Following a California court order requiring [GIB LLC] to cease sales of its original Brazilian Blowout hair-smoothing formula in the state by year-end, members of Congress want to know what FDA is doing to protect the health of salon workers and frizzy-haired consumers nationwide.

In a Dec. 11 letter to FDA, Reps. Edward J. Markey, D-Mass., Jan Schakowsky, D-Ill., and Earl Blumenauer, D-Ore., press the agency to disclose its stance on Brazilian Blowout – and the steps it has taken to ensure that the public is not being exposed to hazardous chemicals through associated hair-straightening treatments – since hitting GIB with a warning letter in August 2011.

“FDA’s inaction on this matter is putting the health of thousands of salon workers and consumers at risk of dangerous formaldehyde exposure from the continued use of not only Brazilian Blowout, but other hair-straightening treatments that contain formaldehyde,” the reps state.

Rep. Markey and colleagues request an update from FDA on the flagship Brazilian Blowout product and urge the agency to investigate GIB’s reformulated product Zero+, marketed with the claim “0% formaldehyde released before, during or after the treatment.”

In FDA’s warning to GIB more than a year ago, the agency identified the firm’s flagship Brazilian Blowout Acai Professional Smoothing Solution as adulterated because it contained high levels of methylene glycol, which converts to formaldehyde when heated in the course of salon procedures, posing potential health risks Also see "FDA Warning To “Formaldehyde-Free” Brazilian Blowout Cites High Methylene Glycol Levels" - HBW Insight, 12 September, 2011..

Moreover, the product was misbranded, the agency said, because it was labeled and marketed misleadingly as “formaldehyde-free.”

GIB was directed to provide FDA with an explanation of the measures the firm was taking to correct the violations and “to assure that similar violations do not occur in the future.”

The North Hollywood-based company has since revised its labeling and now includes a material safety data sheet on its website alerting users to the product’s potentially hazardous properties due to the release of formaldehyde gas.

However, the original Brazilian Blowout formula remains on the market and FDA has not taken enforcement action as threatened – including possible “seizure and/or injunction” – or provided an update on the product’s regulatory status relative to its methylene glycol content.

“Does the FDA still believe…that Brazilian Blowout is adulterated because it contains methylene glycol?” the House members ask. “If yes, what subsequent action has FDA taken to protect the public from this product? If not, why not?”

The reps request documentation from FDA if GIB’s response to the agency’s warning adequately addressed all violations, or if FDA has initiated enforcement action against the company in the absence of such reforms.

Window Closing On Popular Hair Smoothers?

Concerns about formaldehyde-based hair-straightening products and Brazilian Blowout specifically rose in October 2010 when the Oregon Occupational Safety and Health Division released results from testing that found formaldehyde levels in such products far exceeding state standards. The tests were undertaken following reports of adverse events linked to product use.

Federal OSHA soon got involved, conducting its own tests, issuing a hazard alert and cracking down on manufacturers, distributors and salons deemed negligent in protecting professional stylists and consumers against formaldehyde exposure from hair-smoothing treatments.

FDA and the Personal Care Products Council asked the Cosmetic Ingredient Review Expert Panel to take a look at the issue. In October 2011, the panel came to a final determination, declaring methylene glycol/ formaldehyde unsafe for use in heated hair-smoothing products.

In its deliberations, the CIR group grappled with questions concerning its role and the information that should be taken into account in its review of cosmetic substances, concluding that while hair-smoothing products containing methylene glycol/formaldehyde can conceivably be used safely in salons by trained professionals in properly ventilated settings, such conditions are not currently assured Also see "Final CIR Assessment: Formaldehyde Unsafe In Heated Hair-Smoothers" - HBW Insight, 3 October, 2011..

In their letter, Markey, Schakowsky and Blumenauer ask: “What is FDA’s process for evaluating the safety of a cosmetic ingredient when it has already been deemed to be unsafe by industry’s ingredient review board?”

California has gone after Brazilian Blowout specifically. In January 2012, the state’s Attorney General reached a settlement with GIB in legal action taken under California’s Safe Cosmetics Act, requiring the manufacturer to affix “CAUTION” stickers to its products warning users of potential risks and to subject its formulas to testing to determine if they emit volatile organic compounds at levels exceeding state limits Also see "California AG Slaps Brazilian Blowout With Fees, “CAUTION” Labels" - HBW Insight, 6 February, 2012..

In November, the AG ordered GIB to cease sales of Brazilian Blowout in California by year-end, based on test results indicating that VOC levels associated with Brazilian Blowout use are in fact higher than permitted.

Under the order filed in Los Angeles Superior Court, GIB also must test its new reformulated Brazilian Blowout products to ensure they comply with state VOC standards Also see "California Orders Original Brazilian Blowout Formulation Off Market" - HBW Insight, 10 December, 2012..

GIB’s new Brazilian Blowout Zero+ is advertised with the claim: “0% formaldehyde released before, during or after the treatment.”

The House members ask: “Has the FDA evaluated this claim and the company’s labeling practices to determine whether this product may also be considered adulterated and/or misbranded?”

They also request an update on FDA’s investigations into other methylene glycol/formaldehyde-based hair-straightening products on the market, as well as the agency’s position on hair smoothers marketed for home use and the need for appropriate warnings on product labeling.

The reps encourage the agency to provide “a full and complete response” by Dec. 21.

FDA was first contacted by Markey, Schakowsky and former Rep. Tammy Baldwin, D-Wis. – who was elected to the Senate in November – in May 2011, at which time they urged the agency to initiate a voluntary recall of Brazilian Blowout and similar hair-straightening products that release high levels of formaldehyde while claiming to be “formaldehyde-free” Also see "House Democrats Call For FDA Action On Hair-Straightening Formaldehyde" - HBW Insight, 16 May, 2011..

Markey and Baldwin were cosponsors of Schakowsky’s Safe Cosmetics Act, which calls for tighter regulation of cosmetics, including safety data submissions from manufacturers, registration and associated fees Also see "Lawmakers Introduce Revamped Safe Cosmetics Act" - HBW Insight, 27 June, 2011..The legislation is backed by the Campaign for Safe Cosmetics.

House Reps Request Clarification From FDA On Brazilian Blowout Status

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