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.
