It was bound to happen. Just as email and text messages replaced "snail mail," social media made face-to-face communications passé, and the internet rendered libraries all but obsolete, it was only a matter of time before "electronic cigarettes"
Since 2014, [e-cigarettes] have been the most popular nicotine product among American teenagers.
And e-cigarettes' popularity is accelerating: From 2017 to 2018, ...the number of high-school-age children reporting use of e-cigarettes rose by more than 75 percent. Use among middle-schoolers also increased nearly 50 percent. That is an epidemic.
The surge in e-cigarette use by teenagers is alarming because nicotine is highly addictive and can harm brain development, which continues into young adulthood. Worse, kids who start on e-cigarettes are actually more likely than non-user peers to migrate to smoking tobacco ….
It is crucial that e-cigarettes do not become an on-ramp for children to become addicted to nicotine.
...[N]early 90 percent of adult smokers started when they were teens.
Alex M. Azar & Scott Gottlieb, We cannot let e-cigarettes become an on-ramp for teenage addiction , Wash. Post (Oct. 11, 2018) ("Azar & Gottlieb Op. Ed.").
*468To address public health concerns associated with tobacco use, and use by minors in particular, Congress enacted the Family Smoking Prevention and Tobacco Control Act ("Tobacco Control Act"), Pub. L. No. 111-31,
Alarmed by this exemption, the American Academy of Pediatrics; the Maryland Chapter - American Academy of Pediatrics; the American Cancer Society Cancer Action Network; the American Heart Association; the American Lung Association;
*469the Campaign for Tobacco-Free Kids; the Truth Initiative; Dr. Leah Brash, MD; Dr. Cynthia Fishman, MD; Dr. Linda Goldstein, MD; Dr. Steven Hirsch, MD; and Dr. David Myles, MD filed a Complaint for Declaratory and Injunctive Relief against the FDA, then-Commissioner of Food and Drugs Scott Gottlieb, the U.S. Department of Health and Human Services, and Secretary of Health and Human Services Alex M. Azar II. Compl. 1. In Plaintiffs' view, the exemption violates the Tobacco Control Act's requirement of premarket review of newly deemed products before they are marketed or distributed to consumers.
Plaintiffs filed a Motion for Summary Judgment, ECF No. 31, and Defendants filed a Motion to Dismiss or, in the Alternative, for Summary Judgment, ECF No. 36.
On March 13, 2019, while the motion remained pending, the FDA published draft guidance that, "if finalized, would modify the August 2017 Guidance challenged in this case." Mar. 26, 2019 Ltr. Order, ECF No. 62 ; see Defs.' Second Notice, ECF No. 59. Noting that the agency was "accepting public comments on the draft guidance for a 30-day period that closes on April 15, 2019," with the revisions intended to "take effect 30 days after the publication of a final guidance document," I denied the parties' motions without prejudice to renewal following the FDA's finalization or rejection of the draft guidance. Mar. 26, 2019 Ltr. Order; Defs.' Second Notice; see also FDA, Modifications to Compliance Policy for Certain Deemed Tobacco Products: Guidance for Industry: Draft (March 2019), ECF No. 59-1 ; Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars 2 (Mar. 13, 2019), ECF No. 59-2.
Plaintiffs promptly moved for reconsideration, arguing that "[t]here is...no reason to expect that a final Guidance is *470imminent, and substantial reason to doubt that it will issue this year," and that having "the benefit of a ruling on [the August 2017] Guidance" would increase the FDA's "ability to issue a legally sustainable replacement" and "thus obviat[e] or at least simplify[ ] challenges to that replacement." Pls.' Ltr. Mot. 1, ECF No. 63. Defendants responded in favor of "postpon[ing] resolution of this case while the draft guidance is finalized, lest the Court unnecessarily expend resources-and potentially issues what could, in practical terms, largely amount to an advisory opinion-on a policy that is under revision and soon stands to change in material ways." Defs.' Ltr. Opp'n 1, ECF No. 71. They contend that, "[i]f finalized, the draft guidance would modify the deferred-enforcement policy set forth in the August 2017 Guidance challenged in this case with respect to...the[ ] same products [that] are the apparent focus of Plaintiffs' public-health concerns," that is, "e-cigarettes targeted to youth and flavored cigars."
Upon further review of their briefing of Plaintiffs' letter motion for reconsideration, as well as their briefing of their cross-motions for summary judgment, I am persuaded that Plaintiffs have standing and that this Court has jurisdiction to review the August 2017 Guidance, which was not a nonreviewable discretionary decision and which qualifies as final agency action for purposes of the APA. Moreover, the undisputed evidence establishes that Defendants were required to, but did not, follow the APA's notice and comment requirements issuing the August 2017 Guidance, and therefore Defendants violated the APA by issuing it. Accordingly, I will grant Plaintiffs' motion for reconsideration and reopen the parties' cross-motions. Having done so, I deny Defendants' motion, which I treat as a motion for summary judgment; grant Plaintiffs' motion for summary judgment; and order supplemental briefing on an appropriate remedy.
Background
Congress enacted the Tobacco Control Act in 2009 to "protect the public health and to reduce tobacco use by minors." Guidance 2, ECF No. 48-1, at 715, GAR 423. The Act "granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), and smokeless tobacco products...."
The Act requires "[m]anufacturers of products subject to the Act [to] generally register with the FDA, submit lists of their products and ingredients, obtain premarket authorization before marketing new products, and include health warnings on *471packaging and advertisements." Defs.' Mem. 1. To obtain premarket authorization, a manufacturer must submit to the FDA either
(1) a "premarket tobacco application" demonstrating that the product would be appropriate for the protection of the public health, [ 21 U.S.C.] § 387j(b) - (c) ; (2) a "report" establishing that the product is "substantially equivalent" to a predicate product,id. §§ 387j(a)(2)(A)(i), 387e(j)(1) ; or (3) a request for an "exemption" from the substantial equivalence requirement,id. §§ 387j(a)(2)(A)(ii), 387e(j)(3).
If products are marketed without adhering to these requirements, they may be considered "adulterated" and seized, and the manufacturers, distributors and retailers may be subject to civil injunctions and/or criminal prosecutions.
Initially, the Act required the FDA to permit the four products then subject to the Act to remain on the market during premarket review so long as their manufacturers submitted premarket applications by March 2011. But there is no statutory grace period for products later deemed subject to the Act. Thus, when the deeming rule took effect in August 2016, all newly deemed products then on the market were suddenly noncompliant with the statute.
Defs.' Mem. 1.
It is undisputed that the FDA has some "discretion to adapt those provisions to the special circumstances of products that become subject to the TCA [Tobacco Control Act] by virtue of deeming" and, to that end, to "[p]ermit[ ] a compliance period for newly deemed products."
manufacturers of all newly deemed, new tobacco products [would] have a 12-, 18- or 24-month initial compliance period in which to prepare applications for marketing authorization, as well as a 12-month continued compliance period after those dates in which to obtain authorization from FDA (resulting in total compliance periods of 24, 30, or 36 months).
The FDA established these specific compliance periods because it "determined that exercising enforcement discretion indefinitely could put youth and young adults at risk for tobacco-related death and disease."
In May 2017, the FDA extended the compliance deadline by three months. Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule: Guidance for Industry (May 2017), GAR 206, ECF No. 48-1, at 687. Specifically, it provided that
• the "compliance period for manufacturers to submit a substantial equivalence exemption request" was November 8, 2017;
• the "compliance period for manufacturers that have submitted substantial equivalence exemption requests by November 8, 2017 (unless they have received an order denying, or FDA has refused to accept their submission)" was one year later, November 8, 2018;
• the "compliance period for manufacturers to submit a substantial equivalence report" was May 8, 2018;
• the "compliance period for manufacturers that have submitted substantial equivalence reports by May 8, 2018 (unless they have received an order denying, or FDA has refused to accept their submission)" was one year later, May 8, 2019;
• the "compliance period for manufacturers to submit a premarket tobacco product application (PMTA)" was November 8, 2018;
• the "compliance period for manufacturers that have submitted PMTAs by November 8, 2018 (unless they have received an order denying, or FDA has refused to accept their submission)" was one year later, November 8, 2019.
May 2017 Guidance 7-8, GAR 214-15, ECF No. 48-1, at 695-96.
Then, in August 2017, without allowing for a notice and comment period, Pls.' Mem. 7, the FDA issued the August 2017 Guidance (which revised its May 2017 Guidance), "announc[ing] that it would further defer enforcement of the premarket review provision with respect to combustible products (like cigars) until 2021, and noncombustible products (like most e-cigarettes) until 2022-but only for products that were on the market when the deeming rule took effect in August 2016." Defs.' Mem. 2; see Aug. 2017 Guidance 8, GAR 429, ECF No. 48-1, at 721. The August 2017 Guidance explained that the FDA had set "compliance date[s]...as a matter of enforcement discretion, stating that it does not intend to enforce [ ] particular requirement[s] that [were] already in effect for a period of time in order to give industry more time to comply." Aug. 2017 Guidance 4, ECF No. 48-1, at 717, GAR 425. Notably, pursuant to the August 2017 Guidance, "there will be a continued compliance period pending review of [certain] applications," and "[t]his compliance period will continue until the agency renders a decision on an application (i.e., issuance of: a Marketing Order; a No Marketing Order; a Refuse to File; or Refuse to Accept) or the application is withdrawn."
*473During the compliance period, "the agency plans to issue regulations governing the information to be included in premarket applications, to develop standards that certain products must meet, and to publish additional guidance explaining what applications should contain and how they will be reviewed." Defs.' Mem. 2.
The effect of this deferred enforcement is that the products subject to the Act pursuant to the Deeming Rule may remain on the market until 2021 or 2022 without submitting an application or having it reviewed and approved. These products include e-cigarettes. As noted, youth use of e-cigarettes has reached epidemic proportions. Azar & Gottlieb Op. Ed. The FDA recognizes this and professes to be "deeply concerned about the risks that e-cigarettes pose for children, given how quickly teenage use of these products has accelerated."
Standard of Review
Defendants challenge this Court's subject matter jurisdiction based on Plaintiffs' purported lack of standing and their view that the August 2017 Guidance is not subject to judicial review because it was an action within agency discretion and not a final agency action.
Summary judgment is proper when the moving party demonstrates, through "particular parts of materials in the record, including depositions, documents, electronically stored information, affidavits or declarations, stipulations...admissions, interrogatory answers, or other materials," that "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed. R. Civ. P. 56(a), (c)(1)(A) ; see Baldwin v. City of Greensboro ,
Standing
This Court may "adjudicate only actual cases and controversies." Zaycer v. Sturm Foods, Inc. ,
A plaintiff has standing if
(1) [the plaintiff] has suffered an "injury in fact" that is (a) concrete and particularized and (b) actual or imminent, not conjectural or hypothetical; (2) the injury is fairly traceable to the challenged action of the defendant; and (3) it is likely, as opposed to merely speculative, that the injury will be redressed by a favorable decision.
Zaycer ,
Injury in Fact
The Fourth Circuit has held that, where an organization's "efforts to carry out its mission" are impeded, that impediment is a concrete and particularized injury. Lane v. Holder ,
For a plaintiff to have standing based on an informational injury, the plaintiff must "lack access to information to which he is legally entitled and ...the denial of that information [must] create[ ] a 'real' harm with an adverse effect."
The injury also must be "imminent," that is "not too speculative"; in other words, it must be "certainly impending." Lujan v. Defs. of Wildlife ,
Six Plaintiffs are "Organizational Plaintiffs": American Academy of Pediatrics ("AAP"), the American Cancer Society Cancer Action Network ("ACS CAN"), the American Heart Association ("AHA"), the American Lung Association ("ALA"), the Campaign for Tobacco-Free Kids ("CTFK"), and the Truth Initiative. Pls.' Rely & Opp'n 3. Plaintiffs assert that the Organizational Plaintiffs' "missions center on educating the public about the dangers of [new tobacco products]" and "advancing the public health." Id. at 6, 7. To this end, the Organizational Plaintiffs "work daily on the front lines of a multi-faceted effort to eradicate tobacco addiction and to avert the creation of new generations of addicted children and adults." Id. at 2.
Plaintiffs offer evidence that,
[a]s implemented by the Deeming Rule, the Act would have enabled sustained progress toward that goal by subjecting hazardous and addictive products such as cigars and e-cigarettes to premarket review-requiring manufacturers to supply data and other information to FDA showing that the products they seek to market advance the public health, directing FDA to issue public orders determining *476whether the statutory public health standard has been met, and prohibiting the marketing of those products for which premarket orders have not been issued.
...
...Were FDA performing its statutorily required premarket review responsibilities, FDA would be disclosing to the public significant information about new tobacco products that Organizational Plaintiffs would use to further their missions.
FDA's suspension of premarket review requirements for approximately 25,000 new tobacco products deprives Organizational Plaintiffs of access to vital scientific and health information necessarily generated as a part of that process-information Plaintiffs need to carry out their missions.
Pls.' Reply & Opp'n 3.
Additionally, Plaintiffs argue, "the Guidance interferes with Organization Plaintiffs' missions of advancing the public health by allowing nearly 25,000 unreviewed products to remain on the market-requiring Plaintiffs to expend more resources to monitor the marketplace and to counsel and educate the public about e-cigarettes, cigars, or both." Id. at 7. Specifically,
Plaintiff AAP, for instance, has expended "approximately 2000 hours on e-cigarette work" since FDA issued the Guidance, AAP Decl. ¶ 15-hours spent updating and offering educational programs focused on e-cigarettes, id. ¶¶ 16-25; developing and issuing educational curricula and clinical materials, id. ¶¶ 30-34; and researching and publishing a policy statement on e-cigarettes, id. ¶¶ 35-44. The "massive increase in time that [AAP has] had to spend on e-cigarette work in light of the proliferation of products without premarket review" has required the organization to reduce staffing on other projects, postpone new initiatives, spend funds that it would not have otherwise had to, and forgo grant funding-all as a direct result of the Guidance. Id. ¶¶ 45-51. Other Organizational Plaintiffs attest to similar resource expenditures. See, e.g. , ALA Decl. ¶¶ 11-14; ACS CAN Decl. ¶ 15; AHA Decl. ¶¶ 15, 17.
Notably, the Tobacco Control Act is quite clear that its purpose is, in part, "to ensure that consumers are better informed," and, to that end, it "require[s]
*477tobacco product manufacturers to disclose research which has not previously been made available...relating to the health and dependency effects or safety of tobacco products." Pub. Law. 111-31, at § 3(6), 123 Stat 1776, 1782. It recognizes that "the use of tobacco by young people and dependence on tobacco" are "of particular concern to public health officials." Id. § 3(2),
The August 2017 Guidance's provisions, which do not require manufacturers to submit their applications (accompanied by research in support) for five or more years and announce that the FDA will defer enforcement during that period, deny the Organizational Plaintiffs "access to information required to be disclosed by statute." Dreher ,
Moreover, this injury to the organizations' daily operations due to agency action limiting their access to the information is the type of injury that courts have recognized as both concrete and particularized. E.g. , Acosta ,
Further, the injury is not speculative, as the FDA currently is not requiring applications for new products and therefore is not making available the information it otherwise would make available. Additionally, Plaintiffs already have spent time and resources researching and educating the public on e-cigarettes due to the dearth of such information from the FDA. See Phillips (ACS CAN) Decl. ¶ 15 ("Without a prohibition on marketing newly deemed products until review is complete, hundreds of products in thousands of flavors are currently being sold without a decision from FDA on those products' effect on public health. This situation forces ACS CAN to invest considerably more resources in monitoring the market and the products in the market so that we can determine where the greatest risks to public health are arising."); Schoeberl (AHA) Decl. ¶¶ 15-16, ECF No. 39-4 ("In lieu of premarket review, AHA must do its own research and review published research on e-cigarettes and cigars. But due to the paucity of published information, the variable contents of the unregulated products, and the sheer number of products on the market, this endeavor is not only a completely inadequate substitute for premarket review, but also expensive. Similarly, AHA develops resources for individuals, including its 40 million volunteers and supporters. It is currently developing or updating materials on topics such as resources to help quit smoking, whether vaping is safer than smoking, common products such as JUUL, and the public health implications of e-cigarettes. All of this material is more costly to develop-and less complete-due to the absence of premarket review and the information it would provide, as well as the immense diversity of products in the absence of premarket review.").
This Court has held that an organization has standing where, as here, "the defendants' actions 'have caused the organization to divert resources to identify and counteract the defendants' unlawful practices,' and thereby impede[d] and frustrate[d] its core mission." Equal Rights Ctr. v. Equity Residential ,
Traceable Injury
If "the alleged injury is solely 'th[e] result [of] the independent action of some third party not before the court,' " then the "plaintiff may not have standing." Kravitz v. U.S. Dep't of Commerce ,
Here, Plaintiffs' injuries result from the FDA's actions to exempt certain products from premarket review for years. Certainly, the FDA's actions arguably are not "the very last step in the chain of causation," as the manufacturers theoretically could have chosen to submit applications promptly or to remove their products from the market in response to the August 2017 Guidance stating that they were exempt from premarket review and enforcement for five or six years or more. But theory and reality are not always in harmony, and the record before me contains no facts to suggest that manufacturers actually have done so, nor would it be the slightest bit surprising to learn that they have not. And, it is telling that the FDA has not issued any orders on premarket tobacco product applications since 2015 or taken any final action on any premarket tobacco product applications since June 2017. See FDA, Summary of Premarket Tobacco Product Application Final Actions, https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/tobacco-product-marketing-orders; see also Fed. R. Evid. 201(b)(2). Under these circumstances, the injury is undeniably traceable to Defendants' August 2017 Guidance. See Pub. Citizen Health Research Grp. v. Acosta ,
Redressability
A plaintiff's allegations satisfy the redressability prong if it is "likely, and not merely speculative, that a favorable decision will remedy the injury." Friends of the Earth, Inc. v. Gaston Copper Recycling Corp. ,
Therefore, the Organizational Plaintiffs have standing. See Lujan ,
Judicial Review of Nonenforcement Decision
The actions of an agency such as the FDA "are presumptively subject to judicial review." Elecs. of N.C., Inc. v. Se. Power Admin. ,
Further, because an agency's "[r]efusal to take enforcement steps" is "generally...precisely the opposite" of an agency's actions in accordance with "a statute that set[s] clear guidelines for [such actions]," the "presumption of reviewability" does not apply to that refusal. Chaney,
Relying on the U.S. District Court for the District of Columbia's decision in National Association for the Advancement of Colored People v. Trump ,
First, while "an agency's decision whether to take an enforcement action is presumptively unreviewable,...that presumption can normally be rebutted...by pointing to statutory language that constrains the agency's exercise of its enforcement discretion." Trump ,
Additionally, if the agency's decision is " 'tantamount to amending or revoking a rule,' " then it "amounts to substantive rulemaking subject to the APA's constraints and generally reviewable by courts." Public Citizen Health Research Group v. Acosta ,
In Chaney (on which the FDA heavily relies), prison inmates who had been sentenced to death by lethal injection asked the FDA to "take various enforcement actions" regarding the use of drugs for lethal injection; the inmates asserted that the use violated the Federal Food, Drug, and Cosmetic Act,
Specifically, the Chaney Court considered the language of the FDCA, noting that one part "provide[d] only that [t]he Secretary is authorized to conduct examinations and investigations" and did not give any "indication of when an injunction should be sought," and another was "framed in the permissive."
In sum, the Court "conclude[d] that the presumption that agency decisions not to institute proceedings are unreviewable under
For example, Public Citizen Health Research Group v. Acosta ,
Initially, OSHA only occasionally collected these forms from employers, either during on-site inspections or as part of broader industry surveys. But in May 2016, OSHA issued a new rule requiring employers to submit them-three in total-electronically each year. In May 2018, however, and after the first filing deadline had passed, OSHA announced employers were only required to submit one of the three forms while it considered revising or rescinding the existing rule, citing privacy and waste concerns. In fact, OSHA stated that, until it completed its review, it would not accept two of the three forms from employers at all.
*483The court concluded that the plaintiffs sufficiently alleged that "OSHA did not simply exercise its discretion not to enforce the Rule, but suspended its reporting requirement entirely such that covered employers are not legally obligated to submit the forms, regardless of whether OSHA decides to take action against them for not doing so."
The court also considered the mandatory requirements within the statutory language of the Occupational Safety and Health Act ("OSH Act"). Specifically,
Section 673(a) of the OSH Act mandates that OSHA "shall develop and maintain an effective program of collection, compilation, and analysis of occupation safety and health statistics."29 U.S.C. § 673 (a). Similarly, § 657(c)(2) mandates that OSHA "shall prescribe regulations requiring employers to maintain accurate records of, and to make periodic reports on, work-related deaths, injuries and illnesses."Id. § 657(c)(2). And § 673(e) further provides that "[o]n the basis of the records made and kept pursuant to section 657(c)..., employers shall file such reports with [OSHA] as [it] shall prescribe by regulation, as necessary to carry out [its] functions under this chapter."Id. § 673(e).
Here, the parties agree that, pursuant to the August 2017 Guidance, the FDA currently does not have to undertake premarket review for e-cigarettes, cigars, and other newly deemed tobacco products, and manufacturers currently do not have to file applications with the FDA for those products to remain on the market. Pls.' Mem. 1; Defs.' Mem. & Opp'n 2. Defendants acknowledge that Congress did not establish a statutory grace period for new tobacco products as it did "for originally regulated products," but they argue that the inclusion of such a provision in another section of the Act "in no way curtails the agency's inherent discretion to extend a similar grace period to newly deemed products-if anything, it shows that deferring enforcement of this provision for newly regulated products is entirely sensible." Defs.' Mem. 4. But, "[w]here Congress includes particular language in one section of a statute but omits it in another section of the same Act, it is generally presumed that Congress acts intentionally and purposely in the disparate inclusion or exclusion." Nat'l Ass'n of Mfrs. v. Dep't of Def. , --- U.S. ----,
In Defendants' view, the August 2017 Guidance is a nonenforcement decision that is "committed to agency discretion, and thus presumptively immune from judicial review," as explained in Chaney . Defs.'
*484Mem. 21. Certainly, the parties agree that the FDA has some discretion to allow for a compliance period for new tobacco products, and the FDA did just that in the Deeming Rule. But, Plaintiffs insist that "Congress cabined any FDA discretion under the [Tobacco Control] Act," and therefore the Court may review the August 2017 Guidance. Pls.' Reply & Opp'n 23 (quoting Citizens to Preserve Overton Park, Inc. v. Volpe ,
The extent of the FDA's discretion under the Tobacco Control Act is a matter of statutory interpretation.
"The 'first step' of statutory interpretation 'is to determine whether the language at issue has a plain and unambiguous meaning' by looking to 'the language itself, the specific context in which that language is used, and the broader context of the statute as a whole.' " Orquera v. Ashcroft ,357 F.3d 413 , 418 (4th Cir. 2003) (quoting Robinson v. Shell Oil Co. ,519 U.S. 337 , 340-41,117 S.Ct. 843 ,136 L.Ed.2d 808 (1997) ). When the words of the statute are "sufficient in and of themselves to determine the purpose of the legislation" and do not produce unreasonable results "plainly at variance with the policy of the legislation as a whole," courts must follow their plain meaning. United States v. Am. Trucking Ass'ns ,310 U.S. 534 ,60 S.Ct. 1059 ,84 L.Ed. 1345 (1940) (quoting Ozawa v. United States ,260 U.S. 178 , 194,43 S.Ct. 65 ,67 L.Ed. 199 (1922) ). Indeed, "[t]here is...no more persuasive evidence of the purpose of a statute than the words by which the legislature undertook to give expression to its wishes." Am. Trucking Ass'ns ,310 U.S. at 543 ,60 S.Ct. 1059 .
Nat'l Ass'n for the Advancement of Colored People v. U.S. Dep't of Homeland Sec. ,
Plaintiffs rely on 21 U.S.C. § 387j(a)(2) and (c)(1)(A)(i), which provide:
(a) In general
...
(2) Premarket review required
(A) New products
An order under subsection (c)(1)(A)(i) for a new tobacco product is required unless--
(i) the manufacturer has submitted a report under section 387e(j) of this title; and the Secretary has issued an order that the tobacco product--
(I) is substantially equivalent to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007; and
(II) is in compliance with the requirements of this chapter; or
(ii) the tobacco product is exempt from the requirements of section 387e(j) of this title pursuant to a regulation issued under section 387e(j)(3) of this title.
(B) Application to certain post-February 15, 2007, products
Subparagraph (A) shall not apply to a tobacco product--
(i) that was first introduced or delivered for introduction into interstate commerce for commercial distribution in the United States after February 15, 2007, and prior to the date that is 21 months after June 22, 2009; and
(ii) for which a report was submitted under section 387e(j) of this title within such 21-month period, except that subparagraph (A) shall apply to the tobacco product if the Secretary issues an order that the tobacco product is not substantially equivalent.
...
*485(c) Action on application
(1) Deadline
(A) In general
As promptly as possible, but in no event later than 180 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall --
(i) issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or
(ii) issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accompanying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply.
(B) Restrictions on sale and distribution
An order under subparagraph (A)(i) may require that the sale and distribution of the tobacco product be restricted but only to the extent that the sale and distribution of a tobacco product may be restricted under a regulation under section 387f(d) of this title.
(2) Denial of application
The Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Secretary with respect to such tobacco product, the Secretary finds that--
(A) there is a lack of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health;
(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 387f(e) of this title;
(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or
(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under section 387g of this title, and there is a lack of adequate information to justify the deviation from such standard.
21 U.S.C. § 387j(a)(2), (c)(1)(A)(i), (2) (emphases added).
These statutes include mandatory language like that in Acosta , not the permissive language at issue in Chaney . The term "shall," which appears repeatedly in these statutory provisions, "normally creates an obligation impervious to...discretion." Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach ,
*486And, even if the agency's deferral of the premarket approval process constituted an enforcement decision, which would be presumptively unreviewable by the Court, see Chaney ,
I further note that the Tobacco Control Act "has provided guidelines for the agency to follow in exercising its enforcement powers," Chaney ,
Defendants disagree, arguing that these provisions "do not circumscribe the agency's enforcement discretion." Defs.' Reply 6. They reason that "[w]ords like 'required' and 'shall' are common throughout the U.S. Code, yet they have never been thought to 'mandate...prosecution of every violator.' "
*487Chaney ,
Insofar as mandatory language may not "mandate[ ] criminal prosecution of every violator" of a given statute, to hold that such language does not mandate that the agency enforce the statute against any violator would render the language surplusage. The Court "cannot adopt a reading of [the statute] that renders part of the statute superfluous over one that gives effect to its 'every clause and word,' " as doing so would violate the "well-established rule against surplusage." United States v. Simms ,
Final Agency Action
"Judicial review under the APA...is limited to 'final agency actions.' " City of New York v. U.S. Dep't of Def. ,
Defendants argue that, "[e]ven if the Guidance were more than the FDA's 'current thinking' on enforcement of the premarket authorization requirement, Guidance at 1 (GAR 422), it does not satisfy the second criterion because it does not determine any rights or obligations, nor will any legal consequences flow from it." Defs.'
*488Mem. 31 (citation omitted). Defendants cite BBK Tobacco & Foods, LLP v. FDA ,
In any event, case law from the District of Arizona is not binding on this Court, and the only Fourth Circuit case Defendants cite is Flue-Cured Tobacco Coop. Stabilization Corp. v. U.S.E.P.A. ,
The Fourth Circuit's recent decision in Sanitary Board of City of Charleston v. Wheeler ,
Certainly, the Guidance includes boilerplate language that it "does not establish any rights for any person and is not binding on FDA or the public" and that it "do[es] not establish legally enforceable responsibilities...and should be viewed only as [a] recommendation[ ]." Aug. 2017 Guidance 1, GAR 422, ECF No. 48-1, at 714. But it also states: "You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations."
Moreover, with regard to the language purporting to limit the effects of the Guidance, Philip Morris USA Inc. v. United States Food & Drug Administration ,
It noted that "boilerplate language" in the Second SE Guidance stating that it " 'do[es] not establish legally enforceable responsibilities ...and should be viewed only as [a] recommendation[ ]' " and that it " 'does not establish any rights for any person and is not binding on FDA or the public' "-language that is identical to language Defendants cite in the August 2017 Guidance, see Defs.' Mem. 31 (quoting Aug. 2017 Guidance, ECF No. 48-1, at 714 )-could not "dictate whether the Second SE Guidance is a final agency action fit for review." Philip Morris ,
Rather, the court determines whether the guidance has legal consequences based on "the context and form in which the agency action arises." Id. at 46. The Philip Morris Court observed that, while "[n]on-legislative agency statements of the type at issue...generally do not qualify as a final agency action[,]...[t]hat does not mean, however, that such statements can never constitute final agency action." Id. (citing Appalachian Power ,
To determine if an agency's interpretive rule or guidance is sufficiently final to warrant pre-enforcement review, the court may consider a host of factors. The three most important factors are: (1) whether the agency has taken a "definitive legal position" regarding its statutory authority; (2) whether the case presents a "purely legal question of statutory interpretation;" and (3) whether the action "imposes an immediate and significant practical burden on the regulated entity."
*490In Philip Morris , the court concluded that "the first two factors [we]re easily met," and it focused on "whether the action imposes a significant burden on tobacco companies."
Here, the statute requires premarket review for all tobacco products, 21 U.S.C. § 387j(a)(2), (c)(1)(A), and the FDA announced in the August 2017 Guidance that certain products that had been deemed to be tobacco products could remain on the market for five years or more without premarket review. Aug. 2017 Guidance 8, GAR 429, ECF No. 48-1, at 721. Thus, the FDA has "taken a 'definitive legal position' regarding its statutory authority," asserting that it has the authority under the Tobacco Control Act to delay the premarket review requirement. See Philip ,
APA Claims
Plaintiffs claim that the August 2017 Guidance "is ultra vires and unconstitutional," in violation of the APA, in that it "conflicts with the Tobacco Control Act; exceeds FDA's statutory authority; and violates the Constitution's Take Care clause, U.S. Const. art. II, § 3." Compl. ¶ 94; see also id. ¶¶ 92-102 (Count I). They also claim that, because the August 2017 Guidance "is a 'rule' within the meaning of the APA," the FDA violated the APA by issuing it without complying with the notice and comment requirements for rule-making. Id. ¶¶ 105-07; see also id. ¶¶ 103-10 (Count II). Additionally, Plaintiffs claim that the August 2017 Guidance "is arbitrary and capricious" because
FDA offered no contemporaneous explanation whatsoever in the Guidance to justify [its] decisions [regarding deadlines]
*491or to explain how those decisions are remotely consistent with FDA's statutory obligations to protect the public health from the dangers of tobacco products, the purposes of the Tobacco Control Act, the administrative record before the agency in the Deeming Rule, or FDA's own prior findings.
Id. ¶ 113; see id. ¶¶ 111-18 (Count III); see also id. ¶¶ 115-17 (August 2017 Guidance is inconsistent with compliance policy adopted in Deeming Rule and the findings in the Deeming Rule and other FDA statements, and the inconsistencies are unexplained). Specifically, they claim that "FDA failed to address-much less explain-how an indefinite review period comports with the 180-day review period prescribed by Congress in the Tobacco Control Act. 21 U.S.C. § 387j(c)(1)(A)," and did not "identif[y] any basis on which it determined the length of the newly announced compliance periods, nor has it provided any reasoned basis for establishing different compliance periods for different product types-an approach it had previously rejected." Id. ¶ 114. On these bases, Plaintiffs ask the Court to vacate the August 2017 Guidance.
Defendants counter that the August 2017 Guidance "is fully consistent with the statutory text, is a policy statement exempt from notice and comment, and reflects an entirely reasonable enforcement strategy." Defs.' Mem. 33. As they see it, the Guidance "does not purport to modify or interpret any provision of the TCA [Tobacco Control Act]. Rather, it simply states that the FDA 'does not intend to enforce a particular requirement' of the statute for a limited period," which they insist is "an entirely unexceptional exercise of enforcement discretion that conflicts with no legislative directive." Id. (citing Aug. 2017 Guidance 4, ECF No. 48-1, at 717, GAR 425). And, Defendants insist that its publication of the August 2017 Guidance was neither arbitrary nor capricious because it "rationally explained its updated enforcement policy," and its "explanation was more than sufficient." Id. at 43, 45.
Tobacco Control Act's Provisions and Extent of FDA's Statutory Authority
The power of an agency like the FDA "is 'not the power to make law. Rather, it is "the power to adopt regulations to carry into effect the will of Congress as expressed by the statute." ' " Brown & Williamson Tobacco Corp. v. Food & Drug Admin. ,
In Brown , decided more than a decade before the Tobacco Control Act went into effect and authorized the FDA to regulate *492tobacco products' manufacture and distribution, the Fourth Circuit considered a final rule that the FDA published that "set out regulations restricting the sale and distribution of cigarettes and smokeless tobacco (collectively referred to as tobacco products) to minors and limiting the advertising and promotion of tobacco products."
This is not a case about whether additional or different regulations are needed to address legitimate concerns about the serious health problems related to tobacco use, and particularly youth tobacco use, in this country. At its core, this case is about who has the power to make this type of major policy decision.
Id. at 176.
Here, as noted, FDA's across-the-board suspension of the Tobacco Control Act's premarket approval process, with regard to applications, substantial equivalence reports, exemption requests, approval and enforcement of these requirements, amounts to a rule amendment or revocation, as it is inconsistent with the statute. See Acosta ,
Moreover, the August 2017 Guidance defeats, rather than furthers, the purpose of the Tobacco Control Act by allowing unapproved tobacco products to be manufactured, advertised, and sold for five years or longer, and informing the manufacturers that the Tobacco Control Act requirements for premarket review will not be enforced. Instead of addressing public health concerns associated with tobacco use by minors and others, the August 2017 Guidance exacerbates the situation by stating, in essence, that manufacturers can continue to advertise and sell products that are addictive and that target a youth market, like the "Apple Juice" e-cigarette discussed in Plaintiffs' Complaint, at a time when minors' use of tobacco products like e-cigarettes is at an epidemic level and rising. Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that already are approved-results entirely contrary to the express purpose of the Tobacco Control Act. The publication of the August 2017 Guidance clearly was contrary to the Tobacco Control Act's purpose and therefore an ultra vires action through which the FDA "exceeded the authority granted to it by Congress, and its...action cannot stand." See Brown & Williamson ,
*493Defendants argue-and indeed the August 2017 Guidance itself states-that it is an exercise of "enforcement discretion." See Defs.' Mem. 33; Aug. 2017 Guidance 4, ECF No. 48-1, at 717, GAR 425. Certainly, Plaintiffs themselves refer to Defendants' enforcement discretion, but Plaintiffs' use of the term does not mean that it is applicable under the facts of this case.
It is true that the Supreme Court "has recognized on several occasions over many years that an agency's decision not to prosecute or enforce, whether through civil or criminal process, is a decision generally committed to an agency's absolute discretion." Chaney,
Further, the "enforcement discretion" argument is a red herring, because the August 2017 Guidance does not fulfill the purpose for which an agency is granted enforcement discretion. As for why an agency has enforcement discretion, the Supreme Court explained:
[A]n agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its expertise. Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency's overall policies, and, indeed, whether the agency has enough resources to undertake the action at all. An agency generally cannot act against each technical violation of the statute it is charged with enforcing. The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities....
Chaney ,
The Chaney Court also observed that
an agency's refusal to institute proceedings shares to some extent the characteristics of the decision of a prosecutor *494in the Executive Branch not to indict-a decision which has long been regarded as the special province of the Executive Branch, inasmuch as it is the Executive who is charged by the Constitution to "take Care that the Laws be faithfully executed." U.S. Const., Art. II, § 3.
Chaney ,
Notice and Comment
Plaintiffs contend that the August 2017 Guidance must be vacated because the FDA did not follow the APA's notice and comment requirements in issuing it. Pls.' Mem. 16. Defendants counter that the August 2017 Guidance "is a policy statement exempt from notice and comment." Defs.' Mem. 33.
"[W]hen an agency issues new 'legislative' or 'substantive' rules that establish binding norms having the force of law," it must follow the APA's notice and comment requirements. Mallinckrodt Inc. v. United States Food & Drug Admin. , No. DKC-14-3607,
A rule is "the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy."
if any one of the following four questions is answered in the affirmative:
(1) whether in the absence of the rule there would not be an adequate legislative basis for...agency action to confer benefits or ensure the performance of duties,
(2) whether the agency has published the rule in the Code of Federal Regulations,
(3) whether the agency has explicitly invoked its general legislative authority, or
(4) whether the rule effectively amends a prior legislative rule.
Id. at *11-12 (quoting Berlex ,
In Mallinckrodt ,
The existing FDA regulation requires the submission of "data derived from nonclinical laboratory and clinical studies."21 C.F.R. § 601.2 (a). In the guidance document, FDA interpreted that language to include data from clinical studies completed on "comparable" biological products. Comparability Guidance Document, 3. That interpretation extended the boundaries of previous FDA actions and policies, to be sure, but it did not "run[ ] 180 degrees counter to the plain meaning of the regulation," as did the agency directive at issue in National Family Planning and Reproductive Health Ass'n, Inc. v. Sullivan,979 F.2d 227 , 235 (D.C. Cir. 1992).
In McCarthy , the appellate court similarly had considered whether an Environmental Protection Agency ("EPA") guidance document "was a general policy statement or a legislative rule subject to judicial review," concluding that it was a policy statement. Mallinckrodt ,
The court emphasized that in determining whether something is a legislative rule "[t]he most important factor concerns the actual legal effect (or lack thereof) of the agency action in question on regulated entities." The court noted that the guidance document in question...did "not tell regulated parties what they must do or may not do in order to avoid liability[,]" did not impose "obligations or prohibitions on regulated entities[,]" could not serve as "the basis for an enforcement action against a regulated entity[,]" and did "not impose[ ] any requirements in order to obtain a permit or license." In addition, the court assessed the agency's characterization of the guidance, and noted that the document itself "disclaims any intent to require anyone to do anything" and the language used throughout the document was devoid of commands, requirements, or orders.
The Mallinckrodt Court likewise concluded that the FDA draft guidance document *496before it, which reclassified a drug of Mallinckrodt's, "was an interpretive rule rather than a legislative rule." Id. at *13. It reasoned that the FDA had a pre-existing duty to determine whether bioequivalence had been established and therefore had "the authority to require Mallinckrodt to establish the bioequivalence of its drug using the criteria and measurements FDA f[ound] necessary for the given product"; the "FDA did not invoke its general authority" to publish the draft guidance document; the language of the draft guidance document stated that it did "not create or confer any right"; and "the document itself [wa]s devoid of commands, orders, or binding requirements." Id. Additionally, it found that the draft guidance document "did not effectively amend a prior legislative rule because it 'neither repudiate[d] nor [wa]s inconsistent with any pre-existing FDA regulations"; rather, it "merely fine-tuned the measurements and metrics it believe[d] [we]re most useful in measuring bioequivalence" in the drug at issue. Id. at *14. The court explained:
It has done so by altering its 2012 Guidance Document to tweak its recommendations on what measures are most helpful in determining this particular product's bioequivalence. The recommended studies and metrics in the 2014 Guidance Document are consistent with the agency's regulations on bioequivalence and with the recommendations made in the 2012 Guidance Document. The revised 2014 Guidance Document merely requests some additional metrics to ensure the drug's bioequivalence, as the prior metrics may not adequately capture the bioequivalence and efficacy of the drug in the later phases of the twelve-hour dose. The additional metrics requested by FDA fall within the normal range of evidence and measures that FDA may request as part of its process of assessing bioequivalence. Accordingly, FDA's 2014 Guidance Document is not irreconcilable with nor does it repudiate FDA's regulations on bioequivalence or FDA's prior 2012 Guidance Document. The Guidance Document merely clarifies the metrics FDA believes are helpful in showing bioequivalence.
Id. (citations to record and C.F.R. omitted).
National Mining Association v. Jackson ,
As explained above in regard to the Court's finality analysis, based on the record currently before the Court the MCIR Assessment, the EC Process Memoranda, and the Guidance Memorandum all appear to qualify as legislative *497rules because they seemingly have altered the permitting procedures under the Clean Water Act by changing the codified administrative review process. Thus, the MCIR Assessment, the EC Process, and the Guidance Memorandum all seem to "effectively amend" the Clean Water Act's permitting process, Am. Mining Cong.,995 F.2d at 1112 , and represent the EPA's adoption of a new position inconsistent with an existing regulation. U.S. Telecom Ass'n,400 F.3d at 34-35 .
Finally, in National Family Planning and Reproductive Health Ass'n, Inc. v. Sullivan ,
Observing that "[i]t is a maxim of administrative law that: 'If a second rule repudiates or is irreconcilable with [a prior legislative rule], the second rule must be an amendment of the first; and, of course, an amendment to a legislative rule must itself be legislative,' " the court concluded that the directive was a legislative rule because its "interpretation of the [regulation ran] 180 degrees counter to the plain meaning of the regulation" and its earlier interpretation of the regulation.
Here, as discussed with regard to finality, the August 2017 Guidance is not a policy statement; it is tantamount to an amendment to the Tobacco Control Act. As with the guidance and other documents at issue in Jackson , the August 2017 Guidance implements "changes to the statutorily established process."
*498Berlex ,
Conclusion
In sum, Plaintiffs' Motion for Reconsideration, ECF No. 63, IS GRANTED and the parties' cross-motions, ECF Nos. 31 and 36, ARE REOPENED; Defendants' Motion to Dismiss or, in the Alternative, for Summary Judgment, treated as a motion for summary judgment, IS DENIED; and Plaintiffs' Motion for Summary Judgment, ECF No. 31, IS GRANTED. This Memorandum Opinion and the accompanying Order vacate the FDA's August 2017 Guidance.
Given that the application deadlines set in the Deeming Rule and the May 2017 Guidance have passed, Plaintiffs will submit additional briefing regarding a remedy (which should be specific, rather than generalized), in fifteen pages or less, within fourteen days of the date of this Memorandum Opinion. Defendants will have fourteen days to respond, in fifteen pages or less, and Plaintiffs will have five business days to reply, in ten pages or less. Any Guidance providing for a compliance period will, of course, have to adhere to the notice and comment requirements of the APA. Even so, manufacturers long have been on notice that they will have to file premarket approval applications, substantial equivalence reports, and exemption requests, and if they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to comply is of their own making. And, in adopting new Guidance, the APA can propose that the deadlines can be set sufficiently soon beyond the end of the notice and comment period to afford relief to Plaintiffs and to attempt to combat the epidemic-level use of new tobacco products like e-cigarettes, especially by teenagers.
A separate order will issue.
These electronic nicotine products are more accurately-and ironically-called "ENDS"- "electronic nicotine delivery systems." See Stmt. of FBA Commissioner, ECF No. 43-2.
Alex M. Azar is the Secretary of the U.S. Department of Health and Human Services. Until April 2019, Scott Gottlieb was the Commissioner of the Food and Drug Administration ("FDA"). E-cigarettes are devices that use "a small battery to heat a liquid that contains nicotine" and then "turn the liquid into an inhalable vapor." Azar & Gottlieb Op. Ed.
On May 10, 2016, the FDA adopted the "Deeming Rule" to deem electronic nicotine device systems ("e-cigarettes"), cigars, and pipe tobacco subject to regulatory controls under the Tobacco Control Act. See Deeming Rule,
"Citations to 'AR' in the parties' briefs are to the Deeming Rule's administrative record, which has 'FDA' Bates-stamped page numbers. Citations to 'GAR' are to the separate administrative record for the Guidance, which is separately paginated with 'FDA GUID' Bates-stamped pages." Notice 2 n.1, ECF No. 48.
E-cigarettes come in flavors including maple, vanilla, and coconut. See Popcorn Lung: A Dangerous Risk of Flavored E-Cigarettes (ALA July 7, 2016), https://www.lung.org/about-us/blog/2016/07/popcorn-lung-risk-ecigs.html (last updated Sept. 18, 2018). As an example of a tobacco product "targeted at children and teenagers," Plaintiffs note that there is "an 'Apple Juice' e-cigarette product":
Compl. ¶ 41.
The parties fully briefed the motions. ECF Nos. 31-2, 36-1, 39, 43, 44-1. Plaintiffs also filed a Notice of Errata, ECF No. 47, and Notices of Supplemental Authority, ECF Nos. 54, 58, and the parties informally addressed steps that the FDA has taken since the parties filed their motions. ECF Nos. 51, 53, 59, 61. Right to be Smoke-Free Coalition filed an amicus curiae brief. ECF No. 37- 1. A hearing is not necessary. See Loc. R. 105.6.
When a plaintiff does not have standing, its claim is not justiciable. Flast v. Cohen ,
The Tobacco Control Act has been codified, in part, as part of the FDCA. See
On most occasions, the Act refers to the authority of the Secretary of the
Department Health and Human Services (HHS) to take certain actions. However, the Secretary acts through the Commissioner of Food and Drugs.
Brown & Williamson Tobacco Corp. v. Food & Drug Admin. ,
Because the undisputed evidence establishes that the August 2017 Guidance conflicts with the Tobacco Control Act and needed to follow the APA's notice and comment requirements, but failed to do so, I will grant Plaintiffs' motion on those grounds. Therefore, I need not consider their argument regarding whether Defendants' actions were arbitrary and capricious.
As noted above, the second requirement for finality is that "the action must be one by which rights or obligations have been determined or from which legal consequences will flow." Bennett v. Spear,