FDA authorizes first nicotine pouches

Sandhya Raman, CQ-Roll Call on Jan 16, 2025

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WASHINGTON — The Food and Drug Administration Thursday authorized marketing of 20 nicotine pouches — the first time the products have been greenlit by the agency.

Nicotine pouches are tobacco-free sachets filled with nicotine and flavorings that are held between the gums and lips similar to snus, another smokeless tobacco product. Proponents of the pouches argue that they are a less harmful alternative to smoking and other tobacco products, while some public health experts worry about other health consequences related to nicotine, especially on youth.

The FDA authorized the 20 Zyn products under a premarket tobacco product application process granted under a 2009 tobacco control law. Because Zyn includes nicotine, it must abide by the same regulatory process as a tobacco product. Zyn is a subsidiary of Philip Morris International.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

The 20 pouch types include two nicotine strengths of 3 and 6 milligrams and 10 flavors. Separate FDA rulemaking this week proposed a nicotine limit for certain tobacco products, such as cigarettes, of 0.7 milligrams per gram of tobacco. Those limits would not apply to these products.

The FDA’s authorization would not apply to other flavors and does not allow Zyn to make any claims about lesser risks without a separate modified risk tobacco product application.

The authorization means that these pouches can be marketed to adults 21 or older but the agency clarifies it does not mean the products are “safe, nor are they ‘FDA approved.’”

FDA, in its review of existing data and studies, found that youth uptake in the U.S. remained low despite increases in sales.

“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, director of the FDA’s Center for Tobacco Products. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”

Under the authorization, the products are subject to certain marketing restrictions to ensure advertising is targeted to people 21 or older. The FDA has the authority to suspend the marketing standard granted if the agency finds the products are growing in popularity among youth or are detrimental to public health efforts.

Congressional Republicans have criticized the delay in market authorization of nicotine pouches and criticized efforts to limit smokeless alternatives for adults.

Rep. Richard Hudson, R-N.C., shared an image of him holding a canister of Zyn on social media Thursday, following the announcement.

“BREAKING: After my repeated demands to the FDA, Zyn is now officially #authorized,” Hudson posted on X.

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