September 2, 2025 - FDA Urges Nicotine Pouch Manufacturers To Use Child-Resistant Packaging Following Increasing Reports of Accidental Exposure

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," said 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."

The FDA is also issuing information for consumers on how to properly store nicotine pouches and prevent accidental exposure to children. Parents and caregivers should safely store all nicotine products, including pouches, in secure locations away from children in original packaging and seek immediate medical attention if accidental ingestion occurs. If a person of any age eats a nicotine pouch, accidental or not, immediately call Poison Control HELP number at 1-800-222-1222.

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.

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