Citations
- 315 F. Supp. 3d 143
Full opinion text
Amit P. Mehta, United States District Judge
I. INTRODUCTION
On May 10, 2016, the U.S. Food and Drug Administration ("FDA") published a final rule "deeming" cigars, pipe tobacco, and certain other products (e.g., e-cigarettes) subject to the federal Food, Drug, and Cosmetic Act ("FD & C Act"), 21 U.S.C. §§ 301, et seq. , as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 ("TCA"). Known as the "Deeming Rule," the FDA's action subjects these newly "deemed" products to comparable statutory and regulatory requirements already imposed on cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. At the same time, the FDA promulgated a separate rule, referred to as the "User Fee Rule," which assesses "user fees" on manufacturers and importers of cigars and pipe tobacco, but not other newly deemed products, like e-cigarettes. The FDA is statutorily authorized to collect user fees for the purpose of funding the FDA's regulation of tobacco products under the FD & C Act and the TCA.
Plaintiffs in this case are three non-profit associations that represent cigar manufacturers, importers, distributors, suppliers, and consumers, as well as premium cigar and tobacco retail shops. They brought this action in July 2016 against the FDA and its Commissioner, and the U.S. Department of Health and Human Services ("HHS") and its Secretary (collectively, "Defendants"), challenging the Deeming Rule and the User Fee Rule on a host of grounds. For reasons explained later in this opinion, not all of Plaintiffs' challenges to the Rules are presently before the court. Instead, the court addresses only the following subset of challenges: (1) the imposition of health warning requirements for cigar packaging and advertisements; (2) the assessment of user fees on cigar and pipe tobacco products, but not on another newly deemed product, e-cigarettes; (3) the treatment of retailers who blend pipe tobacco in-store as "manufacturers" subject to the regulatory requirements of 21 U.S.C. § 387e ; and (4) the classification of pipes as "components" of tobacco products, thereby subjecting pipe makers to regulation. Plaintiffs also have moved to preliminarily enjoin implementation and enforcement of the Deeming Rule's health warning requirements.
For the reasons set forth below, the court grants in part and denies in part the parties' cross-motions for partial summary judgment and denies Plaintiffs' motion for a preliminary injunction as moot. The Deeming Rule's health warning requirements are upheld in all respects, as is the User Fee Rule in its entirety. The court also affirms the agency's classification of pipes as "components or parts" of tobacco products under the TCA. The court, however, concludes that Defendants' rationale for subjecting retailers who blend pipe tobacco in-store to the requirements of 21 U.S.C. § 387e is arbitrary and capricious and therefore remands that issue to the FDA for further consideration.
II. BACKGROUND
A. Statutory Background
In 2009, Congress enacted the TCA to "provide authority to the [FDA] to regulate tobacco products under the [FD & C Act] by recognizing it as the primary Federal regulatory authority with respect to the manufacture, marketing, and distribution of tobacco products," and "to authorize the [FDA] to set national standards controlling the manufacture of tobacco products and the identity, public disclosure, and amount of ingredients used in such products," among other purposes. Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111-31, § 3, 123 Stat. 1776, 1781-82 (2009). Congress made 49 legislative findings in the Act, in which it acknowledged the "inherent dangerous[ness]" of tobacco products and nicotine and the strong public interest in regulating tobacco products and their advertising and promotion, and discussed Congress's interest in reducing youth tobacco use, in light of judicial findings that major U.S. tobacco companies specifically targeted and marketed their products to youth. TCA § 2. Congress further recognized that no other federal agency except the FDA "possesses the scientific expertise needed to implement effectively all provisions of the [TCA]." TCA § 2(45).
In light of those findings, the TCA authorized the Secretary of Health and Human Services to regulate the manufacture, distribution, and marketing of tobacco products. TCA § 901, codified at 21 U.S.C. § 387a (entitled "FDA authority over tobacco products"). The legislation immediately subjected "all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco" to a panoply of statutory and regulatory requirements, and also reserved future application of the TCA to "any other tobacco products that the Secretary [of Health and Human Services] by regulation deems to be subject to this chapter." 21 U.S.C. § 387a(b) (emphasis added). Congress defined "tobacco product" to mean "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)." 21 U.S.C. § 321(rr)(1). The FDA's decision in 2016 to "deem" cigars and pipe tobacco as "tobacco products," and thus subject them to regulation, gave rise to this litigation.
B. Regulatory Background
1. The Cigar Product
Federal regulations define "cigar" to mean any "roll of tobacco that is wrapped in leaf tobacco or any substance containing tobacco" that is "not a cigarette." 21 C.F.R. § 1143.1. There are three major categories of cigar products: (1) little cigars, (2) cigarillos, and (3) traditional cigars. See Defs.' Cross-Mot. for Partial Summ. J. & Mem. in Support, ECF No. 74 [hereinafter Defs.' Cross-Mot.], at 6-7. Little cigars resemble cigarettes in size and tobacco content and thus "are positioned as cheaper substitutes for cigarettes." See id. at 7. Cigarillos are a shorter, slimmer version of traditional cigars and, generally speaking, contain between 3 and 10 pounds of tobacco per thousand units. See id. at 8. Traditional cigars are the largest cigar product, varying in length and diameter. See id. While little cigars and cigarillos are machine-rolled, traditional cigars may be either machine-rolled or hand-rolled. See id.
Within the category of traditional cigars are a sub-category known as "premium cigars." See id. Premium cigars typically are hand-rolled, made with a higher-grade tobacco, or are more expensive. See id. The term "premium cigar" is not, however, defined by federal statute or regulation. See id.
2. The Existing FTC Health Warning Statements Regime
Long before the FDA's action in 2016, cigar products already were subject to some federal regulation. More than a decade earlier, in 2000, in settlements with the Federal Trade Commission ("FTC"), the seven largest U.S. cigar companies agreed to include warnings about significant adverse health risks on their packaging and advertisements. See, e.g. , Decision & Order, In the Matter of Swedish Match N. Am., Inc. , Docket No. C-3970, 2000 WL 1207446 (F.T.C. Aug. 18 2000). The FTC settlements represented the first national requirements for health warnings on cigar products and applied to approximately 95 percent of the U.S. cigar market at the time. See Press Release, FTC, Nationwide Labeling Rules for Cigar Packaging and Ads Take Effect Today (Feb. 13, 2001), https://www.ftc.gov/news-events/press-releases/2001/02/nationwide-labeling-rules-cigar-packaging-and-ads-take-effect.
Pursuant to the consent orders, which remain in effect today, the covered cigar companies must display one of the five following health warning statements "clearly and conspicuously" on their advertising and packaging:
SURGEON GENERAL WARNING: Cigar Smoking Can Cause Cancers Of The Mouth And Throat, Even If You Do Not Inhale.
SURGEON GENERAL WARNING: Cigar Smoking Can Cause Lung Cancer And Heart Disease.
SURGEON GENERAL WARNING: Tobacco Use Increases The Risk Of Infertility, Stillbirth And Low Birth Weight.
SURGEON GENERAL WARNING: Cigars Are Not A Safe Alternative To Cigarettes.
SURGEON GENERAL WARNING: Tobacco Smoke Increases The Risk Of Lung Cancer And Heart Disease, Even In Nonsmokers.
See Decision & Order, In the Matter of Swedish Match N. Am., Inc. , 2000 WL 1207446, at *3. The FTC consent orders specify the size and formatting of the health warnings, and require that they appear on the principal display panel on cigar packages and be rotated at random on a 12-month basis. See id. at *4-7, *10-12.
Additionally, the FTC consent orders require the health warnings to appear on visual advertisements in a set-off, rectangular box to ensure that the warnings are readily visible and conspicuous. Id. at *5-8. For audio advertisements, the health warning statement must be delivered so that an ordinary consumer can hear and comprehend it. Id. at *8-9. Cigar companies also were required to submit for FTC approval, in advance of the consent orders' effective date, a plan for the rotation and display of the health warnings on cigar packages and advertisements. Id. at *11-12.
3. FDA Rules
a. The Deeming Rule
i. Proposed Rule
In the years following Congress's enactment of the TCA, cigar products were free from FDA regulation because cigars were not expressly listed in the Act's definition of "tobacco product." A harbinger of change arrived in the spring of 2014. On April 25, 2014, the FDA issued a Proposed Rule that would make, or "deem," cigars, pipe tobacco, and e-cigarettes subject to the TCA. See Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products , 79 Fed. Reg. 23,142 (Apr. 25, 2014) ("Proposed Deeming Rule"). In the Proposed Deeming Rule, the FDA announced for consideration two options which "would provide two alternatives for the scope of the deeming provisions and, consequently, the application of the additional specific provisions." Id. at 23,143. Under Option 1, the FDA would deem all products meeting the statutory definition of "tobacco product"-including cigars and pipe tobacco-except accessories of deemed products to be subject to the TCA. Id. Under Option 2, the FDA would deem "only a subset of cigars" and "exclude from the scope of [the] proposed rule certain cigars that we refer to as 'premium cigars.' " Id. To effectuate this carve-out, Option 2 proposed a definition for "covered cigar" as:
[A]ny cigar as defined in this part, except a cigar that: (1) Is wrapped in whole tobacco leaf; (2) contains a 100 percent leaf tobacco binder; (3) contains primarily long filler tobacco; (4) is made by combining manually the wrapper, filler, and binder; (5) has no filter, tip, or non-tobacco mouthpiece and is capped by hand; (6) has a retail price (after any discounts or coupons) of no less than $10 per cigar (adjusted, as necessary, every 2 years, effective July 1st, to account for any increases in the price of tobacco products since the last price adjustment); (7) does not have a characterizing flavor other than tobacco; and (8) weighs more than 6 pounds per 1000 units.
Id. at 23,150. The FDA noted that, while it had proposed a definition with respect to Option 2, it remained "concerned that any attempts to create a subset of premium cigars that are excluded from regulatory authority might sweep other cigar products under its umbrella." Id. The FDA therefore sought comment as to how to refine this definition, within the context of Option 2, "to ensure that the exclusion would apply only to those cigars that, because of how they are used, may have less of a public health impact than other types of cigars." Id.
The FDA sought comment on both options. Its purpose was "to determine whether all cigars should be subject to deeming and what provisions of the proposed rule may be appropriate or not appropriate for different kinds of cigars," as well as to determine the "relative merits of Option 1 versus Option 2, taking into account what is appropriate for the public health, including possible benefits to the public health or possible negative public health consequences of adopting one Option or the other." Id. at 23,143, 23,145. As to Option 2, the FDA noted that while "all cigars are harmful and potentially addictive, it has been suggested that different kinds of cigars may have the potential for varying effects on public health, based on possible differences in their effects on dual use, youth initiation[,] and frequency of use by youth and young adults." Id. at 23,150. Plaintiffs and numerous other members of the public submitted detailed comments on the Proposed Deeming Rule.
ii. Final Rule
a. Health warning requirements
The FDA selected Option 1 and promulgated the final Deeming Rule on May 10, 2016, thus deeming all categories of cigars, including those referred to as "premium cigars," to be subject to the TCA. See Final Rule Deeming Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products , 81 Fed. Reg. 28,974, 29,020 (May 10, 2016) (codified at 21 C.F.R. pts. 1100, 1140, 1143) ("Deeming Rule"). In support of its decision, the FDA stated that it "concluded that deeming all cigars, rather than a subset, more completely protects the public health." Id. The FDA found that: "(1) All cigars pose serious negative health risks, (2) the available evidence does not provide a basis for FDA to conclude that the patterns of premium cigar use sufficiently reduce the health risks to warrant exclusion, and (3) premium cigars are used by youth and young adults." Id.
Under the Deeming Rule as originally announced, the newly deemed products would be subject to comparable TCA provisions and regulatory requirements to which cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco were already subject. Id. at 28,976. These requirements include:
(1) Enforcement action against products determined to be adulterated or misbranded (other than enforcement actions based on lack of a marketing authorization during an applicable compliance period);
(2) Required submission of ingredient listing and reporting of [harmful and potentially harmful constituents];
(3) Required registration of tobacco product manufacturing establishments and product listing;
(4) Prohibition against sale and distribution of products with modified risk descriptors (e.g., "light," "low," and "mild" descriptors) and claims unless FDA issues an order authorizing their marketing;
(5) Prohibition on the distribution of free samples; and
(6) Premarket review applications and approvals.
Id.
And there is more. The Deeming Rule also sets out comprehensive warning statement requirements, for both cigar product packaging and advertisements. By August 10, 2018, cigar product packages must display one of the six following health warning statements:
(i) WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale.
(ii) WARNING: Cigar smoking can cause lung cancer and heart disease.
(iii) WARNING: Cigars are not a safe alternative to cigarettes.
(iv) WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers.
(v)(A) WARNING: Cigar use while pregnant can harm you and your baby. ...
(vi) WARNING: This product contains nicotine. Nicotine is an addictive chemical.
21 C.F.R. § 1143.5(a)(1). These health warnings must be displayed on a rotating basis. See id. On cigar packages, each of the six health warning statements "must be randomly displayed in each 12-month period, in as equal number of times as is possible on each brand of cigar sold in product packaging and be randomly distributed in all areas of the United States in which the product is marketed." Id. § 1143.5(c)(1). On cigar advertisements, the health warning statements "must be rotated quarterly in alternating sequence in each advertisement for each brand of cigar." Id. § 1143.5(c)(2). Each cigar company must submit for FDA approval a plan for rotating warnings twelve months before advertising or commercially marketing a cigar product. Id. § 1143.5(c)(3).
The Deeming Rule also specifies the placement and size of the required health warnings. With respect to packaging, each warning statement must "appear directly on the package" and must be "located in a conspicuous and prominent place on the two principal display panels of the package," comprising "at least 30 percent of each of the principal display panels." Id. § 1143.5(a)(2). For cigars that are sold individually and not in a product package, the health warning statements must be posted at the retailer's point-of-sale on an 8.5 by 11-inch "clear, legible, and conspicuous" sign. Id. § 1143.5(a)(3). As to print and other visual advertisements, the warning statement must be located in the "upper portion of the area of the advertisement" and occupy "at least 20 percent of the area of the advertisement." Id. § 1143.5(b).
These size mandates are more demanding than the size requirements under the FTC consent orders. According to Plaintiffs, the required package warnings are 195 to 237 percent larger on any one panel than under the FTC warnings scheme. And, when the Deeming Rule's additional requirement to cover a second display panel is included, Plaintiffs assert that the FDA's mandate covers approximately 390 to 475 percent more of a package's surface area than is required under the FTC's consent orders.
b. Related deemed products
In addition to cigars, pipe tobacco, and e-cigarettes, the Deeming Rule also deemed the "components or parts" of those newly deemed products to be subject to the TCA. The FDA defines the statutory term "component or part" to mean:
[A]ny software or assembly of materials intended or reasonably expected: (1) [t]o alter or affect the tobacco product's performance, composition, constituents, or characteristics; or (2) [t]o be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product.
81 Fed. Reg. at 29,102 ; 21 C.F.R. § 1100.3. Within the category of "component or part," the FDA included pipes used to consume pipe tobacco. 81 Fed. Reg. at 29,042.
Although it had the authority to do so, the FDA did not deem "accessories" of the newly deemed tobacco products subject to the TCA. The agency reasoned that "accessories, unlike components or parts, are expected to have little direct impact on the public health." Id. at 28,975. The FDA defined "accessories" to mean "any product" intended or reasonably expected to be used with or for the human consumption of a tobacco product, but not containing, made, or derived from, tobacco, that is: (1) "not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product," or (2) "intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product," but solely: (i) "controls moisture and/or temperature of a stored tobacco product," or (ii) provides an external heat source to initiate but not maintain combustion of a tobacco product." Id. at 29,102 ; 21 C.F.R § 1100.3. The FDA identified as examples of unregulated accessories items like "ashtrays, spittoons, hookah tongs, cigar clips and stands, and pipe pouches," as well as "humidors or refrigerators that solely control the moisture and/or temperature of a stored product and conventional matches and lighters that solely provide an external heat source to initiate but not maintain combustion of a tobacco product." 81 Fed. Reg. at 28,975.
b. The User Fee Rule
To fund the regulation of tobacco products under the TCA, Congress requires the FDA to "assess user fees on, and collect fees from, each manufacturer and importer of tobacco products subject to this subchapter." See 21 U.S.C. § 387s. The user fees "are available only for the purpose of paying the costs of the activities of the [FDA] related to the regulation of tobacco products under ... the [TCA]." Id. § 387s(c)(2).
When it promulgated the final Deeming Rule, the FDA simultaneously issued the User Fee Rule. Under that Rule, the FDA announced its intention to collect information from domestic manufacturers and importers of cigars and pipe tobacco in order to calculate the amount of user fees to be collected from these entities. See Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco , 81 Fed. Reg. 28,707 (May 10, 2016) ; 21 C.F.R. § 1150.5. Domestic manufacturers and importers of cigars and pipe tobacco were required to submit information to support the assessment of user fees to the FDA on August 20, 2016. 81 Fed. Reg. at 28,707; 21 C.F.R. § 1150.5. Because the FDA performs class allocations only on a full fiscal-year basis, domestic manufacturers and importers of cigars and pipe tobacco became subject to user fee assessments on October 1, 2016, the first full fiscal year following the User Fee Rule's effective date of August 8, 2016. 81 Fed. Reg. at 28,707.
Notably, the User Fee Rule excluded from coverage other newly deemed products, such as e-cigarettes. The FDA explained that it lacked the statutory authority to impose user fees on any newly deemed products other than cigars and pipe tobacco. See id. at 28,711 -12.
c. FDA's July 2017 Announcement of a "New Comprehensive Plan"
The presidential election of 2016 ushered in change to the FDA's approach to the Deeming Rule. On July 28, 2017, the FDA announced a "new comprehensive plan" for regulating tobacco products and nicotine. See Pls.' Mot. for Partial Summ. J., ECF No. 62 [hereinafter Pls.' Mot.], Ex. D, ECF No. 62-4 [hereinafter FDA Press Release]. In accordance with the plan, the FDA delayed implementation of some provisions of the Deeming Rule, but allowed others to go into effect. For instance, the agency extended until August 8, 2021, the compliance period for tobacco manufacturers to submit applications for newly deemed products that were on the market as of August 8, 2016. See Joint Status Report (dated Sept. 5, 2017), ECF No. 51 [hereinafter Sept. 5, 2017 JSR], ¶ 3; FDA Press Release. The health warning requirements, on the other hand, were left undisturbed.
The FDA also announced its intention to issue Advance Notices of Proposed Rulemaking ("ANPRM"). The contemplated rulemaking included a focus on the previous issue of whether to regulate premium cigars. An ANPRM, the FDA stated, would seek public comment on "the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA's 2016 rule." FDA Press Release. Commenting on the FDA's "new comprehensive plan," Mitch Zeller, Director of the FDA's Center for Tobacco Products, explained: "Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use." Id.
d. Recent Regulatory Developments
In December 2017, the FDA formally announced its intention to initiate a rulemaking process focused on the question of premium cigars. See " Premium Cigars; Request for Scientific Information," Agency Rule List-Fall 2017: Department of Health and Human Services , Unified Agenda of Regulatory and Deregulatory Actions, OIRA, https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201710=&RIN=0910-AH88. The FDA observed that while it had received comments in response to the Proposed Deeming Rule "claiming that the health risks associated with cigar use generally, or with the use of premium cigars in particular were not significant because of the way such products are used," these comments ultimately failed to provide an adequate scientific basis for excluding those products from regulation. Id. The FDA therefore announced its intention to issue an ANPRM to request scientific information "that might support" exempting premium cigars from regulation or regulating them in a manner different from other cigars. Id.
The agency issued the ANPRM in late March 2018. See Defs.' Notice of Publication of ANPRM, ECF No. 91. It explained that in light of "the ongoing interest from many parties and sectors, such as industry and Members of Congress, in the regulatory status of premium cigars," the purpose of the ANPRM is "to request relevant new and different information, data, and analysis not submitted in response to FDA's proposed deeming rule ... that could inform FDA's regulation of premium cigars." See Regulation of Premium Cigars , 83 Fed. Reg. 12,901, 12,902 (Mar. 26, 2018). Specifically, the FDA invited submission of comments, data, research results, and other information related to three topics: (1) the definition of premium cigars; (2) usage patterns of premium cigars; and (3) public health considerations associated with premium cigars. Id. at 12,903. The FDA also asked the public to submit studies or information regarding the Deeming Rule's current health warning statements, and requested comment on "whether any additional or alternative warning statements would be appropriate." Id. at 12,904.
C. Procedural Background
The Cigar Association of America, the International Premium Cigar and Pipe Retailers Association, and Cigar Rights of America (collectively, "Plaintiffs") filed suit in this court, seeking declaratory, injunctive, and other relief from the Deeming Rule and challenging the legality of the User Fee Rule.
After Defendants filed their Answer, Plaintiffs filed an initial motion for summary judgment on February 13, 2017. Thereafter, the newly installed FDA administration signaled an openness to evaluating the agency's approach to aspects of the Deeming Rule. The parties accordingly requested multiple extensions of the briefing deadlines in order "to allow new leadership personnel at [HHS] to more fully consider the issues raised in [the] case and determine how best to proceed." Joint Mot. to Amend Scheduling Order (dated May 1, 2017), ECF No. 34, at 1. The court granted the requests, resulting in over four months of extensions. After the FDA's July 2017 announcement of its new comprehensive plan for the regulation of tobacco products, the parties sought one final 30-day extension of the briefing schedule. Joint Mot. to Amend Scheduling Order (dated Aug. 1, 2017), ECF No. 40, at 2-3. The court also granted this motion. Minute Order Aug. 7, 2017.
In a Joint Status Report dated September 5, 2017, the parties explained that, as a result of the FDA's announcement, they had agreed to defer resolution of certain of Plaintiffs' challenges to the Deeming Rule. Specifically, the parties agreed that Plaintiffs' challenges relating to the premarket review process, the FDA's decision to deem premium cigars subject to regulation, and the agency's cost-benefit analysis underlying the Deeming Rule-claims asserted in Counts I, IV, and V of Plaintiffs' Complaint-"should await the further regulatory action that the FDA has announced it intends to pursue, because those announced regulatory actions may materially change the regulatory scheme underlying these claims." Sept. 5, 2017 JSR at 2. The court agreed to defer resolution of those issues.
Other challenged aspects of the Rules remain unaffected by the agency's July 2017 announcement, id. , and as to those, Plaintiffs filed a new dispositive motion, this time only for partial summary judgment. Of the nine original counts in their Complaint, Plaintiffs presently seek summary judgment on six, asserting that: (1) the Deeming Rule's health warning statement requirements violate the TCA and the Administrative Procedure Act ("APA") (Count VI) and the First Amendment (Count VII); (2) the User Fee Rule's assessment of user fees on domestic manufacturers and importers of cigars and pipe tobacco, but not e-cigarettes, violates the APA (Count II) and the Fifth Amendment (Count III); (3) the Deeming Rule's treatment of retailers who blend pipe tobacco as "manufacturers" within the meaning of 21 U.S.C. § 387e violates the TCA and the APA (Count VIII); and (4) the Deeming Rule's classification of pipes as "components" of a tobacco product subject to regulation-rather than "accessories" not subject to regulation-violates the APA (Count IX). Compl. ¶¶ 100-60; Pls.' Mot. at 2-4; see Sept. 5, 2017 JSR at 3.
In addition, Plaintiffs moved for a preliminary injunction on their challenge to the Deeming Rule's health warnings mandates. See Pls.' Mot. for Prelim. Inj., ECF No. 61. The parties consented to consolidating the motion for preliminary relief with briefing on the merits. See Fed. R. Civ. P. 65(a)(2) ; Order Setting Summ. J. Schedule (dated Sept. 19, 2017), ECF No. 57.
III. LEGAL STANDARD
When reviewing an agency action under the APA, "summary judgment is the mechanism for deciding whether as a matter of law an agency action is supported by the administrative record and is otherwise consistent with the APA standard of review." Louisiana v. Salazar , 170 F.Supp.3d 75, 83 (D.D.C. 2016) (citing Citizens to Preserve Overton Park, Inc. v. Volpe , 401 U.S. 402, 415, 91 S.Ct. 814, 28 L.Ed.2d 136 (1971) ). Pursuant to the APA, the court must uphold an agency's decision unless it is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A). Under the "narrow" arbitrary and capricious standard of review, the court may not "substitute its judgment for that of the agency," but must instead determine whether the agency "examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made." Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co. (State Farm ), 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983) (internal quotation marks omitted). An agency action is "arbitrary and capricious" and will be set aside if the agency "has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise." Id.
In reviewing an agency's interpretation of a statute it is charged with administering, courts apply the familiar two-step framework outlined in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc. , 467 U.S. 837, 842-43, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). Step one requires the court to determine, using "traditional tools of statutory construction," whether "Congress has spoken directly to the precise question at issue." Id. at 842, 104 S.Ct. 2778. If Congress has so spoken, "the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress." Id. at 843 n.9, 104 S.Ct. 2778. But if the statute remains ambiguous-meaning it "can be read more than one way," even after applying "traditional tools of statutory construction," AFL-CIO v. FEC , 333 F.3d 168, 172-73 (D.C. Cir. 2003) -or is silent on the question at hand, courts proceed to step two to determine "whether the agency's answer is based on a permissible construction of the statute." Chevron , 467 U.S. at 843, 104 S.Ct. 2778. Judicial review at step two of Chevron is "highly deferential," Vill. of Barrington v. Surface Transp. Bd. , 636 F.3d 650, 667 (D.C. Cir. 2011), and the court must "accept the agency's [reasonable] construction of the statute, even if the agency's reading differs from what the court believes is the best statutory interpretation," Nat'l Cable & Telecomm. Ass'n v. Brand X Internet Servs. , 545 U.S. 967, 980, 125 S.Ct. 2688, 162 L.Ed.2d 820 (2005).
"In some circumstances, there is an overlap in the analysis required pursuant to Chevron Step Two[ ] and that required under the arbitrary and capricious standard" of the APA. EchoStar Satellite LLC v. FCC , 704 F.3d 992, 1001 (D.C. Cir. 2013) (internal citation omitted). Under Chevron 's second step, a court asks whether an agency's interpretation is "arbitrary or capricious in substance," Judulang v. Holder , 565 U.S. 42, 52 n.7, 132 S.Ct. 476, 181 L.Ed.2d 449 (2011), an inquiry that parallels the standard of review under the APA. "Ultimately, under either standard of review, the relevant question" in this case "is whether the FDA's decision represents the result of a reasonable exercise of its authority." Amarin Pharm. Ireland Ltd. v. FDA , 106 F.Supp.3d 196, 206 (D.D.C. 2015).
IV. DISCUSSION
A. Health Warning Requirements
Plaintiffs' primary challenge is to the Deeming Rule's health warning requirements, which they assert violate the First Amendment, the TCA, and the APA. The court first assesses whether the Deeming Rule's health warning requirements run afoul of the TCA and the APA, and then turns to consider their constitutionality.
1. TCA and APA
Plaintiffs' TCA and APA challenges to the Deeming Rule's health warning requirements are two-fold. First, they assert that the agency failed to make the findings required by the TCA, 21 U.S.C. § 387f(d)(1), to justify the warning requirements. And second, Plaintiffs contend that the agency violated the APA because it failed to explain why the existing FTC warning scheme was inadequate, opting instead to crowd out and restrict manufacturers' ability to communicate with consumers by imposing a requirement to cover 30 percent of two panels of a cigar box and 20 percent of any advertisement with warnings. The court rejects these arguments.
As to their first argument, Plaintiffs claim that the FDA made "no determination at all about the warnings' effect on decreasing cigar or pipe tobacco use," and thus failed to adhere to the statutory mandate provided by 21 U.S.C. § 387f(d)(1). Pls.' Mot. at 34. In pertinent part, that section of the TCA authorizes the FDA to "impose restrictions on the advertising and promotion of a tobacco product" "if the [agency] determines that such regulation would be appropriate for the protection of the public health." 21 U.S.C. § 387f(d)(1). The agency's finding "shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product," and must take into account: "(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products." Id. According to Plaintiffs, the agency did not assess whether the warnings would have any effect on decreasing cigar and pipe tobacco use, and even conceded that it could not make the statutorily-mandated finding. See Pls.' Mot. at 34 (citing A.R. 023973 ).
Plaintiffs' contention is unavailing: The agency did make the required statutory findings. The FDA first connected the Deeming Rule as a whole to the public health standard, stating that it "believes that the sale and distribution restrictions the Agency is proposing," including the "health warning requirements," "meet the public health standard set forth in" 21 U.S.C. § 387f(d)(1). 79 Fed. Reg. at 23,146. The FDA specifically "concluded that the restrictions would be appropriate for the protection of the public health with respect to the risks and benefits to the population as a whole, including the increased likelihood that existing users will quit using tobacco products and the decreased likelihood that new users will initiate tobacco product use." Id. The agency made this statutory determination based on a the following factors: "available data on the addictiveness of nicotine" and nicotine's corresponding deleterious effects on the developing adolescent brain; the fact that newly deemed "combustible products like cigars, pipes, and waterpipes, are known causes of adverse health effects, including certain cancers and heart disease"; and evidence of the potential that users of the newly deemed products would migrate to cigarettes or other regulated products. Id. The agency explained that once finalized, the Deeming Rule's provisions "may lead to a decline in youth initiation for covered products" and "avert cigarette usage." Id. Failure to act and promulgate the Deeming Rule, according to the FDA, created the risk that such inaction would "reinforce consumers' existing confusion and misinformation about these products' safety or lack of harmfulness." Id. Thus, the agency made express findings connecting the Deeming Rule generally to the cessation and prevention of cigar and pipe tobacco use.
The FDA also made findings specific to the importance and efficacy of the health warnings. Under sections titled "Effectiveness of Warnings" and "Proposed Addictiveness Warning" in the Proposed Deeming Rule, the agency observed: (1) "The use of tobacco packages to help consumers better understand and appreciate tobacco-related health risks has a number of advantages"; (2) "Requiring health warnings in advertisements similarly is an important means of helping consumers better understand and appreciate the health consequences of tobacco use"; (3) "FDA believes that the proposed warnings will be effective in helping consumers better understand and appreciate critical information"; (4) "Research has shown that using the largest possible lettering can increase warning effectiveness and increasing font size aids communication"; (5) "The content of the proposed messages also indicates that they should help consumers understand and appreciate the health risks"; and (6) "The absence of a health warning requirement for other tobacco products could reinforce the existing false sense of security that youth have about the safety of those products." Id. at 23,164 -65. In making these findings, the FDA cited both academic studies and international protocols showing that the increased size of warnings improves noticeability and reader recall. See id. It also referenced studies concerning the content of the proposed messages, and explained why the proposed warnings were likely to be more effective. See id. at 23,165. The FDA reiterated and incorporated these findings in the final Deeming Rule. See, e.g. , 81 Fed. Reg. at 29,064 ("FDA agrees that health warnings are an effective means to help consumers understand and appreciate the risks of using tobacco products."); see also id. at 28,982, 28,988 -89, 29,060-73.
Notwithstanding what is plain on the record, Plaintiffs contend that these findings are insufficient for a host of reasons. First, Plaintiffs fault the FDA for making the statutorily required findings only in the Proposed Deeming Rule, and not the final version. Pls.' Reply in Supp. of Pls.' Mots. for a Prelim. Inj. & Partial Summ. J., ECF No. 78 [hereinafter Pls.' Reply], at 30. But that is incorrect. Not only does the final rule expressly incorporate the findings from the Proposed Deeming Rule, see 81 Fed. Reg. at 29,062, but the agency also responded to comments questioning the need and efficacy of warning requirements, and it rejected those views, see id. at 29,063. Accordingly, the agency's findings are adequately reflected in the record after the public had the opportunity of notice and comment.
Second, Plaintiffs assert that FDA "merely mouths the words of the statute, eschews any serious analysis, and hedges its language." Pls.' Reply at 30. But that contention also is misplaced, as both the Proposed Deeming Rule and the final Deeming Rule contain multiple pages devoted to "the effects of larger health warnings on cigars and pipe tobacco," which Plaintiffs claim is lacking, id. See 81 Fed. Reg. at 28,982, 28,988 -89, 29,060-73; 79 Fed. Reg. at 23,146, 23,162 -70. Thus, FDA did more than simply regurgitate the statutory text.
Next, Plaintiffs assert that FDA itself conceded the lack of connection between the required health warnings and the likelihood of reducing cigar and pipe tobacco use, when it admitted that "there has not yet been extensive research regarding the effectiveness of health warnings on tobacco products other than cigarettes." 79 Fed. Reg. at 23,165. But as Defendants explain, that excerpt, derived from the agency's Regulatory Impact Analysis, addresses the agency's inability to quantify the benefits of the Deeming Rule's warning requirements prior to their implementation date. The agency did not concede, as Plaintiffs insist, the absence of any connection between health warnings and reducing and discouraging cigar and pipe tobacco use.
In any event, the relative absence of such studies is not fatal. "It is not infrequent that the available data does not settle a regulatory issue and the agency must then exercise its judgment in moving from the facts and probabilities on the record to a policy conclusion." State Farm , 463 U.S. at 52, 103 S.Ct. 2856. That is precisely what the agency did here. It extrapolated from its experience with other tobacco products-particularly cigarettes-to reach its determination that the health warnings are appropriate for the public health and likely to affect cigar and pipe tobacco usage, as required by 21 U.S.C. § 387f(d)(1). See, e.g. , 79 Fed. Reg. at 23,165 ("FDA believes that the fundamental similarities between cigarettes and smokeless tobacco and other tobacco products allow for the application of data regarding the effectiveness of cigarette and smokeless tobacco warnings to warnings for other tobacco products."); id. ("Although there has not yet been extensive research regarding the effectiveness of health warnings on tobacco products other than cigarettes, existing studies support the use of these messages ." (emphasis added) (citations omitted) ). Thus, the agency's determination that health warnings will likely reduce and prevent cigar and pipe tobacco use, despite limited research studies specific to those newly deemed products, was not arbitrary and capricious.
Finally, Plaintiffs maintain that the "agency cannot seriously contend ... that quantitative data was beyond its grasp," as it "had sixteen years and an entire nation's worth of data to examine the efficacy of the FTC warnings." Pls.' Reply at 31. Plaintiffs, however, have identified no requirement, statutory or otherwise, that compelled the FDA to undertake such studies to make the findings required by 21 U.S.C. § 387f(d)(1). Cf. Am. Wildlands v. Kempthorne , 530 F.3d 991, 1000 (D.C. Cir. 2008) ("[I]n the absence of available evidence, Congress does not require the agency to conduct its own studies."). Plaintiffs' TCA challenge to the health warning requirements therefore fails.
Plaintiffs' APA challenge to the warning requirements suffers the same fate. To the extent Plaintiffs suggest that the warnings mandate violates the APA because the agency failed to make the requisite findings under 21 U.S.C. § 387f(d)(1), the court rejects the argument for the reasons already stated. Plaintiffs offer two other arguments under the APA. First, they assert that the Deeming Rule's health warning requirements are arbitrary and capricious because the agency failed to consider, as an alternative, adopting the existing FTC scheme already in place for much of the cigar industry, which would have been less costly and less burdensome to integrate. And, second, they argue that the warning requirements placed on the cigar industry are disproportionately more onerous than those placed on the cigarette industry, even though the FDA has determined that cigarettes occupy "the most dangerous end of the risk continuum." Pls.' Mot. at 36. Neither argument is convincing.
As to Plaintiffs' first argument, the court takes issue with the notion that the "baseline" for warning statements on cigar packaging and advertising begins with the FTC warning scheme. Plaintiffs cite no case requiring one agency to use as its starting point restrictions adopted by another agency, especially when the other agency's restrictions arose not from rulemaking but from a consent agreement with the regulated parties and, importantly, do not cover all regulated products. In that respect, this case differs materially from State Farm , relied upon by Plaintiffs. There, the agency failed to consider, without explanation, an alternative regulatory approach, which the agency itself previously had endorsed as a way of achieving regulatory objectives. See State Farm , 463 U.S. at 48, 103 S.Ct. 2856. Here, by contrast, the alternative endorsed by Plaintiffs-the FTC consent orders-was the result of another agency's enforcement action and compromise and pre-dates the Deeming Rule by nearly fifteen years. State Farm therefore did not compel the FDA to take as its starting point the FTC warnings scheme.
In developing its own cigar warnings regime, the FDA was well within its discretion to look elsewhere. Primarily, the FDA considered the congressional mandates of the TCA itself and the World Health Organization Framework Convention on Tobacco Control ("FCTC"), to which the United States is a signatory.
The Deeming Rule's warning scheme is comparable to both. Under the TCA, Congress established for smokeless tobacco warning sizes of at least 30 percent of the packaging's two principal panels, and at least 20 percent of the area for each advertisement. 15 U.S.C. § 4402(a)(2)(A), (b)(2)(B). The mandated warning sizes for cigarette packaging and advertising is even larger: 50 percent of the front and rear panels of cigarette packaging and 20 percent for advertising. Id. § 1333(a)(2), (b)(2). In addition, the FCTC, to which the United States became a signatory in May 2004, recommends a warning size of "50% or more of the principal display areas" and "no less than 30% of the principal display areas." World Health Organization, WHO Framework Convention on Tobacco Control, art. 11.1.b.iv (2003). It was perfectly reasonable for the FDA to rely on consensus- and evidence-based reference points for its own rulemaking in lieu of the FTC's warnings regime. See 81 Fed. Reg. at 29,066 (considering but rejecting the FTC's warning scheme in favor of health warnings "similar to the requirements for smokeless products and similar to those suggested by [the WHO's Framework Convention]"); see also id. at 29,064 (citing cohort study finding, AR 18757-64, that after the UK enhanced its textual health warnings to meet the minimum FCTC standard, "UK smokers were more likely to think about quitting, to think about the health risks of smoking, and to be deterred from having a cigarette compared to smokers in Australia and the United States where smaller warnings did not conform to FCTC standards").
Plaintiffs' additional contention that the cigar warning regime is disproportionately more demanding than the required scheme for cigarettes, and therefore arbitrary and capricious, also is not well taken. The congressionally mandated sizes of warnings for cigarette packaging is actually greater than for cigar products. See 15 U.S.C. § 1333(a)(2), (b)(2). Granted, those warning requirements were not yet in effect at the time the FDA finalized the Deeming Rule, see 81 Fed. Reg. at 28,988, but that fact does not render the agency's decision to impose smaller labeling requirements on cigar products arbitrary and capricious.
In sum, because the Deeming Rule's health warning requirements satisfy the TCA and the APA, the court continues on to consider Plaintiffs' constitutional challenges.
2. First Amendment Challenges
Count VII of Plaintiffs' Complaint alleges that the Deeming Rule's health warning and advertising disclosure requirements violate the First Amendment. Compl. ¶¶ 142-48. In their partial summary judgment motion, Plaintiffs assert that the Rule's warnings scheme violates the First Amendment for two reasons: (1) increasing the size of the new health warnings unconstitutionally restricts speech by "crowding out" manufacturers' and retailers' ability to communicate with consumers, and (2) requiring manufacturers and retailers to submit a warning rotation plan to the FDA before they can communicate with consumers constitutes an unconstitutional prior restraint on speech. Pls.' Mot. at 16. The court rejects the first contention as without merit, and does not reach the second because Plaintiffs did not raise a prior-restraint claim in their Complaint.
a. Commercial Speech
Plaintiffs' challenge to the Deeming Rule's warning requirements presents the following issue: Whether a warning statement of the size required by the FDA-comprising 30 percent of the principal panels of a cigar product package and 20 percent of a cigar product advertisement-infringes Plaintiffs' commercial speech rights under the First Amendment. Plaintiffs assert that the Deeming Rule is unconstitutional because it unjustifiably and dramatically increases the size of health warnings already required by the FTC consent orders on cigar packages and advertisements, thereby crowding out and restricting the space available to manufacturers and retailers to communicate with consumers. Defendants counter that the Deeming Rule does not restrict the speech of cigar manufacturers or retailers, but instead merely requires Plaintiffs to make accurate health-related disclosures reasonably aimed at "help[ing] consumers better understand and appreciate the risks and characteristics of tobacco products," and does not otherwise impose an undue burden, and thus falls well within the limits of the First Amendment. See Defs.' Cross-Mot. at 19 (quoting 81 Fed. Reg. at 28,981 ).
As a threshold matter, the parties agree that the warning requirements imposed by the Deeming Rule impact only commercial speech, that is, "expression related solely to the economic interests of the speaker and its audience." Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n of New York , 447 U.S. 557, 561, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980). Although commercial speech enjoys First Amendment protection, it is well established that such protection is "less extensive than that afforded 'noncommercial speech.' " Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio , 471 U.S. 626, 637, 105 S.Ct. 2265, 85 L.Ed.2d 652 (1985). Therefore, there is no contention here that the Deeming Rule's warning mandates are subject to strict scrutiny.
The parties' threshold dispute instead centers on, if not strict scrutiny, then which constitutional test to apply. Plaintiffs maintain that the warning requirements should be assessed under the intermediate scrutiny standard set forth in Central Hudson , the case that typically governs "First Amendment questions arising in the arena of commercial speech." See United States v. Philip Morris USA Inc. , 855 F.3d 321, 327 (D.C. Cir. 2017) (internal quotation marks omitted). For a government restriction on commercial speech to survive intermediate scrutiny under Central Hudson , it must "directly advance a substantial governmental interest and be no more extensive than is necessary to serve that interest." Milavetz, Gallop & Milavetz, P.A. v. United States , 559 U.S. 229, 249, 130 S.Ct. 1324, 176 L.Ed.2d 79 (2010) (alterations and internal quotation marks omitted). The government can establish that its regulation "directly advances" the state interest involved by providing evidence of the measure's effectiveness. See Am. Meat Inst. v. U.S. Dep't of Agric. (AMI ), 760 F.3d 18, 26 (D.C. Cir. 2014) (citing Edenfield v. Fane , 507 U.S. 761, 770-71, 113 S.Ct. 1792, 123 L.Ed.2d 543 (1993) ).
Defendants, on the other hand, argue that the Deeming Rule's warning requirements should be analyzed under the more "relaxed standard of review" set forth in Zauderer v. Office of Disciplinary Counsel . Zauderer applies "when the government uses a disclosure mandate to achieve a goal of informing consumers about a particular product trait," provided "that the reason for informing consumers qualifies as an adequate interest." AMI , 760 F.3d at 26. To withstand scrutiny under Zauderer , the disclosure requirements need only be "reasonably related to the [government's] interest," and not so "unjustified or unduly burdensome" as to chill protected commercial speech. See 471 U.S. at 651, 105 S.Ct. 2265.
Zauderer 's more relaxed standard recognizes that there are "material differences between disclosure requirements and outright prohibitions on speech," which, in the commercial speech context, warrant corresponding levels of scrutiny. Id. at 650, 105 S.Ct. 2265. In Zauderer , the Supreme Court declined to apply Central Hudson 's intermediate scrutiny to analyze a state disciplinary rule requiring attorneys advertising their contingent-fee rates also to disclose that clients would remain responsible for litigation costs. Id. Observing that the rule required the disclosure of "purely factual and uncontroversial information" about contingent-fee arrangements, the court reasoned that the state was not seeking "to prevent attorneys from conveying information to the public" but instead "requir[ing] them to provide somewhat more information than they might otherwise be inclined to present." Id. In such circumstances, the Court concluded, government regulation is assessed under a reasonableness test. Id. at 651, 105 S.Ct. 2265. The Court explained that, "because the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides, [an advertiser's] constitutionally protected interest in not providing any particular factual information in his advertising is minimal." Id.
i. The Applicable Constitutional Test
The challenged provisions of the Deeming Rule require disclosures, but not every disclosure regime is subject to Zauderer 's reasonableness standard. Zauderer applies only to disclosures of "purely factual and uncontroversial information about the good or service being offered." AMI , 760 F.3d at 27 (internal quotation marks omitted). The court therefore must first determine whether the disclosures are "purely factual" and "uncontroversial."
Though the D.C. Circuit has been less than clear in "defin[ing] [the] terms ['purely factual' and 'uncontroversial'] precisely," see Nat'l Ass'n of Mfrs. v. SEC (NAM ), 800 F.3d 518, 528 (D.C. Cir. 2015), at a minimum, "a disclosure requirement is 'purely factual' when there is no dispute about factual accuracy," see Kimberly-Clark Corp. v. District of Columbia , 286 F.Supp.3d 128, 140 (D.D.C. 2017) (citing AMI , 760 F.3d at 27 ). In Zauderer , for instance, the "purely factual" disclosure was that clients in a contingent-fee arrangement with an attorney would still have to pay costs, even if their lawsuit was unsuccessful; there was no dispute that such statement was accurate. 471 U.S. at 651, 105 S.Ct. 2265 ; see also AMI , 760 F.3d at 27 (observing no dispute regarding whether country-of-origin labeling requirements qualify as "purely factual," where "the facts conveyed are directly informative of intrinsic characteristics of the product"). The same is true here. Plaintiffs do not assert that the warning statements are anything but "purely factual."
Moving on, the determination of whether these "purely factual" warning statements are "uncontroversial" poses a different inquiry than mere factual accuracy. See NAM , 800 F.3d at 528 (" '[U]ncontroversial' as a legal test ... must mean something different than 'purely factual.' "). A disclosure is "controversial," the court gathers, when it is "subject to misinterpretation by consumers," or "inflammatory." RJ Reynolds Tobacco Co. v. FDA , 696 F.3d 1205, 1217 (D.C. Cir. 2012), overruled on other grounds by AMI , 760 F.3d at 22. In RJ Reynolds , the D.C. Circuit considered whether proposed graphic-image warnings for cigarette packages constitute the type of "purely factual and uncontroversial" information that triggers review under Zauderer . 696 F.3d at 1216. Among other images, one proposed warning depicted a man smoking through a tracheotomy hole. Id. Though the FDA claimed that the image symbolized the addictive nature of cigarettes, the court concluded that the image would more logically be misinterpreted by consumers to suggest that a tracheotomy is a common consequence of smoking. Id. Other "inflammatory" images-including depictions of a woman crying and a small child-failed to convey any warning information about cigarettes at all, and therefore also fell outside the ambit of Zauderer . Id. at 1216-17, 105 S.Ct. 2265. Plaintiffs do not challenge the warnings at issue here as "controversial" or "inflammatory." Nor, it seems, could they reasonably do so. The textual warnings about the health consequences of cigar use are unambiguous and unlikely to be misinterpreted by consumers.
Although Plaintiffs do not dispute that the Deeming Rule requires display of only "purely factual and uncontroversial information," and thus do not challenge the "criteria triggering the application of Zauderer ," AMI , 760 F.3d at 27, they nonetheless maintain that Central Hudson 's intermediate scrutiny should apply. In Plaintiffs' view, the sheer size, format, and duplication of the warnings required by the Deeming Rule transforms the Rule from a compelled disclosure to a restriction of speech governed by Central Hudson . As Plaintiffs point out, the D.C. Circuit has observed that Zauderer contemplated a line where "the compulsion to speak becomes more like a speech restriction than a disclosure." Pursuing America's Greatness v. FEC , 831 F.3d 500, 507 n.3 (D.C. Cir. 2016) ; see also id. ("[I]n some instances compulsion to speak may be as violative of the First Amendment as prohibition on speech." (quoting Zauderer , 471 U.S. at 650, 105 S.Ct. 2265 ) ). The FDA crossed that line here, say Plaintiffs, by "assault[ing] ... customers' senses" with "blaring government pronouncements" on advertisements, Pls.' Reply at 6, and imposing on the historically "distinctive, artistic, aesthetically pleasing" cigar packaging the jarring juxtaposition of the warning statements in black, bold font on a white background. Pls.' Mot. at 17. Stated differently, Plaintiffs claim that the warnings here are so large and "glaring" as to obscure industry players' messaging and overtake their ability to communicate with their customers. Id. at 18.
The court is unpersuaded. The court has had the benefit of viewing samples of cigar packaging integrating the mandatory warning statements. It may be true, as Plaintiffs contend, that the Deeming Rule's requirements demand "large[r] and stark[er]" warnings on packaging than those required under FTC consent orders, Pls.' Reply at 5, and that the FDA's regime compels use of a larger percentage of advertisements, see id. at 6. But even so, cigar manufacturers and retailers retain sufficient space in which to communicate their messaging: 70 percent of cigar packages and 80 percent of advertisements remain unencumbered and available for speech. Simply put, the Deeming Rule does not impose the "type of restriction-an outright ban on advertising ...-[that] would properly be analyzed under the heightened Central Hudson standard of scrutiny." See Dwyer v. Cappell , 762 F.3d 275, 284 (3d Cir. 2014). In the end, what Plaintiffs find most objectionable is that the Deeming Rule "require[s] them to provide somewhat more information"-or, as more apt here, larger text on a greater surface area-"than they might otherwise be inclined to present." Zauderer , 471 U.S. at 652, 105 S.Ct. 2265. Their corresponding First Amendment interests therefore are "substantially weaker than those at stake when speech is actually suppr