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The U.S. Food and Drug Administration is urging nicotine pouch manufacturers to use child-resistant packaging on their products. This comes as a rise in nicotine pouch exposure cases has been reported among young children – with some causing nicotine poisoning.In an announcement Tuesday, the FDA called on manufacturers to use child-resistant packaging to reduce the risk of these “accidental” and “harmful” exposures.”I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” FDA Commissioner Dr. Marty Makary said in the announcement. “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 noted in its announcement that it has authorized 20 nicotine pouch products, all of which use child-resistant packaging. The FDA gave marketing authorization to certain nicotine pouches for the first time in January.”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,” Philip Morris International, which owns nicotine pouch brand Zyn, said in a statement Tuesday.But several brands of pouches on the market have not received FDA authorization, and not all have child-resistant packaging.The FDA urged manufacturers to contact the agency if they have a pending premarket application for a nicotine pouch product and intend to incorporate child-resistant packaging or other measures to mitigate the risk of accidental exposure to children.Nicotine pouches are small packets, filled with a powder made of nicotine, flavorings and other ingredients, that users can tuck between their lip and gum, where the nicotine is absorbed through mucous membranes.From April 2022 through March 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily climbed, according to the FDA, and about 72% were in children younger than 5.The FDA warned in its announcement that the concentrated nicotine in these products can be harmful or potentially fatal to young children, even in small amounts. In young children, ingestion of doses as low as 1 to 4 milligrams of nicotine has been associated with “toxic effects,” according to the FDA.Symptoms of nicotine poisoning can include abdominal cramps, confusion, seizures, loss of consciousness, headache and vomiting.The FDA offered information for consumers in its announcement on how to properly store nicotine pouches and prevent accidental exposure to children.”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 agency said. And if anyone of any age eats a nicotine pouch, accidental or not, the best first step is to immediately call Poison Control at 1-800-222-1222.”The recent rise in accidental exposure to nicotine pouches is deeply troubling, especially when it involves our youngest and most at risk,” Kathy Crosby, CEO and president at the Truth Initiative, a nonprofit focused on preventing youth and young adult nicotine addiction, said in a statement.”To help safeguard young people from the preventable harms of these products, it’s critical for manufacturers to prioritize child-resistant packaging and that the FDA consider risks of accidental exposure and packaging safety when reviewing new products,” Crosby said. “The FDA can also immediately reduce the likelihood of accidental exposure by ensuring that only authorized products are on store shelves.”Nicotine pouches have become the second most-used nicotine product among young people, according to the US Centers for Disease Control and Prevention.A report released Thursday by the Truth Initiative says that oral nicotine pouch use among high school students has nearly doubled, increasing from 1.3% in 2023 to 2.4% in 2024.Still, the overall user base remains small. Just 0.5% of Americans use nicotine pouches, compared with 9% who smoke cigarettes and 3% who vape or use e-cigarettes, according to U.S. Census Bureau data.
The U.S. Food and Drug Administration is urging nicotine pouch manufacturers to use child-resistant packaging on their products. This comes as a rise in nicotine pouch exposure cases has been reported among young children – with some causing nicotine poisoning.
In an announcement Tuesday, the FDA called on manufacturers to use child-resistant packaging to reduce the risk of these “accidental” and “harmful” exposures.
“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” FDA Commissioner Dr. Marty Makary said in the announcement. “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 noted in its announcement that it has authorized 20 nicotine pouch products, all of which use child-resistant packaging. The FDA gave marketing authorization to certain nicotine pouches for the first time in January.
“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,” Philip Morris International, which owns nicotine pouch brand Zyn, said in a statement Tuesday.
But several brands of pouches on the market have not received FDA authorization, and not all have child-resistant packaging.
The FDA urged manufacturers to contact the agency if they have a pending premarket application for a nicotine pouch product and intend to incorporate child-resistant packaging or other measures to mitigate the risk of accidental exposure to children.
Nicotine pouches are small packets, filled with a powder made of nicotine, flavorings and other ingredients, that users can tuck between their lip and gum, where the nicotine is absorbed through mucous membranes.
From April 2022 through March 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily climbed, according to the FDA, and about 72% were in children younger than 5.
The FDA warned in its announcement that the concentrated nicotine in these products can be harmful or potentially fatal to young children, even in small amounts. In young children, ingestion of doses as low as 1 to 4 milligrams of nicotine has been associated with “toxic effects,” according to the FDA.
Symptoms of nicotine poisoning can include abdominal cramps, confusion, seizures, loss of consciousness, headache and vomiting.
The FDA offered information for consumers in its announcement on how to properly store nicotine pouches and prevent accidental exposure to children.
“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 agency said. And if anyone of any age eats a nicotine pouch, accidental or not, the best first step is to immediately call Poison Control at 1-800-222-1222.
“The recent rise in accidental exposure to nicotine pouches is deeply troubling, especially when it involves our youngest and most at risk,” Kathy Crosby, CEO and president at the Truth Initiative, a nonprofit focused on preventing youth and young adult nicotine addiction, said in a statement.
“To help safeguard young people from the preventable harms of these products, it’s critical for manufacturers to prioritize child-resistant packaging and that the FDA consider risks of accidental exposure and packaging safety when reviewing new products,” Crosby said. “The FDA can also immediately reduce the likelihood of accidental exposure by ensuring that only authorized products are on store shelves.”
Nicotine pouches have become the second most-used nicotine product among young people, according to the US Centers for Disease Control and Prevention.
A report released Thursday by the Truth Initiative says that oral nicotine pouch use among high school students has nearly doubled, increasing from 1.3% in 2023 to 2.4% in 2024.
Still, the overall user base remains small. Just 0.5% of Americans use nicotine pouches, compared with 9% who smoke cigarettes and 3% who vape or use e-cigarettes, according to U.S. Census Bureau data.
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