Vape makers line up to defend FDA's enforcement guidance

Public health groups desire a federal court to strike down FDA’s May 2026 enforcement guidance.

Vape manufacturers, including two Altria subsidiaries, now wish to step in and defend it.

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 collection 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 observe 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 cap that may exclude older applications.

Helix and NJOY defend the guidance in Maryland while challenging FDA’s 2021 PMTA rule in Texas.

(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 also desire 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.

FDA can still act against products raising particular safety concerns, including high nicotine content or missing child-resistant packaging.

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.

Applications submitted before the September 9, 2020 deadline, as USA Vape Lab says its own were, were reviewed before that rule existed.

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.

In September, he dismissed as moot the plaintiffs’ first summary judgment motion, filed in August, after FDA asked the court to pause briefing .

The plaintiffs filed a new summary judgment motion on October 9, along with a request to complete the administrative record.

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