Trial Magazine

Personal care products are something we all use every day—from the shampoo we wash our hair with to the sunscreen we slather on our children to prevent skin cancer. Consumers rely on brands they have built trust in over the years to offer products that are safe, with labels and marketing that accurately represent the product’s ingredients.

But consumers have become more aware, through research and litigation, of what goes into the products they use in their homes, on their bodies, and for their families—and the potentially harmful ingredients they may be exposed to that companies do not disclose or adequately test for. And regulatory gaps and a lack of transparency leave too many questions about exactly what is in the bottle.

Lagging Regulation

The Federal Food, Drug, and Cosmetic Act (FD&C Act) was enacted in 1938 and forms the cornerstone of the FDA today. The FD&C Act authorizes the FDA to oversee food, drug, medical device, and cosmetic safety, and it has been amended multiples times to add new areas of regulation and enforcement.¹ However, the cosmetics provisions of the act were not updated until late last year—over 80 years after they were initially enacted.² The FD&C Act had many shortcomings, particularly in the area of cosmetics.³

Section 201(i) of the FD&C Act defines “cosmetics” as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body . . . for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Under the 1938 act, the FDA did not have authority to regulate cosmetic ingredients—except for color additives⁴—or have the ability to require premarket approval before a cosmetic product entered the market. But the original FD&C Act imposed labeling requirements for cosmetics.⁵ If a cosmetic contains an ingredient or impurity that may make the product harmful to consumers when they use it according to the labeling or in the customary or expected way, that product may be considered “adulterated” or “misbranded” under the law.⁶

Because of the limits of the FD&C Act, most litigation involving personal care products has focused on failure to warn and misbranded/adulterated product claims. Consumers have also brought actions under state consumer protection laws.

The European Union has outlawed more than 1,300 chemicals from being used in consumer personal care products, while the United States has restricted or banned just 11.

Cosmetic regulation in the United States was widely criticized as lacking adequate protections for consumers against harmful ingredients and having substandard labeling requirements.⁷ The United States falls short of other countries that have enacted more stringent restrictions on ingredients for personal care products. The European Union, for example, has outlawed more than 1,300 chemicals from being used in consumer personal care products, while the United States has restricted or banned just 11.⁸

Advocates have pushed for reforms for decades, and states such as California have led the way in enacting more stringent laws to protect consumers.⁹ Nonprofit groups such as the Environmental Working Group and the Campaign for Safe Cosmetics have provided consumers with information about what is in personal care products and potential health risks from toxic exposure.

Late last year, Congress made some progress on improving cosmetic regulation at the federal level with the Modernization of Cosmetics Regulation Act (MoCRA), the first significant update to cosmetics regulation under the FD&C Act since its enactment.¹⁰ The new law—which has received broad support from environmental and consumer safety groups—increases the agency’s regulatory authority over cosmetics, with provisions related to registration of manufacturing and processing facilities, compliance with good manufacturing practices, and mandatory recall abilities, among others.¹¹

Manufacturers also will be required to keep track of serious adverse events and report them to the FDA—although the law does not require public disclosure of the events.¹² Enforcement of several key provisions will begin Dec. 29, 2023.¹³ The law also requires the FDA to promulgate new rules related to talc, cosmetic manufacturing and processing standards, and fragrance allergens.¹⁴

Everyday Products With Hidden Dangers

Even with MoCRA’s updates on the horizon, products are still on the market today that pose risks to consumers. The revelations about asbestos-contaminated talc products that allegedly caused cancer and mesothelioma in thousands of consumers is just one recent example of corporations’ failure to protect consumers from toxic ingredients with devastating health effects.¹⁵ Other recent litigation highlights myriad health risks that may be lurking within personal care products.

Benzene in sunscreen and dry shampoo. In May 2021, Valisure, a pharmacy that frequently conducts independent testing of products in its warehouse, announced that it found high levels of benzene in 27% of sunscreen and after-sun care products it tested—with some containing up to three times the FDA concentration limit of 2 parts per million.¹⁶ A widely used industrial chemical, benzene is a known carcinogen.¹⁷ When inhaled or through direct skin contact, benzene can cause various types of leukemia, as well as other adverse health effects.¹⁸ The source of the contamination was linked to the aerosol propellant used in the packaging.¹⁹

In a citizen petition to the FDA, Valisure argued that benzene is not an unavoidable chemical in sunscreen because some of the products it tested did not indicate benzene contamination—thus no sunscreen product on the market should contain benzene.²⁰ Several months later, popular brands such as Aveeno, Banana Boat, Coppertone, and Neutrogena recalled multiple aerosol sunscreen products for possible benzene contamination.²¹

Litigation against Johnson & Johnson (J&J), the company behind the Aveeno and Neutrogena brands, led to the creation of a multidistrict litigation (MDL) in the Southern District of Florida.²² This February, the judge overseeing the MDL approved a settlement that will refund customers who purchased the contaminated products. The settlement also forces J&J to stop using isobutane aerosol in its containers—which was identified as the likely source of the benzene contamination—and to institute new testing protocols to detect the presence of benzene.²³ A $2.3 million settlement was also reached in litigation against Bayer HealthCare, LLC and Beiersdorf, Inc. for alleged benzene contamination in their Coppertone sunscreen products.²⁴

Valisure also uncovered concerning levels of benzene in dry shampoo packaged in aerosol containers, leading to recalls of multiple brands of these products.²⁵ And similar contamination has been found in aerosol spray deodorants, antiperspirants, and body sprays. Several class actions have been filed in federal courts against Unilever for alleged benzene contamination in its aerosol antiperspirants and dry shampoos.²⁶ And Procter & Gamble recently agreed to an $8 million settlement related to various aerosolized products allegedly contaminated with benzene.²⁷

Endocrine disruptors in hair relaxers. Jenny Mitchell began using chemical hair relaxers when she was 10 years old and continued using them for more than two decades.²⁸ At 28, she was diagnosed with uterine cancer and underwent a full hysterectomy shortly thereafter—even though she had no family history of the disease.²⁹ Sadly, Mitchell is not alone. A study published in the Journal of the National Cancer Institute found that the rate of uterine cancer among women who used hair relaxers is about three times higher than among those who did not.³⁰

Webster Groves, Mo., attorney Jackalyn Olinger Rochelle, who represents plaintiffs injured by toxic products, said, “Women using relaxers suffer from uterine and ovarian cancers, fibroids, endometriosis, and other disorders at alarming rates. These women have disproportionately undergone hysterectomies at young ages, suffered countless miscarriages, had to have blood transfusions, and suffered other serious health issues related to their reproductive organs. Many have been unable to conceive because of these issues, ending the dream of becoming mothers.”

The study, and the stories of thousands of women that followed, shone a light on a pervasive problem in cosmetics and personal care products—the disproportionate effect on people of color.³¹ Hair relaxers use strong chemicals to break down bonds in the shafts of a person’s hair to alter its texture, allowing the hair to be “reshaped” in a straight pattern.³² Predominantly used by Black women and girls, research shows how prevalent the pressure is to use hair relaxers to conform to Eurocentric ideals of appearance. Dove’s 2021 Crown Research Study for Girls focused on the ingrained cultural and systemic biases that Black girls experience about natural hair and protective hairstyles (such as braids or twists to protect hair from breakage and tangling).³³

These negative experiences start early—100% of Black girls participating in the study who attended majority-white schools reported experiencing hair discrimination by age 10.³⁴ An earlier Dove survey examined hair discrimination in the workplace and found that Black women receive pervasive messaging that their natural hairstyles are “unprofessional” and are judged more harshly for their appearances.³⁵

“For decades, Black women and women of color have used hair relaxers as a way to assimilate into society and conform to European standards of beauty. They did and continue to do this to better their lives—get and keep jobs, attend schools, and generally be accepted by others,” Olinger Rochelle said. “Unfortunately, the cost of beauty has been extraordinarily great for these women. They didn’t realize that the companies making these products included harmful chemicals that would later cause them irreversible and devastating reproductive issues.”

The chemicals used in hair relaxers have long been known as potential irritants and allergens.³⁶ But the National Cancer Institute study revealed an even greater risk to women’s health from these products. Among the chemicals typically used in hair relaxers, several—such as phthalates and parabens—are known endocrine disruptors.³⁷ Endocrine disruptors interfere with the normal functioning of hormones within the body, which can lead to reproductive diseases such as uterine and ovarian cancers, uterine fibroids, endometriosis, and breast cancer.³⁸

Mitchell was one of the first plaintiffs to file a complaint against the companies that manufacture and market chemical hair relaxers, and dozens of additional complaints have followed. Federal litigation against these companies has been consolidated in the Northern District of Illinois.³⁹ The cases include products liability and consumer protection claims based on the defendants’ failure to warn consumers about the risks of these chemicals.⁴⁰

PFAS in makeup. From lead in lipsticks to asbestos in makeup palettes marketed to children, toxic ingredients frequently show up in these cosmetic products too.⁴¹ Of increasing concern is the presence of so-called “forever chemicals”—per- and polyfluoroalkyl substances, referred to as PFAS, that are linked to various adverse health effects.⁴²

PFAS are used in all types of household products to resist grease, oil, water, and heat—such as nonstick cookware, food packaging, and waterproofing and stain-resisting products.⁴³ PFAS also show up in cosmetic products. They are added to formulations to improve wearability—such as in waterproof mascara—and to make the skin look luminous and smooth—such as in blushes and foundations.⁴⁴

One study found that of 231 different cosmetic products tested, more than half contained high percentages of fluorine, an indicator of the presence of PFAS.⁴⁵ Waterproof mascara and liquid lipsticks had the highest levels of fluorine.⁴⁶ In 88% of the tested cosmetics, PFAS were not disclosed on the label.⁴⁷

“Manufacturers may dismiss the dangers of PFAS exposure, but the medical and scientific literature is clear,” according to New York City attorney James Bilsborrow, who handles toxic tort and consumer protection cases. “These chemicals are harmful to both humans and animals. They can interfere with a child’s learning, behavior, and growth. They can reduce a woman’s chance of getting pregnant, interfere with the body’s natural hormones, increase cholesterol levels, elevate liver enzymes, increase uric acid levels, and disrupt our immune system. Even more concerning, PFAS can lead to many types of cancer and other diseases. PFAS are definitely not chemicals we want to use on our bodies.”⁴⁸

Several lawsuits have been brought against makeup companies for failing to disclose PFAS in their products, while marketing them as “clean” and “natural.”⁴⁹ Among plaintiffs’ claims are allegations of negligent misrepresentation, breach of warranty, fraud, and violations of state consumer protection statutes for the products’ inclusion of PFAS linked to harmful effects on human health even though the labels and advertising implied that the products did not contain such chemicals. And on the legislative front, several states have passed laws banning or restricting intentionally added PFAS in cosmetics, textiles, and other household products.⁵⁰

While consumers wait for implementation of MoCRA and adoption of related regulations to improve the safety of personal care products and transparency about the ingredients they contain, litigation continues to play a crucial role in protecting and educating the public.

Kate Halloran is the senior associate editor for Trial.

Notes

1. U.S. Food & Drug Admin., Laws Enforced by FDA, https://www.fda.gov/regulatory-information/laws-enforced-fda.
2. See U.S. Food & Drug Admin., Modernization of Cosmetics Regulation Act of 2022, https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022.
3. U.S. Food & Drug Admin., Cosmetics Safety Q&A: Personal Care Products, https://www.fda.gov/cosmetics/resources-consumers-cosmetics/cosmetics-safety-qa-personal-care-products. Some personal care products cross the line into “drugs” under the FD&C Act—meaning that they require premarket approval of whatever ingredient is considered to offer a “therapeutic” purpose (such as UVA and UVB blockers in sunscreen). U.S. Food & Drug Admin., Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?), https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap.
4. U.S. Food & Drug Admin., Cosmetic Products, https://www.fda.gov/cosmetics/cosmetic-products-ingredients/cosmetic-products.
5. See Pub. L. No. 75-717, 52 Stat. 1040, 1054–55 (1938).
6. Compare id. with 21 U.S.C. §§361–362 (2022).
7. See, e.g., Brandin Inouye, On Protecting Consumers From Toxics in Cosmetics, U.S. Lags at Least 80 Countries, EWG, Aug. 10, 2021, https://www.ewg.org/news-insights/news/2021/08/protecting-consumers-toxics-cosmetics-us-lags-least-80-countries; Bella Isaacs-Thomas, Why Your Cosmetics Don’t Have to be Tested for Safety, PBS News Hour, Dec. 16, 2019, https://www.pbs.org/newshour/health/why-your-cosmetics-dont-have-to-be-tested-for-safety.
8. Oliver Milman, U.S. Cosmetics Are Full of Chemicals Banned by Europe—Why?, The Guardian, May 22, 2019, https://www.theguardian.com/us-news/2019/may/22/chemicals-in-cosmetics-us-restricted-eu.
9. Monica Amarelo, California First State to Ban 24 Toxic Chemicals in Personal Care Products and Cosmetics, EWG, Sept. 30, 2020, https://www.ewg.org/news-insights/news-release/california-first-state-ban-24-toxic-chemicals-personal-care-products-and.
10. See Pub. L. No. 117-328, §§3501–3508 (2022); see also U.S. Food & Drug Admin., Modernization of Cosmetics Regulation Act of 2022, supra note 2; Maureen Leddy, FDA Gains New Authority to Regulate Cosmetics Safety, Trial News, Jan. 26, 2023.
11. See Pub. L. No. 117-328, §§3501–3508.
12. Janet Nudelman, Modernization of Cosmetics Regulation Act of 2022: Section-by-Section Analysis, Campaign for Safe Cosmetics, Jan. 10, 2023, https://tinyurl.com/34688dvs.
13. Wade Ackerman et al., MoCRA: 6 Key Takeaways From The New Cosmetics Law, Law 360, Jan. 20, 2023, https://tinyurl.com/3jzhvdaw.
14. Id.
15. For more on this litigation, see Christopher M. Placitella, Dennis M. Geier, & Jared M. Placitella, A 30,000 Foot View of Cosmetic Talc Cases, Trial, Oct. 2020, at 34.
16. Valisure, Valisure Detects Benzene in Sunscreen, May 25, 2021, https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-sunscreen.
17. U.S. EPA, Benzene, https://www.epa.gov/sites/default/files/2016-09/documents/benzene.pdf; Am. Cancer Soc’y, Benzene and Cancer Risk, https://www.cancer.org/healthy/cancer-causes/chemicals/benzene.html.
18. U.S. EPA, supra note 17 at 4.
19. Valisure, supra note 16.
20. Id.
21. Russell Maas, Aveeno, Neutrogena Suncreen Recall Issued Over Cancer-Causing Chemicals in Some Aerosol Spray Cans, About Lawsuits, July 15, 2021, https://www.aboutlawsuits.com/aveeno-neutrogena-suncreen-recall-185937/; Russell Maas, Banana Boat Sunscreen Recall Expanded Due to Benzene Cancer Risks, About Lawsuits, Feb. 2, 2023, https://www.aboutlawsuits.com/banana-boat-sunscreen-recall-benzene-cancer-risks/.
22. In re Johnson & Johnson Aerosol Sunscreen Mktg., Sales Practices & Prods. Liab. Litig., 568 F. Supp. 3d 1412, 1413 (J.P.M.L. Oct. 8, 2021).
23. See In re Johnson & Johnson Aerosol Sunscreen Mktg., Sales Practices & Prods. Liab. Litig., 2023 WL 2284684, at *3 (S.D. Fla. Feb. 28, 2023); Irvin Jackson, Spray Sunscreen Lawsuit Settlement Gets Final Approval Over Benzene in Aveeno, Neutrogena Products, About Lawsuits, Mar. 2, 2023, https://www.aboutlawsuits.com/spray-sunscreen-lawsuit-settlement-aveeno-neutrogena/.
24. Settlement Agreement at 9, Bangoura v. Beiersdorf, Inc. (E.D.N.Y. Aug. 1, 2022) (No. 1:22-cv-00291-BMC).
25. U.S. Food & Drug Admin., Unilever Issues Voluntary U.S. Recall of Select Dry Shampoos Due to Potential Presence of Benzene, https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unilever-issues-voluntary-us-recall-select-dry-shampoos-due-potential-presence-benzene.
26. The Judicial Panel on Multidistrict Litigation denied a motion to consolidate the cases. Order Denying Transfer, In Re Unilever Aerosol Prods. Mktg., Sales Practices, & Prods. Liab. Litig., MDL No. 3068 (J.P.M.L. Apr. 7, 2023).
27. Cosmetics & Toiletries, P&G Pays Out $8M in Benzene Settlement, Dec. 5, 2022, https://www.cosmeticsandtoiletries.com/regulations/safety/news/22591447/pg-pays-out-8-m-in-benzene-settlement.
28. Compl. ¶¶ 189, 191, Mitchell v. L’Oreal USA, Inc. (N.D. Ill. Oct. 21, 2022) (No. 1:22-cv-05815).
29. Id. at ¶ 194.
30. Che-Jung Chang et al., Use of Straighteners and Other Hair Products and Incident Uterine Cancer, 114 J. Nat’l Cancer Inst. 1636, 1638–43 (Oct. 17, 2022), DOI: 10.1093/jnci/djac165.
31. The disproportionate effect on women of color is not unique to hair relaxers. For more, see Patrick Celestine, Righting the Imbalance in Toxic Cosmetics, Trial, May 2020, at 52.
32. Head and Shoulders, Relaxers—How Do They Work?, https://headandshoulders.com/en-us/healthy-hair-and-scalp/hair-care/relaxers-how-do-they-work.
33. JOY Collective, Dove CROWN Research Study for Girls (2021), https://tinyurl.com/y3uaekeh; Michaela Angela Davis, Protective Styles Are the Armor Black Women Have Worn for Centuries, Allure, Nov. 20, 2020, https://www.allure.com/story/protective-styles-meaning-history-michaela-angela-davis.
34. JOY Collective, supra note 33.
35. JOY Collective, Dove CROWN Research Study (2019), https://tinyurl.com/yw5rxt57.
36. U.S. Food & Drug Admin., Hair Dye and Hair Relaxers, https://www.fda.gov/consumers/free-publications-women/hair-dye-and-hair-relaxers.
37. Scott Faber, The Toxic Twelve Chemicals and Contaminants in Cosmetics, EWG, May 5, 2020, https://www.ewg.org/the-toxic-twelve-chemicals-and-contaminants-in-cosmetics.
38. See id.
39. In re Hair Relaxer Mktg., Sales Practices, & Prods. Liab. Litig., 2023 WL 1811936, at *3 (J.P.M.L. Feb. 6, 2023).
40. See id. at *1.
41. Dina ElBoghdady, 400 Lipsticks Found to Contain Lead, FDA Says, Wash. Post, Feb. 14, 2012, https://www.washingtonpost.com/business/economy/400-lipstick-brands-contain-lead-fda-says/2012/02/14/gIQAhOyeDR_story.html; EWG, Alert: Tests Find High Levels of Asbestos in Children’s Makeup Kit, Jan. 16, 2020, https://www.ewg.org/news-insights/news-release/alert-tests-find-high-levels-asbestos-childrens-makeup-kit.
42. Sydney Evans et al., PFAS Contamination of Drinking Water Far More Prevalent Than Previously Reported, EWG, Jan. 23, 2020, https://www.ewg.org/research/national-pfas-testing. The EPA announced in March its first proposed National Primary Drinking Water Regulation to limit levels for six PFAS chemicals in drinking water supplies. U.S. Env’t Prot. Agency, Proposed PFAS National Primary Drinking Water Regulation, Mar. 14, 2023, https://www.epa.gov/sdwa/and-polyfluoroalkyl-substances-pfas.
43. Agency for Toxic Substances & Disease Registry, What Are PFAS?, https://www.atsdr.cdc.gov/pfas/health-effects/overview.html.
44. Elizabeth Gamillo, Scientists Find Toxic ‘Forever Chemicals’ in More Than 100 Popular Makeup Products, Smithsonian Mag., June 22, 2021, https://www.smithsonianmag.com/smart-news/hold-blush-cosmetics-may-contain-toxic-forever-chemicals-180978036/; Heather D. Whitehead et al., Fluorinated Compounds in North American Cosmetics, 8 Env’t Sci. & Tech Letters 538 (2021), DOI: 10.1021/acs.estlett.1c00240.
45. Gamillo, supra note 44.
46. Id.
47. Id.
48. Weitz & Luxenberg, W&L Files Class Action Lawsuits for PFAS in Mascara, Apr. 27, 2022, https://tinyurl.com/2x44m4rt.
49. See, e.g., Compl., Vega v. L’Oreal USA, Inc. (D.N.J. Apr. 8, 2022) (No. 2:22-cv-02049); Compl., Solis v. Cover Girl Cosmetics (S.D. Cal. Mar. 25, 2022) (No. 22CV0400 BEN NLS) (dismissed for lack of standing with leave to file amended complaint, Solis v. Cover Girl Cosmetics, 2023 WL 2394640, at *12 (S.D. Cal. Mar. 7, 2023)); Compl., Onaka v. Shiseido Corp. (S.D.N.Y. Dec. 14, 2021) (No. 1:21-cv-10665); Compl., GMO Free USA v. Cover Girl Cosmetics (D.C. Super. Ct. Dec. 20, 2021) (No. 2021-CA-004786B).
50. Alex Brown, States Take on PFAS “Forever Chemicals” With Bans, Lawsuits, Pew, Sept. 22, 2022, https://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2022/09/22/states-take-on-pfas-forever-chemicals-with-bans-lawsuits. MoCRA also requires the FDA to conduct a risk assessment of PFAS in cosmetics, with its findings released publicly by Dec. 29, 2025.