The FDA Said Flavors Were the Problem in 2020. In 2026, It Approved Four More.

This is the second flavor reversal Rize has tracked in the nicotine-tobacco pouch cluster this summer alone. On Tuesday, four more names got added to the FDA’s list of legally marketable nicotine pouches: Rich Berry, two strengths of Cappuccino, and Autumn Spice, all made by Helix Innovations under its “on!” brand. The agency’s own announcement frames this as routine — the thirtieth, thirty-first, thirty-second, and thirty-third pouch products cleared through a “pilot program” the FDA launched last September to speed up review. Routine is the wrong word for it.

A federal agency that spent the last decade treating flavor as the mechanism of youth nicotine addiction just authorized four more flavors, using a shortcut it created for itself.

That’s not a paraphrase of what critics say. It’s what happened, in the plain language of what a Premarket Tobacco Product Application pilot pathway does: it lets a manufacturer get a product to market faster, with less of the public comment and evidentiary back-and-forth that the standard PMTA process — created by the 2009 Family Smoking Prevention and Tobacco Control Act specifically so nicotine products would have to prove they were “appropriate for the protection of public health” before reaching store shelves — was built to require. Cappuccino and Autumn Spice are not tobacco flavor. Nobody is claiming they were engineered for adults trying to quit menthol cigarettes.

The pilot program is doing exactly what flavor bans exist to prevent

The American Lung Association called the decision “another gamble with kids’ health,” and the American Heart Association said it “threatens to sustain youth nicotine use” — language that reads as boilerplate advocacy-group pushback until you sit with what nicotine pouches already are in a teenager’s world. They’re the second most popular tobacco product among American youth, behind only vapes. They look like a tin of mints. They don’t require lighting, exhaling, or a device that sets off a smoke detector. A flavor line built around dessert and berry names is not incidental to that popularity — it’s aimed at it, the same way Juul’s mango and mint pods were aimed at it in 2018, the same way “light” and “low tar” were aimed at smokers trying to quit fifty years before that.

This isn’t the first flavor reversal this year, either. PBS NewsHour reported that in May, days before Commissioner Marty Makary resigned, the agency issued a six-page “enforcement discretion” memo letting unauthorized flavored vapes — mango, blueberry — stay on shelves while the FDA reviews them, bypassing the public comment period the standard process requires. Makary’s own deputy had blocked the first fruit-flavor authorization back in February. Mitch Zeller, who ran the FDA’s tobacco center for six years under two administrations, told PBS the sequence of events “begs the question of whether the true subject matter experts may have actually opposed this policy” before it was overridden. That’s about as pointed as a former federal regulator gets on the record.

Here’s the layer under the outrage that’s worth sitting with for a second, because it’s not simple: underage vaping is, right now, at its lowest level among U.S. teenagers in more than a decade, and roughly 80% of vapes actually being sold in the U.S. are unauthorized Chinese imports that no PMTA pathway — pilot or standard — touches at all. Jonathan Foulds, a tobacco-addiction specialist at Penn State, made the case to PBS that regulators are “deluged by illegal products coming across the border” and that authorizing a narrower set of legal, tested alternatives is partly a response to a black market the FDA can’t otherwise control. That’s a real regulatory dilemma, not a fig leaf. It’s also not an argument for flavors named after desserts. A legal, harm-reduction-framed pouch in tobacco or mint flavor answers the adult-smoker-alternative case. Cappuccino doesn’t need to exist to serve that case, and the industry knows the difference — which is exactly why it keeps making the dessert flavor anyway.

are unauthorized Chinese imports that no PMTA pathway — pilot or standard — touches at all.

The industry has run this play before, and a judge already ruled on it

In 2006, after a seven-year federal racketeering trial, U.S. District Judge Gladys Kessler ruled that the major tobacco companies had spent nearly fifty years deceiving the public about the health effects of “light” and “low tar” cigarettes — marketing them as a safer alternative for smokers who wanted to quit or cut back, while their own internal research showed smokers simply inhaled harder and longer to get the nicotine dose they were used to. The “reduced risk” claim wasn’t a scientific finding the companies later walked back. Internally, it was known to be false while it was being sold as true, for decades, to smokers who trusted the label. The pattern the court described — introduce a product framed as a safer step down, market it in a way that especially appeals to people who wouldn’t otherwise be using nicotine at all, let regulators catch up years after the products are already embedded in daily life — is not a distant memory. It’s the same shape as a flavored pouch pilot program moving faster than the public comment period meant to check it.

None of that makes flavored pouches a fraud in the legal sense that “light” cigarettes were. Nicotine pouches genuinely deliver less combustion-related harm than a cigarette, and for an adult who smokes and can’t or won’t quit, a tobacco- or mint-flavored pouch is a real harm reduction option worth having on the market — Rize covers that harm reduction case on its own terms. But “less harmful than a cigarette” and “cleared for a flavor line built to taste like a milkshake” are two different regulatory questions, and the FDA’s own pilot program just answered the second one as if it were the first.

For treatment providers and school-facing case managers, the practical takeaway isn’t abstract: if your intake screening for adolescents or young adults still asks generically about “vaping” or “tobacco use,” this is the week to add pouches by name — kids describing pouch use often don’t categorize it as tobacco at all, since there’s no smoke, no vapor, and a marketing language built entirely around flavor rather than nicotine. A screening question that doesn’t say “nicotine pouches” out loud will miss it.

The FDA’s pilot program is, by its own description, winding down — a temporary bridge the agency built to clear a product backlog faster, not a permanent new pathway. The real question was never whether the bridge would close. It’s how many more dessert-flavored products cross it before it does, and the agency has now shown twice this year which way it leans when speed and scrutiny disagree.