Top Takeaways:

• FDA urges nicotine pouch manufacturers to adopt child‑resistant packaging amid rising child poisoning cases.
• Poison control centers reported a sharp increase in ingestion incidents, with a study showing a 763 % surge from 2020 to 2023.
• The majority of exposures involve children under five, and pouch ingestions pose higher risk than other nicotine products.

The U.S. Food and Drug Administration on Tuesday called on nicotine pouch manufacturers to adopt child-resistant packaging after a sharp rise in poisoning cases involving young children.

From April 2022 through March 2025, U.S. Poison Control Centers recorded steadily increasing reports of nicotine pouch exposures, with about 72% involving children under age five, the agency said.

“Nicotine pouches contain concentrated nicotine that can be harmful or even fatal to young children in small amounts,” the FDA said in a statement. Toxic effects have been reported with doses as low as one to four milligrams. Symptoms of poisoning include vomiting, confusion and loss of consciousness.

“I am concerned about rising reports of nicotine exposures in young children,” said FDA Commissioner Marty Makary. “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.”

A peer-reviewed study published this summer in Pediatrics found a 763% increase in pediatric nicotine pouch ingestions between 2020 and 2023. The study concluded that pouch ingestions were more likely to cause serious outcomes and require hospitalization than other nicotine products, a press release states.

Most exposures occur in the home and often involve toddlers. Two deaths during the study period were tied to liquid nicotine, not pouches, but researchers warned that the trend highlights significant public health risks.

The FDA said manufacturers with pending premarket applications should notify regulators if they plan to incorporate child-resistant features or other safeguards. The agency noted that all 20 nicotine pouch products it has authorized to date already use child-resistant packaging.

The FDA also urged parents and caregivers to keep nicotine products in original packaging, store them securely and call Poison Control at 1-800-222-1222 immediately if ingestion occurs.