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FDA Issues Brazilian Blowout Warning Letter

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WASHINGTON—On Aug. 22, 2011, FDA issues a warning letter to GIB LLC for its Brazilian Blowout Acai Professional Smoothing Solution (Brazilian Blowout) product, stating its adulterated and misbranded, and in violation of Section 301(a) of the Act [21 U.S.C. § 331(a)].

The letter stated: “Brazilian Blowout is an adulterated cosmetic because it bears or contains a deleterious substance that may render it injurious to users under the conditions of use prescribed in your labeling. Specifically, based on FDA sample analysis, Brazilian Blowout contains methylene glycol, the liquid form of formaldehyde, which, under the conditions of use prescribed in the labeling, releases formaldehyde when hair treated with the product is heated with a blow dryer and then with a hot flat iron. Methylene glycol is a deleterious substance, which at the levels present in this product, may harm users under the conditions of use prescribed in the labeling thereof. FDA analysis of approximately 50 mg samples of Brazilian Blowout confirmed the presence of methylene glycol, the liquid form of formaldehyde, at levels ranging from 8.7 to 10.4 percent."

 FDA gave the company until Sept. 12 to comply with its directives, otherwise the products could be removed from marketplace shelves. FDA said adverse events have been reported, with iinjuries associated with Brazilian Blowout including: eye disorders, nervous system disorders and respiratory tract. Other reported symptoms included nausea hypotrichosis, chest pain, chest discomfort, vomiting and rash.

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