Bidi Vapor LLC v. U.S. Food & Drug Admin.

47 F.4th 1191

BIDI VAPOR LLC, Petitioner,

v.U.S. FOOD AND DRUG ADMINISTRATION, Acting Commissioner of U.S. Food and Drug Administration, U.S. Department of Health and Human Services, Respondents.

Diamond Vapor LLC, Petitioner,

v.U.S. Food and Drug Administration, Respondent.

Johnny Copper, L.L.C., Petitioner,

v.U.S. Food and Drug Administration, Respondent.

Vapor Unlimited LLC, Petitioner.

v.U.S. Food and Drug Administration, Respondent.

Union Street Brands L.L.C., Petitioner,

v.U.S. Food and Drug Administration, Respondent.

Pop Vapor Co. LLC, Petitioner,

v.U.S. Food and Drug Administration, Respondent.

No. 21-13340

No. 21-13387

No. 21-13438

No. 21-13454

No. 21-13521

No. 21-13522

United States Court of Appeals, Eleventh Circuit.

Filed: August 23, 2022

Eric P. Gotting, Keller & Heckman, Washington, DC, Maureen Berard Soles, Baker & Hostetler, LLP, Orlando, FL, for Petitioner in No. 21-13340.

Jerad Najvar, Austin M.B. Whatley, Najvar Law Firm, PLLC, Houston, TX, Christophir A. Kerr, Christophir A. Kerr, Esq., Largo, FL, for Petitioner in No. 21-13387.

Jerad Najvar, Austin M.B. Whatley, Najvar Law Firm, PLLC, Houston, TX, for Petitioner in Nos. 21-13438, 21-13454, 21-13521.

Eric N. Heyer, Joseph A. Smith, Jessica Tierney, Thompson Hine, LLP, Washington, DC, Seth A. Litman, Thompson Hine, LLP, Two Alliance Ctr, Atlanta, GA, for Petitioner in No. 21-13522.

Alisa Beth Klein, U.S. Attorney General's Office, Washington, DC, Kimberly Ruthsatz Stephens, Hilary Keith Perkins, U.S. Department of Justice, Civil Division, Washington, DC, Daniel J. Berry, Department of Health & Human Services, Office of General Counsel, Washington, DC, Courtney Dixon, U.S. Department of Justice, Civil Division, Appellate Staff, Washington, DC, Perham Gorji, Federal Trade Commission - DC, Washington, DC, David Mednick, Mark Raza, Wendy S. Vicente, Mitch Zeller, U.S. Food and Drug Administration, Office of the Chief Counsel, Silver Spring, MD, for Respondents in No. 21-13340.

Isaac Belfer, Trial Attorney, Zachary Cowan, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, Lindsey Powell, U.S. Attorney General's Office, Washington, DC, Kimberly Ruthsatz Stephens, Jonathan Amgott, Trial Attorney, Hilary Keith Perkins, U.S. Department of Justice, Civil Division, Washington, DC, Daniel J. Barry, Department of Health & Human Services, Office of General Counsel, Washington, DC, Mark Raza, Janet Woodcock, Mitch Zeller, U.S. Food and Drug Administration, Office of the Chief Counsel, Silver Spring, MD, for Respondent in No. 21-13387.

Zachary Cowan, Isaac Belfer, Trial Attorney, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, Joshua Koppel, U.S. Attorney General's Office, Washington, DC, Hilary Keith Perkins, Kimberly Ruthsatz Stephens, U.S. Department of Justice, Civil Division, Washington, DC, Daniel J. Barry, Department of Health & Human Services, Office of General Counsel, Washington, DC, Matthew R. Holman, Grace Kaiyuan, Wendy S. Vicente, Janet Woodcock, Mitch Zeller, U.S. Food and Drug Administration, Office of the Chief Counsel, Silver Spring, MD, for Respondent in No. 21-13438.

Jonathan Amgott, Trial Attorney, Hilary Keith Perkins, Kimberly Ruthsatz Stephens, U.S. Department of Justice, Civil Division, Washington, DC, Zachary Cowan, Isaac Belfer, Trial Attorney, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, Joshua Koppel, U.S. Attorney General's Office, Washington, DC, Daniel J. Barry, Department of Health & Human Services, Office of General Counsel, Washington, DC, Wendy S. Vicente, Janet Woodcock, Mitch Zeller, U.S. Food and Drug Administration, Office of the Chief Counsel, Silver Spring, MD, for Respondent in No. 21-13454.

Zachary Cowan, Isaac Belfer, Trial Attorney, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, Joshua Koppel, U.S. Attorney General's Office, Washington, DC, Jonathan Amgott, Trial Attorney, Hilary Keith Perkins, Kimberly Ruthsatz Stephens, U.S. Department of Justice, Civil Division, Washington, DC, Daniel J. Barry, Department of Health & Human Services, Office of General Counsel, Washington, DC, Wendy S. Vicente, Janet Woodcock, Mitch Zeller, U.S. Food and Drug Administration, Office of the Chief Counsel, Silver Spring, MD, for Respondent in No. 13521.

Joshua Koppel, U.S. Attorney General's Office, Washington, DC, Daniel J. Barry, Department of Health & Human Services, Office of General Counsel, Washington, DC, Isaac Belfer, Trial Attorney, U.S. Department of Justice, Office of Consumer Litigation, Washington, DC, Hilary Keith Perkins, Kimberly Ruthsatz Stephens, U.S. Department of Justice, Civil Division, Washington, DC, Wendy S. Vicente, Janet Woodcock, Mitch Zeller, U.S. Food and Drug Administration, Office of the Chief Counsel, Silver Spring, MD, for Respondent in No. 13522.

J. Gregory Troutman, Troutman Law Office, PLLC, Louisville, KY, for Amicus Curiae 37 National and State Electronic Nicotine Delivery System Product Advocacy Associations in No. 21-13340.

Mary G. Bielaska, Zanicorn Legal, PLLC, New York, NY, James Monroe Chambers, McDowell Hetherington, LLP, Arlington, TX, for Amici Curiae David B. Abrams, Clive D. Bates, David T. Sweanor in No. 21-13340.

Sara Lawson, Zuckerman Spaeder, LLP, Tampa, FL, for Amicus Curiae Medical and Public Health Groups in No. 21-13340.

Sara Lawson, Zuckerman Spaeder, LLP, Tampa, FL, for Amici Curiae Campaign for Tobacco-Free Kids, American Medical Association, American Association of Family Physicians, American Lung Association, American Cancer Society Cancer Action Network, American Academy of Pediatrics, Parents Against Vaping E-Cigarettes, Truth Initiative, 37 National and State Electronic Nicotine Delivery System Product Advocacy Associations in No. 21-13387.

J. Gregory Troutman, Troutman Law Office, PLLC, Louisville, KY, for Amicus Curiae 37 National and State Electronic Nicotine Delivery System Product Advocacy Associations in No. 21-13387.

Sara Lawson, Zuckerman Spaeder, LLP, Tampa, FL, for Amici Curiae Campaign for Tobacco-Free Kids, American Medical Association, American Association of Family Physicians, American Lung Association, American Heart Association, American Cancer Society Cancer Action Network, American Academy of Pediatrics, Parents Against Vaping E-Cigarettes, Truth Initiative in Nos. 21-13438, 21-13454.

Sara Lawson, Zuckerman Spaeder, LLP, Tampa, FL, for Amici Curiae American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, American Medical Association, Campaign for Tobacco-Free Kids, Parents Against Vaping E-Cigarettes, Truth Initiative in No. 21-13521.

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 marketing denial orders to six tobacco companies for their electronic nicotine-delivery systems without considering the companies' marketing 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-access 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 , 576 U.S. 743, 135 S. Ct. 2699, 2706, 192 L.Ed.2d 674 (2015) (quoting Motor Vehicle Mfrs. Ass'n U.S., Inc. v. State Farm Mut. Auto. Ins. Co ., 463 U.S. 29, 43, 103 S.Ct. 2856, 77 L.Ed.2d 443 (1983) ), and the Administration failed to consider the relevant marketing and sales-access-restriction plans, the marketing denial orders were arbitrary and capricious. So, we grant the petitions 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 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 Administration 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 determination, the Administration must 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.

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 Administration'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 Guidance ). E-liquids are defined to "include liquid nicotine, nicotine-containing liquids," and other liquids "that are intended or reasonably expected to be used with or for the human consumption of a tobacco product." Id.

There...