Key takeaways:
- The FDA calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children.
- Child-resistant packaging can serve as an essential safety barrier to prevent children from accidentally ingesting nicotine products.
- To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging,
The U.S. Food and Drug Administration calls on nicotine pouch manufacturers to use child-resistant packaging to protect American children from accidental, harmful exposure. From April 1, 2022, to March 31, 2025, the number of reported nicotine pouch exposure cases reported to U.S. Poison Centers steadily increased. Approximately 72% of nicotine pouch exposure cases occurred in children under 5 years of age.
Nicotine pouches contain concentrated nicotine that can be harmful or potentially fatal to young children, even in small amounts. Toxic effects in young children have been reported with nicotine doses as low as 1 to 4 milligrams. Symptoms of nicotine poisoning may include confusion, vomiting, and loss of consciousness.
“I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches,” says FDA Commissioner Marty Makary, M.D., M.P.H. “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.”
Child-resistant packaging can serve as an essential safety barrier to prevent children from accidentally ingesting nicotine products and demonstrates a manufacturer's commitment to protecting public health. Manufacturers with a pending premarket application for a nicotine pouch product who intend to incorporate child-resistant packaging or other measures to mitigate the risk of accidental exposure to children should contact the FDA through their assigned Regulatory Health Project Manager (RHPM) or at [email protected] or 877-CTP-1373.
To date, the FDA has authorized 20 nicotine pouch products, all of which make use of child-resistant packaging, which are listed at www.fda.gov/authorizednicotinepouches.
