FDA Authorizes 4 New on! Nicotine Pouches: Full 2026 Product List

On August 4, 2026, the FDA’s Center for Tobacco Products cleared four new nicotine pouch products for legal sale in the United States: on! Rich Berry 2 mg, on! Cappuccino 2 mg, on! Cappuccino 4 mg, and on! Autumn Spice 2 mg. All four are manufactured by Helix Innovations LLC, the Altria-owned pouch maker behind the on! and on! PLUS brands, and all four went through the premarket tobacco product application (PMTA) pathway — the same rigorous, evidence-based review that every legally sold nicotine pouch in the U.S. must clear.

The authorization brings the total number of FDA-authorized nicotine pouch products to 30, according to the agency’s own tracker. That number matters for retailers and distributors trying to keep their shelves compliant, and it matters for consumers trying to figure out which pouches are actually legal versus which are being sold in a gray market that federal and state enforcement is increasingly targeting.

What Exactly Did the FDA Authorize on August 4?

The FDA’s review concluded that these products contain lower levels of most harmful and potentially harmful constituents than traditional oral and smokeless tobacco, with many constituents too low to even quantify. For context, the agency’s marketing-authorization standard doesn’t mean a product is safe or “FDA approved” — it means the agency found sufficient evidence that authorizing the product provides a net benefit to the U.S. population as a whole, weighing the potential for adult smokers to switch away from cigarettes against the risk of attracting youth or non-tobacco users.

Why Flavors Are Expanding Beyond Mint, Tobacco and Wintergreen

For the first two years of legal nicotine pouch sales, “FDA-authorized” was basically synonymous with mint, wintergreen, menthol and tobacco. That’s because the first-ever nicotine pouch authorizations — 20 ZYN products cleared in January 2025 — leaned almost entirely on cooling and traditional tobacco profiles, flavors regulators consider lower-risk for attracting youth. When Helix Innovations won authorization for six on! PLUS products in December 2025, mint, tobacco and wintergreen were still the only flavor families on the list.

Cappuccino and Autumn Spice break that pattern. They’re the first widely dessert- and spice-adjacent flavor names to clear the PMTA bar, alongside Rich Berry, a fruit-forward profile FDA also authorized in the same batch. That expansion is the real story behind this authorization: it signals that manufacturers can win marketing orders for flavors outside the traditional “adult-leaning” palette, provided they bring strong enough evidence that the product’s population-level benefit — helping adult smokers switch completely — outweighs any appeal to youth.

The August 4 on! authorizations show the agency applying those same efficiencies to a second, more flavor-diverse application — and the FDA has said it’s now carrying lessons from the pilot into its broader PMTA review process, which suggests more flavor variety, not less, is likely on the way for future applications.

That expansion hasn’t gone unchallenged. The American Lung Association said flavors are a primary driver of youth tobacco use and pointed out that the large majority of young pouch users prefer flavored products. The American Heart Association went further, criticizing the pilot program itself as loosely defined. Both groups’ core objection is the same: every new flavor authorized is, in their view, a new reason for a teenager to try a nicotine product. The FDA’s counterargument, built into every one of its nicotine pouch decisions, is that adults who completely switch from cigarettes to an authorized pouch may meaningfully reduce their exposure to harmful chemicals — but only if they quit combustible tobacco entirely, since using both products together doesn’t deliver the same risk reduction.

The FDA’s Nicotine Pouch Pilot Program, Explained

The pilot program isn’t a shortcut around safety review — it’s a change to how the FDA communicates with applicants during review. Rather than compiling a long deficiency letter at the end of a review cycle, FDA reviewers now have ongoing conversations with applicants to resolve missing information or ambiguities as they come up. The agency has credited this approach with faster issue resolution and more efficient scientific reviews overall. Acting Center for Tobacco Products director Bret Koplow said the program shows rigorous review and efficient review aren’t mutually exclusive, and that adult smokers now have an expanded array of lower-risk options as a result.

As of August 4, 2026, exactly 30 nicotine pouch products are legally authorized for sale in the United States. No other nicotine pouch brand, flavor, or strength may be lawfully marketed — anything outside this list is considered an unauthorized tobacco product subject to FDA enforcement.

Helix Innovations LLC (Altria) — on! and on! PLUS — 10 products

Swedish Match USA, Inc. (Philip Morris International) — ZYN — 20 products

Note on “authorization type”: every product on this list holds a PMTA marketing granted order, which is what makes it legal to sell. The 20 ZYN products additionally hold a separate modified risk order (granted June 30, 2026) permitting a specific reduced-risk marketing claim versus cigarettes — that’s a distinct, additional authorization, not a requirement for legal sale.

FDA Authorization Timeline at a Glance

Pouches are only half the picture. Our complete FDA-authorized product database tracks all 45 authorized ENDS products alongside all 30 authorized nicotine pouches, with the authorization date for each and a note on what a marketing granted order does and does not mean. It is updated on every new FDA decision.

Where to Find These FDA-Authorized Brands

If you’re a retailer or consumer sourcing legally authorized pouches, stick to brands and SKUs that appear on the FDA list above. Wholesale and retail sourcing options carrying FDA-authorized brands include:

As of this writing, neither retailer lists the on! brand specifically, so ZYN remains the most widely available FDA-authorized pouch across mainstream retail and wholesale channels — worth watching as on! distribution expands.

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