A proposed class action lawsuit alleges that Just For Men hair dyes are “more dangerous than an ordinary consumer would expect” in that they not only expose users to a number of chemical irritants but are packaged with misleadingly vague and potentially harmful instructions with regard to a skin allergy test users are encouraged to perform before application.
What’s the lawsuit about?
Filed by plaintiffs from Louisiana, Florida and North Carolina, the 45-page, eight-count lawsuit against defendants Combe Incorporated and Combe International LTD revolves around both a specific chemical ingredient found in Just For Men dyes and the 48-hour skin allergy patch test users are suggested to undergo before using the product.
This specific chemical ingredient is p-phenylenediamine—PPD—a coal tar dye that the complaint says was once sourced from coal tar but is now derived from petroleum products. According to the National Capital Poison Center, PPD is “one of the main culprits” of skin irritation caused from hair dye, and has been associated with both simple irritation (i.e., redness, itching and burning) and more serious allergic reactions.
The case specifies early on that there is an important distinction between irritant contact dermatitis and allergic contact dermatitis. Citing the Mayo Clinic, the suit explains that irritant contact dermatitis is a non-allergic skin reaction primarily affecting the skin’s outermost protective layer, and notes that some individuals can develop a tolerance to certain skin irritants over time. Allergic contact dermatitis, on the other hand, is more serious given that the body’s immune system is reacting toward an allergen, the case says.
The passage of the Food, Drug and Cosmetic Act in 1938 outlawed the use of coal tar dyes for eyelashes and eyebrows, the lawsuit says, yet allowed for the chemicals to be used in hair dye provided a product’s labeling includes the following warning:
Caution—This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.”
According to the complaint, Just For Men hair dyes are not labeled with the above warning, and instead display the following:
Caution: This product contains ingredients which may cause skin irritation on certain individuals and a preliminary 48 hour skin allergy patch (ALERT) test according to accompanying directions should be done first. This product must not be used for dyeing the eyelashes or eyebrows - to do so may cause blindness.”
The plaintiffs charge that the inclusion of the phrase “48 hour skin allergy patch (ALERT) test” materially alters the Food, Drug and Cosmetic Act requirement that a test be conducted for “skin irritation.” The lawsuit argues that given the human body’s immune system response to allergic contact dermatitis, a skin patch test used to determine an allergic reaction, such as that described on Just For Men hair dye labels, is in fact “an article intended for use” in the diagnosis or prevention of a disease. Under the Food, Drug and Cosmetic Act, the case says, articles intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs, and the defendants’ prompt that Just For Men hair dye users perform a 48-hour ALERT allergy patch test prior to use of the product constitutes the dyes’ promotion “for use as a drug.”
That being the case, the lawsuit says, the FDA has some thoughts on the matter. From the complaint:
Drugs must be approved by FDA prior to introduction to the market. Manufacturers of drugs which are not specifically identified as safe for over the counter use by FDA must submit comprehensive safety and efficacy data to FDA in order to obtain marketing approval.”
While Just For Men’s 48-hour skin allergy patch test has not received the FDA’s all-important OK, the case notes that a company called SmartPractice Denmark ApS has gotten FDA approval for a similar product called T.R.U.E. Test—Thin-Layer Rapid Use Epicutaneous Patch Test. That product, according to the lawsuit, is sold as a prescription drug, as it’s reportedly used as an aid in diagnosing allergic contact dermatitis and is applied by a physician trained to distinguish between skin irritation and allergic reactions.
The lawsuit eviscerates the Just For Men 48-hour skin patch as an “unregulated, uncontrolled, open, random experiment” that relies on self-administration of strong allergens by untrained consumers for diagnostic purposes. Whereas the T.R.U.E. Test is controlled, carefully administered and well-validated, the defendants’ ALERT skin patch test, the lawsuit goes on, exposes users to “varying, unregulated amounts of strong allergens,” including potentially dangerous levels of repeated exposure to PPD.
Another vital distinction the lawsuit points out is that the T.R.U.E. Test is, well, a true patch test in that an area of the skin is covered with a patch to protect from deterioration or contamination. The patch is removed after a specified time period, the suit says, and the skin is examined again (usually by a doctor) after 72 to 96 hours. Crucially, the defendants deviate from a standard allergy patch test by instructing Just For Men users to not wash or cover the ALERT test area for 48 hours, which the lawsuit says makes the allergy test an “open test.”
“As such, the Just For Men ALERT allergy test instructs consumers to mix up an undefined amount of two products, apply the mixture at an unknown thickness to an area the size of an unspecified coin, and to leave the area uncovered and unwashed, thereby subjecting the site to contamination or deterioration of test product, for 48 hours,” the complaint reads.
The amount of allergen to which the Just For Men ALERT allergy test exposes users is not only excessive, the lawsuit says, but dramatically increases the risk of sensitization due to the requirement that consumers have to perform the test 48 hours ahead of “each and every use” of the hair dye.
Potential skin depigmentation from increased PPD exposure
Because Just For Men hair dyes come with the suggestion that users repeatedly test themselves for an allergic reaction before each use, proposed class members are consequently exposed to increased levels of PPD, the lawsuit says. Compounding the risk is that darker shades of Just For Men hair dye “contain greater percentages of PPD” than lighter shades, exposing users, who the suit stresses have no training in reading allergy test results, to a greater risk of sensitization and to even higher levels of the possible chemical reactant.
Notwithstanding other potential effects of prolonged exposure to skin allergens, the case focuses on vitiligo, or the depigmentation of the skin. According to the complaint, Just For Men users have no warning that exposure to PPD can cause a vitiligo reaction that can result in “complete and permanent depigmentation of the entire surface area of the face or scalp” on which the hair dye is applied. More troubling, the case continues, is that Just For Men users are also unaware vitiligo can spread to areas that were never even exposed to the dye.
The lawsuit says the defendants’ instructions for use of Just For Men hair dyes are false and misleading because consumers are left unaware that the ALERT skin allergy patch test is actually an allergy test that exposes users to an increased risk of serious allergic reaction. Of the test itself, the case charges the defendants leave users who have no guide or training to test themselves with no more than “vague and incomplete instructions” that amount to unlawful marketing of Just For Men hair dye as a drug as defined by the FDA.
At its core, the Just For Men ALERT skin allergy patch test is “human experimentation for no confirmed benefit,” the suit concludes, and despite a disclaimer, users are left unaware that the test itself creates a “grave risk of sensitization to PPD and other hair dye allergens” that can trigger a toxic response.
For their part, the lawsuit says, Combe Incorporated and Combe International LTD are aware that “consumers are unlikely to conduct the open allergy test (misnamed the allergy patch test) as instructed.” Moreover, the case claims the companies are also aware that Just For Men users lack the understanding of the seriousness of the adverse effects they may experience from using the hair dyes. From the lawsuit:
Even if the Just For Men hair dye products’ instructions provided by Defendants were adequate to prevent or reduce the risk of injury, the products’ accompanying warnings fail to adequately appraise [sic] consumers of the risks/injuries that may result from use of the product and/or failure to follow the instructions for use.
Defendants fail to provide consumers with sufficient warnings to appreciate the significance of the medical risks posed by the products. Unlike some trained medical professionals, lay people do not have the education, training, or expertise to understand the risks of allergic and irritant reactions posed by these products.”
All in all, Just For Men hair dyes are more dangerous than an ordinary user would expect, the lawsuit says.
Who does the lawsuit look to represent?
The suit proposes to cover a class of consumers across the United States who bought a Just For Men hair dye product for personal use and experienced an allergic or irritant reaction within 96 hours of using the product.