Key Points
- Health groups sued the FDA in July to overturn its May 2026 enforcement guidance for vapes and nicotine pouches.
- On Oct 7, American Vapor Manufacturers (AVM), Helix Innovations, and NJOY asked the court to let them join the case on the FDA side.
- The guidance sets lower enforcement priorities for certain unauthorized products with qualifying pending applications.
- The companies warn that killing the guidance could strand inventory, cancel orders, and cost retail shelf space.
- Nothing changes immediately. The guidance stays in place unless the court blocks it.
WASHINGTON: A federal lawsuit over how the U.S. Food and Drug Administration polices vapes and nicotine pouches has turned into a three-way fight, after three major industry players asked a court on Oct 7 to let them defend the agency policy.
What Is This Fight About?
To sell a new tobacco product in the United States, a company must get FDA authorization through a process called a premarket tobacco product application, or PMTA. The FDA must decide whether marketing the product is appropriate for the protection of public health.
The problem is scale. Millions of products flooded the FDA with applications, and many products stayed on the market for years while their applications were pending. The FDA has used enforcement discretion, choosing which violations to prioritize, to manage that reality.
In May 2026, the FDA issued new guidance, “Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization.” In plain terms, it told the market which unauthorized products would face lower enforcement priority: certain e-cigarettes and nicotine pouches that meet specific conditions tied to pending PMTA or supplemental PMTA reviews. Products outside those conditions remain higher priorities for enforcement.
Who Sued the FDA, and Why
In July, the Campaign for Tobacco-Free Kids and other public health and tobacco-control organizations sued to overturn the May guidance. Their argument, as reported, is that the guidance violates federal tobacco law and administrative procedure requirements. In short, they say the FDA cannot use an enforcement policy to let unauthorized products keep selling.
The health groups want the guidance vacated. If they win, the FDA softer enforcement posture for those pending products would fall away, and more products could face enforcement.
Who Stepped In on Oct 7
On Oct 7, three parties filed separate motions to intervene on the FDA side: American Vapor Manufacturers (AVM), Helix Innovations LLC, and NJOY LLC, according to an Oct 7 report by Law360 cited by 2Firsts. Helix and NJOY are subsidiaries of Altria Group, operating in oral nicotine pouches and vapor products respectively.
Why intervene if the FDA is already defending its own policy? The companies argue that although they share the FDA interest in defending the guidance, the agency institutional responsibilities differ from the manufacturers direct commercial interests, so they need their own seat at the table.
What the Companies Say Is at Stake
AVM warned that vacating the guidance could result in canceled orders, stranded inventory, lost retail shelf space, and reduced investment in scientific and regulatory work. In other words, companies built their supply chains, retail plans, and research budgets around the May guidance. Pulling it away mid-stream, they argue, would punish businesses that followed the rules as written.
The health groups see it the opposite way: they argue the guidance itself is the problem, because it tolerates unauthorized products that Congress required to go through premarket review.
What Happens Next
First, the court will decide whether AVM, Helix, and NJOY can intervene. Then the case moves to the merits, whether the May guidance survives. Until a judge rules, the guidance remains in effect.
Retailers and manufacturers should watch two things: whether the court grants intervention, a sign the case will be fully fought out, and whether any judge issues an order pausing or blocking the guidance while the case proceeds.
What This Means for Vapers and Retailers
Short term, nothing changes. Products covered by the guidance are still in the lower-enforcement category, and no court has blocked the policy.
Long term, the stakes are real. If the guidance is vacated, the FDA could be pushed toward stricter enforcement against products with pending applications, which could shrink what is available in stores. If the guidance survives, the current system continues: authorized products plus a defined set of pending products selling under lower enforcement priority.
Federal policy also meets state enforcement on the ground. For an example of how that plays out at the store level, see our report on Pennsylvania Act 57 enforcement, which begins Oct 19. Several states are also running their own state directory laws, which add a second layer of rules on top of federal policy.
Sources: 2Firsts (Oct 9, 2026), citing Law360 (Oct 7, 2026).