FDA Approves Zyn Nicotine Pouches as Safer Alternative for Smokers

WASHINGTON — The U.S. Food and Drug Administration (FDA) on Thursday authorized the sale of Philip Morris International’s Zyn nicotine pouches, marking the first time regulators have approved a nicotine pouch product as a less harmful alternative for adult smokers. The decision comes after a decade-long review of data showing the pouches could help smokers reduce or quit traditional tobacco use.

The FDA approved 10 Zyn flavors, including coffee, mint, and menthol, as part of its effort to provide safer options for smokers. The pouches, which contain nicotine but no tobacco, are placed between the lip and gum, releasing nicotine over time. While the FDA emphasized that Zyn is not risk-free, it is considered less harmful than cigarettes and chewing tobacco, which are linked to cancer and other life-threatening diseases.

“The data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes or smokeless tobacco products,” said Matthew Farrelly of the FDA’s Center for Tobacco Products. The agency noted that a significant number of adults who switched to Zyn completely stopped using traditional tobacco products.

Despite the FDA’s approval, concerns remain about the product’s appeal to teenagers. Social media platforms have seen a surge in videos featuring young people using Zyn, prompting warnings from anti-smoking groups. However, FDA officials cited government survey data showing fewer than 2% of high school and middle school students used nicotine pouches in the past year.

Zyn, marketed in the U.S. by Swedish Match, a subsidiary of Philip Morris, competes with similar products like Altria’s On pouches. The product’s rise in popularity has sparked political debate, with Democratic Sen. Chuck Schumer calling for stricter oversight to prevent underage use, while some Republicans have defended Zyn as a personal choice for adults.

Supporters argue that Zyn functions similarly to nicotine gum and lozenges, offering a safer way to manage nicotine cravings. However, health experts caution that no nicotine product is entirely safe. “While Zyn may be less harmful than cigarettes, the best alternative is to avoid nicotine altogether,” said one public health advocate.

The FDA’s decision reflects a broader shift in the tobacco industry, as companies develop alternatives to combat declining cigarette sales. E-cigarettes, once hailed as a safer option, faced backlash after a spike in underage use. Regulators hope to avoid a similar trend with nicotine pouches by enforcing strict marketing guidelines and monitoring youth usage.