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`In the
`United States Court of Appeals
`For the Eleventh Circuit
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`No. 21-13340
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`BIDI VAPOR LLC,
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` Petitioner,
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`versus
`U.S. FOOD AND DRUG ADMINISTRATION,
`ACTING COMMISSIONER OF U.S. FOOD AND
`DRUG ADMINISTRATION,
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES,
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` Respondents.
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` [PUBLISH]
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`In the
`United States Court of Appeals
`For the Eleventh Circuit
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`____________________
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`No. 21-13340
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`BIDI VAPOR LLC,
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` Petitioner,
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`versus
`U.S. FOOD AND DRUG ADMINISTRATION,
`ACTING COMMISSIONER OF U.S. FOOD AND
`DRUG ADMINISTRATION,
`U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES,
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` Respondents.
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`Opinion of the Court
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`21-13340
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`____________________
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`Petitions for Review of a Decision of the
`Food and Drug Administration
`Agency No. PM0003460
`____________________
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`____________________
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`No. 21-13387
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`____________________
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`DIAMOND VAPOR LLC,
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`versus
`U.S. FOOD AND DRUG ADMINISTRATION,
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` Petitioner,
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` Respondent.
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`____________________
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`Petitions for Review of a Decision of the
`Food and Drug Administration
`Agency No. PM0003472
`____________________
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`21-13340
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`Opinion of the Court
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`____________________
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`No. 21-13438
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`JOHNNY COPPER, L.L.C.,
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`versus
`U.S. FOOD AND DRUG ADMINISTRATION,
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` Petitioner,
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` Respondent.
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`____________________
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`Petitions for Review of a Decision of the
`Food and Drug Administration
`Agency No. PM0003757
`____________________
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`____________________
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`No. 21-13454
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`VAPOR UNLIMITED LLC,
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` Petitioner.
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`versus
`U.S. FOOD AND DRUG ADMINISTRATION,
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` Respondent.
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`____________________
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`Petitions for Review of a Decision of the
`Food and Drug Administration
`Agency No. PM0003581
`____________________
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`____________________
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`No. 21-13521
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`UNION STREET BRANDS L.L.C.,
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`versus
`U.S. FOOD AND DRUG ADMINISTRATION,
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` Petitioner,
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` Respondent.
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`Opinion of the Court
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`____________________
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`Petitions for Review of a Decision of the
`Food and Drug Administration
`Agency No. PM0003525
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`____________________
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`No. 21-13522
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`____________________
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`POP VAPOR CO. LLC,
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`versus
`U.S. FOOD AND DRUG ADMINISTRATION,
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` Petitioner,
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` Respondent.
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`____________________
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`Petitions for Review of a Decision of the
`Food and Drug Administration
`Agency No. PM0002546
`____________________
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`Opinion of the Court
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`21-13340
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`Before WILLIAM PRYOR, Chief Judge, ROSENBAUM, and BRASHER,
`Circuit Judges.
`WILLIAM PRYOR, Chief Judge:
`These petitions for review concern whether it was arbitrary
`and capricious for the Food and Drug Administration to issue mar-
`keting denial orders to six tobacco companies for their electronic
`nicotine-delivery systems without considering the companies’ mar-
`keting and sales-access-restriction plans designed to minimize
`youth exposure and access. The Administration refused to consider
`the marketing and sales-access-restriction plans based on both its
`need for efficiency and its experience that marketing and sales-ac-
`cess restrictions do not sufficiently reduce youth use of electronic
`nicotine products. Because “agency action is lawful only if it rests
`‘on a consideration of the relevant factors,’” Michigan v. Env’t
`Prot. Agency, 135. S. Ct. 2699, 2706 (2015) (quoting Motor Vehicle
`Mfrs. Ass’n U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S.
`29, 43 (1983)), and the Administration failed to consider the rele-
`vant marketing and sales-access-restrictions plans, the marketing
`denial orders were arbitrary and capricious. So, we grant the peti-
`tions for review, set aside the marketing denial orders, and remand
`to the Administration.
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`I. BACKGROUND
`The Tobacco Control Act of 2009 prohibits manufacturers
`from selling any “new tobacco product” without approval from the
`Food and Drug Administration. See 21 U.S.C. § 387j. Any tobacco
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`product that was not on the market as of February 15, 2007, is a
`“new tobacco product.” Id. § 387j(a)(1). The Act instructs the Ad-
`ministration to deny applications for new tobacco products if,
`based on the information before it, the Administration finds “a lack
`of a showing that permitting such tobacco product to be marketed
`would be appropriate for the protection of the public health.” Id.
`§ 387j(c)(2), (2)(A). Whether a new product is “appropriate for the
`protection of the public health” is determined by evaluating “the
`risks and benefits to the population as a whole, including users and
`nonusers of the tobacco product.” Id. § 387j(c)(4). To make this de-
`termination, the Administration must consider both the “likeli-
`hood that existing users of tobacco products will stop using such
`products” and the “likelihood that those who do not use tobacco
`products will start using such products.” Id.
`In 2016, the Administration deemed that electronic nicotine-
`delivery systems using nicotine derived from tobacco—including
`e-liquids and e-cigarettes—were “tobacco products” within the Ad-
`ministration’s regulatory authority. Deeming Tobacco Products to
`Be Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed.
`Reg. 28,974, 29,028 (May 10, 2016) (hereinafter Deeming Rule).
`The Administration defines e-cigarettes as “electronic device[s]
`that deliver[] e-liquid in aerosol form into the mouth and lungs
`when inhaled.” U.S. FOOD & DRUG ADMIN., PREMARKET TOBACCO
`PRODUCT APPLICATIONS FOR ELECTRONIC NICOTINE DELIVERY
`SYSTEMS: GUIDANCE FOR INDUSTRY 6 (2019) (hereinafter 2019 Guid-
`ance). E-liquids are defined to “include liquid nicotine, nicotine-
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`containing liquids,” and other liquids “that are intended or reason-
`ably expected to be used with or for the human consumption of a
`tobacco product.” Id.
`There are two categories of e-cigarettes: open and closed.
`Open e-cigarettes are typically larger and require the user to re-fill
`a tank with e-liquid. Id. Closed e-cigarettes tend to be smaller and
`are either entirely disposable or use disposable, pre-filled car-
`tridges. Id.
`Because many electronic nicotine-delivery systems were al-
`ready on the market by 2016, the Administration decided to stagger
`its evaluation of the products and allow the products to stay on the
`market in the interim. Deeming Rule, 81 Fed. Reg. at 29,009–10.
`The Administration explained that as it gained more experience
`regulating electronic nicotine-delivery systems, it expected to pro-
`vide more guidance to manufacturers as to what information
`would be required in the premarket authorization applications to
`show that a product was “appropriate for the protection of [the]
`public health.” See id. at 28,997. The original application deadline
`for flavored electronic nicotine-delivery systems was September
`2018, but “a series of schedule changes implemented by the [Ad-
`ministration] and federal courts” moved the final deadline to Sep-
`tember 9, 2020. Breeze Smoke, LLC v. U.S. Food & Drug Admin.,
`18 F.4th 499, 504 (6th Cir. 2021); accord Enforcement Priorities for
`Electronic Nicotine Delivery Systems and Other Deemed Products
`on the Market Without Premarket Authorization (Revised), 85
`Fed. Reg. 23,973, 23,974 (Apr. 30, 2020).
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`Before the September 2020 application deadline, the Admin-
`istration issued nonbinding guidance, hosted public meetings, and
`published a proposed rule to explain to manufacturers what evi-
`dence would be required in their applications. The Administration
`repeatedly represented to tobacco companies that marketing and
`sales-access-restriction plans were relevant to its determination of
`whether their products were “appropriate for the protection of the
`public health.” See 21 U.S.C. § 387j(c)(4). For example, at a public
`meeting in 2018, an Administration representative stated that one
`of the considerations the Administration “ha[d] used in deciding
`whether a [tobacco] product [wa]s appropriate for the protection
`of the public health” was whether “the marketing of the new [prod-
`uct] [would] affect the likelihood of nonuser uptake, cessation
`rates[,] or other significant shifts in user demographics in a manner
`to decrease morbidity and mortality from tobacco product use.”
`IILUN MURPHY, PREMARKET TOBACCO PRODUCT APPLICATION
`CONTENT OVERVIEW, U.S. FOOD & DRUG ADMIN. (Oct. 23, 2018),
`https://www.fda.gov/media/117507/download.
`The Administration repeated this advice when it published
`final guidance on premarket authorization applications for elec-
`tronic nicotine-delivery-system products in June 2019. See 2019
`Guidance, supra. The Administration recommended companies in-
`clude any applicable “restrictions on the sales and distribution” of
`their products in their applications “to help support a showing that
`the marketing of the product would be [appropriate for the protec-
`tion of the public health].” Id. at 20–21; accord id. at 12.
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`The Administration communicated its expectation that
`companies submit marketing and sales-access-restriction plans in a
`proposed rule published in September 2019. The proposed rule in-
`cluded a requirement for applicants to submit marketing plans, in-
`cluding “[a]ny means by which youth-access or youth-exposure to
`the products’ labeling, advertising, marketing, and promotion
`would be limited.” Premarket Tobacco Product Applications and
`Recordkeeping Requirements, 84 Fed. Reg. 50,566, 50,643 (pro-
`posed Sept. 25, 2019) (to be codified at 21 C.F.R. pt. 1114). The pro-
`posed rule explained that the information in an applicant’s market-
`ing plan “is critical to [the Administration’s] determination of the
`likelihood of changes in tobacco product use behavior.” Id. at
`50,581; accord id. (stating that the Administration “will review the
`marketing plan to evaluate potential youth access to, and youth ex-
`posure to the labeling, advertising, marketing, or promotion of, a
`new tobacco product” (emphasis added)). As an example, the pro-
`posed rule stated that “heavy use of online social media to promote
`a tobacco product without access restrictions, as opposed to actions
`such as paper mailings directed only to current smokers of legal
`age, indicates the potential for youth to be exposed to the promo-
`tion of the product.” Id.
`In April 2020, the Administration published a guidance doc-
`ument about its enforcement priorities and “current thinking” on
`electronic nicotine-delivery systems, which detailed the most-cur-
`rent data on youth electronic nicotine-delivery-systems use, the en-
`forcement measures employed by the Administration in its attempt
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`to curb minor use, and the considerations of the Administration
`going forward. See U.S. FOOD & DRUG ADMIN., ENFORCEMENT
`PRIORITIES FOR ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS)
`AND OTHER DEEMED PRODUCTS ON THE MARKET WITHOUT
`PREMARKET AUTHORIZATION (REVISED): GUIDANCE FOR INDUSTRY
`2–3 (Apr. 2020) ( hereinafter 2020 Guidance). The 2020 Guidance
`stated that, since 2017, the Administration had seen “an alarming
`increase in the use of [electronic nicotine-delivery systems] by mid-
`dle and high school students.” Id. at 6. The 2020 Guidance ex-
`plained that, in response, the Administration increased enforce-
`ment against and sent warning letters to manufacturers and retail-
`ers who marketed or sold products to youth. Id. at 6–7. Guidance
`also explained that certain kinds of marketing—such as making
`products “resemble kid-friendly foods and drinks” or “ordinary
`items that may not draw the attention of adults”—“can increase
`youth appeal.” Id. at 25–26; see also id. at 25–27 (identifying cartoon
`figures and entertainment media popular with children as market-
`ing tools that increase popularity with minors). And the Guidance
`stated that 71 percent of current youth users reported using the
`products “because they come in flavors [they] like.” Id. at 14 (inter-
`nal quotation marks omitted).
`The 2020 Guidance also expressed the Administration’s po-
`sition that “age verification alone is not sufficient to address [the
`youth-use] issue” and that “many youth obtain their [products]
`from friends or sources in their social networks.” Id. at 44–45. The
`Administration stated that the policy outlined in the 2020 Guidance
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`“[wa]s a more appropriate means to combat youth use of, and ac-
`cess to, these products.” Id. at 44. And in response to these data,
`the Administration explained its rationale for treating flavored, car-
`tridge-based electronic nicotine-delivery systems different from
`other electronic-nicotine-delivery systems.
`With respect to flavored, cartridge-based systems, the Ad-
`ministration explained that “focusing on how the product was sold
`would not appropriately address youth use of the products that are
`most popular among youth.” Id. at 21. The Administration rea-
`soned that “[t]hese products are produced on a large scale, are easy
`to conceal, can be used discretely, and are not the products typi-
`cally produced in vape shops that mix nicotine with e-liquid fla-
`vors.” Id. And “[g]iven the urgent need to address the dramatic rise
`in youth use,” the 2020 Guidance explained the Administration’s
`decision to “prioritize[] enforcement with respect to any flavored,
`cartridge-based [electronic nicotine-delivery system] products . . .
`without regard to the location or method of sale.” Id.
`But with respect to other electronic nicotine-delivery sys-
`tems, the Administration explained that it “intend[ed] to prioritize
`enforcement for lack of marketing authorization for any” elec-
`tronic nicotine-delivery system products “when the manufacturer
`has not taken or is not taking adequate measures to prevent mi-
`nors’ access to these products.” Id. To that end, the Guidance listed
`“factors the [Administration] intend[ed] to consider” when decid-
`ing if a manufacturer had taken adequate precautions to avoid
`youth use for these other products. Id. at 22. Those factors included
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`“[w]hether the manufacturer ha[d] implemented adequate pro-
`grams to monitor retailer compliance with age-verification and
`sales restrictions” such as hotlines for reporting noncompliant sales
`and mystery shopper programs; “ha[d] established and enforce[d]
`penalties against retailers that fail to comply with age-verification
`and sales restrictions”; was “us[ing] adequate age-verification tech-
`nology” for online sales, such as “an independent, third-party age-
`and identity-verification service that compares customer infor-
`mation against third-party data sources, such as public records”;
`and was “limit[ing] . . . the quantity of . . . products that a customer
`may purchase within a given period of time.” Id.
`On July 9, 2021, the Administration circulated an internal
`memorandum instructing staff on how to evaluate the remaining
`applications not yet in substantive scientific review. The memoran-
`dum explained that the “Office of Science ha[d] been tasked with
`developing a new plan to effectively manage the remaining non-
`tobacco flavored [product applications] not in . . . substantive sci-
`entific review . . . in order to take final action on as many applica-
`tions as possible by September 10, 2021.” The Administration’s
`“objective [wa]s to address these applications by applying a stand-
`ard for evidence necessary to demonstrate an incremental benefit
`to adult smokers of non-tobacco flavored [electronic nicotine-de-
`livery systems] products.” To do so, the Administration adopted a
`“fatal flaw” approach: “the evidence necessary for this evaluation
`would be provided by either a randomized controlled trial . . . or a
`longitudinal cohort study” and “[t]he absence of these types of
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`studies [wa]s considered a fatal flaw, meaning any application lack-
`ing this evidence w[ould] likely receive a marketing denial order.”
`On August 17, 2021, the Administration circulated another
`internal memorandum about the standard of review for non-to-
`bacco-flavored products for “a streamlined scientific review.” The
`memorandum reiterated that, “most likely,” the evidence that
`would be necessary to meet the “high burden for applicants seeking
`to demonstrate a potential benefit to adult smokers that could jus-
`tify th[e] risk” to youth would be a randomized controlled trial or
`a longitudinal cohort study. (Footnote omitted.) But the new mem-
`orandum also stated that the Administration “would also consider
`evidence from another study design, provided that it could reliably
`and robustly assess behavior change (product switching or ciga-
`rette reduction) over time, comparing users of flavored products
`with those of tobacco-flavored products.” The memorandum de-
`tailed the risks to youth and potential benefits to adults justifying
`this standard of review.
`
`The August 17 memorandum also addressed the marketing
`and sales-access-restriction plans contained within many of the ap-
`plications. It acknowledged that “[l]imiting youth access and expo-
`sure to marketing is a critical aspect of product regulation.” But it
`explained that, although “[i]t is theoretically possible that signifi-
`cant mitigation efforts could adequately reduce youth access and
`appeal such that the risk for youth initiation would be reduced,”
`the Administration had not yet evaluated an application that had
`“proposed advertising and promotion restrictions that would
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`decrease appeal to youth to a degree significant enough to address
`and counter-balance the substantial concerns, and supporting evi-
`dence, discussed above regarding youth use.” The Administration
`also stated that it was “not aware of access restrictions that, to date,
`have been successful in sufficiently decreasing the ability of youth
`to obtain and use [electronic nicotine-delivery systems],” so “for
`the sake of efficiency, the evaluation of the marketing plans in ap-
`plications w[ould] not occur at this stage of review.” memorandum
`was rescinded one week later on August 25, 2021.
`
`On August 26, 2021, the Administration announced that it
`had denied authorization for 55,000 flavored products from three
`manufacturers in its first adjudications for the applications that pro-
`gressed to substantive scientific review. Press Release, U.S. Food &
`Drug Admin., FDA Denies Marketing Applications for About
`55,000 Flavored E-Cigarette Products for Failing to Provide Evi-
`dence They Appropriately Protect Public Health (Aug. 26, 2021),
`https://bit.ly/32ehP8C. The Administration explained that it de-
`nied the applications for “lack[] [of] sufficient evidence that they
`have a benefit to adult smokers sufficient to overcome the public
`health threat posed by the well-documented, alarming levels of
`youth use of such products.” Id. It explained that the agency re-
`ceived applications for 6.5 million products from over 500 compa-
`nies, with one company accounting for 4.5 million of the applica-
`tions. Id. It reiterated the evidentiary standard from the rescinded
`August 17 memorandum: that “evidence of benefits to adult smok-
`ers for such products would likely be in the form of a randomized
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`controlled trial or longitudinal cohort study, although the [Admin-
`istration] does not foreclose the possibility that other types of evi-
`dence could be adequate if sufficiently robust and reliable.” Id. The
`Administration explained that it issued marketing denial orders
`“[b]ecause this evidence was absent in th[o]se applications.” Id.
`And the Administration stated that it would “continue to review
`other premarket tobacco applications for non-tobacco flavored
`[products] to determine whether there is sufficient product-specific
`scientific evidence of a benefit to adult smokers to overcome the
`risk posed to youth” and that “in the absence of this evidence, the
`agency intend[ed] to issue a[ marketing denial order].” Id.
`Petitioners are tobacco companies that manufacture elec-
`tronic nicotine-delivery system products and applied for premarket
`authorization before the September 2020 deadline. Bidi Vapor LLC
`applied for premarket authorization for eleven electronic nicotine-
`delivery systems called “BIDI Sticks.” BIDI Sticks are disposable,
`closed electronic nicotine-delivery systems pre-filled with flavored
`e-liquid. BIDI Sticks come in eleven flavors: one tobacco and ten
`non-tobacco flavors. Bidi’s application included product infor-
`mation, scientific safety testing, literature reviews, consumer in-
`sight surveys, and details about the company’s youth-access-pre-
`vention measures, distribution channels, and adult-focused mar-
`keting practices. Regarding its marketing and sales-access re-
`strictions, Bidi stated in its application that the company’s “market-
`ing strategies target only existing adult vapor product users, includ-
`ing current adult smokers.” Toward that end, Bidi discontinued
`
`
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`direct sales through its website, declines to advertise anywhere
`other than its age-gated website and adult-only brick-and-mortar
`stores, and monitors its limited distribution channels for compli-
`ance with its adult-only marketing and sales policies. Bidi requires
`all “downstream business partners to establish and publicize a hot-
`line for anonymous reporting of non-compliant sales and [to] im-
`plement a policy of notifying the [Administration] of retailer viola-
`tions.” “Bidi . . . uses a state-of-the-art authentication system to en-
`sure supply chain security and prevent counterfeit . . . products
`from getting in the hands of consumers . . . [and] to safeguard
`against procurement by minors.” And Bidi renamed the flavors of
`its products “to more neutral names” that would be less attractive
`to youth.
`
`Diamond Vapor LLC, Johnny Copper, L.L.C., Vapor Unlim-
`ited LLC, and Union Street Brands L.L.C. applied for premarket
`authorization for numerous e-liquids meant for use in open-tank
`devices. These tobacco companies submitted survey information
`from their customers about smoking cessation, literature reviews,
`scientific studies about switching to e-cigarettes, smoking cessa-
`tion, and the role of flavors, and details about its marketing and
`youth-access-prevention plans. For example, Diamond uses tech-
`nology for its online sales that relies on public records to verify a
`purchaser’s age. Johnny Copper implemented “Trace/Verify tech-
`nology” on all of its bottles of e-liquids, which involved placing a
`unique QR code on each bottle connected to the driver’s license of
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`the purchaser so that authorities can identify the purchaser if the
`product is later found in the possession of a minor.
`Pop Vapor Co. LLC applied for premarket authorization for
`132 e-liquids and 18 disposable devices. In its application, Pop sub-
`mitted a literature review, a marketing plan, proposed reseller re-
`quirements, and post-market surveillance plans. Pop uses age-veri-
`fication technology that uses public records for its online sales, lim-
`its its “sales channels to online retail sites with adequate online age
`verification software,” and uses only black-and-white labeling to
`“minimize the visual appeal of [its] products.”
`Between September 1 and September 16, 2021, the Admin-
`istration issued nearly identical marketing denial orders to each of
`the tobacco companies for their non-tobacco flavored products.
`The orders stated that the “key basis for [the Administration’s] de-
`termination” was that “[a]ll of [the applications] lack[ed] sufficient
`evidence demonstrating that [the] flavored [products] will provide
`a benefit to adult users that would be adequate to outweigh the
`risks to youth.” Because the Administration did not find such evi-
`dence in the tobacco companies’ applications, it could not “find
`that permitting the marketing of [the] new tobacco products would
`be appropriate for the protection of the public health” and did not
`conduct scientific review of “other aspects of the applications.”
`Alongside the orders, the Administration provided Tech-
`nical Project Lead Reviews for each of the applications. The Re-
`views explained the scope of review: an evaluation as to “whether
`the subject [applications] contain[ed] evidence from a randomized
`
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`controlled trial, longitudinal cohort study, and/or other evidence
`regarding the impact of the new products on switching or cigarette
`reduction that could potentially demonstrate the added benefit to
`adult users of their flavored [products] over an appropriate com-
`parator tobacco-flavored [product].” Because the applications did
`not include such evidence, the Administration issued marketing de-
`nial orders to each of the tobacco companies for all of their flavored
`products. The discussion sections of the Reviews were nearly iden-
`tical to the rescinded August 17 memorandum. The Reviews also
`included the same footnote from the August 17 memorandum ex-
`plaining that the Administration did not evaluate the marketing
`plans “for the sake of efficiency” because the Administration was
`“not aware of access restrictions that, to date, have been successful
`in sufficiently decreasing the ability of youth to obtain and use
`[electronic nicotine-delivery systems].”
`
`Finally, the record includes the forms that Administration
`staff used to evaluate the authorization applications. The forms had
`only three criteria: whether the application included a randomized
`controlled trial on new product use and smoking behavior, a lon-
`gitudinal cohort study on the same, or other evidence related to
`the potential benefit to adults of flavored products compared to to-
`bacco-flavored products. For each of the tobacco companies’ appli-
`cations, the checkboxes next to the randomized-controlled-trial
`and longitudinal-cohort-study criteria were marked “absent,” and
`the “[o]ther evidence” criterion was marked “N/A.”
`
`
`
`USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 20 of 70
`
`20
`
`Opinion of the Court
`
`21-13340
`
`After the tobacco companies had received marketing denial
`orders, the Administration published its Final Rule. Premarket To-
`bacco Product Applications and Recordkeeping Requirements, 86
`Fed. Reg. 55,300 (Oct. 5, 2021) (to be codified at 21 C.F.R. pt. 1100
`et seq.). Section 1114.7(f)(2) of the Final Rule explicitly requires ap-
`plications to contain a “Description of Marketing Plans,” which
`must include a description of the companies’ intended audience, its
`plan to target that audience in its labeling, advertising, and market-
`ing, and a discussion of how access to the new products would be
`restricted with respect to youth. See 86 Fed. Reg. at 55,419–20 (to
`be codified at 21 C.F.R. § 1114.7(f)(2)). The explanation accompa-
`nying the Final Rule stated that information contained in market-
`ing plans is “necessary for [the Administration] to properly evaluate
`the extent of youth exposure . . . and youth access to the product”
`and “is directly relevant to the . . . [Administration’s] consideration
`of the likelihood that youth will use the tobacco product and its
`determination that permitting the product to be marketed would
`be [appropriate for the protection of the public health].” Id. at
`55,324.
`
`In response to the marketing denial orders, the tobacco com-
`panies each timely filed petitions for review. We stayed the mar-
`keting denial orders for Bidi Vapor, Diamond Vapor, Johnny Cop-
`per, and Vapor Unlimited. Some of the petitions were consolidated
`before oral argument, and we consolidate the remaining petitions
`for decision.
`
`II. STANDARDS OF REVIEW
`
`
`
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`21-13340
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`Opinion of the Court
`
`21
`
`We “hold unlawful and set aside agency action[s]” that are
`“arbitrary, capricious, an abuse of discretion, or otherwise not in
`accordance with law.” 5 U.S.C. § 706(2), (2)(A); VHV Jewelers, LLC
`v. Wolf, 17 F.4th 109, 114 (11th Cir. 2021). We consider only “the
`basis articulated by the agency itself,” not “appellate counsel’s post
`hoc rationalizations.” State Farm, 463 U.S. at 50; see also Dep’t
`Homeland Sec. v. Regents of the Univ. of Cal., 140 S. Ct. 1891, 1909
`(2020) (‘‘An agency must defend its actions based on the reasons it
`gave when it acted.’’).
`
`III. DISCUSSION
`The “arbitrary-and-capricious standard requires that agency
`action be reasonable and reasonably explained.” Fed. Commc’ns
`Comm’n v. Prometheus Radio Project, 141 S. Ct. 1150, 1158 (2021).
`“It follows that agency action is lawful only if it rests ‘on a consid-
`eration of the relevant factors.’” Michigan, 135 S. Ct. at 2706 (quot-
`ing State Farm, 463 U.S. at 43). “Normally, an agency rule would
`be arbitrary and capricious if the agency . . . entirely failed to con-
`sider an important aspect of the problem . . . .” State Farm, 463 U.S.
`at 43. To determine if an agency considered all the “relevant fac-
`tors” and “important aspect[s] of the problem,” a court may look
`to the language of the relevant statutes, see, e.g., Michigan, 135 S.
`Ct. at 2706–08 (determining whether cost was a relevant factor by
`interpreting the statutory phrase “appropriate and necessary”) (in-
`ternal quotation marks omitted), regulations, see, e.g., Ctr. for Bi-
`ological Diversity v. U.S. Bureau of Land Mgmt., 698 F.3d 1101,
`1122
`(9th Cir. 2012)
`(determining whether “groundwater
`
`
`
`USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 22 of 70
`
`22
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`Opinion of the Court
`
`21-13340
`
`withdrawals were a relevant factor” by looking to the Endangered
`Species Act regulations), the administrative record, see, e.g., id. at
`1123–24 (finding support in the record of “the possible impact of
`ground water withdrawal on surface water levels” and concluding
`that “therefore . . . the Biological Opinion should have addressed
`it”) and even “beyond the administrative record,” id. at 1123 n.14.
`To decide if a new tobacco product is “appropriate for the
`protection of the public health,” 21 U.S.C. § 387j(c)(2)(A), the To-
`bacco Control Act requires the Administration to consider “the
`risks and benefits to the population as a whole, including users and
`nonusers of the tobacco product,” and explicitly instructs the Ad-
`ministration to consider both the “likelihood that existing users of
`tobacco products will stop using such products” and the “likelihood
`that those who do not use tobacco products will start using such
`products,” id. § 387j(c)(4). The Administration’s 2019 Guidance
`recommended that companies include any applicable “restrictions
`on the sales and distribution” of their products in their applications
`“to help support a showing that the marketing of the product
`would be [appropriate for the protection of the public health], 2019
`Guidance, supra, at 20–21, and the Administration’s 2020 Guidance
`included marketing and sales-access-restriction plans in the “factors
`the [Administration] intend[ed] to consider” when deciding if a
`manufacturer had taken adequate precautions to avoid youth use,
`2020 Guidance, supra, at 22. Although there was not a final, pub-
`lished regulation in effect at the time the marketing denial orders
`were issued in September 2021, both the proposed rule published
`
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