U.S. House Reps Reintroduce Federal Bill Banning Intentionally Added PFAS in Cosmetics

On November 30, 23, U.S. Representatives Debbie Dingell (D-MI), Brian Fitzpatrick (R-PA) and Annie Kuster (D-NH) reintroduced H.R. 6519–the “No PFAS in Cosmetics Act“–which would require the Food and Drug Administration (FDA) to ban use of “intentionally added per- and polyfluoroalkyl substances” (PFAS) in cosmetics.

According to the Environmental Protection Agency, PFAS are a group of long lasting manufactured chemicals that have been widely used in industry and consumer products since the 1940s because of their useful properties. There are thousands of different PFAS, some of which have been more widely used and studied than others.

The “No PFAS in Cosmetics Act,” which was previously introduced in Congress in June 2021, and referred to the House Committee on Energy and Commerce on November 30, 2023, would amend the Food, Drug, and Cosmetic Act (FDCA) to require FDA to prohibit intentionally added PFAS in cosmetics within 270 days of the bill’s enactment.

Notably, the bill does not define PFAS beyond “intentionally added” perfluoroalkyl and polyfluoroalkyl substances. Nor does the bill differentiate which chemicals in the PFAS group–for example, Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS),  two of the most widely used and studied chemicals in the PFAS group–should be banned.

Last year’s Modernization of Cosmetics Regulation Act (MOCRA) requires FDA to publish a report within three years (i.e., by end of year 2025) assessing the use of PFAS in cosmetics and their safety, signaling the possibility of further legislation or regulation, if warranted.  Senate appropriators also have directed FDA “to develop a plan outlining research needed to inform regulatory decision-making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics.”

The proposed bill reflects the growing number of state legislatures that have enacted or are considering legislation banning the intentional use of PFAS in cosmetics, as well as other consumer products such as children’s products, menstrual products, cleaning ingredients, dental floss, and textiles. For example:

  • In 2021, Maine became the first state to require manufacturers of products with intentionally added PFAS to report to the Maine Department of Environmental Protection (DEP) documenting the purpose and amount of each PFAS compound used. The law aims to phase out the use of PFAS in cosmetics, among other new consumer products, by 2030.
  • Starting on January 1, 2025, California and Maryland will prohibit the manufacturing, sale, or delivery of cosmetic products containing certain intentionally added PFAS in cosmetics, including PFOA and PFOS, unless they contain technically unavoidable trace quantities of the substances stemming from impurities of natural or synthetic ingredients.
  • Starting January 1, 2025, Minnesota and Colorado will prohibit the sale or distribution of cosmetics (among other consumer products) that contain intentionally added PFAS.
  • Beginning January 1, 2025, Washington State will prohibit the manufacturing, knowing sale, or distribution of cosmetic products containing PFAS, defined as  “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.”
  • Oregon’s Toxic Free Cosmetics Act, which bans the sale or distribution of cosmetics that contain intentionally added PFAS (among other chemicals) is scheduled to take effect on January 1, 2027.

New York, which last year banned the use of intentionally added PFAS in apparel, effective January 1, 2025, is considering several bills that would prohibit the sale or distribution of cosmetics (among other consumer products) that contain intentionally added PFAS.

 

 

 

 

FDA Updates Instructions for Serious Adverse Event Reporting for Cosmetic Products under MoCRA

On December 14, 2023, FDA published updated instructions for reporting serious adverse events for cosmetic products, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), enforceable starting December 29, 2023.

FDA recommends that industry “responsible persons” as defined by MoCRA report serious adverse event reports for cosmetic products by using the current MedWatch Form 3500A , which is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse Event Reporting Program – Mandatory (PDF).

FDA has updated the form’s instructions  to make it easier for the responsible person to complete the form , and requests that the completed form (along with any information to support the report) be submitted to FDA via email at: CosmeticAERS@fda.hhs.gov or by mail to:

FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993

FDA strongly encourages electronic submission of serious adverse event reports to facilitate efficiency and timeliness of data submission and management for the agency.

FDA is developing a process for submitting electronic mandatory adverse event reports for cosmetics, and will provide more information on the launch date for this process in the coming months.

As a reminder, MoCRA requires that a “responsible person” must report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days, and include a copy of the label on or within the retail packaging of such cosmetic product.

If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, the responsible person must submit this new information to FDA within 15 business days.

MoCRA defines the “responsible person” as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the Food, Drug, and Cosmetic Act or section 4(a) of the Fair Packaging and Labeling Act.

Additionally, MoCRA expands the definition of “serious adverse event” ” to include infections or “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other
than as intended, under conditions of use that are customary or usual.”

Products will not be considered “injurious” if they cause minor or transient reactions to certain users.

This expanded definition still includes previously identified adverse events such as death; a life-threatening experience; in-patient hospitalization; a persistent or significant disability or incapacity; a congenital anomaly or birth defect; or medical or surgical intervention to prevent any of these outcomes.

FDA Publishes Updated SPL Implementation Guide with Validation Procedures

Yesterday FDA published an updated  Structured Product Labeling (SPL) Implementation Guide with Validation Procedures, including updates to cosmetics product facility registrations and product listings that are now included within the SPL framework.

Yesterday’s release updates the SPL Implementation Guide published by FDA on October 13, 2023, which included facility registrations and product listings within the SPL framework, and described  the soon-to-be-released Cosmetics Direct electronic submission portal function as an SPL authoring tool intended to feature user friendly data entry forms, perform initial validations, create and save SPL submissions, and submit the SPL forms to FDA for internal processing.

Noteworthy changes to the required technical conformance criteria include:

    • Clarification of initial versus updated cosmetic product coding;
    • Clarification of coding requirements for human OTC drugs that are also cosmetic products;
    • Clarification between “leave-on” versus “rinse-off” product coding, unless the document type is a Cosmetic Facility Registration;
    • Clarification of cosmetic product category and cosmetic product facility codes;
    • Reclassification of “feminine deodorants” as “other personal cleanliness products”;
    • Clarification of market status coding as to discontinued or soon-to-be discontinued cosmetic products; and
    • Replacement of “Registrant” information with “Authorized Agent” information.

FDA has not yet announced when it expects the Cosmetics Direct portal to go live, but anticipates it being available for companies to register facilities and list products sometime before year end.

 

Sephora Disputes “Misleading” Allegations in Clean Beauty Class Action Lawsuit

Introduction

On March 2, 2023, Sephora filed its reply in support of its motion to dismiss proposed class action claims that its “Clean at Sephora” program was false and misleading, disputing allegations that a significant portion of relevant, reasonable consumers were or could be misled about what ‘Clean at Sephora’ means, and that the ingredients permitted by Sephora’s program were potentially harmful to humans.

Sephora’s reply (presumably) concludes preliminary briefing in what has become a closely-watched lawsuit in the beauty and wellness industry over the meaning of the term “clean beauty.”[1] Absent clear regulatory guidance from the FDA and the FTC, companies’ claims involving the terms “clean,” “natural,” “nontoxic,” or “organic” have been scrutinized in social media, and by an increasingly active and organized plaintiffs’ bar.

While it remains to be seen how the court will decide the “Clean at Sephora” case, companies should continue expect more litigation in this area, as what it means for beauty products to be clean, natural, nontoxic, or safe, remains the subject of intense debate. 

Case Background

As explained in our previous publications (here, here, and here), the market for clean beauty is expected to reach an estimated $11.6 billion by 2027.[2] But absent clear regulatory guidance about what it means for beauty products to be “clean,” “natural,” “nontoxic,” or “safe, promoting products as “clean” can carry significant regulatory risks, and leaves the industry ripe for class action litigation.

Sephora launched its “Clean at Sephora” program in 2018.[3] To qualify for inclusion in the program, which spans across various product categories, products must be formulated without certain common cosmetic ingredients—such as parabens, sulfates SLS and SLES, phthalates, formaldehyde and more—that are linked to possible human health concerns.[4]

On November 22, 2023, Plaintiff Lindsay Finster filed a proposed class action lawsuit in the U.S. District Court for the Northern District of New York, alleging that products advertised as part of the “Clean at Sephora” program contain ingredients that are “inconsistent with how consumers understand” the term “clean.”[5]

According to plaintiff, consumers understand the definition of “clean” beauty to mean the dictionary’s definition of “clean”: “free from impurities, or unnecessary and harmful components, and pure.”[6] Thus, to be considered “clean” in the context of beauty, plaintiff alleged that products should be “made without synthetic chemicals and ingredients that could harm the body, skin or environment.”[7] But, as plaintiff contended, “a significant percentage of products with the ‘Clean at Sephora’ [seal] contain ingredients inconsistent with how consumers understand the term.”[8] Consequently, plaintiff alleged that the “Clean at Sephora” program “misleads consumers into believing that the products being sold are “natural,” and “not synthetic” and to paying a price premium based on this understanding.”[9]

Plaintiffs alleged potential class action violations of §§ 349 and 350 of New York’s General Business Law (“NY GBL”), as well as multi-state consumer protection statutes, and breach of express and implied warranty, the Magnuson Moss Warranty Act, fraud, and unjust enrichment claims.[10]

Sephora’s Motion to Dismiss

On February 2, 2023, Sephora moved to dismiss plaintiff’s complaint, arguing that “[i]t is not plausible that reasonable consumers are or could be confused by the ‘Clean at Sephora’ program” for several reasons.[11]

First, Sephora argued that plaintiff relied on unsupported and conclusory allegations about consumers understanding of the word “clean.”[12] While plaintiff argued that consumers understood the definition of “clean” beauty to mean the products made without synthetic chemicals and or potentially harmful ingredients, Sephora countered that plaintiff failed to plead any facts showing that a significant portion of relevant reasonable consumers could be misled by Sephora’s claims into believing that the “Clean at Sephora” program consisted of only natural products and ingredients.[13] As Sephora noted, words like “natural,” “organic,” and the like never appeared on the label or elsewhere.[14] Instead, plaintiff relied upon “on selectively quoted blog posts and webpages from small businesses, which not only lack reliability and authority but are presented without evidence that any significant number of consumers have even read them, let alone agreed with them.”[15]

Second, Sephora argued that plaintiff mischaracterized Sephora’s representations as being about the kinds of ingredients included in the program, rather than excluded.[16] Thus, plaintiff was attempting to turn “Clean at Sephora” into “Natural at Sephora”—claims that Sephora did not make.[17] On the contrary, Sephora’s marketing for the program focused on the exclusion of certain ingredients linked to potential human health outcomes.[18] Because Sephora made no representations about the products or ingredients included, it argued that it could not mislead consumers about the safety of included products or ingredients in the program.[19] Moreover, plaintiff failed to plausibly allege that any of the ingredients included in the program were potentially harmful, relying instead on a series of unattributed and unsubstantiated blog posts.”[20]

Finally, Sephora rejected plaintiff’s contention that it forced consumers to scrutinize product lists in contradiction of the Second Circuit’s 2018 decision in Mantikas v. Kellogg, which prohibits the use of ingredient lists on the side of packaging to clarify otherwise misleading presentations where plaintiff failed to identify any misleading conduct by Sephora.[21]

Sephora also rejected plaintiff’s efforts to seek relief under other unspecified consumer protection statutes, arguing that plaintiff failed to plead how the unspecified consumer protection statutes were similar to the NY GBL,[22] and disputed plaintiff’s breach of warranty, consumer fraud, and unjust enrichment claims as duplicative of plaintiff’s NY GBL claims, or otherwise contingent on the same erroneous premise—that the ‘Clean at Sephora’ label is misleading—and thus, equally deficient.[23]

In opposition to Sephora’s motion to dismiss, plaintiff reiterated that it was sufficiently plausible that reasonable consumers would perceive the “Clean at Sephora” as excluding synthetic ingredients, and that “Clean at Sephora” meant free from potentially harmful ingredients.[24] Plaintiff further contended that resolution of her multi-state claims was not ripe until the class certification stage,[25] and that Sephora’s advertising campaign created an express warranty that “Clean at Sephora” products were formulated without potentially harmful ingredients.[26]

In its reply, Sephora argued that reasonable consumers could not interpret the phrase “Clean at Sephora” as limited to only “natural” ingredients when Sephora “prominently explains, in plain terms, exactly what it means by the phrase: ‘formulated without parabens, sulfates sodium lauryl sulfate (SLS) and sodium laureth sulfate (SLES), phthalates, mineral oils, formaldehyde, and more.’”[27] Sephora also refuted plaintiff’s efforts to characterize the program’s inclusion of the phrase “and more” into an impression that synthetic ingredients were excluded along with the listed ingredients, noting that plaintiff alleged no facts to support her contention that reasonable consumers shared that impression. [28]

Finally, Sephora rejected what it described as plaintiff’s efforts to conflate the meaning of the word “clean” with “non-synthetic” or “natural,” or otherwise assert that because products are not “natural,” they were not safe, noting that not all synthetic ingredients were unsafe, while not all natural ingredients were safe. [29]

Takeaways

Although the recent Modernization of Cosmetics Regulation Act (MoCRA), which was passed by Congress on December 23, 2022, significantly expands FDA’s authority over cosmetics, it provides comparatively little guidance on the kinds of marketing or promotional claims brands can make about the safety or purity of their products. Consequently, these issues are expected to remain the subject of intense scrutiny and costly litigation.

It remains to be seen how the court will rule in the “Clean at Sephora” case. Nevertheless, this case remains closely-watched within the beauty and wellness industry, and we will continue to update you as the case develops.

[1] See Sephora’s Reply in Support of Motion to Dismiss (“Reply”) at 1, Finster, et al, v. Sephora USA, Inc., No. 6:22-cv-1187 (GLS/ML) (N.D.N.Y.), Mar. 3, 2023 (Dkt. No. 18).

[2]Cosmetics Companies Invite Legal Risks With ‘Clean’ Marketing,” Law360, September 1, 2022

[3] https://www.gcimagazine.com/brands-products/news/news/21853297/sephora-launches-clean-at-sephora

[4] Sephora Clean Beauty Guide, https://www.sephora.com/beauty/clean-beauty-products

[5] Complaint (“Compl.”) at ¶ 15, Finster, et al, v. Sephora USA, Inc., No. 6:22-cv-1187 (GLS/ML) (N.D.N.Y.), Nov. 11, 2022 (Dkt. No. 1).

[6] Id. at ¶ 2.

[7] Id. at ¶ 2-4.

[8] Id. at ¶ 15.

[9] Id. at ¶ 35.

[10] Id. at 6-10.

[11] Motion to Dismiss at 1, Finster, et al, v. Sephora USA, Inc., No. 6:22-cv-1187 (GLS/ML) (N.D.N.Y.), Feb. 2, 2022 (Dkt. No. 6-1).

[12] Id. at 7-8.

[13] Id.

[14] Id.

[15] Id. at 9.

[16] Id. at 1.

[17] Id. at 7-8.

[18] Id.

[19] Id. at 10-11.

[20] Id. at 11-12.

[21] See 910 F.3d 633, 636–37 (2d Cir. 2018).

[22] Id. at 14.

[23] Id. at 15-19. Sephora also advanced several pleading deficiency arguments, including plaintiff’s failure to allege the product was advertised as “free from defects” as required by the Magnuson Moss Warranty Act.

[24] See Opposition to Sephora’s Motion to Dismiss (“Opp.”) at 4 (Feb. 23, 2023) (Dkt. No. 15).

[25] Id. at 7.

[26] Id. at 8.

[27] See Reply at 3.

[28] Id.

[29] Id. at 4.

Legal Risks Of Anti-Aging Claims Highlighted by L’Oreal Case

It is a truth universally acknowledged that a woman over 30 must be in want of an eye cream. Or a serum. Or anything, really, so long as it recreates the appearance of youth, vitality or an actual night’s sleep.

The global market for anti-aging cosmetics is expected to reach $93.1 billion by 2027. But as illustrated by a recent decision from the U.S. District Court for the Southern District of New York, Lopez v. L’Oréal USA Inc., promises that a product can turn back time by “restoring skin” or “promot[ing] cell regeneration” can prove costly for brands looking to capitalize on this growing market.

Brands should be mindful of litigation and regulatory risk when making certain anti-aging claims.

To read the full text of this article by Duane Morris associate Kelly Bonner, which was originally published in Law360, please visit the firm website.

© 2009- Duane Morris LLP. Duane Morris is a registered service mark of Duane Morris LLP.

The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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