American Vapor Manufacturers (AVM), Helix Innovations LLC, and NJOY LLC have all filed motions to intervene in a federal lawsuit challenging the FDA’s May 2026 enforcement guidance on certain unauthorized tobacco products with pending premarket applications. The motions were filed October 6 in the U.S. District Court for the District of Maryland.
They follow a September 28 intervention request from California-based Schwartz E-Liquid, doing business as USA Vape Lab, plus an earlier attempt by the maker of Naked 100 products. The industry side of the docket is filling up fast.
The underlying lawsuit was filed July 14 by Campaign for Tobacco-Free Kids (CTFK) and other plaintiffs. It asks the court to overturn the FDA guidance that lays out when the agency generally does not intend to prioritize enforcement against certain products awaiting premarket review.
Plaintiffs contend the guidance improperly allows unauthorized e-cigarettes and nicotine pouches, including flavored products, to remain on the market. They also argue the FDA issued the policy without notice-and-comment rulemaking, which they say the law requires.
The policy itself draws a line around timing. It generally gives lower enforcement priority to qualifying products whose applications have been accepted and filed and have remained pending beyond 180 days. Additional conditions apply to non-tobacco-flavored ENDS.
AVM, represented by law firm Keller and Heckman LLP, argues that overturning the guidance could disrupt companies that invested substantial resources in the PMTA process while awaiting decisions. Its filing identifies Matrix Minds, NicQuid, and Charlie’s Chalk Dust as member companies whose products qualify for the lower enforcement priority.
So the court now faces two competing visions. Public health groups want the policy struck down and flavored unauthorized products off shelves sooner. Industry intervenors want the breathing room preserved for companies that followed the PMTA process.
The outcome matters for anyone who buys vapes in the United States. If the guidance stands, qualifying products stay in a lower enforcement tier while their applications are pending. If it falls, the FDA could face pressure to move against them sooner.
For consumers, the case is also a reminder of how few products have actually cleared the FDA’s authorization bar. VapeFeat tracks them all in our FDA authorized vapes list, and the state-level enforcement picture is covered in our Texas guide.
Source: Intervention motions filed October 6, 2026 in the U.S. District Court for the District of Maryland, reported October 8, 2026.