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FDA authorizes 4 flavored nicotine pouches

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FDA authorizes 4 flavored nicotine pouches
Healthcare FDA authorizes 4 flavored nicotine pouches Comments: by Joseph Choi - 08/04/26 5:52 PM ET Comments: Link copied by Joseph Choi - 08/04/26 5:52 PM ET Comments: Link copied

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The Food and Drug Administration (FDA) on Tuesday granted marketing authorization to four new flavored nicotine pouches as part of the agency’s tobacco review pilot program launched last year.

Four nicotine pouch products — Rich Berry 2 mg, Cappuccino 2 mg, Cappuccino 4 mg and Autumn Spice 2 mg — from Helix Innovations LLC received marketing authorization from the FDA. The authorizations are part of the agency’s pilot program launched in September 2025 meant to “streamline the review process for premarket tobacco product applications.”

“The FDA’s evaluation found that these new products contain lower levels of most harmful and potentially harmful constituents (HPHCs) when compared to other oral and smokeless tobacco products, many of which were too low to be quantified in the new products,” the FDA said in its announcement, calling the move a step toward getting adults to move away from cigarettes.

Since returning to office, President Trump’s administration has pushed regulatory actions favorable towards the tobacco industry, with a particular focus on non-combustible tobacco products. During his reelection bid, Trump vowed to “save vaping.” The FDA in June allowed Zyn nicotine pouches, owned by Philip Morris International, to be marketed as less harmful than cigarettes.

Ten of Zyn’s flavored nicotine pouches have been granted marketing authorization under the same FDA pilot program.

RAI Services Co. — a subsidiary of Reynolds American, which owns brands like Newport, Camel and Pall Mall — was the biggest corporate donor to Trump’s 2024 campaign, according to Federal Election Commission filings, giving more than $10 million to the reelection bid.

Lung health advocates blasted the FDA’s announcement on Tuesday.

“Every new flavored tobacco product authorized by FDA is another gamble with kids’ health. We know flavors drive youth tobacco use,” Ranjana Caple, director of federal advocacy at the American Lung Association, said in statement.

“Over 90% of young people who use nicotine pouches use flavored products, and nicotine pouches are already the second most commonly used tobacco product among youth. These products are attracting kids who otherwise may never have used a tobacco product. FDA should be protecting kids—not authorizing more flavored products. Kids deserve better,” Caple added.

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