Timeline: The FDA’s failure to regulate ‘Brazilian blowout’ hair treatments

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.

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

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.

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

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

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.

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.”

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

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

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

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.

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

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

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

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.

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

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.

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.

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

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.

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

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

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

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.

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.”

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

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.

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

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.

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.”

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

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).

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.

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.

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

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.

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.”

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.

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.

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

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

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.

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

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

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

The FDA inspects Van Tibolli’s facility in Florida.

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

Sadrieh sends Katz an updated draft formaldehyde risk assessment.

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

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

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.”

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.”

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.

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.

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

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

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

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.

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

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

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.”

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.”

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.

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

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

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.

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

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.

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.

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

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

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