The FDA Told Vape Makers It Won't Enforce Its Own Rule. Now It's Being Sued For That.

Here’s what “enforcement discretion” means in practice: a company can keep selling a flavored vape the FDA has never approved, for as long as it wants, as long as it can say an application is technically pending. That’s the guidance FDA quietly issued on May 22 — and on July 14, seven of the country’s largest public health organizations, plus a pediatrician and a parent, sued to stop it.

The FDA didn’t just decline to ban flavored vapes for kids. It told manufacturers, in writing, exactly how to keep selling them anyway.

The lawsuit, filed in the U.S. District Court for the District of Maryland by 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, Truth Initiative, and Parents Against Vaping, argues the guidance “permits potentially thousands of tobacco products to enter and remain on the market for an indefinite period” without ever getting the marketing authorization the law requires. Translated out of legal language: under the Tobacco Control Act, a vape or nicotine pouch is supposed to be illegal to sell until FDA affirmatively signs off on it. This guidance flips the practical effect of that — FDA says a pending application doesn’t create a “legal safe harbor,” but the plaintiffs’ point is that it functions like one anyway, because FDA also said it will publish a running public list of products it doesn’t plan to prioritize for enforcement. A list like that is a green light with extra paperwork.

The guidance didn’t come from nowhere. CNN reported that FDA’s own tobacco-center staff — the people whose job is enforcement — weren’t consulted before it published and learned about it the night before, during outgoing Commissioner Marty Makary’s final week in the role. The same week, FDA authorized four new flavored e-cigarettes, including mango and blueberry.

If you work with teenagers, or have one, the numbers explain why the American Lung Association is a named plaintiff and not just a commentator here. Harold Wimmer, the organization’s president and CEO, called on FDA to “reconsider its decision to authorize kid-friendly e-cigarette flavors and not authorize any flavored tobacco products moving forward” — and the data backs up why flavor is the whole fight: 87.6% of youth who vape use flavored products, 62.8% specifically choose fruit, and 85.6% of young nicotine-pouch users pick a flavored option. Flavor isn’t a side detail in youth nicotine use. It’s most of the mechanism.

Nothing about this is settled. The May guidance is in effect right now — manufacturers are using it today, not waiting on a court date. The lawsuit asks a judge to vacate it; there’s no ruling yet. If you’re a provider screening for nicotine use, the practical takeaway isn’t “wait and see” — it’s that the flavored products your younger patients are already using aren’t a regulatory afterthought anymore. They’re the subject of active federal litigation, which means the ground under “is this even legal” is still moving.