Altria Secures FDA Approval for Six New on! PLUS Nicotine Pouch Variants

MO
December 20, 2025

Altria Group announced that the U.S. Food and Drug Administration granted market authorization for six new on! PLUS nicotine pouch products on December 19, 2025, allowing the company to sell the expanded lineup nationwide under the on! brand.

The approval, issued through the Premarket Tobacco Product Application (PMTA) pathway, covers a range of flavors and nicotine strengths that were previously available only in a handful of states. The decision removes the legal uncertainty that had forced Altria to launch the products in select markets before receiving formal approval, and it opens a full‑scale sales opportunity across the country.

Altria’s move comes as part of its "Moving Beyond Smoking" strategy, which has positioned the oral tobacco segment as the company’s highest‑margin growth engine. In the third quarter of 2025, the oral tobacco business posted an adjusted operating company income margin of 69.2%, up from 67% in fiscal 2023, driven by pricing power and a favorable mix shift toward the higher‑margin on! pouches. The broader company reported Q3 revenue of $5.251 billion, slightly below analyst expectations, but the margin expansion helped offset the revenue shortfall.

The nicotine pouch market is intensely competitive, with Philip Morris International’s Zyn products having secured FDA approval earlier in the year. Altria’s on! brand already holds a significant share of the oral tobacco category, and the new on! PLUS variants are positioned as a premium complement to the core lineup. The expanded product range is expected to capture additional market share in a category that is the fastest‑growing segment of U.S. tobacco products.

Management highlighted the strategic importance of the approval. CEO Billy Gifford said the company’s “vision” is advancing through “strong financial results and significant cash returns to shareholders,” while Helix Managing Director Nick MacPhee noted that the on! PLUS PMTA submission “underscores Altria’s commitment to addressing consumers’ evolving preferences.” Senior Vice President of Regulatory Affairs Paige Magness added that the PMTAs “demonstrate that responsibly marketed on! PLUS pouches can provide a compelling alternative in the marketplace.”

The FDA approval is a key milestone that supports Altria’s transition to smoke‑free products. By removing regulatory barriers, the company can now scale the on! PLUS line, potentially boosting revenue and margin contribution from its highest‑margin segment. The approval also signals to investors that Altria is progressing on its strategic pivot, reinforcing confidence in the company’s long‑term growth trajectory.

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