Congressional Leaders Request FDA to Issue Voluntary Recall of Brazilian Blowout and Other Hair Smoothing Products Containing Formaldehyde

May 11, 2011

By Cassandra A. Soltis

In a May 6, 2011, letter to Dr. Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration (“FDA” or “the Agency”), 10 congressional leaders requested the Agency to “take immediate action” against Brazilian Blowout Solution, Acai Professional Smoothing Solution, and other hair smoothing/straightening products “that have high levels of formaldehyde based on testing information already available.”  This letter follows Representative Earl Blumenauer’s October 5, 2010, letter to Dr. Hamburg, in which Rep. Blumenauer explained that testing by the Oregon Occupational Safety and Health Administration (“Oregon OSHA”) found “significant levels of formaldehyde in bottles of Brazilian Blowout Solution labeled ‘formaldehyde-free’” and requested FDA to investigate the issue. 

The most recent letter to FDA states that Oregon OSHA and the Oregon Health and Science University’s Center for Research on Occupational and Environmental Toxicology “confirmed” that both Brazilian Blowout Solution and Acai Professional Smoothing Solution “contained between 4.85% and 10.6% formaldehyde,” levels well above the 0.2% limit recommended by the Cosmetic Ingredient Review, which is an “industry-funded body tasked with reviewing the safety of ingredients in cosmetics.”  The letter also stated:  “Subsequent air monitoring of salons by federal Occupational Safety and Health Administration (OSHA) led the agency to issue a Hazard Alert warning salons not to use formaldehyde-based hair straighteners, and outlined strict requirements salons must follow if they want to continue their use.”  According to federal OSHA, formaldehyde may be listed on labels as methylene glycol, formalin, methylene oxide, paraform, formic aldehyde, methanal, oxomethane, oxymethylene, or CAS Number 50-00-0. 

In addition to requesting that FDA issue a “voluntary recall” of products containing high levels of formaldehyde, the congressional leaders asked that FDA continue to test hair straighteners for formaldehyde, require warnings on labels for such products that contain formaldehyde, investigate the labeling practices of companies marketing their products as formaldehyde-free, and review whether to ban formaldehyde and formaldehyde-releasing chemicals from hair products, “given the significant health hazard they pose.”

Other than color additives, FDA does not pre-approve cosmetics or cosmetic ingredients.  Although FDA does not have the authority to order a mandatory recall of cosmetics, the Agency can request companies to voluntarily recall products, and if the companies refuse, FDA can issue its own public notice describing the risk and recommending that recipients return the products.  In addition, FDA can take enforcement action, such as a seizure or injunction, if the Agency has evidence that the products are adulterated or misbranded.

Categories: Cosmetics