GRIPUM LLC v. FDA, 47 F.4th 553

Background

Gripum, LLC manufactures flavored e-liquids for open-system ENDS and submitted a PMTA to the FDA (Sept. 2020) seeking authorization to market hundreds of flavored products.
The FDA issued a marketing denial order (Sept. 8, 2021), finding Gripum failed to show its products were “appropriate for the protection of public health” under 21 U.S.C. § 387j(c)(2) because it lacked product-specific bridging studies and relied on speculative adult-benefit evidence that did not overcome youth-initiation risks.
The statutory APPH standard requires weighing population-level risks and benefits, including whether existing users will stop and nonusers will start.
FDA guidance (2019 and 2020) warned that long-term or product-specific data may be necessary if published evidence cannot be adequately bridged to the applicant’s specific products, and emphasized heightened concern about flavored, cartridge-based products and youth use.
Gripum sued in the Seventh Circuit, obtaining a temporary stay pending review, and argued the FDA acted arbitrarily on three principal grounds (lack of ascertainable standards, changed evidentiary rule, and failure to conduct individualized review); Gripum also sought to supplement the record with a post‑argument FDA memorandum (denied).

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether FDA acted arbitrarily by failing to promulgate ascertainable standards for PMTA review	FDA should have issued rules/bright-line thresholds; adjudication arbitrary without them	The statute supplies the comparative APPH standard; agency may apply it case-by-case and need not set numerical thresholds	Court: No; statutory standard suffices and FDA’s case-by-case adjudication was permissible and reasoned
Whether FDA changed its evidentiary standard by later requiring product-specific clinical/longitudinal studies	2019 Guidance indicated long-term studies generally not needed; changing to require product-specific studies violated reliance and was arbitrary	Guidance always contemplated that bridging would be required when existing evidence is not adequately related; no abrupt change	Court: No; 2019 guidance was permissive and consistent with requiring product-specific evidence when bridging is insufficient
Whether FDA failed to engage in individualized review and relied on a categorical presumption that flavors attract youth	FDA used a generalized presumption about youth attraction to flavored products and ignored distinctions (open vs closed systems)	Applicant bears burden to show benefits; FDA reasonably concluded open-system flavored liquids still contribute to youth initiation and Gripum offered no product-specific evidence	Court: No; FDA provided a rational, comparative assessment and Gripum failed to meet its evidentiary burden
Whether the administrative record should be supplemented with an internal FDA memorandum (Bundling and Bracketing memo)	Memo newly released via FOIA is relevant and should be added to the record	Supplemental material is untimely, agency-certified record stands, and the memo would not change the dispositive lack of product-specific benefit evidence	Court: Denied; supplementation untimely and memorandum not sufficiently relevant

Key Cases Cited

Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (U.S. 1983) (APA arbitrary-and-capricious standard: agency must examine relevant data and supply a rational connection between facts and decision)
FCC v. Prometheus Radio Project, 141 S. Ct. 1150 (U.S. 2021) (agency action must be reasonable and reasonably explained under the APA)
DHS v. Regents of the Univ. of Cal., 140 S. Ct. 1891 (U.S. 2020) (when an agency changes course it must consider reliance interests)
FCC v. Fox Television Stations, Inc., 556 U.S. 502 (U.S. 2009) (requirements for adequate explanation when agencies change policy)
Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (U.S. 1971) (presumption of regularity in agency record certification)
Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021) (interpretation of FDA guidance on what evidence may suffice for PMTAs)
Wages & White Lion Invs., LLC v. FDA, 16 F.4th 1130 (5th Cir. 2021) (review of FDA PMTA denials and enforcement discretion)