FDA

FDA urges child-proofing for nicotine pouches amid surge in pediatric poisonings

September 5, 2025

FDA is urging nicotine pouch manufacturers to adopt child-resistant packaging in response to a marked rise in pediatric exposures. Between April 2022 and March 2025, U.S. poison centers reported a steady increase in nicotine pouch ingestion cases, with 72% involving children under age 5. Toxic effects have been documented with as little as 1 to 4 mg of nicotine, and two pediatric fatalities have occurred. To mitigate risk, FDA recommends storing pouches in original containers with child-resistant features, kept out of reach and sight of children. Clinicians should proactively counsel families on the dangers of nicotine pouch exposure, report adverse events, and advocate for regulatory measures that promote safer product design. This growing trend underscores the urgent need for preventive action in both clinical and public health settings.

Source:

U.S. Food and Drug Administration. (2025, September 2). FDA urges nicotine pouch manufacturers to use child-resistant packaging following increasing reports of accidental exposure [Press release]. https://www.fda.gov/news-events/press-announcements/fda-urges-nicotine-pouch-manufacturers-use-child-resistant-packaging-following-increasing-reports.