S Pharmacy, Inc. v. Johnson & Johnson Consumer Inc.

24-3296-cv (L) Sandra Yousefzadeh, et al., Newton's Pharmacy, Inc. v. Johnson & Johnson Consumer Inc., et al. UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT August Term 2025 (Argued: March 4, 2026 Decided: July 30, 2026) Docket Nos. 24-3296 (L), 25-119 (CON) SANDRA YOUSEFZADEH, ET AL., NEWTON'S PHARMACY, INC., Plaintiffs-Appellants, GWEN THOMAS, RHONDA NITTO, Plaintiffs, - against - JOHNSON & JOHNSON CONSUMER INC., RB HEALTH (US) LLC, TARGET CORPORATION, BAYER HEALTHCARE, LLC, A DELAWARE LIMITED LIABILITY CORPORATION, WALMART INC., A DELAWARE CORPORATION, CVS PHARMACY, INC., A DELAWARE CORPORATION, WALGREEN CO., AN ILLINOIS CORPORATION, THE PROCTER & GAMBLE COMPANY, HALEON US HOLDINGS LLC, PUBLIX SUPER MARKETS, INC., AMAZON.COM, INC., AMAZON.COM SERVICES LLC, KENVUE, INC., GLAXOSMITHKLINE LLC, RITE AID CORPORATION, ALBERTSONS COMPANIES, INC., COSTCO WHOLESALE CORP., Defendants-Appellees,  DOES 1-200, GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC, RECKITT BENCKISER LLC, MERCK, MCNEIL CONSUMER HEALTHCARE, SANOFI-AVENTIS U.S. LLC, CHURCH & DWIGHT CO. INC., ASSOCIATED WHOLESALE GROCERS INC, VALU MERCHANDISERS CO., PFIZER INC., PERRIGO COMPANY PLC, HELEN OF TROY LIMITED, DIERBERGS MARKETS, INC., RECKITT BENCKISER PHARMACEUTICALS INC., THE KROGER CO., HARRIS TEETER, LLC, HARRIS TEETER SUPERMARKETS, INC., DOLGENCORP, INC. FAMILY DOLLAR, LLC., Defendants. ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF NEW YORK Before: RAGGI, CHIN, and PÉREZ, Circuit Judges. Consolidated appeals from orders and final judgment of the United States District Court for the Eastern District of New York (Cogan, J.) dismissing all claims in nearly one hundred class actions against drug manufacturers and retailers. Plaintiffs, buyers of nasal decongestants, sued drug manufacturers for advertising and selling over-the-counter drugs allegedly known to be ineffective. Plaintiffs' cases were consolidated in this multidistrict litigation, after which plaintiffs filed a single representative complaint in the Eastern District of New -2- York raising state law claims and a federal claim under the Racketeer Influenced and Corrupt Organizations Act. The district court entered judgment for the defendant drug manufacturers, concluding that the Federal Food, Drug, and Cosmetic Act preempted plaintiffs' state law claims and that plaintiffs lacked statutory standing to bring their federal claim. AFFIRMED in part, VACATED in part, and REMANDED for further proceedings consistent with this opinion. SAMUEL ISSACHAROFF, New York, NY; and Jonathan D. Selbin, Lieff Cabraser Heimann & Bernstein, LLP, New York, NY; Adam J. Levitt, DiCello Levitt LLP, Chicago, IL; Elizabeth A. Fegan, Fegan Scott LLC, Chicago, IL; James E. Cecchi, Carella, Byrne, Cecchi, Brody & Agnello, P.C., Roseland, NJ; Kiley L. Grombacher, Bradley/Grombacher LLP, Westlake Village, CA; Christopher A. Seeger, Seeger Weiss LLP, Ridgefield Park, NJ; Jason P. Sultzer, Sultzer & Lipari, PLLC, Poughkeepsie, NY; Lindsey N. Scarcello, Wagstaff & Cartmell, Kansas City, MO, on the brief, for Consumer Plaintiffs-Appellants. Joe P. Leniski, Jr. and Alyson S. Beridon, Herzfeld, Suetholz, Gastel, Leniski and Wall, PLLC, Nashville, TN, Cincinnati, OH, for Plaintiff- Appellant Newton's Pharmacy, Inc. -3- DAVID M. ZIONTS (Andrew Soukup, Victoria Stilwell, on the brief), Covington & Burling LLP, Washington, D.C., for Defendant-Appellee The Procter & Gamble Company. Jay P. Lefkowitz, P.C., Jacob M. Rae, Robyn E. Bladow, Cole Carter, Kirkland & Ellis LLP, New York, NY, Los Angeles, CA, Chicago, IL, for Defendant- Appellee Haleon US Holdings LLC. Hannah Y. Chanoine, Bruce Crawford, Amy J. Laurendeau, Jason Zarrow, O'Melveny & Myers LLP, New York, NY, Newport Beach, CA, Los Angeles, CA, for Defendant-Appellee Johnson & Johnson Consumer Inc. Jessica L. Ellsworth, James L. Bernard, Lauren S. Colton, Hogan Lovells US LLP, Washington, D.C., New York, NY, Baltimore, MD, for Defendant-Appellee RB Health (US) LLC. Cara D. Edwards, Colleen Carey Gulliver, Christopher G. Campbell, Christopher M. Young, DLA Piper LLP (US), New York, NY, Atlanta, GA, San Diego, CA, for Defendant-Appellee Bayer HealthCare, LLC. Nilda Isidro, Dale Rose Goldstein, Greenberg Traurig, LLP, New York, NY, for Defendants-Appellees CVS Pharmacy, Inc., Target Corporation, Walgreen Co., and Walmart Inc. Christopher J. Walker, U.S. Chamber Litigation Center, Washington, D.C.; Robert E. Dunn, Isaac J. Weitzhandler, Eimer Stahl LLP, Campbell, CA, for Amicus Curiae Chamber of Commerce of the -4-  United States of America, in support of Defendants- Appellees. CHIN, Circuit Judge: For decades, the Food and Drug Administration (the "FDA") and others recognized that oral phenylephrine ("oral PE") -- used in such popular products as Nyquil Severe Cold & Flu, Advil Sinus Congestion & Pain, and Mucinex Sinus Max -- was an effective nasal decongestant. Starting in 2007, however, scientific studies began casting doubt on that finding. Indeed, in 2016, some studies concluded that oral PE "[was] no more effective than [a] placebo" as a decongestant. App'x at 166-67. Yet, the FDA has continued to require manufacturers to adhere to its existing labeling requirements denoting oral PE as effective. In this consolidated case, buyers of nasal decongestants contend that, in the past decade, drug manufacturers have sold some $12 billion's worth of purportedly ineffective nasal decongestants to consumers. After the scientific studies reported the nasal decongestants' alleged deficiency, consumers ("Consumer Plaintiffs") and other entities -- including retail pharmacy Newton's Pharmacy, Inc. ("NPI," and together with Consumer Plaintiffs, "Plaintiffs") -- filed -5- nearly one hundred class actions that were eventually consolidated in this multidistrict litigation. They allege, in sum, that the defendant drug manufacturers and retailers ("Defendant Manufacturers") produce, market, advertise, and sell nasal decongestants containing the active ingredient oral PE, despite having known since at least 2016 that oral PE does not, in fact, decongest. In 2023, the Judicial Panel on Multidistrict Litigation consolidated Plaintiffs' putative class actions and transferred them to the Eastern District of New York. Plaintiffs then collectively filed an "initial streamlined" complaint (the "Complaint") raising claims representative of those brought in the underlying actions. App'x at 123-24. The Complaint alleged (1) New York state statutory and common-law claims against Defendant Manufacturers, see N.Y. Gen. Bus. Law §§ 349, 350; N.Y. U.C.C. Law. §§ 2-313, 2-314, and (2) a federal Racketeer Influenced and Corrupt Organizations Act ("RICO") claim against a subset of drug manufacturers ("RICO Defendants," and together with Defendant Manufacturers, "Defendants"), see 18 U.S.C. § 1962(c)-(d). In response, Defendants filed a motion to dismiss the Complaint for failure to state a claim. After concluding that the Federal Food, Drug, and Cosmetic Act (the "FDCA") barred Plaintiffs' state law claims and that Plaintiffs lacked statutory -6- standing to bring their RICO claim, the United States District Court for the Eastern District of New York (Cogan, J.) granted Defendants' motion to dismiss. 1 It therefore entered judgment on November 12, 2024, dismissing all claims in all underlying cases in the multidistrict litigation, including NPI's Lanham Act claim, which the Complaint had not raised. See In re Oral Phenylephrine Mktg. & Sales Pracs. Litig., 755 F. Supp. 3d 208 (E.D.N.Y. 2024). The district court also denied NPI's subsequent motion for reconsideration, which sought relief from the dismissal of its Lanham Act claim with prejudice. In re Oral Phenylephrine Mktg. & Sales Pracs. Litig., No. 23-cv-9307, 2024 WL 5120039 (E.D.N.Y. Dec. 16, 2024). Plaintiffs now appeal the district court's orders and final judgment. We hold that the FDCA expressly preempts the majority of Consumer Plaintiffs' state law claims and that Consumer Plaintiffs lack a cause of action to bring their RICO claim. Indeed, Defendant Manufacturers followed the FDA's prescribed labeling requirements by designating their decongestants' 1 Although the district court referred to its RICO analysis as a "statutory standing" inquiry, we have clarified that the "'statutory standing' appellation is 'misleading' and 'a misnomer.'" Am. Psychiatric Ass'n v. Anthem Health Plans, Inc., 821 F.3d 352, 359 (2d Cir. 2016) (quoting Lexmark Int'l, Inc. v. Static Control Components, Inc., 572 U.S. 118, 128 n.4 (2014)). Instead, "what has been called 'statutory standing' in fact is not a standing issue, but simply a question of whether the particular plaintiff 'has a cause of action under the statute.'" Id. (quoting Lexmark Int'l, Inc., 572 U.S. at 128). -7- purpose as decongestion. Defendant Manufacturers cannot now be sued for complying with those FDA specifications. Therefore, the claim that Defendant Manufacturers mislabeled their products by indicating their use for decongestion fails. Accordingly, we AFFIRM the district court's entry of judgment for Defendant Manufacturers on the state law claims, with the exception that we VACATE as to (1) the "Maximum Strength" claims and (2) the claims regarding brand-name oral PE products approved through the FDCA's New Drug Application process. We also AFFIRM the district court's dismissal of Consumer Plaintiffs' civil RICO claim and the district court's denial of NPI's motion for reconsideration. Finally, we REMAND for further proceedings consistent with this opinion. BACKGROUND This case requires us to resolve three questions: first, whether the FDCA preempts Consumer Plaintiffs' state law claims; second, whether Consumer Plaintiffs have a cause of action to bring their RICO claim; and third, whether the district court abused its discretion in denying NPI's motion for reconsideration. Because answering the first question requires some familiarity with the "labyrinth" that is the FDCA, see N.Y. State Rest. Ass'n v. N.Y.C. Bd. of -8- Health, 556 F.3d 114, 117 (2d Cir. 2009), we begin with an overview of this statutory and regulatory regime. We then turn to the factual background and procedural history underlying this appeal. I. The FDCA We first describe the basics of the FDCA's over-the-counter ("OTC") drug regulation process. We then discuss each of the three FDCA labeling provisions upon which this appeal's preemption question hinges, namely: (1) the misbranding provision, 21 U.S.C. § 352(a)(1); (2) the "monograph" labeling requirements applicable to oral PE products, 21 C.F.R. § 330.1 and 21 C.F.R. § 341.80; and (3) the express preemption provision that ultimately dooms most of Consumer Plaintiffs' state law claims, 21 U.S.C. § 379r. A. The FDCA's OTC Drug Regulation and Approval Process Enacted in 1938, the FDCA, 21 U.S.C. § 301 et seq., charges the FDA with ensuring the safety and efficacy of drugs, including by promulgating regulations. 21 U.S.C. § 393(b)(2)(B); see id. § 371(a). 2 Because the FDCA does not provide for a private right of action, individual plaintiffs may not sue directly 2 While the statute vests "[t]he authority to promulgate regulations for the efficient enforcement of this chapter" in the Secretary of Health and Human Services, 21 U.S.C. § 371(a), the Secretary can delegate this authority to the FDA, pursuant to which the FDA Commissioner "may propose and promulgate regulations," 21 C.F.R. § 10.40. -9- under the FDCA to enforce the statute's provisions and regulations. See 21 U.S.C. § 337(a); POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102, 109 (2014). Nevertheless, plaintiffs may bring state law misbranding claims that enforce "state laws imposing requirements identical to those contained in the FDCA." Jackson-Mau v. Walgreen Co., 115 F.4th 121, 128 (2d Cir. 2024) (internal quotation marks omitted). In accordance with the FDA's duties to regulate drugs, before a drug manufacturer may introduce a new drug into interstate commerce, the FDA must approve the drug and determine that it is "generally recognized as safe and effective," or "GRAS/E," for the use described in the drug's label. Nat. Res. Def. Council, Inc. v. U.S. Food & Drug Admin., 710 F.3d 71, 75 (2d Cir. 2013); see also 21 U.S.C. §§ 321(p)(1), 355(a), 355h(a)(1). The FDCA establishes two mechanisms for evaluating whether OTC drugs -- such as the nasal decongestants at issue here -- are GRAS/E: (1) the New Drug Application ("NDA") process and (2) the monograph process. The NDA process governs select drugs at issue in this action, while the monograph process governs the rest. 3 3 The record is unclear as to which drugs involved in this lawsuit are regulated through the NDA process and which are regulated through the monograph process. - 10 -  Under the NDA process, manufacturers seek, and the FDA may provide, premarket approval of a drug on an individualized basis. 21 U.S.C. § 355; 21 C.F.R. § 314. The manufacturer's NDA must contain proposed labeling. Wyeth v. Levine, 555 U.S. 555, 568 (2009); 21 U.S.C. § 355(b)(1)(A)(vi). The FDA will then approve the NDA only if it finds, inter alia, that the drug is "safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling," "substantial evidence [exists] that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and the proposed labeling is not "false or misleading in any particular." 21 U.S.C. § 355(d). Meanwhile, under the monograph process, a manufacturer may sell an OTC drug without individualized FDA review if the drug and its label adhere to a "monograph" -- that is, a detailed regulation the FDA promulgates for certain therapeutic categories of drugs (with categories based on the purpose and uses of the drug). More specifically, a monograph establishes the FDA-approved active ingredients for a particular therapeutic class of drugs and identifies the conditions under which each active ingredient is GRAS/E. Id. § 355h; 21 C.F.R. § 330.10(a). If the drug and its label adhere to the appropriate monograph, the - 11 - FDA considers the drug to be GRAS/E. See 21 U.S.C. §§ 355, 355h; see also Nat. Res. Def. Council, Inc., 710 F.3d at 75. If the drug and its label do not observe the monograph requirements, the drug is "liable to regulatory action" by the FDA. 21 C.F.R. § 330.1. Notably, in 1994, the FDA published a final monograph determining that oral PE -- the active ingredient in the OTC drugs at issue in this case -- is GRAS/E as a nasal decongestant. 59 Fed. Reg. 43,386, 43,408 (Aug. 23, 1994). In March 2020, Congress converted the FDA's existing monographs for OTC drugs -- including the monograph covering oral PE -- to administrative orders, 21 U.S.C. § 355h(k)(2)(A), and affirmed that covered drugs must be "marketed in conformity with an administrative order," id. § 355h(b)(1)(B)(ii). B. The FDCA's Labeling Provisions and Regulations 1. The FDCA's Misbranding Provision To ensure the safety and efficacy of drugs on the market, the FDCA prohibits introducing into interstate commerce any drug "that is . . . misbranded." Id. § 331(a). Under the FDCA's misbranding provision, a drug "shall be deemed to be misbranded" if "its labeling is false or misleading in any particular." Id. § 352(a)(1). "All drugs, including those the Food and Drug Administration approves . . . , are subject to" the misbranding provision. 21 C.F.R. § 314.170. In - 12 - this case, as discussed below, the nasal decongestant monograph gives color to the meaning of "misbranded" as that term is used in the misbranding provision. Id. § 341.80 (nasal decongestant monograph clarifying that oral PE products are not misbranded if they adhere to certain requirements). If a drug is alleged to be misbranded, "in determining whether the labeling or advertising is misleading there shall be taken into account (among other things)": not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual. 21 U.S.C. § 321(n) (emphases added). The misbranding provision therefore prohibits not only affirmative misrepresentations but also failures to disclose material facts. 2. The Nasal Decongestant Monograph's Labeling Requirements Under the FDCA regulations, oral PE is GRAS/E and an oral PE drug "is not misbranded" if it complies with (1) the requirements in the monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for - 13 - Over-the-Counter Human Use (the "nasal decongestant monograph"), 21 C.F.R. § 341.80, and (2) the general conditions established in 21 C.F.R. § 330.1. See 21 C.F.R. § 330.1 (emphasis added); see also id. § 341.1; 21 U.S.C. § 355h(a)(1)(A). The nasal decongestant monograph mandates that an oral PE product's label set forth, in addition to certain warnings and directions, a Statement of Identity and Indications for use. See 21 C.F.R. § 341.80(a)-(b). The product's Statement of Identity must identify the product as a "nasal decongestant." Id. § 341.80(a). The product's Indications section must feature -- "as appropriate" -- the phrase "For the temporary relief of nasal congestion" or "Temporarily relieves nasal congestion." Id. § 341.80(b)(1). The label may additionally contain other phrases such as "Temporarily relieves nasal stuffiness" or "Decongests." Id. § 341.80(b)(2)(i)-(ii). The nasal decongestant monograph emphasizes that "[o]ther truthful and nonmisleading statements, describing only the indications for use . . . listed in . . . this section, may also be used . . . subject to the" misbranding provision. Id. § 341.80(b). Meanwhile, 21 CFR § 330.1 establishes the general conditions by which oral PE products must abide. These conditions require the drug's label to include the Indications prescribed in the monograph "or alternative truthful and - 14 - nonmisleading statements" subject to the misbranding provision. Id. § 330.1(c)(2). Moreover, an OTC drug's advertising does not constitute misbranding if it "prescribes, recommends, or suggests [the drug's] use only under the conditions stated in the labeling." Id. § 330.1(d). C. The FDCA's Preemption Provision for Nonprescription Drugs Finally, the FDCA also features a preemption provision. Section 379r -- entitled "National uniformity for nonprescription drugs" -- states that "no State or political subdivision of a State may establish or continue in effect any requirement . . . that is different from or in addition to, or that is otherwise not identical with, a requirement under" the FDCA and its regulations. 21 U.S.C. § 379r(a)(2). In relevant part, the preemption provision provides an exception for product liability claims. Id. § 379r(e). As used in the preemption provision, the term "requirements" includes common-law duties. See Riegel v. Medtronic, Inc., 552 U.S. 312, 324 (2008); Bates v. Dow Agrosciences LLC, 544 U.S. 431, 443 (2005); Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 521 (1992). Thus, consumers may not sue under state law unless they are enforcing state law duties identical with a manufacturer's duties under the FDCA. See Jackson-Mau v. Walgreen Co., 115 F.4th 121, 128 (2d Cir. - 15 - 2024). The statute also specifies that preemptive effect extends to "any requirement relating to public information or any other form of public communication relating to a warning of any kind for a drug." 21 U.S.C. § 379r(c)(2). 4 II. Factual Background 5 In 1994, the FDA published a final monograph recognizing oral PE as effective for nasal decongestion. 59 Fed. Reg. 43,386, 43,408 (Aug. 23, 1994). Since then, for the past thirty years, the nasal decongestant monograph has required that manufacturers label their oral PE products as "decongestants" and indicate their use for decongestion. During that time, Defendant Manufacturers have produced and sold OTC nasal decongestants that utilize oral PE as an active ingredient. The products' labels have accordingly indicated their use for decongestion, as required. By 2007, however, new scientific studies began to cast doubt on oral PE's efficacy as a nasal decongestant. These reports ignited a controversy that 4 This subsection is labeled "Safety or effectiveness," 21 U.S.C. § 379r(c)(2), and thus presumably extends to warnings about both safety and efficacy. 5 We draw these facts, which we assume to be true for the purposes of this appeal, from Plaintiffs' Complaint. See Galper v. JP Morgan Chase Bank, N.A., 802 F.3d 437, 443 (2d Cir. 2015). - 16 - continued to smolder for the next decade. Around this time, RICO Defendants began "[i]nfiltrat[ing]" the Consumer Health Products Association (the "CHPA"), a national trade association of manufacturers and marketers of consumer healthcare products. App'x at 153. The CHPA, steered by RICO Defendants, then hid the inefficacy of oral PE from consumers and delayed the FDA's review of oral PE's efficacy by issuing deceptive press releases and misrepresenting the available scientific evidence about oral PE. Consequently, in 2007, the FDA's Nonprescription Drugs Advisory Committee (the "NDAC") -- which provides the FDA with non-binding advice, see 21 C.F.R. §§ 14.40, 14.100(c)(15) -- declined to recommend changes to the FDA's original approval of oral PE as a nasal decongestant. The NDAC instead informed the FDA that, due to the limitations of the available data (which RICO Defendants had misconstrued through the CHPA), additional studies were required to evaluate the efficacy of oral PE. The final nasal decongestant monograph, classifying oral PE as GRAS/E, thus remained in effect. Over the next ten years, scientific studies surrounding oral PE continued to emerge and develop. By 2016, the science had made "crystal clear" that oral PE "[was] no more effective than [a] placebo" for decongestion. App'x at - 17 - 166-67. Yet the FDA did not reverse course or revoke oral PE's status as GRAS/E for decongestion, and Defendant Manufacturers continued to market, advertise, and label their oral PE products as effective nasal decongestants, in compliance with the nasal decongestant monograph. 6 Since becoming aware of oral PE's ineffectiveness by no later than 2016, Defendant Manufacturers have sold at least $12 billion in oral PE nasal decongestants. In 2020, the FDA converted the nasal decongestant monograph into a final administrative order, again recognizing oral PE as GRAS/E when used as a nasal decongestant. See U.S. Food & Drug Admin., Final Administrative Order OTC000026: Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use (effective Mar. 27, 2020). In September 2023, though, the FDA convened the NDAC panel of experts to again review oral PE's efficacy. At the end of the meeting, the NDAC concluded, by a unanimous vote of 16-0, that oral PE 6 Though of course Defendant Manufacturers were not required to sell their oral PE products in the first place, the Supreme Court has rejected the idea that manufacturers must pull their products from the market if they cannot otherwise comply with both federal and state law. See Mut. Pharm. Co., Inc. v. Bartlett, 570 U.S. 472, 475, 488 (2013) ("We reject this 'stop-selling' rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability."). - 18 - products were ineffective as nasal decongestants. These lawsuits were filed shortly thereafter. After the NDAC issued its conclusion, in November 2024, the FDA proposed an administrative order that would remove oral PE from the nasal decongestant monograph. The FDA explained that "an agency review of the available data [had] determined that oral phenylephrine is not effective for [temporary relief of nasal congestion]." FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review, U.S. Food & Drug Admin. (Nov. 7, 2024), https://www.fda.gov/news-events/press-announcements/fda-proposes-ending- use-oral-phenylephrine-otc-monograph-nasal-decongestant-active-ingredient- after [https://perma.cc/ZM6X-5LTE]. The agency based its determination on a "comprehensive review of all available data on the safety and efficacy of oral phenylephrine." Id. Nonetheless, as oral PE is still considered GRAS/E until the administrative order becomes final, the FDA decreed that, "[f]or now, companies may continue to market OTC monograph drug products containing [oral PE] as a nasal decongestant." Id. - 19 - III. Procedural Background In December 2023, the Judicial Panel on Multidistrict Litigation transferred Plaintiffs' nearly one hundred putative class actions to the Eastern District of New York for consolidated pretrial proceedings. 7 The district court then ordered the parties to engage in a "bellwether" process to test claims and defenses common across the consolidated cases. App'x at 131. Accordingly, Plaintiffs filed the Complaint alleging New York state law claims and a federal civil RICO claim. Plaintiffs' state law claims allege that Defendant Manufacturers misled them by falsely labeling and advertising their oral PE products as effective for nasal decongestion. The RICO claim alleges that RICO Defendants committed mail and wire fraud in furtherance of a scheme to defraud the public and fool the FDA into believing that oral PE works as a decongestant. In October 2024, the district court granted Defendants' motion to dismiss the Complaint for failure to state a claim, holding that the FDCA preempts Consumer Plaintiffs' state law claims and that Consumer Plaintiffs 7 This consolidation included NPI's class action filed in the Southern District of Ohio, which alleged claims under state law and under the Lanham Act, 15 U.S.C. § 1125(a), for false advertising. - 20 - lacked standing to pursue their RICO claim. The district court accordingly entered judgment dismissing all claims in all underlying cases in the multidistrict litigation -- including NPI's Lanham Act claim, which the Complaint did not contain and which the district court's decision did not address. See 755 F. Supp. 3d at 219. Consumer Plaintiffs filed a timely notice of appeal from the district court's judgment. Meanwhile, NPI moved for partial relief from the final judgment under Federal Rules of Civil Procedure 60(b)(1) and 60(b)(6), requesting that the district court reconsider its dismissal of NPI's Lanham Act claim. After the district court denied the motion for reconsideration, see 2024 WL 5120039, at *2, NPI filed a timely notice of appeal from that order. On appeal, Consumer Plaintiffs contend that this Court should (1) reverse the district court's dismissal of their state law claims on preemption grounds and (2) reverse the district court's dismissal of their RICO claim on "statutory standing" grounds. NPI asks this Court to reverse the district court's order denying its motion for partial relief from the final judgment on its Lanham Act claim. - 21 -  DISCUSSION We first discuss the FDCA's preemptive effect on Consumer Plaintiffs' state law claims. We next proceed to Consumer Plaintiffs' right to sue under civil RICO. Finally, we conclude by assessing NPI's challenge to the district court's denial of its motion for reconsideration. I. The FDCA's Express Preemption of State Law Claims Defendant Manufacturers contend, and the district court ruled, that the FDCA expressly preempts Consumer Plaintiffs' state law claims because those claims would impose on Defendant Manufacturers requirements that are "different from," "in addition to," or "otherwise not identical with" labeling requirements under the FDCA (and specifically, under the nasal decongestant monograph). See 21 U.S.C. § 379r(a)(2). Consumer Plaintiffs counter that the FDCA does not preempt their state law claims, as those claims would simply enforce Defendant Manufacturers' duty under the FDCA's misbranding provision not to falsely or misleadingly label their drugs. See id. § 352(a)(1). We conclude that, with two exceptions, the FDCA expressly preempts Consumer Plaintiffs' state law claims. - 22 -  A. Standard of Review We review de novo a district court's grant of a motion to dismiss on preemption grounds. DCC Propane, LLC v. KMT Enters., Inc., 147 F.4th 171, 174 (2d Cir. 2025). 8 At this stage, we accept a complaint's factual allegations as true and view them in the light most favorable to the plaintiff. Galper v. JP Morgan Chase Bank, N.A., 802 F.3d 437, 443 (2d Cir. 2015). Accordingly, we "may find a claim preempted only if the facts alleged in the complaint do not plausibly give rise to a claim that is not preempted." Id. at 444. B. Applicable Preemption Law The Supremacy Clause provides that "the Laws of the United States . . . shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. Consequently, federal legislation may preempt state law. Galper, 802 F.3d at 443. Federal regulations, like federal statutes, can also preempt state law if validly promulgated and falling within the scope of the agency's congressionally delegated authority. Hillsborough County v. Automated Med. Lab'ys, Inc., 471 U.S. 8 Preemption -- although an affirmative defense -- can support a motion to dismiss if the "barrier to suit is evident from the face of the complaint." Glover v. Bausch & Lomb Inc., 6 F.4th 229, 236 n.3 (2d Cir. 2021) (quoting Ricci v. Teamsters Union Loc. 456, 781 F.3d 25, 28 (2d Cir. 2015)). - 23 - 707, 713 (1985); New York v. F.E.R.C., 535 U.S. 1, 18 (2002). Here, the FDCA authorizes the FDA to promulgate regulations, including labeling requirements, that govern OTC drugs; these regulations therefore fall within the scope of the FDA's authority and have preemptive effect. 21 U.S.C. § 393(b)(2)(B); id. § 355h(a)(1)(A). 9 Congress may preempt state law either expressly, through a statute's text, or impliedly, "through [a statute's] structure and purpose." Altria Grp., Inc. v. Good, 555 U.S. 70, 76 (2008). When a federal law contains an express preemption clause -- as here -- "we focus on the plain wording of the clause, which necessarily contains the best evidence of Congress' preemptive intent." 9 To the extent Consumer Plaintiffs contend that Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024), upends this rule by overturning Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), and ending the era of Chevron deference, that argument fails. Following Loper Bright, courts reviewing agency action must "exercise their independent judgment in" interpreting statutes and in "deciding whether an agency has acted within its statutory authority." 603 U.S. at 412 (emphasis added). A statute may nevertheless still authorize an agency to "give meaning to a particular statutory term," id. at 394, and to "prescribe rules to 'fill up the details' of a statutory scheme" through regulation, id. at 395 (quoting Wayman v. Southard, 10 Wheat. 1, 43 (1825)). Thus, Loper Bright does not subvert agencies' authority to promulgate preemptive regulations pursuant to the authority vested in them by statute -- authority the FDCA vests in the FDA here. Indeed, the Supreme Court has given preemptive effect to federal regulations since before Chevron. See, e.g., Fidelity Fed. Savs. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153-54 (1982); United States v. Shimer, 367 U.S. 374, 381- 83 (1961). - 24 - Chamber of Com. of U.S. v. Whiting, 563 U.S. 582, 594 (2011) (internal quotation marks omitted). In other words, when an express preemption clause exists, the plain text of the statute begins and ends our analysis, and courts should not invoke the presumption against preemption. Puerto Rico v. Franklin Cal. Tax-free Tr., 579 U.S. 115, 125 (2016); DCC Propane, 147 F.4th at 174. But cf. Good, 555 U.S. at 77 (noting that when "the text of a pre-emption clause is susceptible of more than one plausible reading," courts typically accept the interpretation disfavoring pre-emption). The mere existence of an express preemption clause, however, "does not immediately end the inquiry"; the court must interpret the clause to determine "the substance and scope of Congress' displacement of state law." Good, 555 U.S. at 76 (emphasis added). "Our inquiry into the scope of a statute's pre-emptive effect is guided by the rule that '"[t]he purpose of Congress is the ultimate touchstone" in every pre-emption case.'" Id. (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)). To determine Congress's preemptive intent, we "begin . . . with the text of the provision in question, and move on, as need be, to the structure and purpose of the Act." N.Y. State Conf. of Blue Cross & Blue Shield Plans v. Travelers Ins. Co., 514 U.S. 645, 655 (1995). - 25 -  C. Section 379r Expressly Preempts Consumer Plaintiffs' State Law Claims As explained above, the FDCA expressly preempts state law claims seeking to enforce state law duties "different from or in addition to, or . . . otherwise not identical with," requirements under federal law. 21 U.S.C. § 379r(a)(2). Accordingly, to decide whether the FDCA expressly preempts Consumer Plaintiffs' state law claims, we must answer two questions. First, we must determine whether the federal government has instituted requirements applicable to the oral PE nasal decongestants at issue. Looking to the FDA's monograph and NDA requirements, we easily answer this first question in the affirmative. Second, we must resolve whether the Consumer Plaintiffs' state law claims are premised on state law requirements "different from or in addition to, or . . . otherwise not identical with" those federal requirements. Id. In other words, we ask if successful state law claims here would hold Defendant Manufacturers liable for labeling (or advertising) approved by the FDCA through the monograph or NDA process. This second question is the subject of our analysis below. Ultimately, we conclude that the answer to this question is also yes, except as to two sets of claims. - 26 -  We therefore hold that the FDCA expressly preempts Consumer Plaintiffs' claims except as to the "Maximum Strength" claims and as to the claims concerning brand-name NDA drugs. To reach this conclusion, we first analyze the FDCA's express preemption of state law claims regarding oral PE drugs regulated through the monograph process -- including (a) Consumer Plaintiffs' labeling claims, (b) their failure-to-disclose marketing and advertising claims, and (c) their "Maximum Strength" claims. Second, we briefly discuss the FDCA's preemption of state law claims regarding oral PE drugs regulated through the NDA process. 1. Monograph Drugs The crux of Consumer Plaintiffs' state law claims is that Defendant Manufacturers misled them by labeling, advertising, and marketing oral PE products as effective for nasal decongestion, thus deceiving Consumer Plaintiffs into purchasing products they would not have bought had they known the truth about oral PE's inefficacy. 10 Consumer Plaintiffs bring three main buckets of state law claims. 10 Specifically, Consumer Plaintiffs challenge the "Indications" section of the products' labels, which states that the products decongest. They do not challenge the "Statement of Identity" section, which identifies the products as decongestants. - 27 -  First, Consumer Plaintiffs contend that Defendant Manufacturers misbranded their drugs by adhering to the nasal decongestant