FDA Weighs Allowing Zyn Pouches to Be Marketed as Lower-Risk Nicotine Option

FRIDAY, Jan. 23, 2026 (HealthDay News) — Flavored nicotine pouches called Zyn could soon be legally advertised as a lower-risk option for adults who smoke, as federal regulators take a closer look at the popular product.

The U.S. Food and Drug Administration (FDA) held a public meeting Thursday to review whether Philip Morris International can market Zyn as a safer alternative to cigarettes.

Government documents released ahead of the meeting suggested FDA scientists may support the request, but outside health experts will also weigh in before a decision is made.

Zyn is a small pouch filled with nicotine powder that users place under their lip. It comes in 10 flavors, including mint, coffee and citrus. Unlike cigarettes, Zyn does not involve burning tobacco.

Philip Morris is asking the FDA for permission to say that switching from cigarettes to Zyn lowers the risk of serious diseases such as lung cancer, heart disease, stroke and mouth cancer.

The company already won FDA approval last January to keep Zyn on the market after years of review. At the time, FDA said the product appeared less harmful than cigarettes and other traditional tobacco products.

Zyn was the first nicotine pouch to receive that authorization.

If the FDA allows the new marketing claims, Philip Morris would be able to use the language in ads aimed at adults who currently smoke or use other tobacco products.

While fewer than 1% of U.S. adults use nicotine pouches, the products are the fastest-growing segment of the tobacco market. Cigarette use continues to fall as people quit, switch products or die from smoking-related illness.

Zyn dominates the nicotine pouch market in the U.S. Last year, the brand posted $3.24 billion in sales, more than two-thirds of the market, according to a Goldman Sachs analysis.

Philip Morris says most Zyn users are in their 30s and 40s and tend to earn more than people who smoke cigarettes or use e-cigarettes.

In a preliminary review posted earlier this week, the FDA said that, after reviewing all available data, the claim that Zyn lowers the risk of smoking-related diseases appears to be “scientifically accurate.”

While Philip Morris did not run long-term studies, the company submitted other evidence, including research on snus, a similar oral tobacco product widely used in Sweden, the FDA said.

Scandinavian studies have consistently found that snus users have much lower rates of lung and mouth cancers than cigarette smokers.

Philip Morris says Zyn may carry even fewer risks than snus, because it contains no tobacco leaves, only nicotine.

Company testing found that 36 of 42 known cancer-causing chemicals found in tobacco products were either not detected or present at extremely low levels in Zyn.

For the remaining six chemicals, FDA reviewers said amounts were “below the level that would be expected to pose a health risk.”

The FDA must also consider whether allowing Zyn to make health claims could encourage use among young people or nonsmokers.