Abuse Liability as an Independently Sufficient Basis for FDA Marketing Denial of ENDS Products

Introduction

This commentary examines the Eleventh Circuit’s April 24, 2025 decision in Bidi Vapor LLC v. U.S. Food and Drug Administration, No. 24-10263. Bidi Vapor sought to market its tobacco-flavored electronic nicotine delivery system (“ENDS”) product, the Bidi Stick – Classic (“Bidi Classic”), by filing a Premarket Tobacco Product Application (“PMTA”) with FDA. After identifying multiple deficiencies, FDA issued a Marketing Denial Order (“MDO”), relying primarily on concerns about Bidi Classic’s high abuse liability. Bidi Vapor challenged the denial under the Tobacco Control Act (“TCA”) and the Administrative Procedure Act (“APA”). The Eleventh Circuit affirmed, holding that the abuse liability deficiency alone provided a rational, legally sufficient basis for FDA’s action.

Summary of the Judgment

The Court of Appeals for the Eleventh Circuit:

Reviewed FDA’s MDO under the APA’s “arbitrary, capricious” standard.
Concluded that FDA carefully examined the evidence showing Bidi Classic delivered nicotine at levels equal to or higher than combustible cigarettes and used nicotine salts that made high concentrations more palatable.
Found a rational connection between those facts and FDA’s determination that the product’s abuse liability posed unacceptable public‐health risks.
Held that because abuse liability was independently sufficient to support denial, the court need not address the other two deficiencies (incomplete leachable‐compound study and inadequate harmful‐constituent comparison data).
Denied Bidi Vapor’s petition for review.

Analysis

Precedents Cited

Tobacco Control Act of 2009 (21 U.S.C. § 387j): Requires FDA to deny any “new tobacco product” that fails to show marketing is “appropriate for the protection of the public health.”
Deeming Rule (81 Fed. Reg. 28974, May 10, 2016): Extended FDA authority to ENDS.
Administrative Procedure Act (5 U.S.C. § 706): Sets the “arbitrary and capricious” review standard.
Motor Vehicle Mfrs. Ass’n v. State Farm (463 U.S. 29, 1983): Requires agencies to “examine the relevant data and articulate a satisfactory explanation” for their decisions.
FDA v. Wages & White Lion Invs., L.L.C. (145 S. Ct. 898, 2025): Reinforced deference to agency expertise in technical determinations.
Fontem US, LLC v. FDA (82 F.4th 1207, D.C. Cir. 2023): Contrasted a denial based solely on technical defects without tying them to public‐health consequences.

Legal Reasoning

The Eleventh Circuit applied the APA’s “arbitrary and capricious” standard, asking whether FDA (1) considered the relevant statutory factors, and (2) connected its fact‐finding to its ultimate decision. Key points in the court’s reasoning include:

Statutory framework: Under 21 U.S.C. § 387j(c)(2)(A), FDA must deny if an applicant fails to show marketing is “appropriate for the protection of the public health.” That inquiry requires balancing benefits to existing users who might switch against risks of new addiction in non‐users.
Abuse liability deficiency: FDA’s review showed Bidi Classic delivered nicotine at levels comparable to or exceeding combustible cigarettes, and its nicotine‐salt formulation increased palatability. These findings supported FDA’s conclusion that Bidi Classic had “high abuse liability,” meaning it would likely foster continued use, addiction, and initiation by youth.
Focused analysis: Because FDA identified abuse liability as an independently sufficient ground for denial, the court declined to reach the leachable‐compound and harmful‐constituent deficiencies.
Deference to FDA expertise: The court emphasized that it should not substitute its own judgment for FDA’s scientific and technical determinations, so long as FDA explained its rationale and considered all relevant factors.

Impact on Future Cases and Law

Establishes that a single, well‐supported deficiency—here, abuse liability—may alone justify FDA’s marketing denial of a new tobacco product.
Reinforces the principle that FDA need not cure every possible application issue (e.g., a second “Cycle 2” toxicology review) once a dispositive deficiency is identified.
Clarifies that FDA may compare new ENDS products not only to combustible cigarettes, but to other FDA‐approved ENDS products, when assessing relative public‐health impact.
Signals to manufacturers the importance of robust abuse liability data and clear evidence of potential public‐health benefits, especially when using high‐nicotine formulations.

Complex Concepts Simplified

Premarket Tobacco Product Application (PMTA): A submission to FDA containing data and studies to show a new tobacco product is “appropriate for the protection of the public health.”
Marketing Denial Order (MDO): FDA’s formal decision preventing a tobacco product from entering commerce.
Abuse Liability: The potential of a product to cause or sustain addiction—measured by nicotine delivery, user behavior, and palatability.
Leachables Study: Analysis of chemicals that can migrate from device materials into the e‐liquid or aerosol over time or under heat.
HPHC Comparison Data: Data on harmful and potentially harmful constituents used to compare a new product’s toxicity against existing products.
Cycle 2 Review: A second round of FDA review in a specific scientific discipline, conducted when initial submissions fall short but may be remediable.

Conclusion

The Eleventh Circuit’s decision in Bidi Vapor LLC v. FDA cements the principle that FDA can lawfully deny a PMTA based on a single, salient public‐health deficiency—here, high abuse liability—even if other technical flaws exist. By upholding FDA’s refusal to market Bidi Classic, the court underscored the strong deference owed to agency expertise in evaluating scientific and behavioral data. Going forward, tobacco product applicants must ensure comprehensive and persuasive evidence on abuse liability and public‐health trade-offs—or risk a standalone denial.