FDA Urges Child-Resistant Packaging for Nicotine Pouches

The FDA is calling on nicotine pouch manufacturers to adopt child-resistant packaging after a surge in accidental poisonings among young children, according to a new statement.¹ Between April 2022 and March 2025, US poison centers reported a steady rise in nicotine pouch exposure cases, with nearly three-quarters involving children under age 5. The FDA warns that even small amounts of concentrated nicotine can be dangerous—and in some cases, life-threatening—for kids.

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. | Image credit: Alexander - stock.adobe.com

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

A recent analysis of US poison center data found 134,663 nicotine ingestions among children younger than 6 years between 2010 and 2023, with the majority occurring in children under age 2 (76.2%), in boys (55.5%), and most often in the home (98.5%).²

“Study findings, including the emergence and comparative severity of nicotine pouch ingestions, support the need for ongoing surveillance and increased efforts to prevent nicotine ingestions among young children,” wrote the researchers of the study.

Ingestion rates rose sharply by 59.4% from 2010 to 2015 (P < .001), driven largely by a 450% surge in liquid nicotine exposures, before declining by 34.1% from 2015 to 2023 (P < .001). Although most cases resulted in no (36.8%) or minor adverse effects (19.6%), there were still 39 major cases and 2 fatalities caused by accidental ingestion, underscoring the potential severity. Notably, nicotine pouch ingestions surged by 763.1% from 2020 to 2023 and were more likely than other formulations to cause serious medical outcomes (OR, 1.53; 95% CI, 1.10-2.13) or require medical admission (OR, 2.03; 95% CI, 1.31-3.15).

These findings highlight an urgent need for preventive measures, including safer packaging and greater public awareness, to protect young children from accidental nicotine poisoning.

“The oral nicotine product market has evolved and grown substantially in recent years, and research about nicotine ingestion among young children in this context, including comparisons among product formulation categories and pediatric outcomes, is needed,” wrote the researchers.

To reduce the risk of accidental poisoning, the FDA also issued information to consumers on how to properly store nicotine pouches. The FDA states that nicotine pouches should always be stored safely and securely and in their original containers, as well as kept out of sight and reach of children and pets, ideally in a locked cabinet or other secure location, and ask visitors who use nicotine pouches to do the same.³ When possible, consumers should choose FDA-authorized products with child-resistant packaging and be sure to fully close the container after each use. Furthermore, consumers should avoid transferring pouches to other holders or containers, which may not be child resistant and can increase the risk of accidental exposure. It’s also important not to use nicotine pouches in front of children and to explain that these products are only for adults and can be harmful if touched or swallowed.

The FDA also encourages manufacturers with pending nicotine pouch applications to incorporate child-resistant packaging or other safety measures and to consult with their assigned Regulatory Health Project Manager for guidance.¹ To date, the FDA has authorized 20 nicotine pouch products, each equipped with child-resistant packaging.

References

1. FDA urges nicotine pouch manufacturers to use child-resistant packaging following increasing reports of accidental exposure. News release. FDA. September 2, 2025. Accessed September 3, 2025. https://www.fda.gov/news-events/press-announcements/fda-urges-nicotine-pouch-manufacturers-use-child-resistant-packaging-following-increasing-reports

2. Olivas M, Hays HL, Kistamgari S, et al. Nicotine ingestions among young children: 2010-2023. Pediatrics. 2025;156(2): e2024070522. doi:10.1542/peds.2024-070522

3. Properly store nicotine pouches to prevent accidental exposure to children and pets. FDA. September 2, 2025. Accessed September 3, 2025. https://www.fda.gov/consumers/consumer-updates/properly-store-nicotine-pouches-prevent-accidental-exposure-children-and-pets