FDA v. Wages and White Lion Investments, LLC
The Supreme Court unanimously ruled that the FDA did not illegally flip the rules on e-cigarette makers when it denied their applications to sell candy-, fruit-, and dessert-flavored vaping products — rejecting the argument that the agency's earlier guidance had locked it into a more permissive standard.
The decision allows the FDA's broad 2021 crackdown on flavored e-cigarettes to largely stand, though one narrow issue — whether the agency's failure to review companies' marketing plans was harmless — goes back to the lower court for further review.
“All four of these principles orbit around the same basic concern: an agency should not mislead regulated entities.”
The majority explaining why all of the companies' objections reduce to a single question under the change-in-position doctrine.
How it got here: The FDA denied the companies' applications; the Fifth Circuit sitting en banc reversed and remanded to the FDA; the Supreme Court then agreed to hear the FDA's appeal.
The Case in Depth
What happened
Two companies that manufacture flavored e-liquids — sold under names like "Killer Kustard Blueberry," "Rainbow Road," and "Suicide Bunny Mother's Milk and Cookies" — applied to the FDA for permission to keep selling their products after a 2009 law required all e-cigarettes to get federal approval. The FDA denied their applications in 2021, saying they had not provided rigorous enough scientific evidence that the benefits of their candy-, fruit-, and dessert-flavored products to adult smokers outweighed the well-documented risk of drawing young people into nicotine addiction.
The question before the Court
Did the FDA act lawfully when it denied applications to sell flavored e-cigarette products, even after issuing guidance that companies say suggested a more lenient review process?
The Court's answer
Yes, largely — the FDA acted lawfully in denying the companies' applications on three of the four main grounds challenged. The Court found that the FDA's pre-application guidance never made hard-and-fast promises about what evidence would satisfy it; required only that applicants without formal clinical trials provide equally rigorous alternative evidence; put companies on notice that flavored products would face heightened scrutiny compared to tobacco-flavored ones; and never created a safe harbor for non-cartridge devices. On each of these points, the denial orders were consistent with — or a natural outgrowth of — the FDA's earlier guidance, so no improper change of position occurred.
On the fourth issue, the Court agreed that the FDA made an error by never reviewing marketing plans it had repeatedly called "critical." But it sent that narrow question back to the lower court, ruling that the Fifth Circuit had applied too strict a reading of a prior Supreme Court decision (Calcutt v. FDIC) when it concluded that this error automatically required a full do-over. The correct harmless-error standard is somewhat broader than the Fifth Circuit used, and the lower court must reconsider the question under the right framework.
Curious how the Court got there? See the step-by-step legal reasoning →
Why it matters
Makers of flavored e-liquids and vaping products lose the legal argument that the FDA misled them into thinking their applications would be judged by easier standards. The ruling reinforces the FDA's authority to deny marketing of flavored vaping products and makes it harder for the industry to challenge similar denials across the more than one million other applications still in the pipeline.
What changes now
The Fifth Circuit must now reconsider the single remaining question: whether the FDA's failure to review the companies' marketing plans was harmless, applying a legal standard less restrictive than the one it previously used. On the three other issues — scientific evidence, comparative efficacy, and device type — the Supreme Court ruled for the FDA, and those rulings are final. The companies' flavored products remain off the market absent new FDA authorization.
What this does not decide
The Court expressly declined to decide whether the FDA was required to use formal notice-and-comment rulemaking, rather than individual case-by-case adjudications, to establish the standards for marketing applications. It also left unresolved the precise boundary between the "remand rule" and the harmless-error rule in administrative cases, describing that reconciliation as a "vexing problem" for another day.
Concurrences and dissents
Concurrence — Justice Sotomayor
Justice Sotomayor joined the full opinion but wrote separately to push back on one characterization. She disagreed with the majority's description of the FDA as an agency that 'was feeling its way toward a final stance and was unable or unwilling to say in clear and specific terms precisely what applicants would have to provide.' In her view, the record shows the FDA reasonably gave manufacturers flexibility on the form of evidence while consistently adhering to its statutory duty to approve only products appropriate for the protection of public health — and applicants should not have been surprised by the rigorous showing required.
How the Court got there
The legal reasoning, step by step
- The Court analyzed the FDA's conduct under the 'change-in-position doctrine' — an administrative-law principle holding that agencies can shift course only if they acknowledge the change, give good reasons for the new policy, and account for the serious reliance interests the old policy may have created. This doctrine was the governing framework for all four of the companies' main objections.
- On scientific evidence: The FDA's guidance never committed to a specific type of study; it consistently told applicants that if they skipped formal randomized controlled trials or longitudinal cohort studies, they still had to supply other rigorous, product-specific evidence. When the FDA denied the companies for failing that alternative test, it was applying — not reversing — the framework it had described all along.
- On comparative efficacy: The FDA's pre-application guidance emphasized cross-product comparisons and specifically flagged that candy, fruit, and dessert flavors were more appealing to young people than tobacco flavors. Requiring applicants to show their flavored products offered benefits over tobacco-flavored ones was a 'natural consequence' of that guidance — not a surprise reversal — and the companies' own applications showed they understood this comparison was expected.
- On device type: The FDA's 2020 enforcement guidance focused mainly on cartridge-based products but also warned it would act against any product likely to attract minors. When the FDA denied the open-system (non-cartridge) companies' products on that basis, it was following its own stated priorities. Even if that amounted to a shift in focus, the FDA offered a good reason: surveillance data showed youth had moved from cartridge-based to disposable devices, suggesting flavor — not device design — was the key driver of youth use.
- On marketing plans: The FDA conceded it never reviewed marketing plans it had called 'critical.' The Court agreed that was error, but held that the Fifth Circuit had read a prior Supreme Court case — Calcutt v. FDIC — too broadly in concluding there is only one exception to the rule that courts must send flawed agency decisions back rather than declaring the error harmless. Long-accepted precedent recognizes additional exceptions, including when an unsound finding had no bearing on the outcome, so the lower court's categorical rule was incorrect.
- Rather than decide the harmless-error question itself, the Court vacated the Fifth Circuit's judgment on the marketing-plans issue and sent it back for the lower court to apply the correct, more nuanced harmless-error standard — one that adapts ordinary civil-litigation harmless-error principles to the administrative context without collapsing the remand rule entirely.
Doctrinal impact
Cases affected by this decision
Limits Calcutt v. FDIC (598 U.S. 623)
The Fifth Circuit read Calcutt to bar nearly all harmless-error findings in APA cases; the Court clarifies the rule has broader exceptions.
Reaffirms FCC v. Fox Television Stations, Inc. (556 U.S. 502)
Reaffirmed as the governing standard for when an agency must justify a change in its policy.
Reaffirms Encino Motorcars, LLC v. Navarro (579 U.S. 211)
Reaffirmed as requiring agencies to acknowledge policy changes and account for reliance interests.