van Tibolli’s contract manufacturer, Chemco Corp., in preparation for regulation.

August 18, 2016


Email from Allison Bonnenburg, regulatory counsel with the FDA, to Sadrieh indicates the FDA is drafting a proposed timeline for a formaldehyde rulemaking.

August 19, 2016


Email from Sadrieh to Katz discusses upcoming legal review of the FDA formaldehyde risk assessment: “Finally, someone who cares about the public.”

September 22, 2016


An email from Charlotte Christin, senior policy advisor, to Katz regarding next steps in preparation for rulemaking says: “Based on the results of an FDA safety review, FDA has determined that formaldehyde is a known carcinogen and should effectively be banned from use in hair smoothing products.” Footnote from Katz clarifies that the FDA may consider allowing some level of formaldehyde to remain in products.

October 5, 2016


In an email about an FDA draft safety review of formaldehyde Sadrieh tells Katz, “it is time to celebrate.”

October 5, 2016


An email from Sadrieh to Bonnenburg includes materials she can use to initiate rulemaking.

October 18, 2016


An email from Sadrieh to Dewan and Katz expresses frustration at delays within FDA getting permission and funding to sample hair-smoothing treatments to test for formaldehyde: “I have learned that it is impossible to fight with incompetence, laziness, and arrogance.”

December 14, 2016


EWG and Women’s Voices for the Earth sue the FDA for unreasonable delay in responding to the EWG citizens’ petition. An email from Sadrieh to Katz about the lawsuit faults the Office of the Chief Counsel for delay in regulation. Says citizens’ petitions “are coming back to haunt us.… Let’s just ban the damn ingredient and get on with our lives.”

December 16, 2016


Email from Sadrieh to Dewan, Meyers and Katz expresses frustration that the Office of Regulations, Policy and Social Sciences removed Bonnenburg from the formaldehyde regulation, casting doubt on whether it will be finished.

December 16, 2016


Email from Dewan says the Brazilian blowout warning letter was issued with “great pain but with our determination to follow through the case.”

December 20, 2016


Email from Sadrieh to Katz expresses frustration with review by Phil Chao, an FDA lawyer who is working on the rule.

December 21, 2016


An email from Lauren Ferguson Baham, an FDA regulatory counsel, to Sadrieh indicates that she is working on a proposed ban and seeking background information.

December 22, 2016


An email exchange between Sadrieh and Tyna Dao, an FDA toxicologist, expresses frustration with the intra-agency process.

2016-2017


The FDA conducts a series of focus groups on salon owners, stylists, consumers and customers to determine their perceptions of formaldehyde hair-smoothing products. The questions focus on potential hazards and participants’ reactions to various types of warning labels.

March 28, 2017


The FDA responds to EWG’s citizen petition, granting it in part and denying it in part. The agency says it is “in the process of completing its scientific evaluation in these areas and analyzing the risks posed to users under the conditions of use as labeled or as customary or usual. The agency will then consider what, if any, additional action is appropriate, including whether or not to propose a rule prohibiting the use of formaldehyde and formaldehyde-releasing chemicals in hair smoothers or requiring warning labels for such products.” The FDA agrees to review whether to ban formaldehyde but denies EWG’s request to require a warning label.

March 19, 2018


The EWG/WVE lawsuit is dismissed on grounds of lacking standing.

May 26, 2020


The FDA closes out its warning letter against Van Tibolli, finding that the firm took corrective actions addressing the violations in the warning letter.

August 31, 2020


California passes the Toxic-Free Cosmetics Act. It was signed into law by Gov. Gavin Newsom.