[PUBLISH] In the United States Court of Appeals Hor the Eleventh Circuit

No. 21-13340

BIDI VAPOR LLC, Petitioner, versus U.S. FOOD AND DRUG ADMINISTRATION, ACTING COMMISSIONER OF U.S. FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, Respondents. USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 2 of 70 2 Opinion of the Court 21-13340

Petitions for Review of a Decision of the Food and Drug Administration Agency No. PM0003460

No. 21-13387

DIAMOND VAPOR LLC, Petitioner, versus U.S. FOOD AND DRUG ADMINISTRATION, Respondent.

Petitions for Review of a Decision of the Food and Drug Administration Agency No. PM0003472

USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 3 of 70 21-13340 Opinion of the Court 3

No. 21-13438

JOHNNY COPPER, L.L.C., Petitioner, versus U.S. FOOD AND DRUG ADMINISTRATION, Respondent.

Petitions for Review of a Decision of the Food and Drug Administration Agency No. PM0003757

No. 21-13454

VAPOR UNLIMITED LLC, Petitioner. USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 4 of 70 4 Opinion of the Court 21-13340 versus U.S. FOOD AND DRUG ADMINISTRATION, Respondent.

Petitions for Review of a Decision of the Food and Drug Administration Agency No. PM0003581

No. 21-13521

UNION STREET BRANDS L.L.C., Petitioner, versus U.S. FOOD AND DRUG ADMINISTRATION, Respondent. USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 5 of 70 21-13340 Opinion of the Court 5

Petitions for Review of a Decision of the Food and Drug Administration Agency No. PM0003525

No. 21-13522

POP VAPOR CO. LLC, Petitioner, versus U.S. FOOD AND DRUG ADMINISTRATION, Respondent.

Petitions for Review of a Decision of the Food and Drug Administration Agency No. PM0002546

USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 6 of 70 6 Opinion of the Court 21-13340 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, 135.8. 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. 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 USCA11 Case: 21-13340 Date Filed: 08/23/2022 Page: 7 of 70 21-13340 Opinion of the Court 7 product that was not on the market as of February 15, 2007, is a “new tobacco product.” /d § 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.” /d. § 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 p