FDA WARNING_LETTER - Brazilian Blowout

On August 22, 2011, the FDA issued a Warning Letter to GIB, LLC dba Brazilian Blowout, regarding their product, Brazilian Blowout Acai Professional Smoothing Solution. The FDA determined the product is a cosmetic under Section 201(i) of the Federal Food, Drug, and Cosmetic Act (the Act).

The product was found to be adulterated under Section 601(a) of the Act and misbranded under Section 602(a) of the Act. Introducing or delivering adulterated or misbranded cosmetics into interstate commerce violates Section 301(a) of the Act.

Brazilian Blowout is adulterated because it contains methylene glycol, the liquid form of formaldehyde, at levels ranging from 8.7% to 10.4%. When heated, this releases formaldehyde, a deleterious substance that may cause injury. Reported adverse events include eye disorders, nervous system disorders, and respiratory tract issues.

The product is misbranded because its labeling falsely states "No Formaldehyde" or "Formaldehyde Free." Additionally, the labeling fails to disclose that formaldehyde is released during the heating process, which is a material fact regarding the product's use and potential consequences.

GIB, LLC is responsible for investigating and correcting these violations and preventing recurrence. Failure to take prompt action may result in enforcement actions like seizure or injunction. The company must respond in writing within fifteen working days, detailing corrective steps