Key Points
- Three parties seek intervention: AVM, Helix Innovations and NJOY filed motions on October 7 seeking to join the FDA's defense of its May 2026 enforcement guidance.
- Health groups challenge the policy: Seven organizations and two individual plaintiffs argue that the guidance violates federal tobacco law and administrative procedure requirements.
- Guidance covers qualifying pending applications: The FDA outlines lower enforcement priorities for certain unauthorized e-cigarette and nicotine pouch products that meet specified PMTA or supplemental PMTA review conditions.
- Manufacturers cite commercial risks: AVM says vacating the guidance could result in canceled orders, stranded inventory, lost retail shelf space and reduced investment in scientific and regulatory work.
2Firsts
October 9, 2026
American Vapor Manufacturers (AVM), Helix Innovations LLC and NJOY LLC have filed separate motions seeking to intervene on the side of the U.S. Food and Drug Administration (FDA) in a federal lawsuit challenging the agency's enforcement guidance for certain unauthorized e-cigarette and nicotine pouch products, according to an October 7, 2026, report by Law360.
Helix and NJOY are subsidiaries of Altria Group, operating in the oral nicotine pouch and electronic vapor product categories, respectively.
The lawsuit was filed in July by the Campaign for Tobacco-Free Kids (CTFK) and other public health and tobacco-control organizations seeking to overturn the FDA's May guidance, Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.
AVM, Helix and NJOY argue that although they share the FDA's interest in defending the guidance, the agency's institutional responsibilities differ from the manufacturers' direct commercial interests, making their independent participation necessary.
AVM and Altria Subsidiaries Cite Risks to Inventory, Distribution and PMTA Investment
According to Law360, AVM, Helix and NJOY filed their motions on October 7, arguing that the challenged guidance directly affects their operations, particularly products with premarket tobacco product applications (PMTAs) still under FDA review.
The proposed intervenors contend that the FDA's litigation strategy may reflect broader governmental and enforcement considerations, while manufacturers face direct consequences for product sales, inventory management, distribution networks and regulatory investments.
AVM said it had previously advocated for enforcement discretion similar to that described in the guidance, although the FDA had denied some requests for such discretion from its members.
The association cited that history as evidence that its interests are not necessarily identical to those of the agency.
AVM warned that vacating the guidance could lead to canceled orders, returns and refunds, stranded inventory, lost retail shelf space, reduced value of PMTA-related assets, and damage to customer relationships and goodwill.
It also argued that manufacturers could face greater difficulty retaining employees, maintaining business relationships and financing additional scientific studies and regulatory compliance work.
Azim Chowdhury, an attorney with Keller and Heckman LLP representing AVM, said in an October 7 statement that affected businesses had invested substantial resources in scientific research and FDA submissions.
Chowdhury emphasized that the guidance does not grant marketing authorization or waive statutory premarket review requirements. Instead, it establishes enforcement priorities while qualifying applications remain under review, with the FDA retaining authority to take enforcement action.
The proposed intervenors also argued that their applications were timely because the case remains at a relatively early stage and their participation would not prejudice existing parties.
FDA Guidance Lowers Enforcement Priority for Certain Products With Pending PMTAs
On May 8, 2026, the FDA issued guidance outlining its enforcement approach toward certain electronic nicotine delivery systems (ENDS) and nicotine pouch products marketed without premarket authorization.
Under the guidance, the FDA generally does not intend to prioritize enforcement of premarket authorization requirements against products meeting specified conditions:
- Standard PMTAs: The application remains pending and has completed FDA acceptance and filing reviews. Those reviews must concern an application submitted on or after November 4, 2021, and subject to 21 CFR Part 1114.
- Supplemental PMTAs (sPMTAs): The supplemental application has been accepted and has remained pending for more than 180 days.
- Non-tobacco-flavored ENDS: In addition to meeting the applicable review conditions, the FDA must have determined that the application includes scientific data necessary to evaluate whether marketing the product would be appropriate for the protection of public health.
The policy also identifies characteristics that may lead to prioritized enforcement, including cartoon-like fictional characters, designs that disguise a product's vaping function, and devices resembling children's toys, mobile phones or gaming equipment.
The guidance does not extend lower enforcement priority to every product with a pending PMTA.
The FDA states that new tobacco products marketed without the required authorization remain unlawfully marketed. Falling within a lower enforcement priority category does not constitute marketing authorization or change statutory premarket review requirements.
When announcing the guidance, the agency said it would continue focusing enforcement resources on products without PMTA submissions, counterfeit products, misdeclared imports and other serious violations.
The FDA also said it would work with the Department of Justice, U.S. Customs and Border Protection and other federal agencies to address unlawful imports.
Seven Public Health Organizations Sue FDA Over Legality of Guidance
The lawsuit was filed on July 14, 2026, in the U.S. District Court for the District of Maryland.
The organizational plaintiffs are the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Parents Against Vaping E-Cigarettes and Truth Initiative.
The case also includes pediatrician Susan Walley and a parent identified as Jane Doe.
The plaintiffs raise three principal legal arguments.
First, they contend that the guidance violates the Family Smoking Prevention and Tobacco Control Act by allowing certain new tobacco products to remain commercially available without the required marketing authorization.
Second, they argue that the FDA failed to provide the required public notice and opportunity for comment before issuing the guidance, in violation of the Administrative Procedure Act.
Third, they allege that the agency failed to adequately explain its departure from previous enforcement policies, particularly its approach toward flavored e-cigarette products.
The plaintiffs have expressed particular concern about non-tobacco-flavored e-cigarettes, arguing that the policy could allow more unauthorized flavored products to remain on the market and undermine efforts to prevent youth nicotine use.
Founded in 1996, CTFK is a prominent U.S. tobacco-control advocacy organization involved in regulatory policy and litigation. It has a longstanding funding and program partnership with Bloomberg Philanthropies, including work on international tobacco-control initiatives.
Helix Operates on! Nicotine Pouches, While NJOY Markets Authorized E-Cigarette Products
Helix Innovations and NJOY are Altria subsidiaries operating in different nicotine product categories.
Helix manufactures and markets oral nicotine pouch products, including the on! and on! PLUS brands.
According to FDA marketing authorization records, Helix has received authorization for specified nicotine pouch products, including additional on! PLUS products authorized in August 2026.
Other Helix nicotine pouch applications remain under FDA review.
NJOY operates in the electronic vapor products category. The FDA has previously issued marketing granted orders for specified NJOY ACE and NJOY Daily products, although those authorizations do not extend to every NJOY product.
The companies' intervention requests concern their commercial interests in products affected by the FDA's enforcement guidance.
Helix and NJOY contend that vacating the guidance could directly affect qualifying products whose PMTAs remain under review.
Other E-Cigarette Manufacturers Have Also Sought to Intervene
AVM, Helix and NJOY are not the first industry participants to seek intervention in the Maryland lawsuit.
According to an October 1 report by Law360, a manufacturer of Naked 100 flavored e-liquid products had also sought to intervene in support of the FDA's existing enforcement guidance.
The manufacturer argued that overturning the guidance could force affected products off retail shelves.
The intervention requests bring manufacturers' commercial interests into a legal dispute initially brought by public health organizations against the FDA.
The case concerns the agency's authority to establish enforcement priorities for products that have not received marketing authorization but are undergoing specified stages of premarket review.
Court Has Yet to Rule on Latest Intervention Motions
The case, Campaign for Tobacco-Free Kids et al. v. Food and Drug Administration et al., is docketed as 8:26-cv-02767 in the U.S. District Court for the District of Maryland, before Judge Adam B. Abelson.
Public court records show that the court has previously addressed the plaintiffs' summary judgment motion and procedural requests submitted by the government.
As of Law360's October 7 report, AVM, Helix and NJOY had filed motions to intervene but had not been confirmed as intervenor defendants.
Law360 reported that a Department of Justice representative declined to comment on the motions. An attorney for the plaintiffs also declined to comment.
The court will consider the intervention requests as the litigation proceeds over the legality of the FDA's May 2026 guidance.
The outcome could affect whether the FDA can continue applying lower enforcement priority to qualifying e-cigarette and nicotine pouch products that remain without marketing authorization while their applications are under review.
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