PFAS (per- and polyfluoroalkyl substances), known for their flame-retardant, water-resistant, and stain-resistant qualities, are commonly used in a plethora of substances across myriad industries, making them ubiquitous in the environment. PFAS have been a part of our daily lives, from cosmetics to clothing to food wrappers. Allegations regarding adverse health impacts from exposure have given rise to increased litigation and regulation, forcing companies and their attorneys to educate themselves and take appropriate action. Given the proliferation of PFAS litigation around the country, Harris Beach continues to examine the emerging regulations and court precedents regarding PFAS to assist manufacturers of FDA-regulated products in navigating the evolving legal landscape and pursuing best practices.
Per- and poly-fluoroalkyl substances, commonly known as PFAS, are a family of man-made, so-called “forever chemicals” manufactured since the 1940s for their stain, water, and oil-resisting properties. PFOA (perfluorooctanoic acid) and PFOS (perfluorooctane sulfonic acid) are the two most produced and studied analytes within the PFAS family, which is typically defined as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom. The carbon/fluorine bonds seen in PFAS are resistant to breakdown. While PFAS were initially associated with fire-fighting foams and Teflon in the public consciousness, they have been used in various fields, including food packaging, electronics, laboratory equipment, cosmetics, and clothing, in addition to pharmaceutical and medical devices. Consistent with this pervasive use, there have been reports of PFAS penetrating soil, contaminating drinking water, and accumulating in wildlife. Due to their longstanding widespread use in all manner of products, allegations regarding adverse health impacts from exposure have given rise to litigation and regulation.
Given the ubiquitous environmental presence of PFAS, these litigations are no longer limited to environmental clean-ups or even manufacturers’ intentional use of the product. Instead, class actions with the potential to threaten all FDA-regulated product manufacturers are growing and attempting to impose liability for even the incidental presence of PFAS in products. Currently, the plaintiffs’ bar is crafting and testing new theories of liability, often by forming a somewhat uneasy alliance between federal PFAS guidelines and proposals about drinking water and consumer protection laws. Many of these litigations focus not on allegations of physical harm but claims of economic injuries stemming from the failure to advise consumers of products’ alleged PFAS presence. Plaintiffs are seeking relief under consumer protection statutes and theories such as fraud, unjust enrichment, and breach of warranty, resulting in their alleged overpayment for products consumers purportedly believed to be PFAS-free. These “price premium” theories not only spare litigants the burden of proving medical causation during a time of a developing science regarding the health effects of PFAS exposure but also assist in plaintiffs’ lawyers’ attempts to obtain class certification by avoiding analysis of plaintiffs’ varying exposures and diverse medical histories.
PFAS litigation is currently moving faster than FDA regulation. For example, although the Modernization of Cosmetics Regulation Act of 2022 (MOCRA) made several substantial updates to the Food, Drug, and Cosmetic Act (FDCA) regarding reporting and labeling for cosmetic manufacturers, it merely tasked FDA with assessing the use and safety of PFAS within three years of MOCRA’s passage. Accordingly, the regulations often cited in litigation come either from the environmental context or involve statutes not drafted explicitly about PFAS.
Given the absence of reliable scientific evidence regarding the necessary level of PFAS exposure to suffer injury, plaintiffs hope to convince courts of a zero-tolerance standard for PFAS product content. To that end, complaints routinely cite the Environmental Protection Agency’s (EPA) 2023 proposals regarding drinking water. Following are some of the relevant federal regulations on PFAS:
Seeking to bolster consumer fraud claims, the plaintiffs’ bar is also citing federal (and relevant analogous state) statutes regarding food labeling to claim the incidental PFAS presence in a product renders the food misbranded or adulterated.
21 USC § 343 prohibits “false or misleading” labeling. Nevertheless, § 342(a)(1) clarifies that an adulterated product is one that “contains any poisonous or deleterious substance which may render it injurious to health.” 21 U.S.C. § 342 (a)(1). Furthermore, “in case the substance is not an added substance such food shall not be considered adulterated . . . if the quantity of such substance in such food does not ordinarily render it injurious to health.” Accordingly, even for plaintiffs seeking to pursue solely economic theories, these misbranding statutes arguably require proof of the level of PFAS exposure necessary to cause harm.
Regarding the incidental presence of PFAS, the 1990 amendment to the FDCA, the Nutrition Labeling and Education Act (NLEA), has typically been cited as a preemption defense against mislabeling claims.
Although NLEA does not directly specify PFAS, it provides that manufacturers need not disclose the presence of “[i]ncidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food,” 21 CFR § 101.100(a)(3), including “[s]ubstances migrating to food from equipment or packaging or otherwise affecting food that are not food additives as defined in section 201(s) of the act.” 21 C.F.R. § 101.100(a)(3)(iii).
In addition to federal regulation, several states have begun passing laws or enacting regulations to phase out the intentional use of PFAS in food distribution, sale, and packaging. In New York, ECL § 37-0203 applies to items such as carrying cases, crates, cups, pails, trays, wrappers, bags, and tubs, as well as consumer goods such as paper plates, cups, and bowls sold to retail locations. Significantly, ECL § 37-0203 does not address the incidental presence of PFAS in food packaging productions, but only PFAS that is “intentionally added” to serve “an intended function in the product component.” Accordingly, while New York does not currently proscribe the use of PFAS as a processing agent, the New York State Department of Environmental Conservation encourages manufacturers to avoid such uses, possibly signaling future requirements outlawing PFAS in food packaging regardless of intent. Indeed, states such as California, Colorado, Connecticut, Hawaii, Maine, Maryland, Minnesota, Rhode Island, Vermont, Virginia, and Washington have already passed laws prohibiting using PFAS as a processing agent.
PFAS litigation includes actions involving cosmetic products such as makeup, nail polish, and hair dyes. These cases include allegations of misrepresentations to consumers regarding the product’s safety and a failure to warn that the product contained PFAS. Some cosmetic litigation involves claims of intentional use of PFAS due to its water-resistant properties. Elsewhere, in the absence of manufacturer claims of products being “PFAS-free,” litigants are claiming representations such as “sustainable” or “clean” as improper due to the so-called “forever chemical” nature of PFAS. Under the “price premium” theories discussed above, litigants claim they overpaid or would have never purchased the products in question but for the allegedly improper promotion, which they claim violates varying state statutes against deceptive practices. Accordingly, these litigations often focus on an analysis of whether such general representations can be deemed deceptive.
The cosmetics litigations have seen some early victories for defendants due to deficiencies in plaintiffs’ pleadings. In Solis, the plaintiff claimed she suffered an economic injury after purchasing a face powder, unaware it contained PFAS. Solis v. Coty, Inc., Case No. 22-cv-0400, 2023 US Dist. LEXIS 38278 (S.D. Cal. Mar. 7, 2023). The court found no misrepresentation in labeling because PTFE, a PFAS chemical, was disclosed on the packaging. Id. at *21; see also GMO Free USA v. Cover Girl Cosmetics, No. 2021 CA 004786 B (DC Super. Ct. June 1, 2022) (dismissing deceptive marketing allegations as PTFE was disclosed on the packaging and there were no allegations regarding “studies or analysis” showing PTFE to be unsafe).
In Brown, plaintiffs alleged violation of New York’s General Business Law against deceptive practices, breach of implied warranty, and unjust enrichment for failure to disclose PFAS in mascara products. Brown v. Coty, Inc., Case No. 22-cv-2696, 2023 US Dist. LEXIS 54316 (SDNY Mar. 29, 2023). The Southern District of New York granted the defendant’s motion to dismiss as the plaintiff failed to specify what type of PFAS the product allegedly contained and in what amounts. Without that information, the court held there was no basis to claim the product was unsafe. The court also found no reasonable basis for a consumer to believe the product did not contain PFAS.
The Northern District of California recently dismissed two putative class actions for deficient pleadings. In Lowe and its related case, Mack, plaintiffs, brought putative class actions against Edgewell Personal Care Company relating to allegations of PFAS contained in two different tampon product lines. Lowe v. Edgewell Pers. Care Co., Case No. 23-cv-00834-AMO, 2024 US Dist. LEXIS 7238 (N.D. Cal. Jan. 12, 2024). The court found the complaint allegations insufficient to state a plausible claim for relief as the testing allegations were cursory and provided no specificity regarding the results reached or any other findings that would support the plaintiffs’ interpretation of those results. As a result, the allegations were “devoid of the factual content necessary to nudge Plaintiffs’ claims, based on the theory that Edgewell’s tampons contain PFAS, from possible to plausible.” (emphasis in original).
Following reports regarding the potential for PFAS migration from food packaging, a string of class action litigations emerged against fast food companies and food product manufacturers. The majority of lawsuits were filed in Illinois, California, and New York, in both state and federal court. Like the cosmetic litigations, these actions essentially allege deceptive trade practices for selling products as safe without disclosing the alleged presence of PFAS, as detected by plaintiffs’ own testing. Again, the claimed injuries are economic under a price-premium theory. Plaintiffs focus their allegations not on express representations of being PFAS-free but on promotional materials expressing the “natural” or the environmentally conscious nature of the products to bolster their claims of consumer reliance and deception.
Thus far, the most significant defense bar success has been in the two related microwave popcorn cases decided jointly, Richburg & Ruiz v. ConAgra Brands, Inc., Case No. 22-cv-2420, 2023 US Dist. LEXIS 21137 (ND Ill. Feb. 8, 2023). There, plaintiffs alleged deceptive practices based on ConAgra’s representation that the products contained “only real ingredients” and “100% ingredients from natural sources.” The court took judicial notice of an FDA document entitled “Authorized Uses of PFAS in Food Contact Applications,” allowing for the use of PFAS, in part, “paper and paperboard food packaging,” including microwave popcorn bags. Unlike the Onaka court, however, the Northern District of Illinois accepted plaintiffs’ limited testing to sustain a price-premium theory. Instead, the court based its decision on whether the PFAS that allegedly migrated from the bag could be considered an “ingredient” such that the defendant’s claim of “only real ingredients” could be deemed misleading. Because the FDA exempts ingredients from “substances migrating to food from equipment or packaging,” the court held that to the extent PFAS did migrate, it could not be considered an ingredient. Any consumer expectation otherwise would not be reasonable. Notably, the court did not decide on preemption grounds but held the packaging was “correct as a matter of law.”
Many cases have been subjected to dismissal for lack of standing where plaintiffs’ pleadings fail to adequately allege an Article III injury-in-fact, therefore lacking subject matter jurisdiction.
In Onaka, plaintiffs alleged breach of warranty, negligent misrepresentation, fraud, and violation of various state consumer protection laws because the defendant claimed its beauty products were “free of harsh chemicals” despite the alleged presence of PFAS detected by plaintiffs. Onaka v. Shiseido Ams. Corp., Case No. 21-cv-10665, 2023 US Dist. LEXIS 53220 (SDNY Mar. 28, 2023). Nevertheless, the court found the plaintiffs’ testing too conclusory to support claims that the plaintiffs actually purchased a product containing PFAS. Therefore, the plaintiffs’ price premium theory could not be sustained by insufficient testing. As such, the litigants had no standing to bring a claim. Specifically, there were no allegations that the purchased products were tested or information regarding the time between testing and the plaintiffs’ purchase. There was also no evidence of widespread contamination. Accordingly, the court held that even assuming plaintiffs had detected PFAS in a specific batch, there was no plausible basis to assume plaintiffs purchased products containing incidental PFAS, suffering an economic injury.
In Esquibel, the plaintiffs alleged third-party testing “detected material levels of multiple PFAS” in the defendant’s mouthwash, including PFOA “in amounts 85 times the EPA’s recommended levels.” Esquibel v. Colgate-Palmolive Co., Case No. 23-cv-00742-LTS, 2023 WL 7412169, at *2 (S.D.N.Y. Nov. 9, 2023). However, because the plaintiffs did not allege the specific bottles they purchased were tested, nor did they plead details relating to the testing, such as how many units were tested, where those units were acquired, where the test took place, or what entity performed the test, the court dismissed plaintiffs’ claims for lack of standing. The court held that the plaintiffs’ claims could not amount to anything more than a “sheer possibility” and, therefore, failed to meet the standard of pleading an Article III injury-in-fact.
Similarly, in Hernandez, the plaintiff alleged third-party testing revealed PFAS in the defendant’s juice products; however, she did not test the bottles she purchased nor provided sufficient details about the testing to allow the court to plausibly conclude she purchased products containing PFAS. Hernandez v. Wonderful Co. LLC, Case No. 23-cv-1242-ER, 2023 WL 9022844, at *6 (SDNY Dec. 29, 2023). The court dismissed the plaintiff’s claims, finding that where it is “only likely” that she purchased mislabeled products, this equates to the plaintiff “impermissibly [asking] the Court to an infer an injury,” and thus she lacked Article III standing to bring her claims.
While the PFAS litigation regarding FDA-regulated products continues to evolve, there are some steps companies can take now to safeguard against potential litigation. Given the growing litigation and increasing amount of legislation, it is essential for companies to determine the presence of PFAS in their products.
Experts should be well-vetted and retained through outside counsel. Experts can advise on issues of testing, the competency of competing labs, and the significance of PFAS levels, if detected, as well as potential sources of their origin. Experts can assist in analyzing the implications of emerging state and federal PFAS legislation and assist should litigation arise.
Due to the number of claims flowing from incidental PFAS content migrating from packaging, manufacturers should take immediate steps to verify the absence of PFAS in the packaging received from suppliers in the form of compliance certifications. Likewise, those in distribution should seek compliance certifications from manufacturers.
Should litigation arise, as indicated by the above precedents, aggressive pre-answer motion practice should be pursued. Even if not entirely successful, a pre-answer motion to dismiss can force plaintiffs to amend their complaints, limiting the scope of allegations and cost of litigation. Lastly, as these complaints typically feature allegations based solely on the plaintiff’s own, undisclosed testing — often with only trace amounts of PFAS allegedly detected — thought should be given to structuring discovery first on the threshold issue of PFAS contamination. As discussed above, discovery on plaintiffs’ laboratory testing may reveal the lack of convincing contamination evidence and support arguments regarding plaintiffs’ lack of standing to bring economic claims. Specifically, similar to the Onaka case above, discovery on testing may indicate an insufficient nexus between the products purchased by plaintiffs and those batches tested by their attorneys to allege, plausibly, that plaintiffs purchased contaminated batches.
We are still in the nascent stages of the PFAS litigation regarding FDA-regulated products. At the time of this publication, myriad motions across product and jurisdiction lines seek to dismiss claims on theories of testing, standing, and even preemption beyond the successful cases reported above. Pending court decisions over the next year will further inform the scope and future of this litigation.
