Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 1 of 53
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`IN THE UNITED STATES DISTRICT COURT FOR
`THE SOUTHERN DISTRICT OF FLORIDA
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`
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`Civil Action
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`Jury Trial Demanded
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`
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`Shirley Dixon,
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`
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`Plaintiff,
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`v.
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`L’ORÉAL USA, INC., L’ORÉAL USA
`PRODUCTS, INC., GODREJ SON
`HOLDINGS, INC., and LUSTER
`PRODUCTS, INC.,
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`
`
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`Defendants.
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`
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`COMPLAINT
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`COMES NOW Plaintiff Shirley Dixon by and through her attorneys, NS PR
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`Law Services LLC, and for their cause of actions makes the following Complaint
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`(“Complaint”) against L’Oréal USA, INC., L’Oréal USA Products, Inc., Godrej
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`SON Holdings, Inc., and Luster Products, Inc., (“Defendants”) alleging as follows:
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`I. NATURE OF ACTION
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`1.
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`This action arises out of Plaintiff Shirley Dixon’s diagnosis of Uterine
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`Cancer and Uterine Fibroids resulting in a hysterectomy. Plaintiff’s Uterine Cancer
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`and Uterine Fibroids resulting in a hysterectomy diagnosis were directly and
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`Page 1 of 53
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`IN THE UNITED STATES DISTRICT COURT FOR
`THE SOUTHERN DISTRICT OF FLORIDA
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`
`
`
`
`
`
`Civil Action
`
`Jury Trial Demanded
`
`
`
`
`
`Shirley Dixon,
`
`
`
`Plaintiff,
`
`v.
`
`L’ORÉAL USA, INC., L’ORÉAL USA
`PRODUCTS, INC., GODREJ SON
`HOLDINGS, INC., and LUSTER
`PRODUCTS, INC.,
`
`
`
`
`Defendants.
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`
`
`
`
`
`
`COMPLAINT
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`COMES NOW Plaintiff Shirley Dixon by and through her attorneys, NS PR
`
`Law Services LLC, and for their cause of actions makes the following Complaint
`
`(“Complaint”) against L’Oréal USA, INC., L’Oréal USA Products, Inc., Godrej
`
`SON Holdings, Inc., and Luster Products, Inc., (“Defendants”) alleging as follows:
`
`I. NATURE OF ACTION
`
`1.
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`This action arises out of Plaintiff Shirley Dixon’s diagnosis of Uterine
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`Cancer and Uterine Fibroids resulting in a hysterectomy. Plaintiff’s Uterine Cancer
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`and Uterine Fibroids resulting in a hysterectomy diagnosis were directly and
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`
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`Page 1 of 53
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 2 of 53
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`proximately caused by her regular and prolonged exposure to endocrine disrupting
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`chemicals found in Defendants’ hair care products.
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`2.
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`Plaintiff brings this action against Defendants for claims arising from
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`the direct and proximate result of Defendants to include their directors, agents, heirs,
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`assigns, and/or their corporate predecessors’ negligent, willful, and wrongful
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`conduct in connection with the design, development, manufacture, testing,
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`packaging, promoting, marketing, distribution, labeling, and/or sale of the products
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`known as Hair Relaxer, Hair Lotion, Leave-in Conditioner, (together, the
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`“Products”) by L’Oréal, its subsidiaries, Godrej SON Holdings, Inc., Johnson
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`Products Company, Inc., and Luster Products, Inc.
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`II. PARTIES
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`3.
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`Plaintiff is a citizen of Florida and resident of the city of Margate.
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`4. Defendant L’Oréal USA, Inc. is, and at all times relevant to this action,
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`is incorporated in Delaware with its principal place of business and headquarters
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`located at 757 Fifth Avenue, New York, New York 10017. Process may be served
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`upon its registered agent, Corporation Service Company, 80 State Street, Albany,
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`New York 12207.
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`5.
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`Defendant L’Oréal USA, Products, Inc., and at all times relevant to this
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`action is incorporated in Delaware with its principal place of business and
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`headquarters located at 10 Hudson Yards 347 10th Avenue, New York, New York
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 3 of 53
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`10001. Process may be served upon its registered agent, Corporation Service
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`Company, 80 State Street, Albany, New York 12207.
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`6. Defendant Godrej SON Holdings, Inc., and at all times relevant to this
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`action, is incorporated in Georgia with its principal place of business and
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`headquarters located at 64 Ross Road, Savannah, Georgia 31405. Process may be
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`served upon its registered agent, Corporation Service Company at 2 Sun Court, Suite
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`400, Peachtree Corner, Georgia 30092.
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`7.
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`Defendant Luster Products, Inc., and at all times relevant to this action,
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`is incorporated in Illinois with its principal place of business and headquarters
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`located at 1104 West 43rd St., Chicago, Illinois 60609. Process may be served upon
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`its registered agent, Joseph D. Palmisano, 19 S Lasalle St., Suite 900, Chicago,
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`Illinois 60603.
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`8. No Defendant in this action is incorporated in the State of Florida,
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`maintains a principal place of business in the State of Florida, or has members who
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`are citizens of the State of Florida. As Plaintiff is a citizen of the State of Florida,
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`complete diversity exists in this action.
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`
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`9. During portions of her life, Plaintiff purchased and used Defendants’
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`Products in the state of Florida.
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`10. As a result of their product use, Plaintiff was exposed to parabens,
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`phthalates, bisphenol A, harmful antimicrobials, ethanolamines, alkylphenols,
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 4 of 53
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`glycol ethers, cyclosiloxanes, benzophenone, formaldehyde, lye, and other harmful
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`chemicals (together, the “Toxic Compounds”).
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`
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`11. As a result of Plaintiff’s toxic exposure, she developed and was
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`diagnosed with Uterine Cancer and Uterine Fibroids resulting in a hysterectomy.
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`12. Portions of the damages alleged herein occurred within the State of
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`Florida.
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`13. Prior to the date that Plaintiff was exposed to these toxic agents,
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`Defendants possessed medical and scientific data from which Defendants knew or
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`should have known that these toxic agents were hazardous to the life, health, and
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`safety of persons who were exposed to them
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`
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`14. At all pertinent times, all Defendants were engaged in the research,
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`development, manufacture, design, testing, sale, and marketing of the Products, and
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`introduced such products into interstate commerce with knowledge and intent that
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`such products be sold in the State of Florida.
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`15. At all times material hereto, Defendants developed, tested, assembled,
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`manufactured, packaged, labeled, prepared, distributed, marketed, supplied, and/or
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`sold the defective Products.
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`16. Defendants placed their defective hair product into the stream of
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`interstate commerce which was used by the Plaintiff from (Products; Dates of Use;
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`Frequency of Use):
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`(a) L’Oréal Hair Relaxer; 1979-2019; Bimonthly
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`(b) Godrej SON Holdings, Inc., Hair Relaxer; 1979-1981; Bimonthly
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`(c) Luster Products, Inc., Hair Relaxer; 1979-2000; Bimonthly
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`(d) Luster Products, Inc., Hair Lotion; 1979-2019; Daily
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`III. FACTS COMMON TO ALL COUNTS
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`1. Marketing
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`17. Black and Brown people make up approximately 13% of the U.S.
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`population, but by one estimate, “African American” spending accounts for as much
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`as 22% of the $42 billion-a-year personal care products market, suggesting that they
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`buy and use more of such products – including those with potentially harmful
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`ingredients– than Americans as a whole (Thandisizwe Chimurenga, How Toxic is
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`Black Hair Care?, New America Media, Feb. 2, 2012, americamedia.org/2012/02/
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`skin-deep-in-more-ways-than-one.php; Personal Care Products Manufacturing
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`Industry Profile, Dun & Bradstreet First Research, August 2016,
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`www.firstresearch.com/Industry-Research/Personal-Care-Products-
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`Manufacturing.html)
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`18.
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`In the U.S. alone, Black consumers spend over $1 trillion each year,
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`with a significant amount of that spending toward hair care products.
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`19.
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`In 2020, the global Black Hair care market was estimated at $2.5 billion
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`20. Defendants have marketed their Products specifically to Black and
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`Brown women across the United States to “tame” their ethnic hair by making it
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`smoother, straighter, and easier to manage.
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`21. These Products specifically marketed to the Black and Brown
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`community contain hormonally active and carcinogenic compounds which are often
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`broadly lumped together as “fragrance” or “perfume.”
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`
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`22. Marketing for many hair care products at issue begins as young as
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`childhood, grooming the next generation and indoctrinating them into a destructive
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`view of beauty standards.
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`23. Marketing for these products hinges on coercing Black and Brown
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`women to conform to a determined “white” beauty standard through the use of: (1)
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`Internalization of acceptable beauty norms, (2) Media and advertisements, (3)
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`Economic security and the ability to be employed, (4) A culture that has been curated
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`to accept these values through the above.
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`24.
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`In a culture where Black women feel reduced to a lower standard of
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`beauty, these factors impact women of color’s decisions to begin and continue using
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`products to alter the natural state of their hair, many times as a protective mechanism
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`against racial discrimination. In the Dove CROWN Study for girls (2021) conducted
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`by JOY Collective, the following statistics were discovered:
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`a.
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`100% of Black elementary school girls in majority-white schools who
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`report experiencing hair discrimination state they experience discrimination by the
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`age of ten (10).
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`b.
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`86% of Black teens who experience discrimination state they have
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`experienced discrimination based on their hair by the age of twelve (12).
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`c.
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`66% of Black girls in majority-white schools report experiencing hair
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`discrimination compared to 45% of Black girls in all school environments.
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`d.
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`53% of Black mothers, whose daughters have experienced hair
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`discrimination, say their daughters experienced the discrimination as early as five
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`(5) years old.
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`e.
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`47% of Black mothers report having experienced discrimination related
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`to their hair.
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` f.
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`Trauma from these experiences cause girls to miss days from school;
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`teenage Black girls are missing a week of school per year due to hair dissatisfaction.
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`g. While 90% of Black girls believe their hair is beautiful, the
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`microaggressions and discrimination she endures has an impact on how she sees
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`herself.
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`h. Black women are 1.5 times more likely to be sent home from the
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`workplace because of their hair.
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`i.
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`Black women are 89% more likely than white women to agree with this
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`statement, “I have to change my hair from its natural state to fit in at the office.”
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`25. The CROWN Act of 2021 is a legislative bill introduced in both houses
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`of Congress to address discrimination against protective hair styles worn
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`predominantly by women of color. While the bill has not yet passed fully on a federal
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`level, eighteen states have signed a version of the bill into state law. Unless and until
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`the CROWN Act makes hair discrimination illegal in every state, teenagers and
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`women of color continue to face discriminatory practices related to their hair
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`choices, with relaxing and straightening their hair being a defensive, yet dangerous
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`and toxic option.
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`2. Medical
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`26.
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`In an analysis of ingredients in 1,177 beauty and personal care products
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`marketed to Black women, about one in twelve (12) was ranked highly hazardous
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`on the scoring system of EWG's Skin Deep® Cosmetics Database, a free online
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`resource for finding less-hazardous alternatives to personal care products, with many
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`products having a score of “high potential hazard”.
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`27. Additional studies and chemical analysis have placed carcinogenic and
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`dangerous chemicals in a plethora of beauty products to include but not limited to
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`hair relaxer/ straightener, anti-frizz, leave-in-conditioner, permanent hair dye, root
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`stimulators, and skin lightening cream:
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`
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`(Jessica S. Elm, et al., Measurement of Endocrine Disrupting and Asthma-associated
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`Chemicals in Hair Products used by Black Women, environmental Research #165,
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`448,450 (2018)
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`28. The Toxic Compounds are absorbed by the scalp or skin and not the
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`hair directly; it is the frequency and thorough use of these products that absorb the
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`Toxic Compounds into the scalp and proliferate it throughout the body, disrupting
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`the endocrine system or causing cancer.
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`29. The endocrine system is indispensable for life and influences nearly
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`every cell, organ, and processes within the body. (Endocrine System: The Endocrine
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`System Includes The Thyroid, Adrenals, and the Pituitary Gland, Science Direct,
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`https://www.sciencedirect.com/topics/ psychology/endocrine system)
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`30. The endocrine system regulates all biological processes in the body
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`from conception through adulthood, including the development of the brain and
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`nervous system, the growth and function of the reproductive system, as well as the
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`metabolism and blood sugar levels (Endocrine Disruption, United States
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`Environmental Protection Agency, Mar. 7, 2022, https://www.epa.gov /endocrine-
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`disruption/what-endocrine-system) :
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`a.
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`The endocrine system is a tightly regulated system made up of glands
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`that produce and release precise amounts of hormones that bind to receptors located
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`on specific target cells throughout the body. (Id.)
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`b. Hormones, such as estrogen, testosterone, progesterone, and androgen,
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`are chemical signals that control or regulate critical biological processes. (Id.)
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`c. When a hormone binds to a target cell’s receptor, the receptor carries
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`out the hormone's instructions, the stimulus, and either switches on or switches off
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`specific biological processes in cells, tissues, and organs. (Id.)
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`d.
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`The precise functioning of the endocrine system is vital to maintain
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`hormonal homeostasis, the body’s natural hormonal production and degradation. A
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`slight variation in hormone levels can lead to significant adverse-health effects,
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`including reproductive impairment and infertility, cancer, cognitive deficits,
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`immune disorders, and metabolic syndrome. (Id.; Michele La Merrill, et al.,
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`Consensus on the Key Characteristics of Endocrine-Disrupting Chemicals as a
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`Basis for Hazard Identification, Nature Reviews Endocrinol, Nov. 12, 2019,
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`https://www.nature.com/articles/s41574-019-0273-8)
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`e.
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`Endocrine disrupting chemicals (“EDCs”) are chemicals, or chemical
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`mixtures, which interfere with the normal activity of the endocrine system.
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`f.
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`EDCs can act directly on hormone receptors as mimics or antagonists,
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`or on proteins that control hormone delivery. (Evanthia Diamanti-Kandarakis, et
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`al., Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement,
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`Endocrine Reviews, June 30, 2009,
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`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2726844/)
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`g.
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`EDCs disrupt the endocrine system and interfere with the body’s
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`hormonal homeostasis in various ways.
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`h.
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`EDCs can cause the body to operate as if there were a proliferation of
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`a hormone and thus over-respond to the stimulus or respond when it was not
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`supposed to by mimicking a natural hormone.
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`i.
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`EDCs can increase or decrease the levels of the body’s hormones by
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`affecting the production, degradation, and storage of hormones.
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` j.
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`EDCs can block the hormone’s stimulus through inducing epigenetic
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`changes, modifications to DNA that regulate whether genes are turned on or off or
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`altering the structure of target cells’ receptors. (Luis Daniel Martínez-Razo, et al.,
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`The impact of Di-(2-ethylhexyl) Phthalate and Mono(2- ethylhexyl) Phthalate in
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`placental development, function, and pathophysiology, Environment International,
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`January 2021, https://www.sciencedirect.com
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`/science/article/pii/S0160412020321838?via%3Dihub.)
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`k.
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`EDCs are known to cause to numerous adverse human health
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`outcomes including endometriosis, impaired sperm quality, abnormalities in
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`reproductive organs, various cancers, altered nervous system and immune function,
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`respiratory problems, metabolic issues, diabetes, obesity, cardiovascular problems,
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`growth, neurological and learning disabilities. (Endocrine Disrupting Chemicals
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`(EDCs), Endocrine Society, Jan. 24, 2022, https://www.endocrine. org/patient-
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`engagement/endocrinelibrary/edcs#:~:text=EDCs%20can%20disrupt%20many
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`%20different,%2C%20certain%20cancers%2C%20respiratory%20problems
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`%2C.)
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`l.
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`EDCs that mimic the effects of estrogen in the body may contribute to
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`disease risk because exposure to estrogen, endogenously and exogenously, is
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`associated with breast cancer, and a woman’s lifetime risk of developing the disease
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`increases with greater duration and cumulative exposure.
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`m. Natural and synthetic EDCs are present in hair products under the guise
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`of “fragrance” and “perfumes,” and thus enter the body when these products are
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`exogenously applied to the hair and scalp. Studies exploring this issue have thus far
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`classified EDCs as estrogens, phthalates, and parabens.
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`n.
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`Indeed, numerous studies spanning more than two decades have
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`demonstrated the adverse impact EDCs including Di-2-ethylhexylphthalate have on
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`the male and female reproductive systems such as inducing endometriosis, abnormal
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`reproductive tract formation, decreased sperm counts and viability, pregnancy loss,
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`and abnormal puberty onset. (Hee-Su Kim, et al., Hershberger Assays for Di-2-
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`ethylhexyl Phthalate and Its Substitute Candidates, Dev Reproduction, Mar., 22,
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`2018, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5915764/.)
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`31. Phthalates are used in a variety of cosmetics and personal care products.
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`Phthalates are chemical compounds developed in the last century that are used to
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`make plastics more durable. These colorless, odorless, oily liquids also referred to
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`as “plasticizers” based on their most common uses.
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`32. Phthalates also function as solvents and stabilizers in perfumes and
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`other fragrance preparations. Cosmetics that may contain phthalates include nail
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`polishes, hair sprays, aftershave lotions, cleansers, and shampoos.
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`33. Phthalates are chemicals used to improve the stability and retention of
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`fragrances and to help topical products stick to and penetrate skin and hair. (Olivia
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`Koski & Sheila Hu, Fighting Phthalates, National Resources Defense Council, April
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`20, 2022, https://www.nrdc.org/stories /fighting-phthalates.)
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`34. Phthalates are known EDCs which interfere with natural hormone
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`production and degradation and are detrimental to human health. (Yufei Wang &
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`Haifeng Qian, Phthalates and Their Impacts on Human Health, Healthcare (Basel)
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`9, 603, May 9, 2021, https://www.ncbi.nlm. nih.gov /pmc /articles/PMC8157593/.)
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`35. Phthalates are commonly used by cosmetics and hair care product
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`manufacturers to make fragrances and colors last longer, and to make hair more
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`flexible after product is applied, among other uses.
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`36. Phthalates can be found in most products that have contact with plastics
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`during producing, packaging, or delivering. Despite the short half-lives in tissues,
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`chronic exposure to phthalates will adversely influence the endocrine system and
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`functioning of multiple organs, which has negative long-term impacts on the success
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`of pregnancy, child growth and development, and reproductive systems in both
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`young children and adolescents. Several countries have established restrictions and
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`regulations on some types of phthalates. Phthalates are a series of chemical
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`substances, which are mainly used as plasticizers added to polyvinyl chloride
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`(“PVC”) plastics for softening effects. Phthalates can potentially disrupt the
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`endocrine system. (Id.)
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`37. Since 1999, the Centers for Disease Control (“CDC”) have found
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`phthalates in individuals studied for chemical exposure. (Biomarker Groups,
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`National Report on Human Exposure to Enviornemntal Chemicals, Center for
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`Disease Control, https://www.cdc.gov /exposure
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`report/pdf/Biomarker_Groups_Infographic-508.pdf.) Neither IARC nor NTP has
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`evaluated DEHP with respect to human carcinogenicity
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`38. One common Phthalate common in hair care products is DEHP.
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`39. When DEHP enters in the human body, it breaks down into specific
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`metabolites. The toxicity of DEHP is mainly attributed to its unique metabolites
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`which include the primary metabolite, mono-(2-ethylhexyl)phthalate (MEHP), and
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`secondary metabolites, mono-(2-ethyl5-hydroxyhexyl)phthalate (MEHHP), and
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`mono-(2-ethyl-5-oxohexyl)phthlate (MEOHP). ( Saab, Yolande, et. al., Risk
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`Assessment of Phthalates and Their Metabolites in Hospitalized Patients: A Focus
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`on Di- and Mono-(2-ethylhexyl) Phthalates Exposure from Intravenous Plastic
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`Bags. Toxics, 10(7), 357, https://pubmed.ncbi.nlm.nih.gov/35878262/; Ishtaf
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`Sheikh, et. at., Endocrine disruption: In silico perspectives of interactions of di-(2-
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`ethylhexyl)phthalate and its five major metabolites with progesterone receptor.
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`BMC Structural Biology Volume 16, Suppl 1, 16, Sept. 30, 2016,
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`https://bmcstructbiol.biomedcentral.com/articles/10.1186/s12900- 016-0066-4
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`(Other secondary metabolites include mono(2-ethyl-5-carboxypentyl)phthalate (5-
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`cx-MEPP) and mono[2-(carboxymethyl)hexyl]phthalate (2-cx-MMHP)).
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`40. DEHP and its metabolites are known to cause significant adverse-
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`health effects including but not limited to endometriosis, developmental
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`abnormalities, reproductive dysfunction and infertility, various cancers, and
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`metabolic syndrome within the human population and their future children.
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`(Richardson, Kadeem et. al., Di(2-ethylhexyl) Phthalate (DEHP) Alters
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`Proliferation and Uterine Gland Numbers in the Uterine of Adult Exposed Mice,
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`Reproductive Toxicology, 77, 70-79, https://pubmed.ncbi.nlm.nih.gov/29458081/;
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`Yufei Wang & Haifeng Qian, Phthalates and Their Impacts on Human Health,
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`Healthcare (Basel) 9, 603, May 9, 2021,
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`https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8157593/.)
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`41. Additionally, Human epidemiological studies have shown a significant
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`association between phthalates exposures and adverse reproductive outcomes in
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`both women and men. (Chapter 2: Health Effects, Toxicological profile for Di(2-
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`ethylhexyl) phthalate (DEHP) (2001), https://www.atsdr.cdc.gov/ToxProfiles/tp9-
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`c2.pdf.)
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`42. Since the turn of the century, restrictions on phthalates have been
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`proposed in many Asian and western countries. In 2008, the US Congress
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 17 of 53
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`announced the Consumer Protection Safety Act (CPSA) that permanently banned
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`the products, especially children’s toys and childcare articles, containing DEHP,
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`DBP, and BBP at levels >0.1% by weight. (Consumer Product Safety
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`Improvement Act of 2008, H.R. 4040, 110th Cong. (2008), https:
`
`//www.congress.gov/110/plaws/publ314/PLAW-110publ314.pdf.)
`
`43. The incidence of uterine cancer in Black women is twice that of White
`
`women. In addition, Black women with uterine cancer carry a poorer prognosis as
`
`compared to White women. (Cancer Stat Facts: Uterine Cancer, National Cancer
`
`Institute, https://seer.cancer.gov/ statfacts/html/corp.html)
`
`44. Though death rates from other cancers in women have declined in
`
`recent years, death rates for uterine cancer have increased by more than 100% in the
`
`last 20 years. Indeed, new cases of uterine cancer have increased by 0.6 percent per
`
`year from 2010 to 2019, and death rates have risen an average of 1.7 percent per year
`
`during the same time frame. (Linda Duska, et al., Treatment of Older Women With
`
`Endometrial Cancer: Improving Outcomes With Personalized Care, American
`
`Society Clinical Oncology
`
`Educational Book,
`
`35:164-74,
`
`2016,
`
`https://pubmed.ncbi.nlm.nih.gov/27249697/; Jack J. Lee, Rising Endometrial
`
`Cancer Rate Spur New Approaches to Prevention, National Cancer Institute:
`
`Division of Cancer Prevention, June 28, 2022, https://prevention.cancer.gov/news-
`
`and-events/blog/rising-endometrial-cancer.)
`
`
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`Page 17 of 53
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 18 of 53
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`45. A groundbreaking study recently found that women who use chemical
`
`hair straightening, or relaxing products have a higher risk contracting of uterine
`
`cancer. Che-Jung Chang, et al., Use of Straighteners and Other Hair Products and
`
`Incident Uterine Cancer, Journal of the National Cancer Institute, Oct. 17, 2022,
`
`https://pubmed.ncbi.nlm.nih.gov/36245087/.)
`
`46. The study found that an estimated 1.64% of women who never used
`
`chemical hair straighteners or relaxers would go on to develop uterine cancer by the
`
`age of 70; but for frequent users, that risk more than doubles, increasing to 4.05%.
`
`47. These risks are more substantial among Black women, who make up
`
`the overwhelming majority of hair straightening and hair relaxing products,
`
`including as Defendants’ products.
`
`48. These same causation links have been found to extend to ovarian
`
`cancer as well. (Alexander White, Use of hair products in relation to ovarian
`
`cancer risk, Carcinogensis Integrative Cancer Research, September 2021,
`
`https://academic.oup.com/carcin/article /42/9/1189/6309952.)
`
`49. These risks extend to Uterine Fibroids and Endometriosis. The Toxic
`
`Chemicals discussed in this section have a direct correlation to the development of
`
`Uterine Fibroids and Endometriosis.
`
`50. Phthalate metabolites were related to increased uterine volume, a sign
`
`of fibroids on ultrasound, 2018.130 The sum of DEHP increased volume risk by
`
`
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`Page 18 of 53
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 19 of 53
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`33% and the sum of androgenic phthalates increased risk by 27%, for example.
`
`(Amir R. Zota et al., Phthalates exposure and uterine fibroid burden among
`
`women undergoing surgical treatment for fibroids: a preliminary study, Fertility
`
`and sterility, Vol. 111(1) (2019), https://www.ncbi.nlm.nih.gov
`
`/pmc/articles/PMC6321778/.)
`
`51.
`
`In another case, a 2012 study in the American Journal of
`
`Epidemiology associated fibroid risk with the use of hair relaxers. In the Black
`
`Women’s Health Study, the authors assessed hair relaxer use in relation to uterine
`
`leiomyomata incidence. In 1997, participants reported on hair relaxer use (i.e., age
`
`at first use, frequency, duration, number of burns, and type of formulation). From
`
`1997 to 2009, 23,580 premenopausal women were followed for incident uterine
`
`leiomyomata. The authors noted that the incidence of uterine leiomyomata was two
`
`to three times higher in US Black women than in US white women, with the
`
`lifetime risk estimated to be 80% in US Black women. The study showed positive
`
`trends for frequency of use, duration of use, and number of burns: “Among long-
`
`term users (>10 years), the incidence rate ratios for frequency of use categories 3-
`
`4, 5-6, and >7 versus 1-2 times/year were 1.04 […], 1.12 […], and 1.15 […],
`
`respectively. (Wise L. A., et al. Hair Relaxer Use and Risk of Uterine
`
`Leiomyomata in African-American Women. American Journal of Epidemiology.
`
`2012;175(5):432–440. https://doi.org/10.1093/aje/kwr351.)
`
`
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`Page 19 of 53
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`
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 20 of 53
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`52. Although typically benign, uterine fibroids can cause significant health
`
`issues such as excessive menstrual bleeding and pelvic pain, which can significantly
`
`affect a woman’s quality of life, and may require invasive surgery. It has been
`
`estimated that uterine fibroids account for approximately 30% of all hysterectomies
`
`performed on women aged 18-44 years (Wise, L.A. et al. Epidemiolgoy of Uterine
`
`Fibroids – From Menarche to Menopause. Clin Obset Gynecol. 2016;59(1):2-24)
`
`and are the leading indication for hysterectomy in the U.S. (Study of Environment,
`
`Lifestyle & Fibroids (SELF), National Institute of Environmental Health Sciences,
`
`https://www.niehs.nih.gov/research/atniehs/labs/epi/studies/self/index.cfm.)
`
`53. Even when composed of “safer” materials, some of the aforementioned
`
`beauty products are incredibly harsh and their processes hinge on the destruction of
`
`the bodies natural structures or systems.
`
`54. Hair relaxing, for example, or lanthionization, can be performed by a
`
`professional cosmetologist in a salon or barbershop, or at home with at-home relaxer
`
`kits designed for individual use. These home kits are sold in grocery, drug, and
`
`beauty supply stores in urban and rural cities throughout the United States.
`
`55. Relaxers are applied to the base of the hair shaft and left in place for a
`
`“cooking” interval, during which the relaxer alters the hair’s texture by purposefully
`
`damaging the hair’s natural protein structure. The effect of this protein damage
`
`straightens and smooths the hair. After a period of weeks (4 – 8 weeks on average),
`
`
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`Page 20 of 53
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 21 of 53
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`depending on the hair’s natural growth rate, the treated portion of the hair grows
`
`away from the scalp as new growth sprouts from the roots, requiring additional
`
`relaxer treatment to smooth the roots. These additional treatments are colloquially
`
`referred to in the community as “re-touches,” resulting in women relaxing their new
`
`growth every four to eight weeks on average, usually for decades.
`
`56. Hair relaxers can, and often do, cause burns and lesions in the scalp,
`
`facilitating entry of Toxic Compounds through more than pure skin absorption.
`
`3. Regulation
`
`
`
`57. The law does not require cosmetic products and ingredients, other than
`
`color additives, to have FDA approval before they go to market. But there are laws
`
`and regulations that apply to cosmetics placed into the market. The two most
`
`important laws pertaining to cosmetics marketed in the United States is the Federal
`
`Food Drug and Cosmetic Ace (“FD&C Act”) and the Fair Packaging and Labeling
`
`Act (“FPLA”).
`
`
`
`58. The FD&C Act expressly prohibits the marketing of “adulterated” or
`
`“misbranded” cosmetics in interstate commerce.
`
`
`
`59. Adulteration refers to a violation involving product composition
`
`whether it results from ingredients, contaminants, processing, packaging shipping or
`
`handling.
`
`
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`Page 21 of 53
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`
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 22 of 53
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`
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`60. Under the FD&C Act a cosmetic is adulterated if: 1) it bears or contains
`
`any poisonous or deleterious substance causing injury to the product user and 2) if
`
`its container is composed in whole or in part, of any poisonous or deleterious
`
`substance which may render the contents injurious to health.
`
`
`
`61. Misbranding refers to violations involving improperly labeled or
`
`deceptively packaged products.
`
`
`
`62. Under the FD&C Act, a cosmetic is misbranded if 1) labeling is false
`
`or misleading, 2) the label does not include all required information, 3) required
`
`information is not prominent and conspicuous, 4) the packaging and labeling is in
`
`violation of an applicable regulation issued pursuant to section 3 and 4 of the Poison
`
`Prevention Packaging Act of 1970. (Food and Drug Administration Cosmetic Act §
`
`602 (1938)).
`
`
`
`63. However, it is against the law to put an ingredient in a cosmetic that
`
`makes the cosmetic harmful when used as intended.
`
`
`
`64. On May 19, 2022, the FDA issued a rule to amend its food additive
`
`regulations to no longer provide for most previously authorized phthalates to be used
`
`as food additives because these uses have been abandoned by industry. (§ 87 FR
`
`31080). The FDA revoked authorizations for the food contact use of 23 phthalates
`
`and two other substances used as plasticizers, adhesives, defoaming agents,
`
`lubricants, resins, and slimicides. (Phthalates in Food Packages and Food Contact
`
`
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`Page 22 of 53
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`
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`Case 0:23-cv-60096-RS Document 1 Entered on FLSD Docket 01/19/2023 Page 23 of 53
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`Applications, U.S. Food and Drug Administration, https://www.fda.gov/food/food-
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`ingredients-packaging/phthalates-foodpackaging-and-food-contact-applications).
`
`
`
`65. Under U.S. law, cosmetic manufacturers are not required to submit their
`
`safety data to the FDA.
`
`
`
`66. Companies and/or individuals who manufacture or market cosmetics
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`have a legal responsibility and duty to ensure the safety of their own products.
`
`Neither the law nor FDA regulations require specific tests to demonstrate
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