QUICK ANSWER
Seven health groups are suing the FDA in federal court in Maryland to overturn its May 2026 guidance, which says the agency generally will not prioritize enforcement against vapes and nicotine pouches whose applications are still under review. The groups filed for summary judgment on October 9, 2026, and vape makers including NJOY, Helix and American Vapor Manufacturers have asked to join on the FDA’s side. A hearing is reportedly set for December 11. Until the judge rules, the guidance stays in effect.
What the FDA guidance does
In May 2026, the FDA issued guidance titled “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” It was published in the Federal Register on May 12 and took effect right away. In plain terms, it tells companies which unauthorized products the FDA is unlikely to go after while their applications are pending.
Who it covers: e-cigarettes and nicotine pouches with a premarket tobacco application (PMTA) that the FDA has accepted and filed, or a supplemental application pending more than 180 days.
Date cutoff: only applications submitted on or after November 4, 2021.
Flavors: for non-tobacco flavors, the FDA must also have found that the application has the data needed for review.
Not covered: products with youth-appealing designs (cartoons, toy-like or disguised devices), plus products with high nicotine, fire risks or missing child-resistant packaging.
A public list: the FDA says it will keep a list of products it does not intend to prioritize. Being on it is not a sign of future authorization.
Who sued and why
On July 14, 2026, 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, Parents Against Vaping E-Cigarettes and Truth Initiative sued the FDA in the U.S. District Court for the District of Maryland. A pediatrician and a parent joined as individual plaintiffs.
They argue the guidance:
Conflicts with the Tobacco Control Act by letting new products stay on the market without authorization
Skipped the notice-and-comment process required by the Administrative Procedure Act
Does not explain why the FDA changed course, especially on flavored e-cigarettes
The groups warn the policy could let thousands of unauthorized products be sold indefinitely. It is the same court that, in 2019, ruled against an earlier FDA policy that delayed vape application deadlines.
Vape makers want to defend the FDA
In an unusual twist, companies are lining up on the FDA’s side. According to trade press reports:
Late September: Schwartz E-Liquid (USA Vape Lab) asked to intervene. The maker of Naked 100 also sought to join.
Early October: American Vapor Manufacturers, a trade group whose members include NicQuid, Matrix Minds and Charlie’s Chalk Dust, filed to intervene, as did Altria’s NJOY and Helix (maker of on! pouches).
The health groups oppose the intervention requests. The FDA has not taken a position. As of mid October, the court had not ruled on them.
Their argument is simple: their products are still under FDA review, and if the guidance is thrown out, they could face enforcement before the FDA ever rules on their applications.
What happens next
.1.Oct 9, 2026: summary judgmentThe health groups filed a motion asking the court to vacate the guidance and declare it unlawful. Health and medical groups have filed amicus briefs in support.
.2.Nov 6, 2026: FDA respondsThe FDA’s response and any cross-motion are reportedly due.
.3.Dec 11, 2026: hearingA motions hearing is reportedly scheduled before Judge Adam B. Abelson.
.4.Then: a rulingThe judge could uphold the guidance, send it back to the FDA, or vacate it. Any ruling could be appealed.
What it means for adult vapers
Nothing changes yet. The guidance stays in effect while the case is pending.
If the groups win, many pending-application products, including some flavored e-liquids, could face FDA enforcement much sooner.
If the FDA wins, products with pending applications can likely stay on shelves until the FDA decides on them.
State laws are separate. State directory laws, like those in Virginia and Pennsylvania, can still block products the FDA is not prioritizing.
Frequently asked questions
What is the FDA enforcement guidance on pending PMTAs?
Issued in May 2026, it says the FDA generally will not prioritize enforcement against e-cigarettes and nicotine pouches with an accepted and filed application submitted on or after November 4, 2021, with extra conditions for flavored products and exclusions for youth-appealing designs.
Who is suing the FDA over the guidance?
Seven groups: the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Parents Against Vaping E-Cigarettes and Truth Initiative, plus two individuals.
Which vape companies are defending the FDA guidance?
Companies that asked to intervene include NJOY, Helix, American Vapor Manufacturers and Schwartz E-Liquid (USA Vape Lab), according to trade press.
When will the court rule?
A hearing is reportedly set for December 11, 2026. A ruling could come after that, and it could be appealed.