FDA pushes nicotine pouch makers to use child-resistant packaging

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(The Center Square) – The Food and Drug Administration is pushing nicotine pouch manufacturers to use child-resistant packaging in response to an increase in accidental exposures among children.


All 20 FDA-authorized nicotine pouch products already use child-resistant packaging.


The number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased from April 1, 2022, to March 31, 2025. About 72% of exposure cases occurred in children younger than five.


Nicotine pouches – including Zyn, Velo, Rogue, On, and Grizzly – contain concentrated nicotine. That can be harmful or potentially fatal to young children, even in small amounts.


Toxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams. Nicotine pouches are sold in a range of strengths from about 3 to 15 mg of nicotine per pouch. Symptoms of nicotine poisoning may include confusion, vomiting and loss of consciousness.


"I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches," FDA Commissioner Dr. Marty Makary said. "The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children. Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion."


The FDA also told users to prevent accidental exposure to children by storing products in a safe place in their original packaging. In case of accidental exposure, parents should seek immediate attention. If a person of any age eats a nicotine pouch, accidental or not, immediately call the Poison Control HELP number at 1-800-222-1222.


Zyn maker Philip Morris International said it launched its product 11 years ago with child-resistant packaging.


"ZYN is the only nicotine pouch authorized by the FDA as appropriate to protect public health," the company noted. "In making that conclusion the agency noted that ZYN's packaging is designed to be child resistant – and has been since its launch 11 years ago."


The FDA asked for more time to respond to a question from The Center Square about who was being asked to use child-resistant packaging given that approved FDA products already come employ such packaging.

 

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