Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 1 of 86
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`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`
`DAIAN ONAKA, TORSHIA WOODS,
`SHELI ZELLER, MARGO FERGUSON,
`and EVA BAILEY, individually and on behalf of
`all others similarly situated,
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`
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`v.
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`SHISEIDO AMERICAS CORPORATION,
`
`Defendant.
`
`______________________________________/
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`Plaintiffs,
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`Case No. 1:21-cv-10665-PAC
`Honorable Paul A. Crotty
`
`
`
`
`
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`SECOND AMENDED CLASS ACTION COMPLAINT
`
`Plaintiffs Daian Onaka, Torshia Woods, Sheli Zeller, Margo Ferguson, and Eva Bailey
`
`(“Plaintiffs”) bring this Second Amended Class Action Complaint against Defendant Shiseido
`
`Americas Corporation (“Shiseido” or “Defendant”), individually and on behalf of all others
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`similarly situated, and complain and allege upon personal knowledge as to themselves and their
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`own acts and experiences and, as to all other matters, upon information and belief, including
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`investigation conducted by their attorneys:
`
`NATURE OF THE ACTION
`
`1.
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`This is a civil class action brought by Plaintiffs on behalf of all consumers who
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`purchased certain bareMinerals products, which are marketed as clean and natural beauty products
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`for normal, everyday use, but which contain harmful per- and polyfluoroalkyl substances
`
`(“PFAS”) (collectively, “PFAS Makeup” or “Products”).1
`
`
`1 The action concerns the following bareMinerals products that contain PFAS: BAREPRO®
`Performance Wear Liquid Foundation SPF 20, BAREPRO® 16-Hr Full Coverage Concealer,
`Original Liquid Mineral Foundation Broad Spectrum SPF 20, GEN NUDE® Matte Liquid
`
`
`
`
`1
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 2 of 86
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`2.
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`The bareMinerals brand differentiates itself in the highly competitive beauty market
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`by uniformly advertising its products as being “free of harsh chemicals and unnecessary additives,
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`and full of . . . natural minerals,”2 “rigorously safety tested,” “pure”3 and “clean, conscious beauty
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`that’s good to your skin, good for the community and good for the planet.”4 In fact, Defendant
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`describes itself as the “Creators of Clean Beauty”5 and “the original creators of mineral makeup
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`and clean beauty.”6 Defendant proclaims that “bareMinerals started the clean beauty revolution
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`when it launched its best-selling mineral foundation in 1995, and since then, the brand has
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`continued to create clean, cruelty-free makeup . . .”7
`
`3.
`
`As one of the largest cosmetic companies in the world, with a portfolio including
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`dozens of high-end brands, Defendant knows that when it comes to marketing and labeling, words
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`matter. Defendant intentionally joins the words “bare” and “minerals” as its brand name to
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`convince consumers that its products are clean and natural. The Merriam-Webster definition of
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`“bare” is “having nothing left over or added” and connotes something that is basic or simple—
`
`without addition. The Merriam-Webster definition of “mineral” means “a naturally occurring
`
`homogonous substance,” and minerals are commonly known as substances essential for health and
`
`
`Lipstick. As alleged herein, Defendant conceals the inclusion of PFAS in the Products from
`consumers.
`2 About bareMinerals, BAREMINERALS, https://www.bareminerals.com/discover/about-
`us.html (last visited Nov. 27, 2021).
`3 Id.
`4 Our Purpose, BAREMINERALS, https://www.bareminerals.com/our-purpose/ (last visited
`Nov. 27, 2021).
`5 About bareMinerals, supra note 2.
`6 bareMinerals Brand, SHISEIDO, https://corp.shiseido.com/en/brands/bareminerals/ (last
`visited Nov. 27, 2021).
`7 Id.
`
`
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`2
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 3 of 86
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`meeting basic nutritional requirements. Reasonable consumers, therefore, fairly, and reasonably
`
`understand that a product named bareMinerals, which is marketed as clean and natural, would not
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`contain human-made chemicals like PFAS. As a result of its brand name and marketing campaign,
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`over the course of several decades, Defendant’s bareMinerals brand of cosmetics has unfairly
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`gained the trust of consumers, who reasonably believe that the PFAS Makeup are made without
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`non-clean or non-natural ingredients, such as PFAS. Consumers, including Plaintiffs, relied upon
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`the “bareMinerals” name in purchasing the PFAS Makeup.
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`4.
`
`Globally, the clean beauty market is estimated to reach $22 billion by 2024,
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`becoming a fast-growing category within the cosmetics industry.8 It is no surprise that cosmetic
`
`companies, like Defendant, are eager to garner market share in the incredibly lucrative and
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`expanding “clean beauty” movement.
`
`5.
`
`The clean beauty movement has caused a revolution in the beauty industry and is
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`the result of increased demand for “clean” products that contribute to their overall health and
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`wellness goals. Over the last 10-15 years, clean beauty products have emerged as key players in
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`the ever-growing cosmetics market, leading companies, such as Defendant, to set themselves apart
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`with attractive marketing claims, even if those claims are unsupported by what is actually in the
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`product.
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`6.
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`Defendant knows that consumers are focused on what they put on their face and
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`how the products they use impact the environment.9
`
`
`8 Kristin Larson, Shopper Demand for Clean Beauty and Increased Transparency Continues,
`FORBES.COM (June 30, 2021, 6:47 PM)
`https://www.forbes.com/sites/kristinlarson/2021/06/30/shopper-demand-for-clean-beauty-
`and-increased-transparency-continues/.
`9 The Clean Beauty Trend is More Than Skin Deep, NIELSENIQ (July 29, 2021)
`nielseniq.com/global/en/insights/education/2021/the-clean-beauty-trend-is-more-than-skin-deep/.
`
`
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`3
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 4 of 86
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`7.
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`Consumers pay the price they do—and Plaintiffs paid the price they did—for
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`bareMinerals’ self-proclaimed “clean beauty” makeup based upon Defendant’s pervasive
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`marketing that centers on the importance of using “clean” and “natural” cosmetics for makeup
`
`application.
`
`8.
`
`Through bareMinerals’ “clean beauty” campaign, Defendant capitalizes on ever
`
`increasing consumer demand for “clean” beauty products, which are generally understood to have
`
`eliminated ingredients shown or suspected to be harmful to human health. This generally accepted
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`meaning of “clean” is supported by bareMinerals own descriptions of “clean beauty,” which refers
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`to its products as “contain[ing] only what’s needed, and nothing else,”10 and “100% free” of
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`various chemicals known to cause adverse health effects.11
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`9.
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`Defendant’s marketing campaign is replete with examples of its intention to
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`convince consumers that its bareMinerals brand is a “clean,” natural mineral makeup that is good
`
`for skin and contains “only what’s needed, and nothing else.”12
`
`10.
`
`Consumers expect the ingredient listing on the packaging and labels of cosmetics
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`like the PFAS Makeup to accurately disclose all of the product’s ingredients. However, Defendant
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`does not disclose that the Products contain PFAS, a chemical which is entirely inconsistent with
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`its clean beauty campaign, the disclosure of which would inevitably impact its sales and standing
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`in the rapidly growing clean beauty market. Defendant’s failure to disclose the presence of PFAS
`
`in the Products is driven by Defendant’s desire to maximize sales revenue.
`
`
`10 Our Purpose, supra note 4.
`11 Clean Beauty Makeup, BAREMINERALS, https://www.bareminerals.com/our-purpose/look-
`good/clean-beauty/ (last visited Nov. 27, 2021).
`12 Id.
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`4
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 5 of 86
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`11.
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`In reality, the PFAS Makeup is not clean or natural as it contains potentially harmful
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`chemicals that are in no way “clean” or “natural.”
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`12. The presence of PFAS in the Products is inconsistent with the bareMinerals brand
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`name and its uniform, pervasive clean beauty marketing and advertising campaign, which leads
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`reasonable consumers to believe that the Products do not contain potentially harmful chemicals
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`that pose a risk to humans and the environment. No reasonable consumer would deem the PFAS
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`Makeup clean or natural if they knew the Products contain harmful PFAS.
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`13. Further, the presence of PFAS in the PFAS Makeup renders it adulterated,
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`misbranded, and illegal to sell under federal and state law.
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`14.
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`Defendant’s misconduct is uniform and widespread. Defendant formulates,
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`designs, manufactures, markets, advertises, distributes, and sells its bareMinerals-branded PFAS
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`Makeup to consumers throughout the United States, including in the State of New York.
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`15.
`
`Defendant distributes and sells its bareMinerals line of cosmetics, including the
`
`PFAS Makeup, on its bareMinerals website, in its bareMinerals retail stores, and through various
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`authorized brick-and-mortar and online retailers such as ULTA, Sephora, Macy’s, Nordstrom and
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`Amazon.
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`16.
`
`The PFAS contained in the PFAS Makeup is not disclosed by Defendant on its
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`website, in its ingredients, on its packaging, or in any other manner; however, Plaintiffs tested each
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`of the Products they purchased, and all of the Products contained undisclosed PFAS.
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`17.
`
`Plaintiffs retained a third-party independent lab, which is accredited by the
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`American Association for Laboratory Accreditation (A2LA), to conduct this testing.
`
`18.
`
`Plaintiffs conducted testing on each of the PFAS Makeup, which were purchased
`
`by Plaintiffs, proximate in time to Plaintiffs’ purchases. On September 9, 2021, Plaintiffs
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`5
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 6 of 86
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`conducted testing on two separate samples of Defendant’s BAREPRO® Performance Wear Liquid
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`Foundation SPF 20, which revealed significant levels of organic fluorine in both samples.
`
`19.
`
`On October 26, 2021, Plaintiffs conducted additional testing on two separate
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`samples of Defendant’s BAREPRO® 16-Hr Full Coverage Concealer, BAREPRO® Longwear
`
`Lipstick, Original Liquid Mineral Foundation, GEN NUDE® Matte Liquid Lipstick, which
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`revealed significant levels of organic fluorine in every sample tested.
`
`20.
`
`There are more than 9,000 PFAS chemicals currently in existence.13 Accordingly,
`
`it is impractical, if not impossible, for scientists and researchers to test for the presence of each of
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`these 12,000 chemicals in any particular sample. Organic fluorine has recently emerged as an
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`indicator that encompasses the total content of both known and unknown types of PFAS, unlike
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`traditional targeted analyses that can reliably quantify only a few dozen known PFAS that have
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`commercially available analytical standards.14
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`21.
`
`Because the presence of organic fluorine in a sample reliably indicates that the
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`sample contains man-made PFAS, this method has been widely adopted, including by the state of
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`California in its regulation of PFAS in consumer products. See Cal. Health & Safety Code §
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`109000.
`
`22.
`
`The presence of PFAS in the PFAS Makeup has recently been identified in several
`
`products, including in a recent study conducted by scientists from the University of Notre Dame
`
`and other universities, in collaboration with the Green Science Policy Institute, who found PFAS
`
`in a number of cosmetics purchased between 2016 and 2020, including more than three-quarters
`
`
`13 https://www.niehs.nih.gov/health/topics/agents/pfc/index.cfm (last visited Mar. 30, 2023).
`14 https://pubs.acs.org/doi/10.1021/acs.est.2c05198 (last visited Mar. 30, 2023).
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`6
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 7 of 86
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`of waterproof mascara, almost two-thirds of foundations and liquid lipsticks, and over half of the
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`eye and lip products (“the PFAS Makeup Study”) (attached hereto as Exhibit A).15
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`23.
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`Following this PFAS Makeup Study, Plaintiffs conducted independent third-party
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`testing of the bareMinerals PFAS Makeup products that corroborated the results of the PFAS
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`Makeup Study. Similar to the findings in the Notre Dame PFAS Makeup Study, independent third-
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`party testing conducted by Plaintiffs, which tested bareMinerals foundation and face products
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`(defined as powdered foundation, powders, blush, highlighters, bronzers, primers, finishing and
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`priming sprays)—specifically purchased by Plaintiffs Onaka, Woods, and Zeller within the same
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`month of Plaintiffs’ testing, confirmed the presence of PFAS. Plaintiff Ferguson’s purchases of
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`the PFAS Makeup occurred within nine months of Plaintiffs’ testing. Plaintiff Bailey’s purchases
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`of the PFAS Makeup occurred within six months of Plaintiffs’ testing.
`
`24.
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`Notably, the PFAS Makeup Study determined that raw ingredients in cosmetics are
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`frequently treated with PFAS by suppliers in order to increase their hydrophobic properties, which
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`improve the durability and wear of applied cosmetics. Based on their findings, the PFAS Makeup
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`Study concluded that these ingredients are described on labels using only their generalized name.
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`In other words, none of the labels indicate that the individual ingredients in the products are treated
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`with PFAS.
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`25.
`
`The PFAS Makeup Study identified numerous ingredients which can be treated
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`with PFAS and/or have a fluorinated alternative, including, inter alia: mica, talc, silica, Nylon-12,
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`methicone, dimethicone, titanium dioxide, iron oxide, and various coloring agents. Every Product
`
`tested by Plaintiffs contains some combination of these ingredients, as shown in the chart below:
`
`
`15 https://pubs.acs.org/doi/10.1021/acs.estlett.1c00240
`
`
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`7
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 8 of 86
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`Product
`
`Ingredients That Are A Possible or Likely
`Source of PFAS
`
`BarePro 24 Hour Performance
`Foundation
`
`Silica, Peg-10 Dimethicone, Methicone, Titanium
`Dioxide, Iron Oxides
`
`Original Liquid Mineral Foundation
`
`Titanium Dioxide, Iron Oxides
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`Gen Matte Nude Lipcolor
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`16 Hour Full Coverage Concealer
`
`BarePro Longwear Lipcolor
`
`Nylon-12, Caprylyl Methicone, Mica, Blue 1 Lake
`(Ci 42090), Yellow 5 Lake (Ci 19140), Iron Oxides
`(Ci 77491, Ci 77492, Ci 77499), Red 28 Lake (Ci
`45410), Red 33 Lake (Ci 17200), Red 7 Lake (Ci
`15850), Titanium Dioxide (Ci 77891)
`
`Methicone, Peg-10 Dimethicone, Silica, Titanium
`Dioxide (Ci 77891), Iron Oxides (Ci 77491, Ci
`77492, Ci 77499)
`
`Dimethicone, Silica, Mica, Titanium Dioxide (Ci
`77891), Iron Oxides (Ci 77491, Ci 77492, Ci
`77499), Blue 1 Lake (Ci 42090), Red 6 (Ci
`15850), Red 7 Lake (Ci 15850), Red 28 Lake (Ci
`45410), Red 33 Lake (Ci 17200), Yellow 5 Lake
`(Ci 19140), Yellow 6 Lake (Ci 15985)
`
`26.
`
`The PFAS Makeup Study found that the ingredients Ci 77491, Ci 77499, Silica,
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`Mica (all of which are present in the PFAS Makeup) were most frequently found in cosmetic
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`products containing PFAS.
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`27.
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`This is logical, given that mica, silica, and color additives can (and are) treated with
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`PFAS to improve the durability and wear of applied cosmetics.
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`28.
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`Likewise, methicone and dimethicone—both of which are found in the PFAS
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`Makeup—are readily available in fluorinated versions from chemical suppliers. For example,
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`Siltech and Phoenix Chemical, Inc. both sell fluorinated versions of these ingredients to cosmetic
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`manufacturers.
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`8
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 9 of 86
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`29.
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`However, PFAS is not listed as an ingredient on any of the PFAS Makeup products.
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`In fact, on its official website, Defendant affirmatively denies the use of PFAS as an ingredient in
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`any of its products, stating that “All of our products undergo rigorous quality, health, and safety
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`assessments, including ingredient review, and we are confident they are safe for use. We do not
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`use PFAS as an ingredient in any of our products.”16
`
`
`
`30.
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`Defendant’s concealment of this material information makes its false and
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`misleading marketing even more egregious.
`
`31.
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`Defendant’s misrepresentations are intentional, or otherwise entirely careless, and
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`render the PFAS Makeup worthless or less valuable. If Defendant had disclosed to Plaintiffs and
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`putative Class Members that the PFAS Makeup contained PFAS, Plaintiffs and putative Class
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`Members would not have purchased the PFAS Makeup, or they would have paid less for it.
`
`
`16 Foundation, BAREMINERALS
`https://www.bareminerals.com/makeup/face/foundation/barepro®-24hr-performance-wear-
`liquid-foundation-broad-spectrum-spf-20/US83542.html#tab-ingredients (last visited Mar. 31,
`2023).
`
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`9
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 10 of 86
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`32.
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`Alternative formulation, designs and materials were available to Defendant at the
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`time it formulated, designed, and manufactured the PFAS Makeup, and such alternative
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`formulations and designs were and are used by other manufacturers to produce and sell clean,
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`natural makeup.
`
`33.
`
`Plaintiffs seek damages and equitable remedies for themselves and for the proposed
`
`Classes.
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`JURISDICTION AND VENUE
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`34.
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`This Court has subject matter jurisdiction over this matter pursuant to 28 U.S.C. §
`
`1332 of the Class Action Fairness Act of 2005 because: (1) there are 100 or more putative Class
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`Members; (ii) the aggregate amount in controversy exceeds $5,000,000.00, exclusive of interest
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`and costs; and (iii) there is minimal diversity because Plaintiffs and Defendant are citizens of
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`different states. This Court has supplemental jurisdiction over Plaintiffs’ state law claims pursuant
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`to 28 U.S.C. § 1367.
`
`35.
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`This Court has personal jurisdiction over Defendant because it is headquartered in
`
`this District, has substantial aggregate contacts with this District, including engaging in conduct
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`that has a direct, substantial, reasonably foreseeable, and intended effect of causing injury to
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`persons throughout the United States, and purposely availed itself of the laws of the United States
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`and the State of New York.
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`36.
`
`In accordance with 28 U.S.C. § 1391, venue is proper in this District because a
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`substantial part of the conduct giving rise to Plaintiffs’ claims occurred in this District, Defendant
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`transacts business in this District, and Defendant has intentionally availed itself of the laws and
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`markets within this District.
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`10
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 11 of 86
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`PARTIES
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`37.
`
`Plaintiff Daian Onaka is a resident and citizen of San Jose, California, who
`
`purchased and used the following PFAS Makeup most recently on September 19, 2021:
`
`BAREPRO® Performance Wear Liquid Foundation SPF 20, BAREPRO® 16-Hr Full Coverage
`
`Concealer, Original Liquid Mineral Foundation, GEN NUDE® Matte Liquid Lipstick.
`
`38.
`
`Plaintiff Torshia Woods is a resident and citizen of Horn Lake, Mississippi, who
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`purchased and used the following PFAS Makeup most recently on October 15, 2021: BAREPRO®
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`Performance Wear Liquid Foundation SPF 20 and Original Liquid Mineral Foundation.
`
`39.
`
`Plaintiff Sheli Zeller is a resident and citizen of Franklin, Ohio, who purchased and
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`used the following PFAS Makeup most recently on October 11, 2021 and July 8, 2021,
`
`respectively: BAREPRO® Performance Wear Liquid Foundation SPF 20 and GEN NUDE® Matte
`
`Liquid Lipstick.
`
`40.
`
`Plaintiff Margo Ferguson is a resident and citizen of Clifton, New Jersey, who
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`purchased and used the following PFAS Makeup most recently on January 15, 2021: BAREPRO®
`
`Performance Wear Liquid Foundation SPF 20.
`
`41.
`
`Plaintiff Eva Bailey is a resident and citizen of Marion, North Carolina, who
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`purchased and used the following PFAS Makeup most recently on March 1, 2021: BAREPRO®
`
`Performance Wear Liquid Foundation SPF 20 and 16 Hr Full Coverage Concealer.
`
`42.
`
`Defendant Shiseido Americas Corporation is incorporated in Delaware with its
`
`principal place of business located at 390 Madison Avenue, New York, NY 10017.
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`FACTUAL ALLEGATIONS
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`bareMinerals Cosmetics
`
`43.
`
`bareMinerals products, including foundation, lipstick, mascara, and other makeup
`
`for the face, eyes, and lips, are sold throughout the United States.
`
`44.
`
`Included among bareMinerals products is the PFAS Makeup, which includes, but
`
`is not limited to, BAREPRO® Performance Wear Liquid Foundation SPF 20, BAREPRO® 16-Hr
`
`Full Coverage Concealer, BAREPRO® Longwear Lipstick, Original Liquid Mineral Foundation,
`
`GEN NUDE® Matte Liquid Lipstick.
`
`45.
`
`bareMinerals products are sold at mass market beauty retailers and department
`
`stores in the United States, including ULTA, Sephora, Macy’s, and Nordstrom, in addition to being
`
`sold at bareMinerals’ own retail stores. The products are also sold on the bareMinerals website
`
`and by other online retailers such as Amazon.
`
`46.
`
`As the self-proclaimed “Creators of Clean Beauty,” bareMinerals takes credit for
`
`starting “the clean beauty revolution” by launching its best-selling mineral foundation in 1995—a
`
`makeup product utilizing just 5 mineral ingredients.17
`
`47.
`
`Defendant acquired the bareMinerals brand in 2010. From that time until the
`
`present, Defendant has continued to grow—and profit from—bareMinerals’ well-established
`
`position as a leader in the “clean beauty” market.
`
`48.
`
`Since its introduction into the consumer marketplace, and continuing since
`
`Defendant’s acquisition, the brand’s entire marketing focus has centered on promotion of its
`
`
`17 About bareMinerals, supra note 2.
`
`
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`12
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 13 of 86
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`“clean” message. For example, it represents that since its 1995 launch it has “continued to create
`
`clean, cruelty-free makeup and skincare products that never compromise on performance.”18
`
`49.
`
`Defendant further states that the Products are “Full of what’s good. Free of
`
`chemicals” as shown below.19
`
`PFAS
`
`50.
`
`PFAS are a category of highly persistent and potentially harmful human-made
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`chemicals.20
`
`
`
`
`
`18 Id.
`19 Id.
`20 PFAS Explained, EPA, https://www.epa.gov/pfas/pfas-explained (last visited Nov. 27,
`2021).
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`51. While there are thousands of varieties of PFAS chemicals in existence, all PFAS
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`contain carbon-fluorine bonds—one of the strongest in nature—which makes them highly
`
`persistent in the environment and in human bodies.21
`
`52.
`
`PFAS chemicals are sometimes called “forever chemicals” and have been
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`associated with a variety of negative health effects for humans and the environment.
`
`53.
`
`Humans can be exposed to PFAS through a variety of ways, including ingestion,
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`inhalation, and skin absorption.22
`
`54.
`
`According to the FDA, PFAS are “intentionally added” to products such as lotions,
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`cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara “to
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`condition, smooth or make skin appear shiny.”23 PFAS are also added to cosmetics to increase
`
`their durability and water resistance.”24
`
`55.
`
`By law, all ingredients contained within cosmetics are required to be listed on the
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`product label, in descending order of magnitude.
`
`56.
`
`Common
`
`names
`
`for PFAS
`
`found
`
`in
`
`cosmetics
`
`include PTFE
`
`(polytetrafluoroethylene),
`
`perfluorooctyl
`
`triethoxysilane,
`
`perfluorononyl
`
`dimethicone,
`
`perfluorodecalin, and perfluorohexane.
`
`57.
`
`In order to assess the potential health and environmental risk of PFAS in cosmetics,
`
`a study was conducted in June 2021 entitled “Fluorinated Compounds in North American
`
`
`21 Per- and Polyfluoroalkyl Substances (PFAS), NATIONAL TOXICOLOGY PROGRAM,
`https://ntp.niehs.nih.gov/whatwestudy/topics/pfas/index.html (last visited Nov. 27, 2021).
`22 Id.
`23 Sandee LaMotte, Makeup may Contain Potentially Toxic Chemicals Called PFAS, Study
`Finds, CNN (June 15, 2021, 7:46 PM) https://www.cnn.com/2021/06/15/health/makeup-toxic-
`chemicals-wellness/index.html.
`24 Heather Whitehead et al., Fluorinated Compounds in North American Cosmetics, ENVIRON.
`SCI. TECHNOL. LETT. (June 15, 2021) https://pubs.acs.org/doi/10.1021/acs.estlett.1c00240.
`
`
`
`14
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 15 of 86
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`Cosmetics” (the “Study”). The Study analyzed more than 231 cosmetic products purchased in the
`
`United States and Canada to determine the presence of PFAS.25
`
`58.
`
`The Study explained likely reasons for the use of PFAS in makeup:
`
`PFAS are used in cosmetics due to their properties such hydrophobicity and film-
`forming ability, which are thought to increase product wear, durability, and
`spreadability. Additional claimed benefits are increased skin absorption of the
`product and improvements in the appearance or texture of skin.26
`
`59.
`
`Despite being required by the US Food and Drug Administration to list all
`
`
`
`ingredients present in cosmetics, the Study found some 88% of the tested products failed to
`
`disclose on their labels any ingredients that would explain those chemical markers.
`
`60.
`
`In order to analyze the presence of PFAS, the Study used a marker for PFAS—the
`
`chemical fluorine, which is different than the inorganic fluorine added to drinking water.
`
`61.
`
`“We found fluorine as a surrogate for PFAS was in all sorts of cosmetics. We didn’t
`
`expect almost every cosmetic to light up like it did,” said study author, Graham Peaslee, a professor
`
`of physics, chemistry, and biochemistry at the University of Notre Dame.27
`
`62.
`
`The Study concluded that more than three-quarters of waterproof mascara, nearly
`
`two-thirds of foundations and liquid lipsticks, and more than half of eye and lip products had high
`
`fluorine concentrations, indicating PFAS were likely present.
`
`63.
`
`In addition, samples from 29 of the products with the highest levels of fluorine were
`
`sent to an outside lab for an in-depth analysis that could identify 53 specific PFAS chemicals. The
`
`analysis found each of those 29 products contained at least four PFAS chemicals of concern.
`
`
`
`25 Id.
`26 Id.
`27 LaMotte, supra note 20.
`
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`15
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 16 of 86
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`64.
`
`In 28 of the 29 products—like the PFAS Makeup here—PFAS chemicals were not
`
`disclosed on the label.
`
`Risks Associated with PFAS in Cosmetics
`
`65.
`
`“PFAS in cosmetics may pose a risk to human health through direct and indirect
`
`exposure, as well as a risk to ecosystem health throughout the lifecycle of these products.”28
`
`66.
`
`Of particular concern with PFAS utilized in cosmetics “is that these classes of
`
`cosmetics are applied close to the eyes and the mouth, which could increase exposure and hence
`
`risk due to enhanced absorption and ingestion.”29
`
`67.
`
`As skin is the body’s largest organ,30 subjecting it to absorption of PFAS through
`
`foundation and concealers is very concerning.
`
`68.
`
`A figure utilized in the Study demonstrates how PFAS in cosmetics are introduced
`
`to the human body:
`
`
`
`69.
`
`As one blogger noted, in quoting a notable dermatologist:
`
`Unfortunately, the technological innovations that PFAS helped create also came
`with a price: Serious health effects. Jennifer Herrmann, MD, FAAD, a board
`
`28 Whitehead et al., supra note 21.
`29 Id.
`30 Gary Swann, The Skin is the Body’s Largest Organ, JOURNAL OF VISUAL COMMUNICATIONS
`IN MEDICINE (Volume 33, November 19, 2010) https://doi.org/10.3109/17453054.2010.525439.
`
`
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`16
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`Case 1:21-cv-10665-PAC Document 56 Filed 04/09/24 Page 17 of 86
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`certified, fellowship-trained dermatologist and dermatologic surgeon at Moy
`Fincher Chipps Facial Plastics / Dermatology, says that PFAS may impact
`‘increased cholesterol, liver inflammation, increased blood pressure in pregnancy,
`decreased birth rate of children, decreased vaccine response in children, and
`increased risk of kidney or testicular cancer.’31
`
`70.
`
`In 2018, Denmark’s EPA performed a “Risk assessment of fluorinated substances
`
`in cosmetic products.” As noted in the assessment:
`
`This project is part of the Danish Environmental Protection Agency’s chemical
`initiative, with the aim of assessing consumers' exposure to problematic
`chemistry… The purpose of this project is to build knowledge of fluorinated
`substances in cosmetic products and to clarify whether the use of cosmetic products
`containing certain fluorinated substances presents a health risk to consumers. The
`project focuses on perfluoroalkyl and polyfluoroalkyl substances (PFAS), which
`are also denoted fluoroalkyl substances. PFAS and other fluorinated compounds
`are used in a variety of cosmetic products such as foundation, moisturizer,
`eyeshadow, powder, lipstick, and shaving cream.
`
`71.
`
`As the study explained, cosmetics such as foundation and concealer are “‘leave-on’
`
`products, i.e., they are intended to stay on the skin all day, with a consequently greater exposure
`
`expected compared to other product types that are intended to be washed off immediately after
`
`application (‘rinse-off’ products).” [Emphasis added].
`
`72.
`
`The study further noted, “Dermal absorption is set conservatively at 70%. As
`
`mentioned earlier, the value is based on a study (Franko et al., 2012) which showed that
`
`approximately 25% PFOA (as acid) was absorbed through the skin and that 45% of the substance
`
`was retained in the epidermis.”
`
`
`31 Marie Lodi, “Forever Chemicals” & Cosmetics: What You Need To Know About PFAS,
`ROSE INC, https://www.roseinc.com/blogs/education/pfas-forever-chemicals-cosmetics-makeup-
`explainer?_pos=1&_sid=6962ca83a&_ss=r (last visited Nov. 27, 2021).
`
`
`
`
`17
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`73.
`
`In a 2019 study, the U.S. Department of Health and Human Services’ National
`
`Toxicology Program found that PFAS has adverse effects on human organ systems, with the
`
`greatest impact seen in the liver and thyroid hormone.32
`
`74.
`
`A figure from the European Environmental Agency (“EEA”) shows the “[e]ffects
`
`of PFAS on human health:”33
`
`
`
`
`32 PFAS Explained, supra note 17.
`33 Emerging chemical risks in Europe — ‘PFAS’, EUROPEAN ENVIRONMENT AGENCY (Dec.
`12, 2019, last modified Mar. 9, 2021) https://www.eea.europa.eu/publications/emerging-chemical-
`risks-in-europe.
`
`
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`75.
`
`The EEA article further explained that “[p]eople most at risk of adverse health
`
`impacts are those exposed to high levels of PFAS, and vulnerable population groups such as
`
`children and the elderly.”34
`
`76.
`
`The Center for Disease Control’s Agency for Toxic Substances and Disease
`
`Registry has recognized that exposure to high levels of PFAS may impact the immune system and
`
`reduce antibody responses to vaccines.35
`
`77.
`
`The danger of PFAS chemicals is well known. On September 20, 2020, a New York
`
`Times article titled “These Everyday Toxins May Be Hurting Pregnant Women and Their Babies”
`
`reported on the dangers of PFAS—particularly during gestation and in early childhood
`
`development:36
`
`Scientists think these widely used industrial chemicals may harm pregnant women
`and their developing babies by meddling with gene regulators and hormones that
`control two of the body’s most critical functions: metabolism and immunity.
`
`More disturbing, PFAS can also alter levels of both mothers’ and babies’ thyroid
`hormones, which oversee brain development, growth, and metabolism, and also
`play a role in immunity. Prenatal PFAS exposures that disrupt metabolism and
`immunity may cause immediate and lasting effects on both mother and child.
`Women exposed to PFAS during pregnancy have higher risks of gestational
`diabetes and pre-eclampsia, a type of high blood pressure. Their babies are more
`likely to undergo abnormal growth in utero, leading to low birth weight, and later
`face increased risk of childhood obesity and infections.
`
`78.
`
`Additionally, according to the EEA:
`
`Costs to society arising from PFAS exposure are high, with the annual health-
`related costs estimated to be EUR 52-84 billion across Europe in a recent study
`(Nordic Council of Ministers, 2019). The study notes that these costs are likely
`
`
`34 Id.
`35 What are the health effects of PFAS?, AGENCY FOR TOXIC SUBSTANCES AND DISEASE
`REGISTRY, https://www.atsdr.cdc.gov/pfas/health-effects/index.html (last visited Nov. 27, 2021).
`36 Liza Gross, These Everyday Toxins may be Hurting Pregnant Women and Their Babies,
`NEW
`YORK
`TIMES
`(Sept.
`23,
`2020,
`updated
`Oct.
`18,
`2021)
`https://www.nytimes.com/2020/09/23/parenting/pregnancy/pfas-toxins-chemicals.html.
`
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`19
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