arrow-left-endarrow-right-end

News & Updates

The Latest on Internet Pharmacies, Supplements, Designer Drugs, and Other High-Risk Merchants

Brazilian Blowout needs additional regulation, lawmakers tell FDA

Three members of Congress have demanded more action from the Food and Drug Administration to regulate hair-straightening products such as Brazilian Blowout, which has been found to contain excessive amounts of formaldehyde. In a letter sent to the FDA on Tuesday, Reps. Earl Blumenauer, Edward Markey and Jan Schakowsky reiterated complaints lodged in early 2011 over the high levels of formaldehyde in the Brazilian Blowout products, including Acai Professional Smoothing Solution. At the time, the lawmakers sought a voluntary recall of such products for the protection of consumers and salon employees.

LegitScript classifies Brazilian Blowout and related products as “per se problematic,” meaning that these products are generally disallowed from being advertised on major search engines like Google, Bing and Yahoo. We also work with companies like Amazon and Twitter to notify them about these problematic products. The lawmakers’ letter underscores LegitScript’s concerns (which the FDA, of course, shares) regarding the potential dangers of these products.

“The FDA should … investigat(e) … the serious health impacts associated with Brazilian Blowout and other hair straighteners that contain toxic levels of formaldehyde,” Markey said. “The FDA should immediately take action to stop the sale of these potentially carcinogenic hair straightening products and continue to evaluate whether to ban formaldehyde from hair straighteners altogether.”

FDA analysis of samples of Brazilian Blowout confirmed the presence of formaldehyde at levels ranging from 8.7% to 10.4%. Exposure to excess formaldehyde can result in breathing trouble and burning eyes, nose and throat, according to Health Canada, which also warned about the hair straighteners in 2011. In the US, the Occupational Safety and Health Administration regulates the substance, which must be disclosed as an ingredient at 0.1%. OSHA’s safety limits are “0.75 parts of formaldehyde per million parts (or ppm) of air during an 8-hour work shift or 2 ppm during any 15-minute period.” Health Canada provided the following table of products containing excess formaldehyde — noting that it permits the substance in cosmetics at levels of no more than 0.2%:

hair straightener formaldehyde

After the representatives’ 2011 complaint, the FDA issued a warning letter to the manufacturer of Brazilian Blowout/Acai Professional Smoothing Solution, GIB LLC, calling the product an adulterated and misbranded cosmetic. The warning letter instructed GIB to make immediate product changes or face enforcement actions such as seizure or injunction. However, GIB LLC has not changed the formula in the products to remove formaldehyde.

LegitScript identifies and monitors many websites, such as brazilianblowoutathome.com and braziliankeratinusa.com, that sell products including but not limited to Brazilian Blowout and thousands of other problematic dietary supplements or designer drugs (which we typically refer to as “psychoactive highs”). Together with the Internet pharmacies in our database, we monitor well over 200,000 currently or formerly active websites selling dietary supplements, cosmetics and designer drugs.

The lawmakers also are now seeking additional testing from the FDA on other hair straighteners, pointing out that after the agency’s warning letter, GIB LLC introduced Zero+, marketed as “new and improved” and claiming that “0% formaldehyde [is] released before, during or after the treatment.” The lawmakers’ letter states that the FDA has not taken any additional enforcement action against GIB or substantiated its claims of the safety of Zero+.

LegitScript product classification standards for dietary supplements are recognized by the National Association of Boards of Pharmacy. We recommend that consumers avoid purchasing or using dietary supplements or products like Brazilian Blowout that are classified by LegitScript as “per se problematic.”