---
title: "FDA approves 11 new ZYN ULTRA nicotine pouch varieties: 9 mg and 11 mg nicotine options now legally sold in the US"
description: "The US FDA has approved the sale of 11 new ZYN ULTRA nicotine pouch varieties manufactured by Philip Morris — ten with 9 mg and one with 11 mg of nicotine. The regulator found them to have lower levels of toxic constituents."
date: 2026-08-31T10:28:00.000Z
lang: en
url: https://xab.info/en/posts/fda-approves-11-new-zyn-ultra-nicotine-pouches-9-11-mg
tags: [fda, nicotine-pouches, zyn, philip-morris, tobacco, public-health]
publisher: "XAB.info"
---

# FDA approves 11 new ZYN ULTRA nicotine pouch varieties: 9 mg and 11 mg nicotine options now legally sold in the US

![ZYN ULTRA nicotine pouches in an open tin: new 9 and 11 mg nicotine strengths approved by the FDA](https://xab.info/media/2026/08/31/fda-odobrilo-11-novyh-vidov-nikotinovyh-pauchey-zyn-ultra/fda-odobrilo-11-novyh-vidov-nikotinovyh-pauchey-zyn-ultra-1.webp)

## 🎯 Key Points

- FDA approved 11 new ZYN ULTRA varieties: 10 with 9 mg and 1 with 11 mg of nicotine, manufactured by Swedish Match USA (Philip Morris International).
- The evaluation was conducted under an expedited review pilot program; in total, the FDA has authorized 43 pouch varieties, 23 of them through the pilot program.
- According to the FDA, the new products contain lower levels of harmful constituents than other smokeless tobacco products and may reduce cravings in adult smokers.
- The FDA previously allowed the sale of 20 ZYN varieties with a modified risk claim, positioning them as a less harmful alternative to cigarettes.

The US Food and Drug Administration (FDA) has authorized the sale of 11 new varieties of ZYN ULTRA brand nicotine pouches. According to the regulator, the approval now covers ten pouch varieties with a nicotine concentration of 9 mg and one variety with a concentration of 11 mg. The approved products are manufactured by Swedish Match USA, a company in the Philip Morris International portfolio. As a result, the American market now offers a wider range of dosages, effectively expanding the lineup of legal smokeless nicotine products.

### What exactly the regulator approved

A key condition of any FDA authorization is the presence of sufficient evidence that a new product brings more benefit to society than potential risks. As noted in the report, "to obtain marketing authorization, the FDA must have sufficient evidence that the new products pose greater benefit to public health than potential risks." In its scientific assessment, the regulator considers the risks and benefits for the US population as a whole: both the potential benefit for adults switching from conventional tobacco products to a lower-risk product, and the possible risks for youth and non-tobacco users.

### How risks and nicotine levels were assessed

When reviewing nicotine pouch applications, the FDA analyzes the nicotine exposure level associated with each individual product. This level depends not only on the nicotine content declared on the packaging, but also on the composition, materials used, and other characteristics affecting the amount and rate of nicotine delivery to the body. The assessment showed that the new ZYN varieties, including the 11 mg option, contain lower levels of most harmful and potentially harmful constituents compared to other oral and smokeless tobacco products; the levels of many substances were so low that they could not be quantified. In addition, according to the regulator's assessment, the new products can provide sufficient nicotine delivery to reduce cravings and withdrawal symptoms, which may encourage behavior change — for example, switching to a less harmful product — among adults using more dangerous tobacco products. For adults aged 21 and over who smoke cigarettes or use smokeless tobacco, a full switch to FDA-authorized pouches may reduce exposure to many harmful chemicals.

### Pilot program and overall authorization statistics

The applications were reviewed under the FDA's pilot program for expedited evaluation of nicotine pouches. To date, the regulator has authorized a total of 43 nicotine pouch varieties, of which 23 were approved specifically under the pilot program. It is worth noting separately that the FDA previously allowed the sale of 20 ZYN nicotine pouch varieties with a modified risk claim, i.e., positioned as a less harmful alternative to cigarettes. The 11 new authorizations complement this lineup and expand the available dosages.

### What nicotine pouches are

Nicotine pouches (or nicotine pads) are small packets placed under the upper lip. Upon contact with the oral mucosa, nicotine is gradually released from the pouch and absorbed into the body over 20–30 minutes. Unlike traditional smokeless tobacco, these pouches do not contain tobacco leaves: their composition typically includes nicotine, a filler (cellulose), water, flavorings, and glycerin. It is precisely the absence of tobacco material and the low level of toxic impurities, according to the FDA's assessment, that underpin the conclusion of a lower risk level compared to cigarettes and classic smokeless tobacco products.

## 🔍 Fact-Check Verification

- [US expands list of approved nicotine pouches: 9 mg and 11 mg now available](https://www.rbc.ua/ukr/news/ssha-rozshirili-perelik-dozvolenih-prodazhu-1788168621.html) - Подтверждает расширение списка и дозировки 9 и 11 мг.
- [FDA allows ZYN nicotine pouches to be positioned as a modified risk product](https://www.obozrevatel.com/novosti-obschestvo/fda-razreshilo-pozitsionirovat-nikotinovyie-pauchi-zyn-kak-produkt-s-modifitsirovannyim-riskom.htm) - Подтверждает статус modified risk для ZYN.
- [11 new Philip Morris nicotine pouch products registered in the US](https://remedium.ru/news/v-ssha-zaregistrirovano-11-nov/) - Подтверждает количество (11) и связь с Philip Morris.
- [FDA finds ZYN nicotine pouches less harmful than cigarettes](https://minfin.com.ua/2026/07/03/177015746/) - Подтверждает вывод о более низком уровне вреда относительно сигарет.

## ❓ FAQ

### Q: How many new ZYN ULTRA pouch varieties did the FDA approve?
**A:** 11 new varieties: ten with a nicotine concentration of 9 mg and one with a concentration of 11 mg.

### Q: Who manufactures the approved products?
**A:** Swedish Match USA, a company owned by Philip Morris International.

### Q: Why did the FDA allow the sale of these pouches?
**A:** The regulator determined that the new products contain lower levels of harmful constituents than other smokeless tobacco products and may reduce cravings in adults switching from more harmful tobacco products.

### Q: What are nicotine pouches and how do they work?
**A:** They are small packets without tobacco leaves (nicotine, cellulose, water, flavorings, glycerin) placed under the upper lip; nicotine is absorbed through the mucosa over 20–30 minutes.

### Q: How many pouches has the FDA authorized in total?
**A:** A total of 43 nicotine pouch varieties, of which 23 were authorized under the expedited review pilot program; previously, the sale of 20 ZYN varieties with a modified risk claim was permitted.