FDA says Van Tibolli Corp's GK Hair Taming System with JUVEXIN products are adulterated and misbranded due to inadequate labeling instruction to minimize risks of formaldehyde exposure when the methylene glycol-containing hair-smoothers are heated during the application process.

The Sept. 2 warning letter comes roughly four years after FDA warned GIB, LLC for similar issues associated with its Brazilian Blowout Acai Professional Smoothing Solution, following reports linking the product to eye irritation, headaches, dizziness, nausea, respiratory difficulty and chest pain.

FDA's intervention was seen as lagging by some NGOs and Congress members, occurring more than 10 months after Health Canada issued an advisory urging stylists to stop using Brazilian Blowout products and at least four months after the federal Occupational Safety and Health Administration got involved Also see "FDA Warning To “Formaldehyde-Free” Brazilian Blowout Cites High Methylene Glycol Levels" - HBW Insight, 12 September, 2011..

The delay in FDA's response likely was due in part to the agency needing time to conduct analyses of Brazilian Blowout samples, which confirmed the presence of methylene glycol at levels ranging from 8.7% to 10.4%.

Nevertheless, the media storm surrounding the issue heightened calls for legislation to strengthen FDA's authority over the cosmetics sector, drawing support to the Safe Cosmetics Act then in play Also see "Safe Cosmetics Act Would Remedy “Broken Regulatory System,” Says CFSC" - HBW Insight, 4 July, 2011..

The warning letter to Van Tibolli closely mirrors that issued to GIB and could renew efforts behind similar legislation in the current Congress – the Personal Care Products Safety Act (S. 1014) – which has failed to move since its introduction in the Senate in April.

National Brazilian Blowout Day, declared in August, prompted the Environmental Working Group to issue a report – "Brazilian-style Blowouts: Still Poisonous, Still in Salons" – reminding consumers of the dangers associated with professional hair-straightening systems formulated with methylene glycol, and questioning why such products remain on the U.S. market despite risks identified by federal regulators.

In the report, EWG staff attorney Tina Sigurdson suggested that Brazilian Blowout's continued availability may reflect limitations in FDA's power, specifically its lack of authority to mandate product recalls. She cited the Personal Care Products Safety Act as a potential solution Also see "EWG Celebrates 'National Brazilian Blowout Day' With Plea For Regulatory Reform" - HBW Insight, 21 August, 2015..

Not An Ingredient Safety Issue Per Se

In 2011, an FDA spokesperson stressed that its warning to GIB/Brazilian Blowout “should not be interpreted as a broad evaluation of the safety of formaldehyde.”

Rather, the action was aimed at addressing potential risks that could arise through Brazilian Blowout's use under company-prescribed conditions, the rep said, adding that the agency would continue evaluating the safety of formaldehyde and products containing or releasing formaldehyde on a case-by-case basis.

FDA's takes a similar position in its warning to Van Tibolli, indicating that the presence of methylene glycol is not what makes the GK Hair Taming System products adulterated, although the agency recognizes methylene glycol, "the liquid form of formaldehyde," as a "deleterious substance" under certain conditions.

It notes that methylene glycol releases formaldehyde when hair treated with the GK Hair Taming formulas is heated with a blow dryer and then with a hot flat iron in accordance with user instructions in product labeling.

Further, FDA acknowledges that formaldehyde "is a highly reactive chemical that readily reacts with biological tissues, particularly the mucous tissues lining the respiratory tract and the eyes," as well as "a recognized carcinogen."

However, under the Federal Food, Drug and Cosmetic Act, a cosmetic can contain a potentially hazardous substance if its risks are effectively managed. To be deemed adulterated, the ingredient's presence renders the cosmetic potentially "injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual."

In Van Tibolli's case, the company's product labeling lays out conditions for use without including "instructions to (1) use these products in a facility with adequate ventilation, (2) avoid direct eye and skin contact, and (3) avoid unnecessary repeated use," according to the warning letter.

Van Tibolli's Curly and Resistant hair-smoothing products, part of the Fort Lauderdale, Fla.-based company's GK Hair Taming System with JUVEXIN line, contain methylene glycol in concentrations of 3.9% and 4.85%, respectively, based on FDA's analysis provided in the warning letter.

The amounts of methylene glycol detected in Van Tibolli's offerings may actually be lower than levels in Brazilian Blowout's "original" hair-smoothing solution, which have been reduced in recent years in response to regulatory and legal action but still range from 3% to 7%, according to a Material Safety Data Sheet on the brand's website.

But an FDA spokesperson signaled that the agency may not be through with Brazilian Blowout just yet.

Asked whether FDA considers Brazilian Blowout compliant at this stage in the game, the rep noted in an email that FDA "cannot comment on products that are the subject of ongoing investigations, such as those addressed in the warning letters to GIB LLC, dba Brazilian Blowout, and Van Tibolli Beauty Corp."

Firm's Warning Label Is Inadequate

Van Tibolli's GK Hair Taming formulas are misbranded, in addition to adulterated, along similar lines.

FDA says the company's product labeling and instructions for use "fail to reveal material facts with respect to consequences that may result from the use of the product." The same problem was noted in the agency's warning to GIB/Brazilian Blowout.

FDA notes that the GK hair smoothers at issue do bear warnings – "Product releases formaldehyde" – and labeling directs professionals to wear protective clothing, includes instruction for washing in the event of skin contact and advises users to call a physician if they ingest the product or it comes in contact with their eye.

Labeling also directs individuals nursing or pregnant to consult a physician before using the products.

Further information on its products' physical and health hazards, and safety data sheets, can be obtained from the company, the labeling says.

However, FDA maintains that the warning statement and product labeling are inadequate, as they fail to inform users of the adverse events that may result from formaldehyde release into the air during the application process, "which can have short-term and long-term health effects."

The agency cites eye and throat irritation, dizziness, burning sensations, breathing problems, nosebleeds and chest pain among potential risks, adding that "long-term exposure may potentially cause certain cancers."

Further, the company does make clear to users that "concurrent uses of these products in the same facility may increase the concentration of formaldehyde in the air, which could increase the risk of adverse effects," FDA says.

Van Tibolli must respond within 15 working days of receiving the letter with specific steps it has taken to correct the violations and ensure against recurrence.

Potential For Home Use May Have Raised Flags

Labeling for the GK hair-straightening products indicates that the products "must be applied by hair professionals only."

However, FDA notes that consumers may also be using the products at home, as they are available for purchase in beauty retail stores and through the internet, as was Brazilian Blowout at the time of FDA's intervention.

FDA recommends that Van Tibolli work with its distributors to address the issue.

The company showcases but does not sell its GK Hair Taming System with JUVEXIN range at GKHair.com, where it describes JUVEXIN as "a special blend of proteins and peptides optimized specifically for hair."

No mention is made of methylene glycol, though one product in the line, The Best, is specifically marketed as "keratin without formaldehyde." Van Tibolli states: "There is nothing artificial and no harsh chemicals are used."

In a 2012 interview, Colleen Martorano, former director of education and marketing at Van Tibolli, acknowledged that products in the GK hair line contained methylene glycol, but at levels "well below" OSHA standards. She called it "unfortunate" that some of the brand's competitors "weren't complying and did things they weren't supposed to do" Also see "Van Tibolli’s The Best Targets Blowout Market With “Safe” Straightening" - HBW Insight, 16 April, 2012..

The company also markets a TIBOLLI line of professional hair treatments powered by Trioxxy, a "synergy of keratin proteins that replenish hair from the inside out," featured at Tibolli.com.

FDA Warns Brazilian Blowout-Like Brand For Undeclared Formaldehyde Risks

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