FDA’s overhaul of cosmetics regulation comes with a loophole allowing cancerous hair relaxers on shelves

By Jonathan Sharp

In December 2022, the Consolidated Appropriations Act bolstered the FDA’s regulatory abilities to address vital safety issues in the widely-unregulated cosmetics industry. The bill’s subtitle, known as the Modernization of Cosmetics Regulation Act (MoCRA), represents the first significant reform targeting cosmetic products since 1938.

While MoCRA is regarded as a belated, yet welcomed, development, several provisions containing insufficiently defined parameters, terms, and limitations create loopholes that would enable manufacturers to continue using unsafe ingredients. The implications are especially concerning for Black women, whose frequent use of hair products is linked to higher risks of cancer and other similar health conditions. 

Hair Relaxer Products and Cancer Risks

A study published by the National Institute of Health in October 2022 found that the frequent use of hair-relaxing products was correlated to a higher risk of uterine cancer (UC). Researchers drew information from the more expansive Sister Study, tracking data on nearly 34,000 participants (35-to-74 years) over an 11-year period. 

They found that women who frequently used hair relaxers (<4 times a year) had a UC incidence rate (4.05 percent) that was more than double that of women who never used them (1.64 percent). Notably, this correlation wasn’t applicable to other tested products. 

Over the past decade, a growing body of clinical literature has uncovered a concerning link between the use of hair care products like relaxers and female-specific diseases such as cancer (breast and ovarian), uterine fibroids, and endometriosis. What is common among all studies is the presence of endocrine-disrupting and carcinogenic chemicals, including phthalates, parabens, ‘fragrances,’ formaldehyde, and sodium hydroxide (lye). 

UC is the most common gynecological cancer affecting US women (second only to ovarian), with approximately 66,000 new diagnoses and 12,550 associated fatalities in the past year. Although diseases affect individuals indiscriminately, a 2019 study found that Black women were more prone to aggressive types of uterine cancer than other ethnicities, accounting for 60 percent of respondents who reported frequent hair relaxer use. 

A few factors fuel this discrepancy. African-American women face more societal pressures to conform to Western beauty standards that favor straight hair, meaning they’re more likely to use hair relaxers at younger ages and incur a longer exposure time. Other motivations, like the desire for greater versatility in hairstyles, also contribute to Black women’s frequent use of straightening products. Seeking to capitalize on such aspects, companies that produce hair relaxers have increasingly marketed their products specifically toward the Black demographic.

Looming Legislative Loopholes 

Prior to MoCRA, the FDA’s authority was limited to only requesting that manufacturers voluntarily recall products when their safety was justifiably called into question, even when widespread contamination was confirmed. After it became law, MoCRA significantly expanded the FDA’s regulatory abilities, enabling it to issue mandatory recalls and establish federally-applicable industry standards. 

Cosmetics companies will now be required to register their manufacturing facilities, comply with “good manufacturing practice” guidelines, expand on ingredient labeling, report adverse effects expeditiously, maintain detailed records, and offer proof of safety substantiation to the FDA. Despite these crucial developments, several MoCRA provisions raise doubts over the extent of its scope and capacity to holistically ensure consumer safety.

While manufacturers will be legally obliged to disclose information on ‘fragrances’ and other known allergens to the FDA, they’re not required to do the same for consumers. At the same time, these disclosure requirements apply only to ‘allergens,’ discounting other hazards like phthalates or PFAS, whose detrimental effects manifest over years of exposure. In the past, cosmetics companies would keep product formulations confidential by labeling them ‘trade secrets’ or would use umbrella terms like ‘perfume’ or ‘fragrance’ to obscure the presence of toxic substances.

An even more contentious aspect with significant public health implications is MoCRA’s vague definition of safety substantiation. Due to the loosely-defined terms and parameters, manufacturers would be able to submit safety determinations drafted by groups whose corporate support creates evident conflicts of interest. This is especially problematic because MoCRA won’t require manufacturers to emit premarket notifications or have to pass an FDA review and approval process before placing their products on the market.

Developing legal and regulatory landscape

Although MoCRA is seen mainly as a positive step forward, its limitations and loopholes remain glaring issues for individuals that are more vulnerable to the toxins it’s supposed to regulate. A 2018 study analyzing the hormone-disrupting chemicals in hair products used by African-American women found that all samples tested positive for ‘fragrances,’ 78 percent contained parabens, and 84 percent of the detected hazards weren’t listed on product labels. Moreover, hair relaxers marketed at children had the highest levels of 5 chemicals banned in the EU and regulated by California’s Proposition 65. 

Additionally, chemical exposure also represents an occupational risk for people of color who work in professional hair salons and use potentially hazardous substances regularly. A 2021 pilot study conducted in the D.C. and Maryland area found that Black and Hispanic hairdressers reported phthalate metabolite levels that were 10 times higher than office workers of the same ethnic background.

In October 2022, one week after the NIH published its eye-opening study, cosmetics companies that sold hair relaxers found themselves embroiled in a growing wave of litigation. The first lawsuit was filed by Jenny Mitchell, an African-American woman from Missouri who claims that her regular use of hair relaxers since she was 8 led to her UC diagnosis and hysterectomy at 28. Since then, plaintiffs have moved to consolidate all claims into an MDL, with a decision expected to be pronounced by the Judicial Panel on Multidistrict Litigation later this month. 

Until the courts reach a final decision in a process that can last months or even years, the FDA should leverage its newly bolstered authority to amend some of MoCRA’s inconsistencies and prevent hazardous substances from making their way onto shelves. Some more apparent aspects that could be improved include expanding ingredient disclosures to cover a wider range of toxins, enforcing broader transparency requirements for manufacturers, and establishing better-defined safety substantiation standards before products are allowed on the market.

Jonathan Sharp serves as CFO at Environmental Litigation Group PC, a law firm from Birmingham, Ala., that specializes in toxic exposure cases and helps individuals harmed by unsafe and defective products.  

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