By JONATHAN SHARP
Environmental Litigation Group
Just before the end of 2022, the FDA’s regulatory abilities in the mostly-unregulated cosmetics industry were significantly bolstered with the adoption of the Modernization of Cosmetics Regulation Act – known as MoCRA – as part of the more expansive Consolidated Appropriations Act. Notably, this is the first major overhaul of legislation regulating the cosmetics industry in over eight decades since the passing of the Food, Drug, and Cosmetics Act of 1938.
Despite its largely positive reception as a vital yet long-overdue development, several provisions within MoCRA contain ambiguously worded terms, parameters and limitations that may unwittingly allow manufacturers to continue using carcinogenic ingredients. The implications for Black women are especially concerning in light of recent studies indicating that the regular use of hair straightening products is linked to higher risks of cancers and reproductive issues.
Cancer-causing chemicals in hair relaxers
Last year, a study conducted by the NIH found that frequent habitual use of chemical hair relaxers held a high correlation with uterine cancer incidence. The authors drew information from the broader Sister Study, covering nearly 11 years of data on approximately 34,000 U.S. women, ages 35 to 74.
Compared to women who never used such products (1.64%), women that reported frequent hair relaxer use (+ 4 times a year) had more than double the UC incidence rate (4.05%). Researchers didn’t note any similar correlation for other tested products.
Over the last decade, an increasing volume of medical studies has uncovered disquieting associations between the regular use of hair-straightening products and women-specific diseases such as ovarian and breast cancer, endometriosis and uterine fibroids. These harmful effects are widely considered to result from carcinogenic and hormone-disrupting ingredients like bisphenol A, parabens, phthalates, “fragrances,” lye and formaldehyde.
Although relatively rare, UC is the most prevalent gynecological cancer among U.S. women, with 66,200 new diagnoses and 13,030 related fatalities estimated this year. In Texas, the highest UC incidence is reported in counties where minorities are overrepresented, with Dallas (23.8% Black and 41.4% Hispanic) also numbering among the counties that exceed the state average.
In spite of UC’s seemingly low occurrence, clinical research has noted that Black women face higher risks of developing more aggressive variants, also making up 60% of reported frequent hair relaxer users. Recent studies also point out that Black women struggling with UC have higher fatalities and worse survival rates than any other demographic.
This discrepancy is likely fueled by several factors. Black women face higher social pressures to conform to Eurocentric aesthetic standards that favor straight hair, incurring longer exposure times if they begin using hair relaxers at early ages. Meanwhile, the desire for more flexibility in hairstyles and fashion also contributes to regular use. Moreover, cosmetics companies have aimed to capitalize on such considerations by increasingly marketing their products for textured hair to Black women.
Legislative Loopholes
Previously, the FDA could only request that manufacturers recall products when their safety was questioned on justifiable grounds, even in instances of blatant widespread contamination. With MoCRA’s adoption, the FDA has federal authority to issue mandatory recalls and establish enforceable industry-wide standards.
Additionally, cosmetics manufacturers must register their production facilities, implement “good practice” guidelines, expand on ingredient labeling, maintain detailed records and expedite adverse event reporting, and provide the FDA with product safety substantiation. Despite the progress it achieves, a few of MoCRA’s stipulations have raised doubts over its scope and ability to comprehensively protect consumers’ health.
Even if manufacturers are obliged to disclose details on fragrances and other allergens to the FDA, they’re not required to make such information public to consumers. Furthermore, these ingredient disclosures target only allergens, discounting other hazards like phthalates or PFAS, whose effects manifest over years and decades. In the past, manufacturers would attempt to hide the presence of dangerous ingredients by labeling them as confidential trade secrets and generically listing them as “perfume” or “fragrance.”
Perhaps the most controversial aspect surrounding MoCRA is its ambiguous wording of what constitutes proper safety substantiation. In its current form, it would inadvertently allow cosmetics companies to submit safety determinations compiled by groups whose corporate backing creates glaring conflicts of interest. The implications are all that more concerning given that the bill doesn’t require manufacturers to provide premarket notifications or have their products undergo a review and approval process before they make it to the market.
Evolving Legal and Regulatory Landscape
Although MoCRA is a sign of promising reform, its limitations remain problematic for individuals prone to higher rates of exposure to toxins that the new law is meant to regulate. Research tracking endocrine-disrupting chemicals in hair products used by Black women found ‘fragrances’ in every tested sample, 78% contained phthalates and parabens, 84% of the identified hazards weren’t listed on product labels, and hair-straightening products marketed towards children had the highest concentrations of five chemicals regulated under Proposition 65 or outlawed in the EU.
In the wake of the NIH’s 2022 study, leading cosmetic companies were faced with a growing wave of litigation from outraged consumers. The first legal action of this type was filed by Jenny Mitchell, a Black woman who alleges that her UC diagnosis and hysterectomy at 28 stemmed from her regular use of hair-relaxing products beginning at the age of 8.
In February 2023, all similar claims were centralized in a class-action lawsuit in Illinois’ Northern District Court. Presiding judge Mary M. Rowland recently allowed all future cases from across the country to be filed directly in the MDL per a short-form complaint to streamline the process.
Until the courts reach a final decision in a legal process that can span over the years, the FDA has the opportunity to amend MoCRA’s inconsistently defined provisions and prevent harmful products from reaching vulnerable consumers. The FDA should leverage its newly acquired authority to mandate better transparency requirements in the cosmetics industry, including a broader range of chemical hazards on product labeling, and establish clear-cut safety substantiation standards that aren’t subject to interpretation.
Jonathan Sharp serves as CFO at the Birmingham, Alabama-based Environmental Litigation Group PC, a law firm that specializes in toxic exposure litigation and assists individuals harmed by hazardous products.