Photo Credit:
https://tommybeautypro.wordpress.com/2013/01/05/makeup-101-colour-theory-make-up-artistry/ (last visited July 15, 2021).
Written By: Mickala Lewis
Research and Writing Editor, American Journal of Trial Advocacy
Two class actions against Huda Beauty were recently consolidated in the Central District of California.[1] Huda Beauty is a cosmetics company that sells over 140 different products and brings in over 250 million in sales annually.[2] In 2019, Huda Beauty released Neon Obsession, a line of three different “pressed pigment palettes.”[3] Plaintiffs purchased Neon Obsession products from Huda Beauty, believing the products to be eyeshadow palettes.[4] However, after applying the products to their eyes, they experienced eye irritation, redness, and itchiness that lasted for several days.[5] They also experienced stained the skin around their eyes where they applied the product.[6] Upon a closer examination of the packaging, they discovered a disclaimer on the inner page of the back label that read, “not intended for the eye area.”[7]
In the United States, the Federal Food and Drug Administration (“FDA”) does not regulate cosmetics.[8] However, the FDA does strictly regulate color additives.[9] Color additives are “dyes, pigments, or other substances that can impart color when added or applied to a…cosmetic.”[10] During the approval process, the FDA evaluates the safety data and determines whether there is “reasonable certainty of no harm” based on the color additive’s proposed use.[11] The color additives can only be used in compliance with the FDA’s approved uses, specifications, and restrictions.[12]
The FDA separates color additives into two categories: certifiable and exempt.[13] Certifiable color additives are man-made, while exempt color additives are obtained largely from plant, animal, or mineral sources.[14] In addition to undergoing approval, certifiable color additives must also undergo batch certification, in which the manufacturer submits a sample to the FDA to determine composition and purity.[15] Exempt color additives do not have to undergo batch certification.[16] Regardless of whether a color additive is certifiable or exempt, the FDA prohibits color additives from being used in cosmetics unless they are approved specifically for the intended use.[17] For example, some color additives are approved for cosmetic use in general but not approved for areas near the eyes.[18]
For eye cosmetics, the FDA regulation for the color additive must explicitly mention that is safe to use in the eye area, otherwise, it is not safe for that use.[19] If a product contains a “not intended for the eye area” disclaimer, that means the product contains a color additive the FDA has concluded should not be used around the eyes.[20] However, the disclaimer usually does not contain an explanation of the FDA’s reasoning.[21] It could be for any number of reasons, but most commonly it is because the product either stains the skin or an ingredient in the product is associated with skin irritation.[22]
Neon shades often cannot be created without unapproved additives.[23] Indeed, there are only seven fluorescent colors approved by the FDA for use in cosmetics: D&C Orange No. 5, No. 10, and No. 11; and D&C Red No. 21, No. 22, No. 27, and No. 28, none of which are approved for use on the eye area.[24] Additionally, very few red pigments are approved for the eye area due to staining.[25] The Huda Beauty products at issue in the case contained the following color additives that the FDA has not deemed eye safe: D&C Red No. 6, No. 22, No. 28, and D&C Yellow No. 10.[26]
Huda Beauty is not the only brand that sells products marketed as eyeshadow that contain some of the ingredients listed above.[27] Urban Decay, Anastasia Beverly Hills, Jeffree Star Cosmetics, and Colourpop all sell similar products.[28] Indeed, most vegan or cruelty brands that want to create red, pink, or purple eye pigments, have to use color additives not approved by the FDA for eye use because the main FDA approved additive needed to create such colors is carmine, which is made from crushed beetles.[29]
In responding to consumer concerns about the unsafe ingredients, many companies point out that the United States is the only country that imposes these restrictions.[30] The European Medicines Agency, the European Union equivalent of the FDA, has approved these additives for use in the eye area.[31] In every other country, companies are allowed to label products with these color additives as “eyeshadow,” but due to FDA regulations, in the United States, the same products, with the same ingredients, must be labeled “pressed pigments.”[32]
The issue in the Huda Beauty case is one of disclosure. While the Neon Obsessions products were labeled “multiuse pigment palettes” instead of “eyeshadow,” Plaintiffs claim Huda Beauty’s marketing and advertisements represented that the products were intended for the eye area, and the disclaimer regarding the product’s approved use was not adequately disclosed.[33]
The Neon Obsessions products were in the same type of packaging as the brand’s eyeshadow products.[34] The “not intended for the eye area” disclosure was not visible prior to purchase because the product was wrapped in plastic.[35] Once the product was unwrapped, the consumer had to lift the first page of the ingredient label on the back of the product to view the approved use disclaimer on the second page.[36] Further, the disclaimer was not bolded, underlined, or italicized and instead buried among a myriad of text in tiny print.[37]
Plaintiffs further allege that the disclaimer directly contradicts the products’ marketing and advertising because they were marketed and advertised as eyeshadow.[38] For example, before the launch of the products, Huda Beauty posted a video on their YouTube channel, with over 3.9 million subscribers, encouraging consumers to apply the product to the eye area.[39] Prior to the lawsuit, a “how to use” section of Huda Beauty’s website instructed consumers to apply Neon Obsession to the “inner corners of eye” and “either on the eyelid, or along to lower lash line.”[40] Promotional videos on Huda Beauty’s website also show models holding the products up to their eyes, which have bright neon colors on them, corresponding to the shades in the palettes.[41] Additionally, Sephora, one of Huda Beauty’s retail partners, lists the Neon Obsessions products on its website under the “Eyeshadow Palettes” dropdown menu.[42]
FDA approval is not the end all be all for color additives in eye cosmetics. Just because a product contains a color additive not approved by the FDA for eye use, does not mean all users will have an adverse reaction to it.[43] On the other hand, even if the FDA has deemed an ingredient safe for eye use, that does not guarantee a consumer will not have an adverse reaction to it.[44] Further, while an adverse reaction to one of the unapproved additives may be unpleasant, in most cases, the effects are not long term or life threatening.[45] More importantly, however, is the company’s transparency regarding the ingredients used in their products and the products’ intended uses.[46]
[1] Consolidated Class Action Complaint at 9, Ramirez v. HB USA Holdings, Inc., No. 5:20-cv-01016-JGB-SHK (C.D. Cal. January 25, 2021).
[2] Id.
[3] Id.
[4] Id. at 24-36.
[5] Id.
[6] Consolidated Class Action Complaint at 24-26, Ramirez, No. 5:20-cv-01016-JGB-SHK.
[7] Id.
[8] FDA, Cosmetics Basics, http://wayback.archiveit.org/7993/20170111055138/http://www.fda.gov/AboutFDA/Transparency/Basics/ucm193940.htm (last visited March 26, 2021).
[9] U.S. Food & Drug Administration, Color Additives and Cosmetics: Fact Sheet, https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet (last visited March 26, 2021).
[10] FDA, How Safe are Color Additives?, https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives (last visited March 26, 2021).
[11] Id.
[12] Id.
[13] Id.
[14] Id.
[15] FDA, How Safe are Color Additives?, https://www.fda.gov/consumers/consumer-updates/how-safe-are-color-additives (last visited March 26, 2021).
[16] Id.
[17] FDA, Color Additives and Cosmetics: Fact Sheet, https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet (last visited March 26, 2021).
[18] Id.
[19] Id.
[20] A.A. Newton, Is Your Eye Makeup Actually ‘Eye Safe,’ SELF.com, https://www.self.com/story/eye-safe-makeup (last visited March 26, 2021).
[21] Id.
[22] Id.
[23] Id.
[24] FDA, Color Additives and Cosmetics: Fact Sheet, https://www.fda.gov/industry/color-additives-specific-products/color-additives-and-cosmetics-fact-sheet (last visited March 26, 2021).
[25] Newton, supra note 20.
[26] Consolidated Class Action Complaint at 17, Ramirez, No. 5:20-cv-01016-JGB-SHK.
[27] Amanda Krause, The FDA warns that neon makeup might not be as safe to wear as you might think,
Insider.com, https://www.insider.com/fda-might-consider-neon-makeup-unsafe-around-eyes-2019-7 (last visited March 26, 2021).
[28] Id.
[29] Id.
[30] Krause, supra note 27.
[31] Id.
[32] Id.
[33] Consolidated Class Action Complaint at 17-18, Ramirez, No. 5:20-cv-01016-JGB-SHK.
[34] Id. at 3.
[35] Id. at 23.
[36] Id.
[37] Id.
[38] Consolidated Class Action Complaint at 5, Ramirez, No. 5:20-cv-01016-JGB-SHK.
[39] Id. at 9-10.
[40] Id. at 9.
[41] Id. at 12.
[42] Id. at 14.
[43] A.A. Newton, Is Your Eye Makeup Actually ‘Eye Safe,’ SELF.com, https://www.self.com/story/eye-safe-makeup (last visited March 26, 2021).
[44] Id.
[45] Id.
[46] Amanda Krause, The FDA warns that neon makeup might not be as safe to wear as you might think, Insider.com, https://www.insider.com/fda-might-consider-neon-makeup-unsafe-around-eyes-2019-7 (last visited March 26, 2021).
American Journal of Trial Advocacy 