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FDA Warns Brazilian Blowout for Methylene Glycol Formulation
Posted: September 8, 2011
The US Food and Drug Administration (FDA) has sent a warning letter to Brazilian Blowout for its Açai Professional Smoothing Solution. The FDA finds the product to be misbranded by stating on its label that it does not contain formaldehyde and is adulterated by containing methylene glycol, a liquid form of formaldehyde.
The 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% in an analysis of 50 mg samples. According to the FDA, 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." The FDA found this to be a false and misleading statement given that the product contains methylene glycol. The FDA also noted that the product is also misbranded for not disclosing information on the product's label about the release of formaldehyde as a result of heating the product.
Brazilian Blowout is advised to respond within 15 days of the letter with actions it intends to take to rectify the violations. Failure to do so can result in seizure and/or injuction.