FDA wants nicotine pouch manufacturers to use child-resistant packaging

The FDA is urging manufacturers of nicotine pouches to use child-resistant packaging to prevent accidental exposures. According to a press release from the federal agency, approximately 72% of nicotine pouch exposure cases took place in children under 5 years of age.¹

Recent data on pediatric nicotine pouch exposure

According to a July 14, 2025, study from the American Academy of Pediatrics, investigators found that ongoing support and surveillance are needed to prevent ingestions among young children. The study found that from 2010 to 2023, among children aged younger than 6 years, there were 134,663 ingestions reported to US centers. Most (76.2%) were among children younger than 2 years of age.²

The study found that the rate of nicotine ingestions increased by 59.4% from 2010 to 2015 (P < .001) before decreasing by 34.1% from 2015 to 2023 (P < .001). However, from 2020 to 2023, the rate of nicotine pouch ingestions increased by 763.1%.^2,3

Overall, 36.8% of ingestions were associated with no effect. Minor effect was reported in 19.6% of ingestions, in addition to 1.2% that were associated with moderate effects. Thirty-nine ingestions had major effects, and there were 2 fatalities reported. Overall, 81.3% of individuals who had an ingestion did not receive treatment at a health care facility. Compared to other product formulations (combined), nicotine pouches were more likely to be associated with a serious medical outcome (odds ratio [OR] .53, 95% CI: 1.10–2.13) or medical admission (OR: 2.03, 95% CI: 1.31–3.15).

“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” said Marty Makary, MD, MPH, commissioner, FDA, in a statement. “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.”¹

Properly storing nicotine pouches

In an effort to curb exposures, the FDA released tips to properly store and handle nicotine pouches. These tips can be shared with families during well visits as a reminder of the dangers associated with accidental exposures and how to take proper action when storing these products.

Tips, courtesy of the FDA⁴:

Keep the containers out of reach and view of children and pets, such as a high cabinet that locks. Ask family members and visitors who use nicotine pouches to also safely store their products.

Choose FDA-authorized nicotine pouches with child-resistant packaging, especially if there are children in your household. Fully close the container and engage any child-resistant features of the packaging when you’re not using the nicotine pouches.

Store nicotine pouches in their original containers. Avoid transferring nicotine pouches to other containers/holders that could increase the risk of accidental exposure because they may not be child-resistant.

Don’t use nicotine pouches in front of children. Explain to children that these products should not be touched and should only be handled by adults.

References:

1. FDA urges nicotine pouch manufacturers to use child-resistant packaging following increasing reports of accidental exposure. FDA. Press release. September 2, 2025. Accessed September 2, 2025. https://www.fda.gov/news-events/press-announcements/fda-urges-nicotine-pouch-manufacturers-use-child-resistant-packaging-following-increasing-reports?utm_medium=email&utm_source=govdelivery
2. Olivas M, Hays H, Kistamgari S, et al. Nicotine ingestions among young children 2010-2023. Pediatrics. August 2025. doi:10.1542/peds.2024-070522
3. New study finds sharp increase in nicotine pouch ingestions among young children. Nationwide Children's. Press release. https://www.nationwidechildrens.org/newsroom/news-releases/2025/07/nicotine_exposures
4. Properly store nicotine pouches to prevent accidental exposure to children and pets. FDA. Press release. September 2, 2025. Accessed September 2, 2025. https://www.fda.gov/consumers/consumer-updates/properly-store-nicotine-pouches-prevent-accidental-exposure-children-and-pets