The lawsuit brought by public health groups against the U.S. Food and Drug Administration (FDA) over its May 2026 enforcement guidance is turning into a crowded courtroom. On October 6, American Vapor Manufacturers (AVM), a trade group of U.S. e-liquid makers, and two Altria subsidiaries, Helix Innovations and NJOY, filed motions to intervene in the case, on the agency’s side. They follow The Schwartz E-Liquid, the California company that does business as USA Vape Lab and makes Naked 100 e-liquids, which filed a similar request on September 28.
According to reports of their filings, all of them make the same argument: if the court strikes down the guidance, products that have been waiting years for an FDA decision could suddenly become enforcement targets.
- Seven health organizations sued FDA on July 14 to overturn its May 2026 enforcement guidance.
- The guidance lowers enforcement priority for certain unauthorized e-cigarettes and nicotine pouches whose applications are under review.
- AVM, Helix, NJOY and USA Vape Lab want to intervene to defend it, citing the risk of products being pulled from shelves.
- The guidance only covers applications submitted on or after November 4, 2021, a limit that may exclude older applications.
- Helix and NJOY defend the guidance in Maryland while challenging FDA’s 2021 PMTA rule in Texas.
The guidance under fire
The case, Campaign for Tobacco-Free Kids et al. v. FDA et al. (No. 8:26-cv-02767-ABA), was brought on July 14, 2026, through a complaint filed in federal court in Maryland by 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, joined by a pediatrician and a parent. They ask the court to vacate the guidance, arguing that it exceeds FDA’s authority under the Tobacco Control Act, was adopted without notice and comment, and is arbitrary and capricious. They also want to stop FDA from publishing a list of the products it does not intend to prioritize for enforcement.
Under the guidance itself, which FDA announced in May, the agency generally does not intend to prioritize enforcement against unauthorized e-cigarettes and nicotine pouches whose applications have been accepted and filed, or whose supplemental applications have been accepted and pending for more than 180 days. For non-tobacco-flavored e-cigarettes, FDA must also have determined that the application contains the data needed to assess whether the product is appropriate for the protection of public health.
The policy has limits. It does not cover products with features FDA considers presumptively appealing to minors, such as cartoon characters or designs resembling toys, phones or gaming devices. FDA can still act against products raising particular safety concerns, including high nicotine content or missing child-resistant packaging. The agency also stresses that falling under the policy has no bearing on whether a product will eventually be authorized.
Manufacturers step in
According to filings reviewed by the trade publication Nicotine Insider, AVM is acting for member companies whose products currently benefit from the guidance, including Matrix Minds, NicQuid and Charlie’s Chalk Dust. NicQuid’s applications went back to FDA for review after the Fifth Circuit vacated its marketing denial orders in August. AVM argues that losing the guidance would mean canceled orders, stranded inventory and lost shelf space, and that its members’ business interests differ from FDA’s regulatory interests even though both defend the same policy.
According to the same report, USA Vape Lab’s request concerns three tobacco-flavored bottled e-liquids for refillable devices. The company says FDA accepted its applications in September 2020 and filed them for scientific review the following month, and that they are still pending.
On the court docket, Helix and NJOY’s motion is listed as partially opposed. The court has not yet ruled on any of the requests.
A cutoff date in the fine print
One detail of the guidance could complicate some of these arguments. A footnote specifies that the acceptance and filing reviews must concern applications submitted on or after November 4, 2021, the date the PMTA rule codified in 21 CFR Part 1114 took effect.
Applications submitted before the September 9, 2020 deadline, as USA Vape Lab says its own were, were reviewed before that rule existed. On a literal reading, they fall outside the policy. FDA has not publicly explained how it applies this limit to older applications, and the motions, as described, do not resolve the question.
Altria on both sides
Helix and NJOY’s position is more ambivalent. In their Maryland motion, as reported by Nicotine Insider, they defend the guidance as a way to focus FDA’s limited enforcement resources on products that were never submitted for review. But in the complaint they filed in Texas on September 2, the same companies argue that the May guidance and the nicotine pouch pilot program cannot remedy the delays caused by the 2021 PMTA rule, which they ask the court to vacate.
The two positions are consistent from Altria’s point of view: the guidance protects its pending products today, while the Texas suit targets the review process itself. That second front may already be bearing fruit, as FDA announced on September 28 that it intends to replace the 2021 rule.
What comes next
The case is before Judge Adam B. Abelson. In September, he dismissed as moot the plaintiffs’ first summary judgment motion, filed in August, after FDA asked the court to pause briefing. In that motion, the agency said it intends to raise threshold defenses, including the plaintiffs’ lack of standing, and noted that the administrative record had not yet been produced.
The plaintiffs filed a new summary judgment motion on October 9, along with a request to complete the administrative record. FDA has yet to respond. Until the court rules, the guidance remains in effect.
