Gripum, LLC v. U.S. Food & Drug Admin.

• Citation: 47 F.4th 553
• Decision Date: 29 August 2022
• Docket Number: 21-2840
• Parties: GRIPUM, LLC, Petitioner, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Respondent.
• Court: U.S. Court of Appeals — Seventh Circuit

47 F.4th 553

GRIPUM, LLC, Petitioner,
v.
UNITED STATES FOOD AND DRUG ADMINISTRATION, Respondent.

No. 21-2840

United States Court of Appeals, Seventh Circuit.

Argued April 20, 2022
Decided August 29, 2022

J. Gregory Troutman, Attorney, Troutman Law Office, PLLC, Louisville, KY, for Petitioner.

Lindsey Powell, Department of Justice, Civil Division, Appellate Staff, Washington, DC, Kate Talmor, Attorney, Department of Justice, Civil Division, Federal Programs Branch, Washington, DC, Daniel J. Barry, Department of Health and Human Services, Washington, DC, for Respondent.

Mary G. Bielaska, Attorney, Zanicorn Legal PLLC, New York, NY, for Amici Curiae David B. Abrams, Doctor, Clive D. Bates, David T. Sweanor.

Rodney L. Lewis, Attorney, Polsinelli PC, Chicago, IL, for Amici Curiae American Academy of Family Physicians, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association.

Before Wood, Hamilton, and Kirsch, Circuit Judges.

Wood, Circuit Judge.

47 F.4th 555

Gripum, LLC, manufactures and distributes hundreds of flavored liquids for use in e-cigarette devices. Seeking to take its products to market, Gripum submitted a "premarket tobacco product application" to the federal Food and Drug Administration (FDA) in September 2021. But the agency denied the application, reasoning that Gripum had failed to demonstrate public-health benefits as required by the Family Smoking Prevention and Tobacco Control Act (the Act), see 21 U.S.C. § 387j. We now deny Gripum's petition for review of the FDA's decision, finding that the agency's approach to adjudicating the application was both reasoned and consistent with the Act.

I

A

Commonly known as "e-cigarettes," electronic nicotine delivery systems (called ENDS in bureaucratese) vaporize nicotine-laden "e-liquid" for users to inhale. Users have a choice of devices that accomplish that function and thus allow "vaping." The delivery systems come in an open form, which takes refillable cartridges, and a closed form, which requires single-use cartridges. There is a huge number of flavor options for the cartridges. Some e-liquids mimic traditional cigarette flavors such as tobacco or menthol. Others, like the e-liquid products at issue in this case, taste like candy, fruit, or baked goods. All, however, are laced with nicotine.

Under the Act, manufacturers of a "new tobacco product"—defined as a product that was not on the market as of February 15, 2007—must receive authorization from the FDA prior to marketing that product. As concern grew over the dangerous health consequences of vaping and e-cigarette use, the FDA promulgated the "Deeming Rule" in May 2016. See 81 Fed. Reg. 28,974 (May 10, 2016). This brought all "tobacco" products, including e-cigarettes and their delivery systems, under the Act's premarket-authorization requirements.

Most relevant for our purposes is the Act's command that the Secretary of Health and Human Services "shall deny an application" to market a new tobacco product if the manufacturer fails to show that the product would be "appropriate for the protection of public health." This is commonly referred to as the "APPH" standard, but in the interest of using plain English, we will call it the "appropriateness" standard. 21 U.S.C. § 387j(c)(2). To determine whether a product meets the appropriateness standard, the Secretary must consider "the risks and benefits to the population as a whole, including users and nonusers of the tobacco product." Id. That assessment, in turn, must take into account the "increased or decreased likelihood that":

(A) "existing users of tobacco products will stop using such products"; and

(B) "those who do not use tobacco products will start using such products."

Id. § 387j(c)(4). In other words, the Secretary must weigh a product's risks of hooking new users (typically youth) into the world of tobacco, broadly defined, against its potential to help existing users (typically adults) wean themselves from tobacco's unhealthier forms (namely, combustible cigarettes).

47 F.4th 556

As a matter of enforcement discretion, the FDA specified in its 2016 Deeming Rule that manufacturers would be given two to three years to prepare market applications for the e-cigarette products already on the market. See 81 Fed. Reg. at 28,978. Soon thereafter, youth e-cigarette use exploded across the country. From 2017 to 2018, the number of high schoolers using e-cigarettes rose by over seventy-five percent. See FDA, Results From 2018 National Youth Tobacco Survey Show Dramatic Increase in E-Cigarette Use Among Youth Over Past Year (Nov. 15, 2018). With the urgency of the situation in mind, the FDA began around late 2017 to step up its enforcement efforts against products that targeted youth. See Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised): Guidance for Industry 6–7 (Apr. 2020) (hereinafter 2020 Guidance).

In 2019, the FDA issued a guidance document to help manufacturers prepare applications. See Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems: Guidance...