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FDA Grants Authorization for Zyn Nicotine Pouches: A Smoking Cessation Tool

FDA Grants Authorization for Zyn Nicotine Pouches: A Smoking Cessation Tool
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  • PublishedJanuary 18, 2025

The US Food and Drug Administration (FDA) has officially authorized the marketing of Zyn nicotine pouches as a tool to help adults quit smoking.

This decision, announced on Thursday, permits 10 Zyn flavors—including mint, coffee, cinnamon, and menthol—to remain on the market. The authorization follows years of review since the product, made by Philip Morris International, was first introduced to US consumers over a decade ago.

Zyn nicotine pouches are tobacco-free products designed to release nicotine when placed between the gum and lip. Unlike snus, a smokeless tobacco product commonly used in Norway and Sweden, Zyn pouches do not contain any tobacco. Their design is similar to traditional smoking cessation aids such as nicotine patches or gum.

The FDA’s decision emphasizes that while Zyn pouches are not without risk, they are considered less harmful than smoking cigarettes or using other smokeless tobacco products. The agency reviewed scientific data showing that many adults who used cigarettes or smokeless tobacco switched completely to nicotine pouches.

The FDA stressed that its authorization does not equate to an endorsement of Zyn products as “safe” or “FDA-approved.” The agency noted that there is no such thing as a risk-free tobacco product. Additionally, officials emphasized that youth should avoid using nicotine pouches and urged adults who do not use tobacco products to abstain from starting.

Although Zyn has gained significant popularity in recent years, particularly among adults, fewer than 2% of middle and high school students reported using nicotine pouches in 2024, according to the National Youth Tobacco Survey. Brian King, director of the FDA’s Center for Tobacco Products, stated that the agency would closely monitor the market to prevent youth misuse of the product.

Zyn’s rise in popularity has sparked significant discussion. Sales have surged, and Philip Morris is constructing a $600 million factory in Colorado to meet growing demand. Online influencers unaffiliated with the company have also promoted Zyn, leading to debates reminiscent of the teen vaping boom of the late 2010s.

Notably, the FDA authorized Zyn products in two nicotine strengths (3 mg and 6 mg) across several flavors. The decision aligns with the FDA’s broader efforts to regulate nicotine consumption. Earlier in the week, the agency proposed a rule to cap nicotine levels in cigarettes, cigars, and rolling tobacco.

With input from BBC and Axios.

Written By
Joe Yans