U.S. FDA calls for child-resistant nicotine pouch packaging amid accidental exposures

The U.S. Food and Drug Administration (FDA) has urged manufacturers of nicotine pouches to adopt child-resistant packaging following a rise in reported cases of accidental exposure among young children.

Between April 2022 and March 2025, reports to U.S. Poison Centres of accidental nicotine pouch exposure steadily increased, with around 72% of cases involving children under the age of five.

Nicotine pouches contain concentrated amounts of nicotine, which can be toxic to children even in small quantities. According to the FDA, doses as low as one to four milligrams have been linked to harmful effects. Reported symptoms of nicotine poisoning include vomiting, confusion, and loss of consciousness.

In addition to its call to manufacturers, the FDA has issued guidance for consumers on safe storage of nicotine products. Parents and caregivers are advised to keep nicotine pouches and related products out of children’s reach, in their original packaging, and to seek urgent medical attention in cases of accidental ingestion. The U.S. Poison Control Help Line (1-800-222-1222) remains available for immediate assistance.

The FDA noted that child-resistant packaging provides an important layer of protection against accidental poisoning and reflects a company’s commitment to public health. Manufacturers with premarket applications for nicotine pouch products that plan to introduce child-resistant packaging are encouraged to contact the FDA.

FDA Commissioner Marty Makary, M.D., M.P.H., said: I am concerned about rising reports of nicotine exposures in young children caused by nicotine pouches. The fruity flavours and bright, colourful 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.

At present, the FDA has authorised 20 nicotine pouch products, all of which already use child-resistant packaging.