The FDA Stopped Chasing You. It Did Not Make You Legal

In 2019, right before the first wave of flavor restrictions landed, I talked with a shop owner who had been off cigarettes for ten years on mango pods. He was already looking at commercial real estate across the state line. They think they are protecting kids, he told me, but they are killing adults.

I was in the building for all of it. Not on the byline for most of those years. My name went on very little of it. What I did was read every draft, check every claim, and call the sources back when something did not add up. I was angry then. I am still angry.

Here is what I could not reconcile in 2019 and cannot reconcile now. A gas station on every corner in America legally sells the product that kills roughly 480,000 of us a year, with a license, a tax stamp, and a rack behind the register. At the same time the federal government went after the thing smokers were switching to, hard enough and long enough that the goal stopped looking like caution and started looking like removal.

I have my suspicions about why, and I am going to label them as suspicions rather than dress them up as reporting. Roughly ninety percent of the world’s vaping hardware is built in China, most of it inside a few square miles of Shenzhen. An industry that concentrated is a convenient thing to squeeze for reasons that have nothing to do with anybody’s lungs. I cannot prove that was ever the motive and I am not going to pretend I can. What I will say is that I stopped believing it was incompetence somewhere around the second year.

The result is not in dispute. Businesses closed in every state and the jobs went with them. A share of the people pushed off flavored products went back to cigarettes, and that part is not a hunch on my end. Abigail Friedman at Yale found that San Francisco’s flavor ban was followed by rising high school smoking while comparable cities kept declining, a finding that has been argued over since, and later work using retail sales data tied flavor restrictions to higher cigarette sales. Some people set a cigarette down and never think about it again. Others cannot, and that difference is substantially inherited: twin studies put the heritability of nicotine dependence near sixty percent. Policy that removes the off-ramp does not land on everyone equally. It lands hardest on the people who were least able to quit unaided, which is the group the policy claimed to be protecting.

Blame it accurately while you are at it. The January 2020 policy that pulled flavored cartridges came out of the Trump FDA. The denial wave that buried nearly everyone else came under Biden. Both parties took their run at this industry, and both of them handed customers back to the cigarette companies. When I decided to rebuild this site I believed there was a road back. There is. It will never be as free or as open as what we had.

Seven years on, the agency has moved. Not with a repeal, not with an act of Congress, and not with anything the mainstream press covered properly. It moved with a guidance document, which is the quietest instrument in the regulatory toolbox and the one most worth reading closely.

What the May 8 guidance says

The document is called Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization. It went out on May 8, 2026 and hit the Federal Register on May 12. It supersedes every previous enforcement discretion policy the agency has published, including the April 2020 guidance that put flavored cartridge systems at the top of the target list.

The substance is narrow and specific. For vapes and oral nicotine pouches sold without authorization, the FDA says it generally does not intend to prioritize enforcement of the premarket requirement when the product is covered by a PMTA the agency has accepted and filed for scientific review, or by a supplemental application that has been accepted and pending more than 180 days. For non-tobacco flavors, the agency expects that application to contain the switching data showing an added benefit to adult smokers.

Then comes the part that makes this real rather than rhetorical. The FDA is building a public webpage listing the manufacturers and products that fall inside the policy, updated on a rolling basis, with products added and removed as their status changes. Manufacturers already in scientific review are told to contact their review project manager to request inclusion.

A published list of products the government has decided not to pursue is a different animal from a vague promise of restraint. Retailers can check it. Distributors can check it. So can the state attorney general who is deciding where to spend a Tuesday.

This is not the Supreme Court backing down

Plenty of coverage has tied the May guidance to the litigation, and the sequence gets told backwards almost every time. Here is the order it happened in.

On April 2, 2025, the Supreme Court decided FDA v. Wages and White Lion Investments. The judgment was vacated and remanded, 9 to 0, in an opinion by Justice Alito, with Justice Sotomayor concurring. The Court rejected the argument that the FDA had changed its position on scientific evidence, comparative efficacy, and device type between its guidance and its denial orders. On that ground the agency won cleanly, and it won unanimously in a Court that agrees on very little.

One thread was left hanging. The FDA never contested that it had told manufacturers their marketing plans would be critical and then failed to consider them. It argued that the error was harmless. The Fifth Circuit had rejected that using a reading of an earlier case the Supreme Court found too broad, so the question went back down for the appeals court to decide fresh. That piece is still unresolved.

Now put the dates side by side. The agency won at the Court in April 2025. Thirteen months later, owing nothing to anybody, holding a unanimous decision in its hand, it published a policy that lets thousands of unauthorized products sit on shelves while their applications wait. Nobody forced that. An agency that gives ground after winning is conceding something it did not have to concede, and that concession is the story.

The two conditions, and the trapdoor

Enforcement discretion is not a shield, and anyone selling it to you as one is selling something else too. Three limits matter.

The first is legal. A guidance document establishes no enforceable rights. The FDA says so in the document itself. Under the Food, Drug, and Cosmetic Act, a new tobacco product without premarket authorization is still adulterated and still cannot lawfully be sold. What changed is where the agency points its resources, not what the statute says about your shelf.

The second is the exclusion list. Products carrying presumptively underage-appealing features are carved out no matter what application is pending: cartoon-like characters, packaging that disguises the device as something else, and anything built to resemble a toy, a phone, or a gaming platform. Products lacking child-resistant packaging, presenting a fire hazard, or showing a pattern of serious adverse experiences are out as well. Half the disposables I see marketed on social media in a given week would fail one of those tests.

The third is the trapdoor. The list is a webpage the agency maintains, and it has told everyone in advance that products come off it as well as on. There is no notice period in a webpage. What a webpage grants, a webpage can take back.

What it does not touch at all

Federal enforcement discretion buys a vaper in Boston or Los Angeles exactly nothing. State flavor bans do not sit underneath federal policy waiting to be preempted. They sit on top of it, and they go further. Massachusetts and California will still be Massachusetts and California in the morning.

The state picture got considerably harder this summer, which is the part of this story with the most immediate effect on what you can buy.

The import side has not softened either. The agency describes its work at the border in the same document, in the same breath, in noticeably harder language: counterfeits, misdeclared shipments, and products whose makers never bothered to file anything at all remain the priority, in coordination with the Justice Department and Customs and Border Protection. Nothing about May 8 helps a container of unfiled disposables. If anything it sharpens the contrast, because the agency has now drawn a bright line between companies that engaged with the process and companies that ignored it.

The evidence the agency is finally acting on

The case for harm reduction has been sitting in plain sight for a decade, and the strongest version of it is not the number everyone quotes.

The 95 percent figure from the 2015 Public Health England report is the one that gets repeated, and it is the weakest brick in the wall. It came from an expert panel exercise, it has been argued over ever since, and Britain’s own later reviews stopped leaning on the specific number. Cite it as history, which is what it is.

The 2024 Cochrane review is the citation that carries weight, and it is the one nobody in the mainstream press seems to have read. Cochrane found high certainty evidence that nicotine e-cigarettes help more people stop smoking than traditional nicotine replacement therapy. High certainty is not a phrase Cochrane hands out for encouragement. Set that against roughly 480,000 American deaths a year from smoking and the arithmetic is not subtle.

What May 8 signals is an agency that has stopped treating complete nicotine abstinence as the only acceptable outcome. That is a real shift in posture, and it took long enough.

Where this leaves the market

The growth era is over and it is not coming back. The days when anyone with a garage, a supply of PG, and a decent flavor palate could launch a brand ended with the deeming rule. The PMTA framework, whatever else it did, built a wall that favors companies with legal departments, and the agency has rejected north of 26 million applications on the way here.

I have written before about who that wall was built for, and nothing in the May guidance changes it. Enforcement discretion rewards the companies that could afford to file in the first place.

What comes next looks like three tiers rather than one market. At the top, a small authorized shelf where the entry ticket is not flavor tolerance but device-level control. The Glas products cleared in May did not win because the FDA developed a taste for mango. They won because the device locks out anyone who cannot pass a government ID check and a Bluetooth handshake.

In the middle, a large and now semi-official tier of products that are technically unlawful, publicly listed as unpursued, and sold in every state that has not written its own registry law. Below that, the unfiled imports, which are getting squeezed harder than ever.

The vaping industry does not need another 2015 to do the only job that has ever justified it, which is keeping people who will not quit nicotine away from burning tobacco. It needs to stay reachable and legal enough for the smoker who has not switched yet. On May 8 the federal government made that a little easier and wrote the terms down. Read the terms. They are conditional, they are revocable, and they are published on a page that can be edited on a Tuesday afternoon without anyone asking your opinion.