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Manufacturers of hair-care products, which comprise a global industry expected to exceed $102 billion by 2024, are facing allegations that their shampoos, conditioners, and soaps cause women to experience undesirable symptoms contradictory to labeled outcomes. Class action filings describe alleged scalp blisters, dull hair, hair breakage, rashes, inflammation, redness, and alopecia (hair loss) due to the use of these products. Cosmetics like hair shampoos are used frequently — sometimes daily – by their consumers and contain a mixture of botanicals, fragrances, emulsifiers, and detergents.3
The FDA does not require testing to prove the safety of personal care products, however, agencies including the CIR, SCCS, RIFM, IFRA, and Personal Care Products Council suggest that companies conduct ingredient safety assessments based on how a product is used by consumers.
A suit filed against Unilever in 2021 alleged Suave hair products included a formaldehyde-containing preservative that causes hair loss and scalp irritation.5 Subsequently, on December 15, 2022, a class action filing alleged OGX dry shampoo brands distributed by Johnson & Johnson and Vogue International contained dangerously high levels of benzene (sometimes as much as 3.98 ppm).6 Beyond the alleged negative effects of benzene, the initial complaint alleged that the misbranded product not including benzene on its product label constituted an illegal action.4 Now, Olaplex is facing lawsuits from 28 women alleging hair loss and scalp blisters, and these plaintiffs claimed that the firm concealed dangers of the products as their basis for action.2
In December of 2018 a study published by the American Contact Dermatitis Society evaluated the impact of daily exposure to fragrance chemicals using the maximum recommended concentration of select fragrance chemicals present in various leave-on and rinse-off products.1 Results of the study show that rinse-off products, including facial cleansers, body washes, shampoos, and conditioners, are not likely to cause skin sensitization while the risk of skin sensitization due to exposure to leave-on products is increased among high-use consumers.
Another study evaluated the safety of individual ingredients in the three most commonly purchased products from WEN by Chaz Dean (WCD). A sensitization risk assessment of constituents of the cleansing conditioners and characterization of the potential health risks associated with topical use of WCD cleaning conditioners on scalps of adult women was conducted.3 The reported margins of safety (MOSs) for ingredients with allergenic potential were all less than 1. This meant that exposure to individual ingredients of the cleansing conditioners would likely not cause dermal sensitization, and that, despite their wide use, serious adverse health effects from cosmetic and personal care products would be relatively rare in the general population.3
Employees of Paustenbach and Associates were actively involved in some of the above-mentioned studies. Our scientists have over 50 years of experience in conducting safety assessments and in evaluating the potential health risks of impurities in consumer products. We have conducted hundreds of risk assessments over the years. We have assisted several firms who have faced challenges involving benzene and formaldehyde in their product(s) as they deal with the press, regulatory agencies, and litigation.
DA, Towle KM, Fung ES, Novick RM, Paustenbach DJ, Monnot AD. Skin Sensitization
Induction Potential From Daily Exposure to Fragrances in Personal Care
Products. Dermatitis. 2018 Nov/Dec;29(6):324-331. doi:
10.1097/DER.0000000000000412. PMID: 30422886.
2. Michelle Albahae et al v. Olaplex Holdings, Inc et al, Docket No. 2:23-cv-00982 (C.D. Cal. Feb 09, 2023), Court Docket.
AD, Towle KM, Warshaw EM,
Fung ES, Novick RM, Paustenbach DJ, Drechsel DA. Skin Sensitization Induction
Risk Assessment of Common Ingredients in Commercially Available Cleansing
Conditioners. Dermatitis. 2019 Mar/Apr;30(2):116-128. doi:
10.1097/DER.0000000000000445. PMID: 30829810.
v. Johnson & Johnson Consumer, Inc. et al, Docket No. 1:22-cv-07069 (N.D.
Ill. Dec 15, 2022), Court Docket. https://www.bloomberglaw.com/product/blaw/document/X67DFOMH3RA8DKRFE1O7S447PNA
5. Steinberg, Julie. Unilever Sued Over Formaldehyde-Related Shampoo Preservative. Unilever United States, Inc. 2021 June 21. https://www.bloomberglaw.com/product/blaw/document/QV2561DWLU68
6. Valisure Citizen Petition on Benzene in Dry Shampoo Products, Oct. 31, 2022, Valisure-Citizen-Petition-on-Benzene-in-Dry-Shampoo-Products_103122.pdf