Many people have turned away from cigarettes in recent years, opting for “healthier,” smokeless alternatives. Now the Food and Drug Administration has effectively backed up this claim by updating its regulations — specifically for a crowd-favorite brand.
The FDA permits ZYN nicotine pouches, manufactured by Swedish Match USA Inc., to be marketed with language stating that using them instead of cigarettes puts users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
This regulatory shift allows the product label to explicitly state: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The update applies to 10 flavors of ZYN’s original line — chill, cinnamon, citrus, coffee, cool mint, menthol, peppermint, smooth, spearmint, and wintergreen — at two strengths (three milligrams and six milligrams). It does not extend to ZYN’s new flavors: peach, black cherry, and dragonberry.
Bret Koplow, acting director of the agency’s Center for Tobacco Products, explained that “FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products.” He added, “Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”
The FDA clarified this update constitutes a marketing authorization, not an approval. The agency emphasizes no tobacco product is safe and focuses on relative risk comparisons. According to FDA requirements, such authorization demands proof that switching to the product significantly reduces harm and tobacco-related disease risk for individuals and public health.
Philip Morris U.S. CEO Stacey Kennedy described the decision as critical for over 45 million legal-age nicotine consumers: “Today’s news ensures these adults have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer.”
