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FDA Authorises 11 More ZYN ULTRA Nicotine Pouches
The US regulator has cleared 11 ZYN ULTRA products from Philip Morris's Swedish Match unit, taking its total authorised nicotine pouches to 43.
On 21 August 2026 the US Food and Drug Administration (FDA) authorised the marketing of 11 new nicotine pouch products made by Swedish Match USA, the Philip Morris International (PMI) business behind ZYN. They are sold under the ZYN ULTRA name.
Which products were authorised
According to the FDA, the list is ZYN ULTRA Chill, Citrus, Cool Mint, Deep Freeze, Menthol, Peppermint, Smooth, Spearmint, Wintergreen Chill and Wintergreen at 9 mg, plus ZYN ULTRA Smooth at 11 mg.
How the decision was made
The products went through the premarket tobacco product application (PMTA) route and were reviewed under the FDA's nicotine pouch pilot programme. The FDA says it has now authorised 43 nicotine pouch products overall, 23 of them through the pilot.
The wider ZYN story
- In January 2025 the FDA authorised 20 ZYN products, the first nicotine pouches it had ever cleared.
- On 30 June 2026 it granted those 20 products modified risk orders, allowing a specific claim that using ZYN instead of cigarettes lowers the risk of several smoking-related diseases.
These are US decisions and do not change how pouches are sold in the UK. For UK rules, see our guide to the 29 October 2026 changes.
Sources
- FDA Authorizes 11 New Nicotine Pouches, U.S. Food and Drug Administration (21 August 2026)
- FDA Authorizes 20 ZYN Nicotine Pouches to Be Marketed with Specific Modified Risk Claim, U.S. Food and Drug Administration (30 June 2026)
- FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review, U.S. Food and Drug Administration (16 January 2025)
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