©2014. Published in Landslide, Vol. 7, No. 1, September/October 2014, by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association or the copyright holder.
Federal false advertising lawsuits have increasingly required courts to address the relationship between the Lanham Act and the administration by the Food and Drug Administration (FDA) of the federal Food, Drug, and Cosmetic Act (FDCA).1 In POM Wonderful LLC v. Coca-Cola Co.,2 the Supreme Court clarified that relationship in the context of FDA regulations governing food and beverage labels. In doing so, it held that compliance with those regulations does not immunize the content of labels from false advertising challenges under § 43(a) of the Lanham Act.3
This article examines the interplay between § 43(a) and the FDCA, as well as the significance of the Supreme Court’s decision to interpretations of those statutes. The article begins by examining the myriad ways in which courts historically have addressed claims of false advertising related to products falling within the scope of the FDCA. It then addresses the three substantive opinions to emerge from the litigation in POM Wonderful. It concludes that the ultimate outcome in that litigation promises to lead to increased challenges to federally regulated labels on a going-forward basis, including those for products other than the juice at issue in POM Wonderful.
Pre-POM Wonderful Judicial Treatment of the Lanham Act—FDCA Intersection
Because the extent to which the FDCA preempts state-law challenges to allegedly false advertising occurring within industries covered by that statute is not always readily apparent,4 plaintiffs wishing to bring claims against participants in those industries typically rely in whole or in part on § 43(a). On its face, the language of § 43(a) at issue in POM Wonderful is simple: It recognizes a private cause of action against “any person” who, “in commercial advertising or promotion, misrepresents the nature, characteristics, qualities, or geographic origin of his or her or another person’s goods, services, or commercial activities.”5 In contrast, the FDCA and its implementing regulations create a complex framework of circumstances under which either the FDA or industry participants within its jurisdiction are obligated either to take or to refrain from taking particular actions. Some of those circumstances relate to the issue of whether a food or beverage product is “misbranded,” or, in other words, whether “its labeling is false or misleading in any particular.”6
The FDCA does not authorize a private cause of action for the enforcement of its provisions, including those relating to alleged misbranding.7 As a consequence, some plaintiffs have turned to § 43(a) for redress against allegedly false advertising implicating the FDCA, but invocations of that statute have produced a rather Balkanized body of case law that varies from product to product. In particular, the broad range of the FDA’s possible regulatory activity—or inactivity—in particular scenarios precludes a unified doctrinal rule governing the disposition of federal false advertising claims bearing on matters within the FDCA’s scope.
For example, many plaintiffs advancing § 43(a) claims against defendants in industries covered by the FDCA have not fared well.8 In one case appealed to the Seventh Circuit, the district court had dismissed a § 43(a) challenge to allegedly false claims on labels for the defendants’ oral laxative products that those products were available by prescription only.9 Unfortunately for the plaintiff, the FDA was conducting a parallel proceeding to determine whether the defendants’ products were misbranded under the FDCA. This led the Seventh Circuit to conclude that the plaintiff’s complaint properly had been dismissed without prejudice pending the disposition of the FDA’s misbranding inquiry. As it explained, “findings by the FDA in the misbranding proceeding may cast the issue of consumer confusion in a different light.”10
In an appeal involving the licensure of medical devices, PhotoMedex, Inc. v. Irwin,11 the Ninth Circuit also concluded that the FDCA can, under certain circumstances, trump § 43(a)’s prohibitions against false advertising. The parties in that litigation were competitors in the market for dermatological lasers, instruments considered to be “Class II” devices under the FDCA. The significance of that designation was that, if “substantially equivalent” to preexisting devices with FDA clearance, Class II devices could be marketed “without further regulatory analysis.”12 At the same time, FDA guidelines placed responsibility for determining whether substantial equivalency existed on the manufacturer of the second device.13 The defendants concluded that their laser was indeed substantially equivalent to a prior-licensed laser produced by a third party. The plaintiff disagreed and filed suit alleging that the defendants’ description of their laser as FDA-approved constituted false advertising.
Because the plaintiff previously had taken its concerns to the FDA, and because the agency had declined to act, the Ninth Circuit affirmed the district court’s entry of summary judgment in the defendants’ favor. Citing to § 337(a) of the FDCA, which provides that “all . . . proceedings for the enforcement, or to restrain violations, of this [Act] shall be by and in the name of the United States,”14 the appellate court held:
The FDCA explicitly says that enforcement power is reserved to the federal government. To permit [the plaintiff] to proceed with a claim that Defendants violated this law when the FDA did not so determine would, in effect, permit [the plaintiff] to assume enforcement power which the statute does not allow and require the finder of fact to make a decision that the FDA itself did not make.15
Although the court made clear that there might be some circumstances under which a cause of action would lie for the false advertisement of products regulated by the FDCA,16 no such circumstances existed in the case before it.
Some district court opinions have reached similar conclusions in different contexts. For example, in another case leading to a defense victory, the parties were competing manufacturers of prenatal vitamins not subject to FDA approval that objected to each other’s marketing practices.17 One theory asserted by the counterclaim plaintiff was that the counterclaim defendant improperly had advertised its products as the generic versions of the counterclaim plaintiff’s goods, notwithstanding the counterclaim defendant’s failure to establish for the FDA that its products were bioequivalent to those of the counterclaim plaintiff. Nevertheless, the court noted that “[t]he FDA has not required either parties’ [sic] drugs to obtain FDA approval. Thus, neither party has tested, nor were they required to test their drugs for bioequivalence and therapeutic equivalence.”18 The court therefore dismissed that aspect of the counterclaims as an improper attempt to enforce the FDCA through a Lanham Act private cause of action: “[T]his type of claim is better left to the FDA who has the expertise in enforcing and interpreting its own complicated regulations. This is especially true in this case where the FDA has not even required prenatal vitamins to meet any standards.”19
Consistent with the Ninth Circuit’s opinion in PhotoMedex, however, some courts have held that the FDCA does not bar all § 43(a) false advertising claims bearing on the food, drug, or cosmetic industries,20 especially if those claims do not overlap with the subject matter of an active FDA investigation. One example of this phenomenon came in an action brought by a manufacturer of children’s medicines against a manufacturer of competitive products that allegedly could be substituted for those of the plaintiff.21 As framed by the parties’ cross-motions for summary judgment, a key issue in the case was whether the FDCA precluded a federal false advertising cause of action, especially as the parties’ products did not require either new drug applications or abbreviated new drug applications and therefore were not listed in the Orange Book, a standard reference for the identification of bioequivalent preparations.22 Under these circumstances, the court held that a Lanham Act claim was not precluded.23
Similar conduct by the same lead defendant produced another treatment of the same issue in a different case.24 Once again, no product at issue was listed in the Orange Book and there was “no record of the FDA evaluating the two products for pharmaceutical equivalence.”25 Under these circumstances, the court declined to hold that the FDCA precluded the plaintiffs from challenging the defendants’ claims they were marketing generic but equivalent versions of the plaintiffs’ products. As the court explained, “In the absence of any FDA ruling or ongoing investigation, there is little chance that the court will usurp the role of the FDA.”26
Finally, some pre-Wonderful § 43(a)-based attacks on fruit juice labels succeeded, at least at the pleadings stage, notwithstanding FDA regulations governing the informational content of those labels.27 For example, in an earlier false advertising action brought by POM Wonderful against a different competitor,28 the court proved unreceptive to a motion to dismiss for failure to state a claim grounded in the allegedly preclusive effect of the following regulation:
(c) If a diluted multiple-juice beverage or blend of single-strength juices contains a juice that is named or implied on the label or labeling other than in the ingredient statement (represented juice), and also contains a juice other than the named or implied juice (nonrepresented juice), then the common or usual name for the product shall indicate that the represented juice is not the only juice present (e.g., “Apple blend; apple juice in a blend of two other fruit juices.”)
(d) In a diluted multiple-juice beverage or blend of single-strength juices where one or more, but not all, of the juices are named on the label other than in the ingredient statement, and where the named juice is not the predominant juice, the common or usual name for the product shall:
(1) Indicate that the named juice is present as a flavor or flavoring (e.g., “Raspcranberry”; raspberry and cranberry flavored juice drink); or
(2) Include the amount of the named juice, declared in a 5-percent range (e.g., Raspcranberry; raspberry and cranberry juice beverage, 10 – to 15-percent cranberry juice and 3 – to 8-percent raspberry juice). The 5-percent range, when used, shall be declared in the manner set forth in [21 C.F.R.] § 102.5(b)(2).29
According to the court, “the key issue in the line of cases dealing with [FDCA] or FDA regulation preclusion of Lanham Act claims is whether the false advertising involves a fact that can be ‘easily verified,’ without requiring the truth of the fact to be determined by the FDA.”30 The court determined that such a fact was at issue, namely, whether the defendant had falsely advertised a beverage composed almost entirely of apple and grape juice as one containing cranberry and pomegranate juice. The court noted that “it is theoretically possible to create a scenario where a court decision regarding Defendant’s product label may conflict directly with FDA regulations; but on its face Plaintiff’s complaint does not contest or attempt to enforce the [FDCA] or FDA regulation requirements.”31 It therefore denied the motion to dismiss, holding that “[t]o the degree that Plaintiff’s claims may cause actual conflict with federal regulations, the Court declines to limit the scope of Plaintiff’s allegations at [the pleading] stage, without a better developed factual record and construing Plaintiff’s complaint in the light most favorable to it.”32
POM Wonderful v. Coca-Cola
The alleged false advertising at issue in the litigation reviewed by the Supreme Court was the Coca-Cola Company’s promotion of a “Pomegranate Blueberry Flavored Blend of 5 Juices,” of which only 0.3 percent consisted of pomegranate juice and only 0.2 percent consisted of blueberry juice. Challenging the accuracy of the “pomegranate” reference on Coca-Cola’s label, which was accompanied by a prominent pomegranate design, POM Wonderful brought suit on the theory that the label’s contents were actionable false advertising under § 43(a).33 The district court credited Coca-Cola’s argument that the company’s label complied with the FDA regulation quoted above. It then held:
The FDA has directly spoken on the issues that form the basis of Pom’s Lanham Act claim against the naming and labeling of the Juice, and has therefore, reached a conclusion as to what is permissible. Indeed, the FDA has spoken on several occasions, and each time, it has concluded that manufacturers of multiple-juice beverages may identify their beverages with a non-primary, characteristic juice, as Coca-Cola does here. The rules promulgated by the FDA are intended to protect the public from unsafe or mislabeled products by setting forth federal labeling requirements, and with which the Juice’s naming and labeling comply.34
Without addressing a point later held to be significant by the Supreme Court, namely, that the regulations did not require the FDA’s preapproval of the label, not to mention that the FDA often does little on its own initiative to enforce misbranding regulations in the food and beverage context,35 the district court therefore entered summary judgment in Coca-Cola’s favor.
The Ninth Circuit affirmed.36 The appellate court set forth its understanding of the doctrinal rules in the area in the following observation:
[C]ourts have agreed that the FDCA limits claims under the Lanham Act. A plaintiff may not, for example, sue under the Lanham Act to enforce the FDCA or its regulations because allowing such a suit would undermine Congress’s decision to limit enforcement of the FDCA to the federal government. Nor may a plaintiff maintain a Lanham Act claim that would require a court originally to interpret ambiguous FDA regulations, because rendering such an interpretation would usurp the FDA’s interpretive authority.
Where the FDA has not concluded that particular conduct violates the FDCA, . . . a Lanham Act claim may not be pursued if the claim would require litigating whether that conduct violates the FDCA.37
The Ninth Circuit concluded that POM Wonderful’s Lanham Act claims fell afoul of these principles. Noting that “FDA regulations authorize the name Coca-Cola has chosen,” the court held that “Pom’s challenge to the name ‘Pomegranate Blueberry Flavored Blend of 5 Juices’ would create a conflict with FDA regulations and would require us to undermine the FDA’s apparent determination that so naming the product is not misleading.”38 The same result transpired with respect to POM Wonderful’s claims that the words “pomegranate” and “blueberry” were inappropriately emphasized on Coca-Cola’s label: “If the FDA believes that more should be done to prevent deception, or that Coca-Cola’s label misleads consumers, it can act. But, . . . for a court to act when the FDA has not—despite regulating extensively in this area—would risk undercutting the FDA’s expert judgments and authority.”39
After granting POM Wonderful’s petition for a writ of certiorari, the Supreme Court reversed.40 The Court summarized its holding in the following manner:
The ruling that POM’s Lanham Act cause of action is precluded by the FDCA was incorrect. There is no statutory text or established interpretive principle to support the contention that the FDCA precludes Lanham Act suits like the one brought by POM in this case. Nothing in the text, history, or structure of the FDCA or the Lanham Act shows the congressional purpose or design to forbid these suits. Quite to the contrary, the FDCA and the Lanham Act complement each other in the federal regulation of misleading food and beverage labels. Competitors, in their own interest, may bring Lanham Act claims like POM’s that challenge food and beverage labels that are regulated by the FDCA.41
Elaborating on its statutory text point, the Court noted that “neither the Lanham Act nor the FDCA, in express terms, forbids or limits Lanham Act claims challenging labels that are regulated by the FDCA.”42 For one thing, § 43(a)’s “comprehensive imposition of liability [for false advertising] extends, by its own terms, to misrepresentations on labels, including food and beverage labels. No other provision in the Lanham Act limits that understanding or purports to govern the relevant interaction between the Lanham Act and the FDCA.”43 And, for another, “the FDCA, by its terms, does not preclude Lanham Act suits. In consequence, food and beverage labels regulated by the FDCA are not, under the terms of either statute, off limits to Lanham Act claims.”44
Moving beyond the statutes’ express texts, the Court also was swayed by congressional inaction during the nearly seven decades in which the Lanham Act and the FDCA had coexisted. On that issue, the Court explained that “[i]f Congress had concluded, in light of experience, that Lanham Act suits could interfere with the FDCA, it might well have enacted a provision addressing the issue during these 70 years.”45 According to the Court, this failure to enact “a provision addressing the preclusion of other federal laws that might bear on food and beverage labeling” was “‘powerful evidence that Congress did not intend FDA oversight to be the exclusive means’ of ensuring proper food and beverage labeling.”46
The Court also considered it significant that “[w]hen two statutes complement each other, it would show disregard for the congressional design to hold that Congress nonetheless intended one federal statute to preclude the operation of the other.”47 Addressing the particular statutes before it, the Court then determined that “[t]he Lanham Act and the FDCA complement each other in major respects, for each has its own scope and purpose. Although both statutes touch on food and beverage labeling, the Lanham Act protects commercial interests against unfair competition, while the FDCA protects public health and safety.”48 Moreover:
The two statutes complement each other with respect to remedies in a more fundamental respect. Enforcement of the FDCA and the detailed prescriptions of its implementing regulations is largely committed to the FDA. The FDA, however, does not have the same perspective or expertise in assessing market dynamics that day-to-day competitors possess. Competitors who manufacture or distribute products have detailed knowledge regarding how consumers rely upon certain sales and marketing strategies. Their awareness of unfair competition practices may be far more immediate and accurate than that of agency rulemakers and regulators. Lanham Act suits draw upon this market expertise by empowering private parties to sue competitors to protect their interests on a case-by-case basis. . . . Allowing Lanham Act suits takes advantage of synergies among multiple methods of regulation. This is quite consistent with the congressional design to enact two different statutes, each with its own mechanisms to enhance the protection of competitors and consumers.49
Those differing mechanisms were particularly appropriate, the Court suggested, because “[u]nlike other types of labels regulated by the FDA, such as drug labels, it would appear the FDA does not preapprove food and beverage labels under its regulations and instead relies on enforcement actions, warning letters, and other measures.”50 From this, the Court concluded, “It is unlikely that Congress intended the FDCA’s protection of health and safety to result in less policing of misleading food and beverage labels than in competitive markets for other products.”51
Finally, the Court rejected a series of arguments advanced by either Coca-Cola or the solicitor general in support of the Ninth Circuit’s dismissal of POM Wonderful’s false advertising cause of action. Allowing a § 43(a) challenge to Coca-Cola’s labels would not jeopardize national uniformity in labeling, the Court held, because “[t]he centralization of FDCA enforcement authority in the Federal Government does not indicate that Congress intended to foreclose private enforcement of other federal statutes.”52 Such a challenge also would not undermine the FDCA’s preemption of state-law causes of action, because “the pre-emption provision by its plain terms applies only to certain state-law requirements, not to federal law.”53 The argument that “the FDCA, and particularly its implementing regulations, addresses food and beverage labeling with much more specificity than is found in the provisions of the Lanham Act” was similarly without merit on the ground that “this greater specificity would matter only if the Lanham Act and the FDCA cannot be implemented in full at the same time.”54 And the theory that “the FDCA and its regulations are at least in some circumstances a ceiling on the regulation of food and beverage labeling” could not withstand scrutiny because, to reiterate, “Congress intended the Lanham Act and the FDCA to complement each other with respect to food and beverage labeling.”55
On a going-forward basis, the most likely effect of the Court’s opinion will be an increase in the number of federal false advertising challenges to conduct regulated by the FDA. Nevertheless, in light of the Court’s numerous express references to “food and beverage labels,” the decision’s significance to § 43(a) claims bearing on products falling within the FDCA’s scope other than foods and beverages is less certain. This is especially true for products such as prescription pharmaceuticals and medical devices, as to which the FDA’s regulatory activities are far more aggressive than the mere promulgation of regulations that, in an environment of budgetary constraints, often leave compliance up to industry participants themselves. So too is it an open question whether POM Wonderful will influence the availability of § 43(a) in other industries in which product labels are subject to similar or more stringent federal scrutiny.56 The long-term implications of the Court’s holding therefore remain to be seen.
1. Pub. L. No. 75-717, §§ 1–902, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301–97 (2012)).
2. 134 S. Ct. 2228 (2014).
3. 15 U.S.C. § 1125(a) (2012).
4. The FDCA contains a limited preemption measure relevant to the subject matter of the POM Wonderful litigation. See 21 U.S.C. § 343-1(a)(2) (2012) (preempting state laws conflicting with federal requirements governing the identification of: (1) the name and location of the manufacturer, as well as the weight or quantity of food contained in a package; and (2) the percentage of fruit or vegetable juice contained in a beverage). Not all courts, however, have given it an expansive effect. See, e.g., Holk v. Snapple Beverage Corp., 575 F.3d 329, 339 (3d Cir. 2009) (“[N]ot only do we lack a ‘clear and manifest’ statement from Congress of its intent to preempt, but we also note that the claims in this case are governed by the presumption against preemption. These factors, along with the Supreme Court’s direction that we should not infer field preemption from the comprehensiveness of a regulatory scheme alone, lead us to conclude that neither Congress nor the FDA intended to occupy the fields of food and beverage labeling and juice products.”); Chavez v. Blue Sky Natural Beverage Co., 268 F.R.D. 365, 372 (N.D. Cal. 2010) (“Although [the FDCA] and the regulations promulgated by the FDA may raise an inference that federal law preempts individual state laws governing food labeling, defendants have not met their burden to demonstrate ‘clear and manifest’ intent by Congress to occupy the entire field of food labeling so as to preempt state consumer protection laws which are traditionally within the realm of state police power.”).
5. 15 U.S.C. § 1125(a)(1)(B).
6. 21 U.S.C. § 343(a)(1).
7. See generally Pac. Trading Co. v. Wilson & Co., 547 F.2d 367, 368, 370–71 (7th Cir. 1976).
8. See, e.g., Mylan Labs. Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993) (dismissing federal false advertising claim on ground that “[w]e agree with the defendants that permitting [the plaintiff] to proceed on the theory that the defendants violated § 43(a) merely by placing their drugs on the market would, in effect, permit [the plaintiff] to use the Lanham Act as a vehicle by which to enforce the Food, Drug, and Cosmetic Act (“FDCA”) and the regulations promulgated thereunder.”); Sandoz Pharm. Corp. v. Richardson–Vicks, Inc., 902 F.2d 222, 230-31 (3d Cir. 1990) (affirming denial of motion for preliminary injunction against allegedly false representation that children’s cough syrup “starts to work the instant it is swallowed” on ground that FDA had not had opportunity to classify ingredient in syrup as either active or inactive).
9. Schering-Plough Healthcare Prods., Inc. v. Schwarz Pharma, Inc., 586 F.3d 500 (7th Cir. 2009).
10. Id. at 513.
11. 601 F.3d 919 (9th Cir. 2010).
12. Medtronic, Inc. v. Lohr, 518 U.S. 470, 478 (1996).
13. See Food & Drug Admin., Deciding When to Submit a 510(k) for a Change to an Existing Device, 1997 WL 33793777 (Jan. 10, 1997).
14. 21 U.S.C. § 337(a) (2012).
15. PhotoMedex, 601 F.3d at 930.
16. As the court explained:
[W]e do not suggest that the Lanham Act can never support private party claims involving FDA approval or clearance of drugs or medical devices. That is not the case. If, for example, it was clear that an affirmative statement of approval by the FDA was required before a given product could be marketed and that no such FDA approval had been granted, a Lanham Act claim could be pursued for injuries suffered by a competitor as a result of a false assertion that approval had been granted. But this case does not fit that pattern.
Id. at 924–25.
17. Ethex Corp. v. First Horizon Pharm. Corp., 228 F. Supp. 2d 1048 (E.D. Mo. 2002).
18. Id. at 1055.
20. See, e.g., Mutual Pharm. Co. v. Ivax Pharm., Inc., 459 F. Supp. 2d 925, 935 (C.D. Cal. 2006) (“So long as courts are not required to perform authoritative interpretation and direct application of FDA regulations, then the simple fact that a matter touches upon an area dealt with by the FDA is not a bar to proceeding with a claim under the Lanham Act.” (citation omitted) (internal quotations marks omitted)).
21. See Pediamed Pharm., Inc. v. Breckenridge Pharm., Inc., 419 F. Supp. 2d 715 (D. Md. 2006).
22. See Food & Drug Admin., Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (33d ed. 2013).
23. Pediamed Pharm., 419 F. Supp. 2d at 724–25. In contrast, however, the court also held that the defendants’ unclean hands argument, which was based in the theory that the plaintiff had marketed its product without the required FDA approval, did merit deference to the FDA. Id. at 726–27.
24. See Schwarz Pharma, Inc. v. Breckenridge Pharm., Inc., 388 F. Supp. 2d 967 (E.D. Wis. 2005).
25. Id. at 975.
27. See, e.g., Grove Fresh Distribs., Inc. v. Flavor Fresh Foods, Inc., 720 F. Supp. 714, 715–16 (N.D. Ill. 1989) (declining to dismiss at pleadings stage Lanham Act false advertising cause of action challenging defendant’s use of “100% orange juice from concentrate,” notwithstanding FDA definition of phrase).
28. Pom Wonderful LLC v. Ocean Spray Cranberries, Inc., 642 F. Supp. 2d 1112 (C.D. Cal. 2009).
29. 21 C.F.R. § 102.33(c)–(d) (2008).
30. Ocean Spray, 642 F. Supp. 2d at 1118 (quoting Mut. Pharm. Co. v. Ivax Pharm., Inc., 459 F. Supp. 2d 925, 934–35 (C.D. Cal. 2006)).
31. Id. at 1120.
33. POM Wonderful LLC v. Coca-Cola Co., 727 F. Supp. 2d 849 (C.D. Cal. 2010), aff’d, 679 F.3d 1170 (9th Cir. 2012), rev’d, 134 S. Ct. 2228 (2014).
34. Id. at 871 (citations omitted).
35. As one commentator has noted:
The FDA does not have the resources to sufficiently address the current state of labeling, nor is there funding allocated to feasibly increase its enforcement power. Due to competing interests and First Amendment concerns, the FDA has not utilized what little authority it does have to adequately address food misbranding or revise current regulations on permissible claims. Thus the FDA’s current system of enforcement is essentially based on voluntary compliance. The agency issues a Warning Letter to put a company on notice that it violated a regulation; this is typically the extent of its enforcement activity.
Jennifer L. Pomeranz, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels, 39 Am. J.L. & Med. 617, 619 (2013) (footnote omitted).
36. POM Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012), rev’d, 134 S. Ct. 2228 (2014).
37. Id. at 1175–76 (citations omitted).
38. Id. at 1176–77.
39. Id. at 1177.
40. POM Wonderful LLC v. Coca-Cola Co., 134 S. Ct. 2228 (2014).
41. Id. at 2233.
42. Id. at 2237.
46. Id. (quoting Wyeth v. Levine, 555 U. S. 555, 575 (2009)).
47. Id. at 2238.
49. Id. at 2238-39.
50. Id. at 2239 (citation omitted).
54. Id. at 2240.
56. For example, alcoholic beverage labels must be preapproved by the Alcohol and Tobacco Tax and Trade Bureau before being introduced into the marketplace, see 27 U.S.C. § 205(e) (2012); similarly, labels for pesticides and related products must be registered with the Environmental Protection Agency. See 7 U.S.C. § 136a (2012).