The FDA Said It Would Stop Chasing Unauthorized Vapes. Lung Doctors Want a Court to Make It Start.

The American Thoracic Society and the American College of Chest Physicians filed a joint amicus brief on October 16 in a federal courtroom in Maryland, joined by the American Academy of Allergy, Asthma & Immunology and the American Academy of Otolaryngic Allergy. They are not plaintiffs. They are not regulators. They are the physicians who see what nicotine does to a lung twenty years after the first pod, and they have decided that the ordinary administrative process has run out.

The case they are weighing in on, Campaign for Tobacco-Free Kids et al. v. Food and Drug Administration et al., asks a judge to throw out a guidance document the FDA issued on May 8. That document, numbered 2026-09368 in the Federal Register, tells vape and nicotine pouch manufacturers when the agency does not intend to prioritize enforcement against products that were never legally authorized. In practical terms, it tells a large part of an unregulated market that the government is looking elsewhere.

What the May Guidance Actually Does

The guidance is short and carefully hedged, which is exactly what makes it consequential. It does not authorize anything. It describes when FDA will not spend enforcement resources.

The agency says it generally will not prioritize products whose applications have been accepted and filed, or whose supplemental applications have been accepted and pending for more than 180 days. For non-tobacco-flavored e-cigarettes, there is an additional condition: FDA must have determined that the application contains the data needed to assess whether the product is appropriate for the protection of public health. The policy carves out products with features the agency considers presumptively appealing to minors, including cartoon-like fictional characters, designs that disguise the product as something other than a vaping device, and hardware that resembles a children's toy, a phone or a gaming platform. FDA also reserved the right to act on products posing a specific safety concern, such as unusually high nicotine content or missing child-resistant packaging.

There is one more piece, and it is the piece the plaintiffs single out. FDA said it would create and maintain a public list of manufacturers and products that fall under the policy, so retailers and consumers can see who is covered. Public health groups read that as the government publishing a permission slip.

The agency is emphatic that none of this bears on whether a product will eventually be authorized. Being tolerated is not being approved. But in a market where the median application has been pending for years, a document that says we will not come for you yet functions as the operating license nobody granted.

The Docket Filled Up in Six Weeks

The complaint was filed on July 14 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, Parents Against Vaping E-Cigarettes and the Truth Initiative, along with a pediatrician and a parent as individual plaintiffs. It argues that the guidance exceeds FDA's authority under the Tobacco Control Act, was adopted without notice and comment, and is arbitrary and capricious. The plaintiffs also want the court to stop the agency from publishing its list. The case is before Judge Adam B. Abelson in the District of Maryland.

FDA has not rushed to defend the merits. In September the agency asked the court to pause briefing on the plaintiffs' first summary judgment motion, saying it intended to raise threshold defenses including standing, and noting that the administrative record had not yet been produced. The judge dismissed that motion as moot. On October 9 the plaintiffs filed a new summary judgment motion along with a request to complete the administrative record. FDA has not yet responded, and the guidance remains in force while the litigation proceeds.

What changed the shape of the case was not the plaintiffs. It was the intervenors. The Schwartz E-Liquid company, a California firm doing business as USA Vape Lab and making Naked 100 e-liquids, asked to intervene on September 28. On October 6 it was followed by the American Vapor Manufacturers trade group and by Helix Innovations and NJOY, two Altria subsidiaries whose motion is listed as partially opposed. Their argument is commercial and concrete: if the guidance is vacated, products that have been waiting years for an agency decision could become enforcement targets overnight, with canceled orders, stranded inventory and lost shelf space. They are defending the same policy the government is defending, for entirely different reasons.

Altria is meanwhile fighting on a second front. On September 2 the company filed a complaint in Texas asking a court to vacate the 2021 premarket review rule itself, arguing that the guidance and a parallel nicotine pouch pilot program cannot fix the delays that rule created. FDA announced on September 28 that it intends to replace the 2021 rule. The two positions are not contradictory from the company's perspective: the guidance protects its pending products today, while the Texas suit attacks the machinery that keeps them pending.

The Footnote That Decides Part of It

Buried in the guidance is a condition that may determine who is actually covered. A footnote specifies that the acceptance and filing reviews must concern applications submitted on or after November 4, 2021, the date the premarket review rule at 21 CFR Part 1114 took effect.

Applications submitted before the September 9, 2020 deadline were reviewed before that rule existed. Read literally, they fall outside the policy entirely. FDA has not publicly explained how it applies the limit to older applications, and none of the pending motions resolve the question. USA Vape Lab says its applications were accepted in September 2020, filed for scientific review the following month, and are still pending. Under a strict reading of the footnote, the company the policy was written to accommodate may not be covered by it at all.

Two Million Students, and a Market That Kept Growing

The public health case against the guidance does not depend on the litigation. It depends on arithmetic.

In June 2026 FDA published its analysis of the 2025 National Youth Tobacco Survey. About 2 million middle and high school students reported current use of a tobacco product, meaning use on at least one day in the previous 30 days. E-cigarette use declined across 2022 through 2025. Nicotine pouch use stayed low and stable between 2024 and 2025, and that stability is the number the agency's critics keep returning to: a market that has been expanding commercially while youth use flattens is a market that has learned to sell to adults who already smoke, and to a smaller number of adolescents who would not otherwise have started.

At the same time FDA has been granting authorizations. Its tobacco center has announced new nicotine pouch authorizations repeatedly in 2026, including a batch of eleven, another four under a pilot program, and twenty ZYN products cleared to carry a specific modified risk claim. The agency has received roughly 27 million premarket applications and decided more than 26 million of them, a backlog that explains both why the guidance exists and why the plaintiffs believe it is a surrender dressed as prioritization.

"To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks," Matthew Farrelly, director of the Office of Science at FDA's Center for Tobacco Products, said when the ZYN decision was announced. The guidance does not apply that test. It postpones it.

Why the Lung Doctors Signed On

The societies that filed on October 16 did not mince the accusation. Christy Sadreameli, a member of the ATS Tobacco Action Committee, put the failure at the door of the agency rather than the industry: "In 2009, Congress gave the FDA the authority to regulate tobacco products. For nearly two decades the agency has failed to use that authority to effectively regulate tobacco products, especially e-cigarettes. Our children have paid the price for the FDA's inaction."

Neil S. Freedman, president of CHEST, framed it as a treatment problem rather than a regulatory one. "CHEST members treat the lung disease, respiratory injuries, and nicotine dependence these products leave behind," he said. "The FDA's responsibility is to protect public health." He called for the guidance to be reversed and for premarket review to remain the price of entry.

That is the rarer argument in this fight. Most tobacco litigation is about money or marketing. This one is about whether a product can reach a shelf without anyone having decided it should, and the signatories are the clinicians who inherit the result.

What This Means for Treatment

Nothing in the lawsuit will help anyone who is already dependent. That work happens in clinics, and it is thinner than the scale of the market suggests. Nicotine dependence responds to the same evidence-based tools used for other substances — cognitive behavioral therapy combined with pharmacotherapy has the strongest record — but it is often treated as an afterthought in programs built around alcohol and opioids, and rarely appears in the discharge plan of someone leaving treatment for something else.

Where nicotine use overlaps with anxiety, depression or co-occurring mental health conditions, the clinical picture gets harder and the treatment gap gets wider. Adolescents who start on high-nicotine products are the population least likely to be screened and least likely to be offered structured cessation support, which is the quiet cost of a market that grows faster than the services meant to catch its casualties.

The Limits of a Courtroom Fix

A ruling for the plaintiffs would vacate a guidance document. It would not hire inspectors, fund a laboratory, or clear 27 million applications. The pre-May status quo, after all, is the situation the plaintiffs themselves describe as nearly two decades of failed enforcement. Restoring it returns the fight to an agency that has already demonstrated it cannot keep up, and it may not even last: if FDA replaces the 2021 premarket rule as it told the industry it would, some of the plaintiffs' arguments about delay may be overtaken by the new framework.

There is also a real cost on the other side, and the intervenors are the ones voicing it. Thousands of products are currently sold by companies whose applications sit in a queue. Vacatur converts a queue into a cliff, and the businesses that fall off it employ people.

None of that resolves the underlying question the brief poses. The guidance says the agency will not prioritize enforcement against products nobody authorized. The doctors who treat the consequences are asking a court to say that is not a choice the agency gets to make quietly. Until a judge rules, the products stay on the shelves, the applications stay in the queue, and the pulmonologists stay in the exam rooms.