Research and anecdotal evidence connecting contact dermatitis of the scalp to hair loss may have factored in FDA’s early focus on the MI/MCI preservative combination as it investigates the safety of WEN Cleansing Conditioners.

The agency swapped letters in March with Rep. Frank Pallone, D-N.J., who inquired into FDA’s regulatory response to reported adverse effects linked to the product line, including balding, irritation and rashes.

According to FDA’s response, obtained by the Rose Sheet via a Freedom of Information Act request, the agency’s investigation is “active and ongoing” as it continues to evaluate information provided by celebrity stylist Chaz Dean, who created the WEN conditioner as an alternative to conventional shampoos, and Guthy-Renker LLC, which manufactures and markets it ([A#02160711001]).

FDA also conducted site inspections in 2014 and 2015 and is still going through its officials’ findings.

There is a clear trend in the kinds of adverse experiences cited by consumers online, in notifications to FDA and in lawsuits against the WEN line’s marketers, with many reports accompanied by photos of users’ inflamed and balding scalps.

However, no single theory or argument has emerged with popular consensus as to why WEN Cleansing Conditioners would be causing users’ hair to come out “in clumps,” as some allege.

Plaintiffs Amy Friedman and Judi Miller, who filed a proposed class action against Guthy-Renker in California’s Central District Court in July 2014 seeking economic and other damages, attribute the ill effects nonspecifically to “an inherent design and/or manufacturing defect” Also see "Complaints Allege Guthy-Renker’s WEN Conditioner Line Causes Hair Loss" - HBW Insight, 27 March, 2015..

Another suit being mediated in the same court, involving 850 plaintiffs, suggests that one or more ingredients in the WEN conditioner “act as a depilatory and caustic agent, either by causing a chemical reaction that damages the hair strand and/or follicle.”

In a July 6 email, a Guthy-Renker spokesperson stressed that there is no evidence that Wen products or any individual ingredients they contain cause hair loss.

“WEN is used by hundreds of thousands of satisfied customers around the world, and all formulations of the product comply with applicable regulations wherever it is sold. We have always cooperated fully with the FDA with respect to any inquiries regarding WEN and will do continue to so because we have confidence in WEN,” he said.

In FDA’s response to Pallone, the agency says it reviewed product labeling for the WEN Cleansing Conditioners in 2013 and found nothing concerning in the way of banned ingredients or substances that wouldn’t normally be found in a cosmetic product.

The agency does, however, indicate that two listed ingredients drew special scrutiny – the preservatives methylisothiazolinone (MI) and methylchloroisothiazolinone (MCI), which often are paired in cosmetics as a system to prevent spoilage and microbial contamination.

FDA says it tested WEN product samples and found levels of MI and MCI to be consistent with amounts used in similar products on the market. At the same time it notes: “These ingredients are known sensitizers and irritants.”

Users are encouraged to wash their hair with the WEN conditioner daily, using as many as 32 pumps of the product, to apply a small amount afterward on a leave-on basis and to pair the product with WEN Replenishing Treatment Mist, which also contains MI, according to QVC.com.

While the MI/MCI combination’s use in cosmetics is not banned or restricted in the US, the preservative system is subject to tight restrictions in Europe due to sensitization risks. In rinse-off products the duo can be employed in concentrations not exceeding 15 parts per million, while its use in leave-on products has been prohibited outright in the EU since September 2014 Also see "Europe Bans Preservative Mixture MCI/MI In Leave-On Cosmetics" - HBW Insight, 26 September, 2014..

The ban on leave-on use followed MI’s designation in 2013 as the American Contact Dermatitis Society’s Allergen of the Year, owing to data suggesting escalating allergy incidence. Previously, MI’s sensitization potential was widely believed to be less than that of MCI.

Compared with European authorities, the Cosmetic Ingredient Review Expert Panel has taken a less stringent stance on use of MI/MCI and MI specifically, issuing safety assessments in recent years with the goal of heading off what it sees as overly conservative regulatory movement across the Atlantic that is contributing to the rapid depletion of industry’s preservative palette Also see "Attn. Europe: CIR Identifies Safe Limit For Preservative MI In Leave-Ons" - HBW Insight, 16 June, 2014..

Industry has sought to demonstrate that standalone MI can be safely used in leave-on hair products specifically, as well as rinse-off cosmetics, at levels up to 100 ppm, a position backed by CIR’s experts but rejected by the EC’s Scientific Committee on Consumer Safety in a December 2015 opinion Also see "European Scientific Committee Not Budging On Recommended MI Restrictions" - HBW Insight, 15 July, 2015..

It’s increasingly clear that MI and the MI/MCI combination have no future in leave-on cosmetics in Europe.

Contact Dermatitis Behind WEN Hair Loss?

In the US, the preservative system may remain an option for personal-care formulators looking to avoid use of demonized parabens, for example.

But if MI/MCI has played a role in the adverse events reported by WEN users, its use in hair care and other cosmetic products could represent an emerging legal risk.

Organizations including the Belgravia Centre, a London-based hair clinic, and the nonprofit Hair Foundation in Chicago say that irritant and allergic contact dermatitis can lead to hair loss.

A 2001 study published in JAMA Dermatology concluded that “allergic contact dermatitis of the scalp should be included among the possible cause of telogen effluvium,” a form of hair loss that results when follicles are pushed into a dormant state, typically due to stress or another trigger.

A case report featured in ISRN Dermatology in 2011 documents the experience of a 41-year-old woman who suffered severe hair loss – approximately 90% – as the result of allergic contact dermatitis brought on by exposure to a hair-dye ingredient.

The MI/MCI concentrations in WEN Cleansing Conditioners may not be atypical in the US compared with similar products available for sale, as FDA observes in its letter. However, exposure is dictated to large extent by how the product is used by consumers.

A “How to Use” page on the brand’s website instructs users to apply the conditioner and let it sit on their hair for the remainder of their shower, to rinse and repeat for best results, and to use up to 32 pumps of the formula overall for each cleansing session.

Further, consumers are advised to apply a small amount of the product to the ends of their wet hair after showering to function as a leave-in conditioner.

On an FAQ page of its website, the brand says the product can be used daily to gently cleanse and hydrate hair. It also recommends use of the WEN Replenishing Treatment Mist between cleansings for a “quick pick-me-up.” Described as an “ultra-light-weight, leave-in conditioner,” the mist also contains MI, according to ingredient details at QVC.com.

FDA says 92% of the AE reports it received exclusively cited WEN Cleansing Conditioners. The remaining 8% also implicated other WEN products, including the Replenishing Treatment Mist and WEN Moist Intensive Hair Treatment. The latter features the MI/MCI preservative system, based on Sephora.com’s ingredient listing.

WEN Cleansing Conditioner formulations may vary. FDA indicates in its letter that Chaz Dean, Inc. and Guthy-Renker both manufacture and distribute the products, and each responded to FDA’s inquiries separately.

Ingredient lists for WEN Cleansing Conditioners at Sephora’s e-commerce site include preservative phenoxyethanol, as well as preservative enhancer ethylhexylglycerin, rather than MI/MCI.

The Environmental Working Group has suggested that known allergens in the WEN conditioner’s fragrance component, including hydroxycitronellal and hydroxyisohexyl 3-cyclohexene carboxaldehyde, are possible culprits in the rash of reported AEs ([A#02160111004]).

At WEN.com, Guthy-Renker says it has “great emphathy for anyone experiencing hair loss or scalp issues,” while maintaining that scientific evidence has not been presented that identifies the WEN brand as a cause.

The firm notes that it has shipped more than 10 million WEN products since 2008.

Meanwhile, it continues to defend against lawsuits filed by WEN users, including a proposed class action in California that is moving toward settlement ([A#02160711003]).

FDA Tests WEN Conditioner’s MI/MCI Content In Pursuit Of Hair-Loss Answers

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