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FDA says only 43 nicotine pouches can legally be sold in the US. ZYN's newest flavors aren't among them.

PMI put Black Cherry, Peach and Dragonberry front and center at the NACS Show in Las Vegas. FDA's own list of authorized pouch products — the only ones it says may lawfully be sold — doesn't include them.

PouchDaily Desk·
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At the industry's biggest US retail trade show this week, the largest nicotine pouch brand in America put its newest products on a two-story booth. Cross-reference those products with FDA's own authorization list, and several of them aren't there.

What happened

Philip Morris International displayed its full US portfolio at the NACS Show in Las Vegas, which wrapped up October 9. Reporting from the booth by trade outlet 2Firsts, plus the booth materials themselves, showed:

  • ZYN Ultra in 9 mg and 11 mg, with a redesigned can and a "hydro-boosted" pouch
  • The flagship ZYN range in 1.5, 3, 6 and 8 mg
  • Black Cherry, Peach and Dragonberry listed under a "New Flavor" heading

Then there's FDA's list. The agency keeps a public list titled "Nicotine Pouch Products Authorized by the FDA," and its own wording is blunt: 43 authorized products, and "these are the only nicotine pouch products that may be lawfully sold in the United States." PouchDaily enumerated the ZYN entries on the live list: exactly 20 flagship products (ten flavors in 3 mg and 6 mg, authorized January 2025) and 11 ZYN Ultra products (authorized August 2026 — ten 9 mg variants and a single 11 mg, Smooth).

What's missing from that list is exactly what was on the booth:

  • All three new fruit flavors — Black Cherry, Peach and Dragonberry launched in the US this summer in 3 mg and 6 mg. None appear on the authorized list in any strength.
  • The 1.5 mg and 8 mg flagship strengths — the list covers 3 mg and 6 mg only.
  • ZYN Ultra Arctic Mint 11 mg — the August authorization included Cool Mint 9 mg but not its 11 mg sibling. Arctic Mint is the commercial name for Cool Mint, and 11 mg Smooth (sold as Signature Smooth) is the only 11 mg Ultra on the list.

Why it matters

To be clear about what this is and isn't. PMI said in August that applications for other 11 mg Ultra variants remain under FDA scientific review, and new products from the category leader going through review is normal. Displaying a product at a trade show is not the same as selling it. But the fruit flavors aren't hypothetical booth displays — they launched this summer and are on store shelves, and FDA's page says products not on its list may not lawfully be sold. Either those applications get granted, or this becomes an enforcement question in the category's biggest market.

It also puts a number on how much of ZYN's US lineup now sits outside formal authorization. Of the roughly 30-plus ZYN variants PMI is now marketing, the flavors and strengths drawing the most attention this year — the new fruit line, the extreme ends of the strength range — are precisely the ones with no marketing granted order. The authorized list still covers the core mint, coffee and citrus range that carries most of the volume, which is why this hasn't slowed ZYN's momentum.

The context around it is moving fast. FDA just issued its first-ever modified-risk claim for 20 ZYN products in June, authorized the Ultra line in August, and proposed replacing its entire PMTA framework in late September. PMI also began producing ZYN commercially at its new Aurora, Colorado plant in July — part of roughly $1.2 billion in planned US investment through 2028 — and told the booth the newer IQOS ILUMA system remains under FDA review, with current-generation IQOS sold in just three states.

Watch whether FDA grants orders for the fruit flavors and the missing strengths in the coming months. If it does, this becomes a footnote. If it doesn't, the gap between what's on shelves and what's on FDA's list becomes the biggest enforcement question in the pouch category.

Compare ZYN's authorized and full range side by side at PouchFinder.

SOURCES