FDA WARNING_LETTER - Van Tibolli Beauty Corp

On September 2, 2015, the FDA issued a Warning Letter to Van Tibolli Beauty Corp. regarding their GK Hair Taming System with JUVEXIN® Curly and Resistant hair smoothing products. The FDA determined these products are cosmetics under Section 201(i) of the Federal Food, Drug, and Cosmetic Act (the Act).

The products were found to be adulterated under Section 601(a) of the Act because they contain methylene glycol, which releases formaldehyde when heated. FDA analysis confirmed 3.9% and 4.85% methylene glycol in the Curly and Resistant products, respectively. Formaldehyde is a deleterious substance and a recognized carcinogen, with reported adverse events including eye, nervous system, and respiratory disorders. The product labeling was deemed inadequate as it failed to instruct users on proper ventilation, avoiding direct eye/skin contact, and avoiding unnecessary repeated use.

Furthermore, the products were deemed misbranded under Section 602(a) of the Act because their labeling is false or misleading. The warning statement on the labels is insufficient, failing to fully disclose the adverse effects of formaldehyde release (short-term and long-term health effects, including potential cancers) and the increased risk from concurrent use of multiple products in the same facility. The FDA noted that despite being targeted for professional use, the products are available to the general public, increasing the need for comprehensive warnings.

Van Tibolli Beauty Corp.