FDA Allows Philip Morris To Market Zyn Nicotine Pouches As Less Harmful Than Cigarettes

WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration (FDA) has authorized Philip Morris International to market its Zyn nicotine pouches as a lower-risk alternative to cigarettes, marking a significant milestone for the fast-growing smokeless nicotine category.The FDA said 20 Zyn nicotine p…

The FDA said 20 Zyn nicotine pouch variants can now be marketed with the claim that 'using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.'

The agency concluded that the available scientific evidence supports the claim and that the products could significantly reduce harm and the risk of tobacco-related disease for adult smokers who switch completely from cigarettes.

The decision follows years of regulatory review as health officials weighed the products' potential harm-reduction benefits against concerns that nicotine pouches could attract new users, including young people.

The FDA said its review is intended to provide adult tobacco users with accurate, science-based information about the relative risks of different nicotine products.

The ruling represents a major win for Philip Morris, which acquired Zyn manufacturer Swedish Match and has argued that smokers need clear information about lower-risk alternatives.

Zyn has become the fastest-growing nicotine product in the U.S., with Philip Morris selling 794 million cans in 2025, more than double its 2023 sales. Critics, however, continue to raise concerns about the products' cardiovascular risks and their appeal beyond former smokers.