FDA authorises ZYN nicotine pouches to carry reduced-risk health claim

The United States Food and Drug Administration (FDA) has authorized 20 ZYN nicotine pouch products to be marketed with a specific reduced-risk health claim, the agency announced on June 30, 2026.

The claim states that using ZYN instead of cigarettes puts users at lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.

The FDA issued the orders to Swedish Match USA, a subsidiary of Philip Morris International (PMI), following what the agency described as an extensive scientific review. The 20 products span 10 flavors, including Cool Mint, Wintergreen, Citrus, and Coffee, each sold in 3 milligram and 6 milligram nicotine strengths.

The products have been legally sold in the United States since January 2025. This new authorization, known as a Modified Risk Tobacco Product (MRTP) order, allows the company to advertise the specific health claim, something it could not do before.

Why the FDA approved the claim

Bret Koplow, acting director of the FDA's Center for Tobacco Products, said the review is meant to give adult tobacco users clear, science-based information about relative harms so they can make informed choices.

The agency said its decision was based on the relative health risks of the products, how consumers understand and perceive the claim, data on youth risk, and the likely impact on the wider population. It also weighed input from a January 2026 scientific advisory committee meeting and public comments.

Under the order, Swedish Match must carry out postmarket surveillance and studies tracking user behavior and understanding of the risk information. The authorization expires in five years and can be withdrawn earlier if the FDA finds it no longer benefits public health, including if youth uptake rises significantly.

The FDA was clear that this does not mean the product is safe. The agency stated there is no safe tobacco product and that people should not start using tobacco. It added that adults who currently smoke would benefit most from quitting all tobacco use entirely, but that switching completely from cigarettes to authorized nicotine pouches may lower exposure to harmful chemicals found in cigarettes.

The FDA has authorized 26 nicotine pouch products to date.

Company reaction

PMI, which markets ZYN in the United States, called the decision a milestone. PMI U.S. chief executive Stacey Kennedy said the FDA's decision is a decisive moment for the more than 45 million legal-age nicotine consumers in America, giving them access to accurate, science-based information.

The company said the ruling marks the first time the FDA has granted MRTP orders to a nicotine pouch product. PMI also holds similar modified-risk authorizations for its IQOS heated tobacco devices and for General snus, another nicotine pouch brand.

PMI reported that its smoke-free product category, which includes nicotine pouches, accounted for 43 percent of its total net revenue in the first quarter of 2026.

Background: Maldives moves the opposite direction on cigarette tax

While the United States tightens its evidentiary framework for harm-reduction claims, the Maldives has taken a different path on tobacco policy in the same period.

On July 1, 2026, the Maldives Parliament voted unanimously to cut the specific import duty on cigarettes, cigars, and heated tobacco sticks from MVR 8 to MVR 4 per stick and lowered the ad valorem rate from 50 percent to 30 percent. The Standard Maldives reported that the change also applies to bidis. Parliament separately voted to remove import duty entirely on nicotine replacement products such as gum and patches.

The cut reverses a duty increase introduced in November 2024. According to Maldives Independent, the bill's own annex showed cigarette imports had fallen 77.5 percent in 2025 and a further 21.4 percent by May 2026, while duty receipts collapsed from more than MVR 100 million to around MVR 5 million. Opposition lawmakers had put the wider revenue loss at roughly MVR 2 billion since the 2024 hike, a figure that has not been independently verified against Ministry of Finance data.

Government lawmakers said the reduction reflects evidence that the Maldives' vape ban and a generational tobacco sales ban that took effect in November 2025 had not pushed more people toward smoking and that high duties had instead fueled a black market. President Dr. Mohamed Muizzu said the change follows a World Health Organization-recommended rate and does not reverse the country's tobacco control direction. The Maldives Independent reported that the WHO declined to comment directly on the policy when approached and referred questions to the Ministry of Health.

The measure passed six days before a by-election that the ruling party lost, a timing opposition figures have pointed to, though no direct causal link has been established.