The Food and Drug Administration (FDA) is asking manufacturers of nicotine pouches to use child-resistant packaging to protect young children from accidental, harmful exposure, the agency said on Monday.
“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said FDA Commissioner Marty Makary. “The fruity flavors and bright, colorful designs of nicotine pouch products could resemble candy and seem attractive to children.”
From April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased, the agency reported, adding that approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.
“Manufacturers should consider what steps they can take to prevent accidental exposures and ingestion,” Makary said.
To date, the FDA has authorized 20 nicotine pouch products “all of which make use of child-resistant packaging,” the agency said.
On Monday, a Philip Morris International (PMI) U.S. spokesperson issued the following statement to CSP: "Zyn is the only nicotine pouch authorized by the FDA as appropriate to protect public health. 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."
In January, the agency issued marketing granted orders to 20 Zyn flavored nicotine pouches.
The FDA said manufacturers with a pending premarket application for a nicotine pouch product that intend to incorporate child-resistant packaging or other measures to lessen the risk of accidental exposure to children should contact the agency through their assigned Regulatory Health Project Manager (RHPM) or at AskCTP@fda.hhs.gov or 877-CTP-1373.
“The recent rise in accidental exposure to nicotine pouches is deeply troubling, especially when it involves our youngest and most at risk,” said Kathy Crosby, CEO and president of Truth Initiative, which is a nonprofit public health organization dedicated to preventing youth and young adult nicotine use and addiction. “To help safeguard young people from the preventable harms of these products, it’s critical for manufacturers to prioritize child-resistant packaging and that FDA considers risks of accidental exposure and packaging safety when reviewing new products,” she said.
Crosby said that the FDA can also “immediately reduce the likelihood of accidental exposure by ensuring that only authorized products are on store shelves.”
The FDA has also issued information on its website for consumers on how to safely store nicotine pouches.
“Parents and caregivers should safely store all nicotine products, including pouches, in secure locations away from children in original packaging and seek immediate medical attention if accidental ingestion occurs,” the FDA said.
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