Cosmetics Regulation and Litigation in Evolution

The Modernization of Cosmetics Regulation Act (MoCRA) was signed into law on December 29, 2022, and while its effects are still being understood and implemented, a few things are certain: MoCRA strengthens the prior legal requirements for cosmetic companies, and it is likely to change the landscape of cosmetics litigation. 

Before MoCRA, the Federal Food, Drug, and Cosmetic Act (FDCA) and the Fair Packaging and Labeling Act (FPLA) created general guidelines and protections that have governed the cosmetic industry for over 80 years. The FDCA, passed in 1938, permitted the Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. It required finished cosmetics to be safe when used by customers in accordance with product labeling or customary usage. Similarly, the FPLA, passed in 1966, required cosmetics that were marketed for retail to consumers to contain honest and informative labeling and safeguarded against deceptive practices in packaging and labeling. Since the passage of these acts, other legislation has been drafted, such as the 2017 Personal Care Products Safety Act, but none (until MoCRA) gained the requisite traction or support to be made into law.

During the pre-MoCRA days, litigation under the earlier FDCA and FPLA framework took a number of different forms. Under the FDCA, the Department of Justice, which litigates on behalf of the FDA, can initiate injunction actions upon referral from the FDA to stop firms and individuals from violating the FDCA. In the alternative, the Department of Justice could initiate a seizure action when certain identified lots of violative product were present.

In addition, private litigants have brought state law claims based on violations of either the FDCA or FPLA or state law. Litigants have sued on several theories—alleging, for example, misbranded or adulterated products (suing for alleged false claims such as the ability to treat wrinkles), labeling violations (suing for alleged misrepresentation of product content, net weight, or other essential information), failure to provide material facts (suing for alleged lack of proper usage directions or safety warnings), or beauty-from-within claims (suing for marketing claims that allegedly did not comply with regulations).

Lawsuits have also arisen when cosmetics allegedly caused harm due to contamination or unsafe manufacturing practices. Several of these lawsuits have been in the form of class actions under state consumer protection statutes, such as deceptive trade practice, false advertising, and unfair competition laws. Equally common have been lawsuits based on common-law theories such as misrepresentation, breach of warranty, and fraud.

The passage of MoCRA, as an amendment to the FDCA, disrupted the long-standing status quo in the cosmetics industry. MoCRA increases FDA oversight of the cosmetics industry and places certain requirements on cosmetic manufacturers, packers, importers, and distributors that market products in the United States. Under MoCRA, companies that sell their cosmetic products in the United States must register their facilities with the FDA and submit a list of their products, including ingredient information, to the agency (sections 604 and 607). MoCRA also requires the FDA to establish regulations for good manufacturing practices (section 606) and imposes certain requirements for cosmetic product labeling, such as the inclusion of information when a product is for professional use, contact information for reporting adverse events, and information concerning fragrance allergens (section 609). In addition, under MoCRA, a company must maintain records substantiating the safety of their cosmetic products (section 608), as well as monitor, keep records of, and report to the FDA “serious adverse events” involving their products (section 605).

Another significant aspect of MoCRA is that it gives the FDA recall authority over cosmetic products, including authorizing the FDA to request a voluntary recall or issue a mandatory recall of a cosmetic product if it believes a product is adulterated or misbranded or that exposure to it is likely to cause serious adverse health consequences or death (section 611). MoCRA also expressly precludes state and local governments from establishing any law or regulation that is “different from or in addition to” FDA requirements for a cosmetic product’s registration and product listing, safety substantiation, good manufacturing practices, records, adverse event reporting, and recalls (section 614). Other important aspects of MoCRA include certain requirements for the FDA to issue regulations concerning the detection of asbestos in talc-containing cosmetic products (section 3505) and to study the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetics (section 3506).

Notably, and particularly for those practicing in the mass tort and class action fields, many features of MoCRA parallel long-standing FDA regulations and requirements for medical devices and pharmaceutical drug products. As a result, it is likely that plaintiffs will not only continue to pursue the above-mentioned theories of relief in cosmetics cases but will also begin to bring claims similar to those asserted, often unsuccessfully, in the drug and device context. Specifically, following MoCRA, plaintiffs may attempt to bring claims scrutinizing the product ingredient information submitted to the FDA or safety substantiation, or may attempt to challenge a company’s compliance with safety substantiation requirements, good manufacturing practices, or adverse event reporting. Claims involving the presence of asbestos or PFAS in cosmetic products may also evolve as the FDA issues further regulation on these subjects pursuant to MoCRA.

Cosmetic defendants would have several defenses to these claims, which would in many respects mirror those seen in drug and device cases. Cosmetic defendants could argue that state law claims challenging or attempting to impose different requirements on their product listing, safety substantiation, manufacturing practices, adverse event reporting, or recall decision-making are expressly preempted by federal law, in light of MoCRA’s preemption clause (section 614(c)). A cosmetic defendant also may be able to demonstrate that claims solely alleging a purported failure to comply with MoCRA requirements or FDA regulations are impliedly preempted as attempts to enforce federal law, which only the federal government has the authority to do. See, e.g., Collyer v. Catalina Snacks Inc., No. 23-CV-00296-AMO, 2024 WL 202976, at *6 (N.D. Cal. Jan. 18, 2024) (applying implied preemption precedent from pharmaceutical drug context to food-labeling case and finding that the “FDCA impliedly preempts [a] state law claim that ‘originates from, is governed by, and terminates according to federal law’” (citation omitted)); Wilson v. ColourPop Cosmetics, LLC, No. 22-CV-05198-TLT, 2023 WL 6787986, at *8 (N.D. Cal. Sept. 7, 2023) (applying implied preemption precedent from pharmaceutical drug context to cosmetics case in which the plaintiff sought “to enforce the FDCA by holding [the d]efendant liable for its alleged use of Harmful Ingredients—which are not approved by the FDA for use in the eye area—in Products for which ‘the only reasonable and foreseeable use . . . is cosmetic application in the eye area,” because only “[t]he FDA is responsible for investigating potential violations of the FDCA”), appeal dismissed, No. 23-2627, 2023 WL 9112928 (9th Cir. Dec. 20, 2023).

Other defenses common in drug and device cases also may apply. For example, regarding a purported violation of good manufacturing practices, a cosmetic defendant could contend that good manufacturing practices are too general to support any state law duties that could underlie a negligent manufacturing defect claim, and in cases involving a recalled product, a cosmetic company could assert that a recall is not indicative of a defect, particularly in a case in which the recall was voluntary or precautionary or both.

In cases involving talc use or the presence of PFAS, other defenses may be available as well, such as lack of standing, lack of adequate testing, and primary jurisdiction. Primary jurisdiction has been asserted, though infrequently, in prior cosmetics and food products cases. See, e.g., Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, 761 (9th Cir. 2015) (primary jurisdiction properly invoked where plaintiff challenged use of “natural” in cosmetic labeling). The primary jurisdiction doctrine “permits courts to determine ‘that an otherwise cognizable claim implicates technical and policy questions that should be addressed in the first instance by the agency with regulatory authority over the relevant industry rather than by the judicial branch.’” Id. at 760 (citation omitted). Now, following the passage of MoCRA, a cosmetic defendant facing a talc- or PFAS-related claim may assert that the FDA’s duty to investigate the use of talc or PFAS in cosmetics should give rise to primary jurisdiction and warrants a stay or dismissal of the case. See id. at 761.

While several MoCRA requirements have already taken effect, additional measures are forthcoming. Thus, it will take some time to see the full impact of MoCRA and particularly its effect on cosmetics litigation. It is important that companies track these developments and carefully create policies and procedures not only to fully comply with MoCRA requirements but also to best position them to defend against potential future litigation.