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News analysis

US FDA authorises On! Plus pouches in first win for new fast-track pilot scheme

Written by || 22nd December 2025 || News analysis | Flavours | Modern oral | Regulation and legislation | US federal regulation | GeographiesNorth America United States

The first nicotine pouches have successfully passed through the US Food and Drug Administration (FDA) plot programme that aims to increase efficiency and streamline the review process for premarket tobacco product applications (PMTAs) for nicotine pouch products.

The agency announced that it had authorised six pouch products made by Helix Innovations and sold under the On! Plus brand.

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Freddie Dawson

Senior contributing editor
Freddie studied at King’s College, London and City University and worked for publications including The Times, The Malay Mail, PathfinderBuzz and Solar Summary before joining the TobaccoIntelligence team. He has extensive experience in covering fast-moving consumer goods (FMCG), manufacturing and technological innovation.

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