Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs, cosmetics, dietary supplements, medical devices, and other consumer products subject to the Act.The FDCA provides for exclusive enforcement by the FDA and has no private right of action. Implied preemption also extends to state law claims based on allegations that the defendant violated FDA regulations.Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S.341, 349 n.4 (2001) (citing 21 U.S.C. §337(a)) (“The FDCA leaves no doubt that it is the Federal Government rather than private litigants who [is] authorized to file suit for noncompliance with” the FDCA’s substantive provisions). This article addresses recent federal cases supporting FDCA preemption of state law claims that require the fact finder to improperly assume the FDA’s enforcement power, particularly in the class action context.Recent Cases Show FDCA Implied Preemption Remains a Strong DefenseIn Nexus Pharms., Inc. v. Cen

e, … disgorgement … [has not] historically been viewed as punishment.’” (Slip. Op. at 8.) (citations omitted).Third Circuit Affirms Rejection of Conspiracy Charge under the Federal Food, Drug, and Cosmetic ActUnited States v. Vepuri, et al. (July 20, 2023), No. 22-1562http://www2.ca3.uscourts.gov/opinarch/221562p.pdf Unanimous decision: Chagares (writing), Scirica, RendellBACKGROUNDDefendants manufactured and sold a generic drug that required FDA approval. Defendants had received approval for abbreviated new drug applications (ANDA) for the specific drug. In their applications, they represented they would source the drug’s active ingredient from certain facilities. But, without notice to the FDA, the Defendants sourced the active ingredient elsewhere and distributed the drug. The district court dismissed a portion of the Defendants’ conspiracy charge — specifically, that the Defendants conspired to introduce unapproved new drugs in violation of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq.HOLDINGThe Third Circuit affirmed. It reasoned that the relevant statutory provision of the FDCA did not, in fact, prohibit introduction of the drug as the Government charged. The Government had not demonstrated that an entirely new drug was introduced into the market absent approval of an ANDA that was effective with respect to the new drug. See 21 U.S.C. § 355(a). That is, an alteration in the source for the active ingredient, alone, did not violate this provision.KEY QUOTE“The superseding indictment in this case does not include any allegations that the KVK-Tech Hydroxyzine manufactured with active ingredient from DRL had a different composition or labeling than the KVK-Tech Hydroxyzine with the effective approval. In the language of the statute, the ‘new drugs’ at issue here are the ‘such drugs’ that have an effective approval. The Government, therefore, cannot state an offense under this theory of liability.” (Slip Op. at 14-15.)Third Circuit Affirms Admission of Evidence

njali Dhamsania, Thomas Feil, and Matthew Kelly for their help conducting research for this article.2 570 U.S. 136 (2013).3 Nine products, because they were the subject of suits brought by multiple plaintiff groups (including the FTC) and/or against multiple defendants, fall into more than one category. Opana, for example, falls into four.4See e.g. In re Lipitor Antitrust Litig., 868 F.3d 231, 245 (3rd Cir. 2017) (in addition to challenging the settlement, Plaintiffs alleged that Pfizer engaged in monopolization via fraudulent patent procurement, false Orange Book listings, sham litigation, and sham citizen petitions.); In re Humira Antitrust Litig., 465 F. Supp. 3d 811 (N.D. Ill. 2020), aff’dsub nom., Mayor of Balt. v. AbbVie Inc., 42 F.4th 709 (7th Cir. 2022) (Plaintiffs alleged that AbbVie created a “minefield” of over 100 Orange Book patents on Humira, allegedly to deter challenges).5 35 U.S.C. § 101 et seq.6 Hatch-Waxman Act amendments to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq.7Id.8See In re Ciprofloxacin Hydrochloride Antitrust Litig., 544 F.3d 1323 (Fed. Cir. 2008), cert. denied, 557 U.S. 920 (2009); In re Tamoxifen Citrate Antitrust Litig., 429 F.3d 370 (2d Cir. 2005), cert. denied, 551 U.S. 1144 (2007); Schering-Plough Corp. v. FTC, 402 F.3d 1056 (11th Cir. 2005); Valley Drug Co. v. Geneva Pharms., Inc., 344 F.3d 1294 (11th Cir. 2003), cert. denied, 543 U.S. 939 (2004).9In re K-Dur Antitrust Litigation, 686 F.3d 197, 218 (3d Cir. 2012).10FTC v. Watson Pharms., Inc., 677 F.3d 1298, 1315 (11th Cir. 2012), rev’d and remanded sub nom Actavis, 570 U.S. 136.11Id. at 153.12Id. at 158.13Id. at 159-160.14Id. at 160.15Id. at 164.16In re Cipro Cases I & II, 348 P.3d 845 (Cal. 2015) (between 1997 and 2003, Bayer allegedly paid Barr $398.1M to stay off the market until patent expiration).17Actavis, 570 U.S. 136, 145 (“Solvay agreed to pay millions of dollars to each generic—$12 million in total to Paddock; $60 million in total to Par; and an estimated $19–$30

HDPE containers, PFAS compounds may be formed and then partly leach into the products inside the containers." This resulted in EPA's March 2022 warning to manufacturers about the risk of PFAS formation in fluorinated polyolefins, as described in Holland & Knight's previous blog post, "PFAS in Plastic Pesticide Containers: Latest Update," March 18, 2022.The results of EPA's study also raised concerns at FDA. On Aug. 5, 2021, FDA published a letter reminding manufacturers and users of fluorinated polyethylene food contact articles that FDA's regulationsauthorize only certain types of fluorinated polyethylene containers for food contact use. Specifically, FDA reminded manufacturers that nitrogen was the only permissible inert diluent allowed during food contact fluorination processes – not oxygen, water or other substances. Food containers "not manufactured in compliance with [this requirement] are adulterated" as defined by the federal Food, Drug and Cosmetic Act(FD&C Act), as amended, 21 U.S.C. § 301 etseq. The FD&C Act prohibits the sale or introduction of adulterated items into interstate commerce and authorizes penalties of $1,000 per violation, up to 364 days of prison or both. FDA concluded its August 2021 letter by encouraging manufacturers and distributors to "consult with FDA regarding the regulatory status of any substances used in contact with food, including processes used during the manufacturing of the final food container."Almost a year after its Aug. 5, 2021, letter, FDA requested more information on the use and safety of PFAS in food containers. In a notice published in the Federal Register on July 22, 2022, FDA announced that it was "opening a docket to obtain [...] scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and safety of per- and polyfluoroalkyl substances that may migrate from fluorinated polyethylene food containers." FDA has requested this information "to

behalf of a putative class, alleged that they purchased an OTC laxative product that contained a bacterial contaminant. The defendant had recalled the product. The plaintiffs asserted that they became ill as a result of the bacteria, but their claim was not for personal injury, it was for the money they paid for the laxative. According to the plaintiffs, the laxative label was deficient because it did not list the bacteria as an ingredient, nor did it warn of the possibility of bacterial contamination. The plaintiffs contended that they, naturally, would not have purchased the product if they knew of the bacterial contamination. The product was worthless. The plaintiffs wanted their money back. The complaint set forth causes of action for deceptive acts or practices and false advertising under New York General Business Law.The defendant filed a motion under Fed. R. Civ. P. 12(b)(6) to dismiss the complaint because the claims were expressly preempted by the Food, Drug and Cosmetic Act, 21 U.S.C. section 301 et seq. (FDCA). The FDCA contains an express preemption provision for state laws governing OTC drugs, including laxatives. Under that express preemption provision, no state can enforce any OTC labeling requirement not “identical” to what the FDA requires. In essence, the plaintiffs were attempting to turn what amounted to manufacturing defect allegations (if the bacteria was in the laxative, it got in by mistake) into a warning claim more amenable to class action status by claiming that a possible contaminant should have been listed as an “ingredient” in the OTC product’s labeling. We’re tempted to call the claim clever, but it actually isn’t. We’ve seen it before and it has failed before. The FDA promulgated regulations define a drug active “ingredient” as a substance “intended” to furnish pharmacological activity or other direct effect in the diagnosis, mitigation, treatment, or prevention of disease. A contaminant does not come close to fitting the bill. An inactive ingredient is a

the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a major shift in cosmetic industry regulations. This article is one of a series of posts diving into each aspect of MoCRA as we await its full implementation. To begin, we will discuss whether MoCRA applies to your product and, if so, which entity should serve as the responsible person for ongoing compliance.Am I making a “cosmetic product”?If you are a manufacturer, packer, importer, or distributor, the first question you should be asking is whether your product falls under the definition of a “cosmetic product,” which determines whether MoCRA pertains to your product at all.Under MoCRA, a “cosmetic product” is defined as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.” 21 U.S.C. § 364(2). As indigestible as this definition may be, it turns on what constitutes a “cosmetic,” a term defined under the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301, et seq., “the Act”). The Act defines a “cosmetic” as:(1) article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and(2) article intended for use as a component of any such articles;except that such term shall not include soap.21 U.S.C. § 321(i).While “soap” is excluded from the definition of a “cosmetic,” the U.S. Food and Drug Administration defines this term narrowly as an “article[] that meet[s] the following conditions:(1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and(2) The product is labeled, sold, and represented only as soap.”21 C.F.R. § 701.20(a).Products regulated as drugs and medical devices are also exempt from MoCRA. This includes over-the-counter products (“OTC”) with a

On March 3, 2023, the Consumer Protection Branch (CPB) of the Civil Division of the U.S. Department of Justice (DOJ) publicly released a new voluntary self-disclosure policy (“CPB VSD Policy”). The CPB VSD Policy seeks to encourage companies to self-report any potential criminal violations directly to CPB. The CPB VSD Policy applies to any violations of federal criminal law involving products regulated by, or conduct under the jurisdiction of, the U.S. Food and Drug Administration (FDA), as well as disclosure failures or misrepresentations to FDA.As background for our food clients, CPB is the DOJ component responsible for enforcing laws that protect consumers’ health, safety, economic security, and identity integrity.1 As part of this broad mandate, CPB handles both civil and criminal enforcement matters against food and dietary supplement companies for alleged violations of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 301, et seq., and other federal statutes and regulations. CPB partners closely with FDA and law enforcement agencies, as well as U.S. Attorney’s Offices around the country, which must notify and consult with CPB upon opening any criminal investigation involving an FFDCA violation.2As noted above, the recently released CPB VSD Policy seeks to encourage companies to self-report potential criminal violations directly to CPB and applies to any violations of federal criminal law involving products regulated by, or conduct under the jurisdiction of, FDA, including failing to disclose or misrepresenting information to FDA.A Broader Effort to Incentivize Self-DisclosureCPB’s new VSD Policy underscores the DOJ’s stated commitment to uniformly incentivize self-disclosure and corporate cooperation across all DOJ components and across the country.3 In the September 15, 2022 “Monaco Memo,” Deputy Attorney General Lisa Monaco directed each prosecutorial DOJ component to review, or in some cases to draf

1).Gonzales v. Raich, 545 U.S. 1 (2005).Conant v. Walters, 309 F.3d 629 (9th Cir. 2002).Id.See also Bierbach v. Digger’s Polaris and Musta v. Mendota Heights Dental Center, No. 21-676 and 21-998, 2022 WL 1560177 (U.S. May 16, 2022); Empyreal Enterprises LLC v. United States, No. 5:22-cv-00094 (C.D. Cal. Jan. 14, 2022).Northeast Patients Group et al. v. Figueroa, 2022 WL 94114 (1st Cir.). Joe Cocker, Feelin’ Alright? (1969)(“Hey, you feelin’ alright?”). You Can’t Always Get What You Want, The Rolling Stones (1969). Agricultural Improvement Act of 2018, Pub. L. 115-334.Id. Alexandra Nseir, Value of hemp production totaled $824 million in 2021, U.S. Dept. of Agriculture (Feb. 17, 2022), . Dario Sabaghi, How the 2023 Farm Bill May Reshape the Hemp Industry, Forbes, (Aug. 3, 2022) https://www.forbes.com/sites/dariosabaghi/2022/08/03/how-the-2023-farm-bill-may-reshape-the-hemp-industry/?sh=6aaa3bca7a67. The Joker, Steve Miller Band (1973)(“I’m a joker, I’m a smoker, I’m a midnight toker.”). 21 U.S.C.A. § 301 et seq.Id. 21 U.S.C. 321, 355.Supra note 37. FDA Commissioner Scott Gottlieb, M.D., Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds (Dec. 20, 2018), https://www.fda.gov/NewsEvents/Newsroom/Press Announcements/ucm628988.thm.Id. U.S. Food & Drug Administration, Warning Letters and Test Results for Cannabidiol-Related Products, (May 6, 2022), https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products.See Ahumada v. Global Widget, LLC, 2020 WL 5669032, at *1 (D. Mass. Aug 11, 2020)(The primary jurisdiction doctrine is “a set of precedents that guide court s in deciding when an issue should be resolved in the first instance by an agency that has special competence to address it.”).Dasilva v. Infinite Product Company, 2021 WL 900642 (C.D. Cal. Mar. 3, 2021).Id. at *2. U.S. Food & Drug Administrat

Companies interested in understanding more about the cultured cells, or with a desire to provide formal comments for submission to FSIS, are encouraged to contact our team. Cooley’s lawyers bring decades of experience helping agtech and foodtech companies navigate complex legal issues involving intellectual property; litigation; FDA regulatory; licensing, collaboration and M&A deals; and capital raises including venture financing and public and private capital markets.NotesSee Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), and the Fair Packaging and Labeling Act (15 U.S.C. § 1451, et seq.)See Federal Meat Inspection Act (FMIA; 21 U.S.C. § 601 et. seq); Poultry Products Inspection Act (PPIA; 21 U.S.C. § 451,et seq.)21 U.S.C. §§ 601(n)(1) and 453(h)(1); 21 U.S.C. § 343(a).

Specifically, the statute requires that an interchangeable product is biosimilar and can be expected to produce the same clinical result as the reference product in any given patient; and that for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. 42 U.S.C. §§ 262(I)(3) and 262(k)(4).Insulins are in a unique class of biologic drugs that, for historical reasons, were approved under the Food, Drug, and Cosmetics Act (codified at 21 U.S.C. § 301 et seq.). The BPCIA provided a sunset date of March 23, 2020 for such approvals; the FDA finalized rulemaking on this change on February 20, 2020.