By Timothy S. Donahue

Top Takeaways:

• Growing intervention: AVM, Altria, NJOY and USA Vape Lab have asked to intervene in a lawsuit challenging FDA’s May 2026 enforcement guidance.
• Business stakes: The groups argue that overturning the guidance could expose products with pending PMTAs to more enforcement risk.
• Regulatory battle: The filings follow Naked 100’s earlier intervention as manufacturers continue challenging FDA’s broader PMTA framework.

The line of companies wanting to join FDA’s latest legal fight keeps getting longer.

American Vapor Manufacturers (AVM), Helix Innovations LLC, and NJOY LLC have filed motions to intervene in a federal lawsuit challenging the Food and Drug Administration’s May 2026 enforcement guidance on certain unauthorized tobacco products with pending premarket applications.

The motions, filed Oct. 6 in the U.S. District Court for the District of Maryland, follow a Sept. 28 intervention request by California-based Schwartz E-Liquid, doing business as USA Vape Lab, and an earlier attempt by the maker of Naked 100 products to join the litigation.

The underlying lawsuit, filed on July 14 by Campaign for Tobacco-Free Kids (CTFK) and other plaintiffs, seeks to overturn the FDA’s guidance on when the agency generally does not intend to prioritize enforcement against certain products awaiting premarket review.

The plaintiffs contend that the guidance improperly allows unauthorized e-cigarettes and nicotine pouches, including flavored products they argue pose risks to youth, to remain on the market. They also challenge the agency’s decision to issue the policy without notice-and-comment rulemaking.

The policy generally gives lower enforcement priority to qualifying products whose applications have been accepted and filed and remain pending beyond 180 days. Additional conditions apply to non-tobacco-flavored electronic nicotine delivery systems (ENDS).

AVM, represented by Washington-based law firm Keller and Heckman LLP, argues that eliminating the guidance could disrupt companies that have invested substantial resources in the PMTA process while awaiting FDA decisions.

Its filing identifies Matrix Minds, NicQuid, and Charlie’s Chalk Dust as member companies whose products qualify for lower enforcement priority under the guidance.

According to the filing, Matrix Minds had marketing denial orders rescinded for certain products in May, returning those applications to scientific review. NicQuid’s applications also returned to FDA review after the Fifth Circuit vacated the challenged marketing denial orders in August.

Meanwhile, Charlie’s Chalk Dust said at least 56 products remain under scientific review. The company received an August FDA notice that referenced the enforcement guidance and indicated the agency generally did not intend to pursue enforcement against those products during review.

AVM argues that losing the policy could lead to canceled orders, stranded inventory, lost retail shelf space, and reduced resources for ongoing regulatory compliance.

In its memorandum, AVM said the affected manufacturers have economic and business interests distinct from those of both the plaintiffs and the FDA, arguing that its members “would be directly harmed if it is vacated.”

The filing also states that eliminating the guidance could cause “significant disruption” to manufacturers’ employees, inventory, distribution networks, retailers, lenders, business partners, and customers.

In a declaration accompanying the motion, NicQuid stated that products covered by its May 2024 marketing denial order accounted for approximately 56% of its sales.

“NicQuid’s concern, therefore, is enforcement and forced market disruption before FDA completes that review, particularly after we have spent millions of dollars supplying the information,” the company said.

Helix Innovations and NJOY make a similar argument, stating that the litigation directly affects their products, commercial partners, and customers.

The companies contend that the FDA’s failure to complete PMTA reviews within statutory deadlines has left manufacturers facing prolonged regulatory uncertainty, while products submitted without applications continue to circulate in the market.

They argue that the May guidance helps direct the FDA’s limited enforcement resources toward products that have never been submitted for regulatory review. “The May 2026 Guidance helped alleviate this uncertainty for Intervenors,” the companies said, arguing that the policy also helped address commercial threats posed by illicit products.

But Helix and NJOY are also pursuing a separate challenge to the FDA’s underlying PMTA regulations. In a lawsuit filed Sept. 2 in the Northern District of Texas, the companies seek to overturn the FDA’s 2021 PMTA rule, arguing that its requirements hinder the agency’s ability to complete reviews within the statutory 180-day period.

“The Guidance is not a sufficient solution to the untimely review of PMTAs the Guidance describes,” the companies said in their Maryland filing.

They argue that the underlying review process must also change, maintaining that the 2021 rule imposes requirements that prevent the FDA from meeting its statutory review deadlines. USA Vape Lab’s intervention request focuses on tobacco-flavored bottled e-liquids for use in refillable vaping devices.

The company said the FDA accepted its PMTAs in September 2020 and filed them for substantive review the following month. According to the motion, its applications for three tobacco-flavored varieties remain pending.

USA Vape Lab argues that those products qualify under the enforcement guidance and could face heightened enforcement risk if the court sets the policy aside. “If the Court were to set aside the Enforcement Guidance, however, UVL’s tobacco-flavored e-liquids could be subject to FDA enforcement action,” the company said in its filing.

The companies seeking intervention also argue that their commercial interests differ from the FDA’s broader regulatory responsibilities, even though they support the agency’s position in the Maryland litigation.

The plaintiffs oppose the intervention requests. The FDA has taken no position on the motions, reserving the right to respond.

The court’s schedule requires the plaintiffs to file their revised summary judgment motion on Oct. 9, with FDA’s response and any cross-motion due Nov. 6. A motions hearing is set for Dec. 11.

The case is Campaign for Tobacco-Free Kids et al. v. FDA et al., No. 8:26-cv-02767-ABA, in the U.S. District Court for the District of Maryland.