FDA Lawsuit: The Two Cases in the News and Whether You Can Sue the FDA
Questions about this case?
AI Legal Assistant · free · answers in seconds · general information, not legal advice
Two lawsuits against the FDA are driving the headlines in October 2026. Health groups are suing in Maryland over a May 2026 policy that lets unauthorized e-cigarettes and nicotine pouches stay on sale. Louisiana is suing over mail and telehealth access to the abortion pill mifepristone. Both ask a court to change an FDA rule. Neither is a class action, and neither pays anyone money: there is no settlement, no claim form and no deadline for consumers.
Editorially Reviewed — Content reviewed for accuracy using published legal research, government data, and verified court records. See our methodology
Reviewed by Leonard Goldberg, Editor · Last updated
What the Lawsuits Against the FDA Say
The e-cigarette case. In May 2026 the FDA issued enforcement guidance saying it generally will not prioritize action against unauthorized e-cigarettes and nicotine pouches whose applications are under review. The plaintiffs — the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, Truth Initiative, Parents Against Vaping, a pediatrician and a parent — allege the guidance violates the Tobacco Control Act, skipped the notice-and-comment process the Administrative Procedure Act requires, and is “arbitrary and capricious.” They also object to the FDA's plan to publish a list of products it will not prioritize.
The mifepristone case. Louisiana alleges the FDA violated the Administrative Procedure Act when it changed the drug's safety program (the REMS) in 2023 to drop the in-person dispensing requirement, which allowed mail and pharmacy dispensing. The state also claims the change conflicts with the Comstock Act. These are allegations; the FDA is defending the suit, and the drug's manufacturers have intervened as defendants.
Case Details
Campaign for Tobacco-Free Kids et al. v. FDA et al., No. 8:26-cv-02767-ABA, U.S. District Court for the District of Maryland, before Judge Adam B. Abelson, filed July 14, 2026. It is the same court that struck down an FDA e-cigarette guidance issued in 2017.
State of Louisiana v. U.S. Food and Drug Administration, No. 6:25-cv-01491, U.S. District Court for the Western District of Louisiana, before Judge David C. Joseph, filed in October 2025. An appeal of his April 7, 2026 order is pending in the Fifth Circuit, and the Supreme Court has already ruled once on emergency relief.
Status as of October 2026: Active, No Settlement
Louisiana (mifepristone): The district court case is paused while the FDA reviews the drug. In a status report filed October 7, 2026, the FDA said it expects study results by mid-December 2026 and to finish its review no later than March 2027. The Fifth Circuit heard argument on September 9, 2026 and had not ruled as of October 12, 2026. Under the Supreme Court's May 14, 2026 order, telehealth prescribing and mail dispensing remain in place for now.
Neither case has a settlement, a fund, an administrator or a claim form.
Follow this case
There's no claim deadline yet. We'll email you if a settlement opens a claim period.
Who Is Affected
Nobody signs up for either case. They are challenges to agency rules brought by named plaintiffs, not class actions on behalf of consumers.
The vape case affects anyone who buys, sells or makes e-cigarettes or nicotine pouches: if the guidance is struck down, products still waiting for an FDA decision could become enforcement targets again. The mifepristone case affects patients and prescribers nationwide, because the rule at issue governs how the drug can be dispensed in every state. If either outcome changes what you can buy or how you get a prescription, the change comes through the FDA and your pharmacy or clinician — not through a payment.
Is There Money? No.
Money claims against the federal government run through the Federal Tort Claims Act, and its exception for “discretionary” functions (28 U.S.C. 2680(a)) is the main reason suits blaming the FDA for approving a drug rarely get far. If a drug or device hurt you, the claim is usually against the manufacturer — see our class action lawsuits list for active cases against companies.
FDA Lawsuit Timeline
- 1
October 2025 — Louisiana Sues the FDA
Louisiana files in the Western District of Louisiana, challenging the 2023 mifepristone rule change that allowed mail and pharmacy dispensing.
- 2
April 7, 2026 — Mifepristone Case Paused
Judge David C. Joseph leaves the 2023 rule in place and pauses the case while the FDA reviews the drug, ordering a status report within six months.
- 3
May 14, 2026 — Supreme Court Stay
After a Fifth Circuit panel reinstated in-person dispensing nationwide on May 1, the Supreme Court stays that order, keeping telehealth and mail access while the case continues.
- 4
July 14, 2026 — Health Groups Sue Over Vapes
Public health groups, a pediatrician and a parent sue the FDA in Maryland over its May 2026 e-cigarette and nicotine pouch enforcement guidance.
- 5
September 9, 2026 — Fifth Circuit Argument
Appeals judges press Louisiana on whether it has standing to sue. No decision was issued.
- 6
October 7–9, 2026 — Status Report and New Motion
The FDA tells the Louisiana court its review should finish no later than March 2027. In Maryland, the plaintiffs file a new summary judgment motion on October 9. No settlement exists in either case.
Three Things to Watch For
“Lawsuit against the FDA” headlines invite messages promising money that does not exist:
“Claim your FDA lawsuit payment”
Neither the vape case nor the mifepristone case has a settlement, a fund or a claims site. A page asking for your Social Security or bank details to “release” an FDA settlement is collecting data, not filing a claim.
“Join the class action lawsuit against FDA”
There is no consumer class to join in these cases. The plaintiffs are named organizations, a state and a few individuals. A sign-up form that charges a fee or asks for medical history to “add you” is not part of either case.
Messages about your abortion pill prescription
As of October 2026, the Supreme Court's May 14 order keeps telehealth and mail dispensing of mifepristone in place. A text or call saying your prescription is “cancelled by the lawsuit” and asking for personal details is not from the court or the FDA — check with your own clinician or pharmacy.
FDA Lawsuit — Questions People Actually Ask
What is happening with the FDA right now?
In court, two cases lead the news. Health groups are suing over the FDA's May 2026 policy on unauthorized e-cigarettes and nicotine pouches (No. 8:26-cv-02767, District of Maryland); a new summary judgment motion was filed October 9, 2026. Louisiana is suing over mifepristone mail access (No. 6:25-cv-01491, Western District of Louisiana); on October 7, 2026 the FDA said its drug review should finish no later than March 2027.
Is there an FDA lawsuit settlement or claim form?
No. As of October 12, 2026 neither case has a settlement, fund, administrator, claim form or deadline. Both ask a court to change or restore an FDA rule, not to pay the public.
Can you sue the FDA?
Yes, but usually not for money. Under the Administrative Procedure Act (5 U.S.C. 702), a person harmed by agency action can ask a court to review it — which is what both current cases do — but that law covers relief other than money damages. Money claims go through the Federal Tort Claims Act, which excludes claims based on an agency's “discretionary function” (28 U.S.C. 2680(a)), and decisions like approving a drug are typically argued to fall there.
How to sue the FDA for money?
Under the Federal Tort Claims Act you must first file a written claim with the agency within two years after the claim accrues (28 U.S.C. 2401(b)). You can go to court only after the agency denies it in writing, or after six months without a decision (28 U.S.C. 2675(a)); after a written denial you have six months to sue. Talk to a licensed attorney before relying on these deadlines.
Is there a class action lawsuit against FDA I can join?
Not in the cases in the news. The vape case is brought by named public health groups, a pediatrician and a parent; the mifepristone case by the State of Louisiana. Other suits challenge the FDA too — the ACLU filed a records lawsuit over the mifepristone review in November 2025, and a separate Texas and Florida mifepristone case was reported paused until December — but none of them is a consumer class with payments.
Does the mifepristone lawsuit change access today?
Not as of October 12, 2026. The Supreme Court's May 14, 2026 order keeps telehealth prescribing and mail or pharmacy dispensing in place while the case continues. The FDA's review could lead to changes after it ends; the agency told the court that should be no later than March 2027.
Will the vape lawsuit take e-cigarettes off the shelves?
Not yet. The guidance remains in effect until the Maryland court rules. It covers products whose applications are under FDA review, including supplemental applications pending more than 180 days, and only applications submitted on or after November 4, 2021. If the guidance is vacated, those products could again be enforcement targets.
What pharmaceutical company is being sued?
That is a different question from suing the FDA. Lawsuits over a drug's side effects are brought against the manufacturer, not the agency, and this page does not track them. For those, see our pages on specific products, such as the Ozempic lawsuit or the Zyn lawsuit.
Separate from this case: were you injured in the last 2 years?
Class-action payouts are fixed amounts through an administrator. A personal injury claim is a different case — and often worth far more. Free estimate, no obligation.
Related Consumer Brand Lawsuits
Open Class Action Settlements
Settlements that are actually taking claims right now
Zyn Lawsuit
The consumer case against the nicotine pouch maker itself
Class Action Court Documents
How to find and read the filings behind any case
Settlement Payout Calculator
Estimate what a real class settlement could pay you