The FDA has issued its first official warning to Brazilian Blowout, the manufacturers of the Brazilian Blowout Acai Professional Smoothing Solution, calling the product an unadulterated and misbranded cosmetic. The warning gives the company until September 12 to comply with the directives in the FDA letter; if the company does not comply, the product will be removed from U.S. shelves and additional action will be taken by the FDA.
The warning comes after the FDA conducted its own analysis of approximately 50-mg samples of the Smoothing Solution. According to FDA guidelines, a product is considered adulterated if it contains poisonous or deleterious substances; the FDA analysis of Brazilian Blowout found that the product contained methylene glycol, the liquid form of formaldehyde, at levels from 8.7% to 10.4%. Also according to FDA guidelines, a product is considered misbranded if its labeling is incorrect or misleading in any way. The FDA analysis of the Smoothing Solution found that the labeling of the product — including directions for use — contains misleading statements about the ingredients and does not reveal material facts about consequences that may result upon use of the product. Specifically, according to the FDA, Brazilian Blowout contains the liquid form of formaldehyde (methylene glycol) but the label on the product declares that it is formaldehyde-free.
In regard to the labeling of the Brazilian Blowout as adulterated, the FDA warning letter states that the primary route of exposure to formaldehyde when the product is used correctly is through inhalation. According to the FDA, the chemical reacts readily with biological tissues, especially in the mucous tissues in the respiratory tract and eyes, and the following adverse events have been reported in association with the Brazilian Blowout: eye disorders (irritation, increased lacrimation, blurred vision and hyperaemia); nervous system disorders (headache, burning sensation, dizziness and syncope); and respiratory tract disorders (dyspnea, cough, nasal discomfort, epitaxis, wheezing, rhinorrhea, throat irritation and nasopharyngitis).
According to the National Healthy Nail and Beauty Salon Alliance (NHNBSA), the controversy over the Brazilian Blowout Smoothing Solution began almost a year ago. NHNBSA also reports that the product has been banned in Australia, Canada, Ireland, France and Germany.
For more information on the large number of potential irritants and allergens encountered during a hairdressing sessions, see Allergen Focus: Hair Styling Dermatitis featured in the September issue of Skin & Aging.
