Vape Makers Move to Defend FDA Enforcement Guidance as Courtroom Fills
The federal challenge to the FDA's May 2026 enforcement guidance has become a crowded courtroom. On 6 October, the American Vapor Manufacturers trade group and two Altria subsidiaries, Helix Innovations and NJOY, filed motions to intervene on the government's side in Campaign for Tobacco-Free Kids v. FDA (No. 8:26-cv-02767, District of Maryland), joining the U.S. in defending the policy the public health plaintiffs want vacated.
The lawsuit, filed 14 July 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 and Parents Against Vaping E-Cigarettes, argues that the guidance unlawfully keeps unauthorized products on the market.
All the intervenors make the same core argument. Under the guidance, FDA 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 pending for more than 180 days. If the court strikes the policy, manufacturers say, products that have been waiting years for a decision could suddenly become enforcement targets.
The American Vapor Manufacturers filed on behalf of member companies whose products currently benefit from the guidance, including Matrix Minds, NicQuid and Charlie's Chalk Dust. NicQuid's applications had been returned to FDA for review after the Fifth Circuit vacated its marketing denial orders in August. AVM argued that losing the guidance would leave canceled orders and pending applications exposed.
A separate motion, from USA Vape Lab, concerns three tobacco-flavoured bottled e-liquids for refillable devices, which FDA accepted in September 2020 and filed for review the following month; they remain pending. That position carries a catch. A footnote in the guidance limits the acceptance-and-filing reviews to applications submitted on or after 4 November 2021, the effective date of the PMTA rule codified in 21 CFR Part 1114. Products filed before the 9 September 2020 deadline, as USA Vape Lab's were, were reviewed before that rule existed and, on a literal reading, fall outside the policy. FDA has not publicly explained how it applies that limit to older applications.
The two Altria positions are deliberately different. In Maryland, Helix and NJOY defend the guidance as a way to focus enforcement on products that were never submitted. In their 2 September Texas complaint, the same companies argued that the guidance and the nicotine pouch pilot program cannot remedy the statutory review delays, asking the court to vacate the 2021 rule. From Altria's perspective, the two moves are consistent: the guidance protects its pending products today while the Texas suit targets the process. The court in Maryland, Judge Adam B. Abelson, has not yet ruled on any intervention request.