The US Food and Drug Administration (FDA) has urged manufacturers of nicotine pouches to implement child-resistant packaging to safeguard children from accidental exposure.

Reports of nicotine pouch exposure to children rose between 1 April 2022 and 31 March 2025, with around 72% of incidents involving children under five.

Nicotine pouches contain high concentrations of nicotine, which can be harmful or sometimes lethal to young children, even in minimal doses.

Toxic reactions have been documented in children with nicotine amounts as low as 1mg to 4mg, according to the US federal agency.

Symptoms associated with nicotine poisoning can include confusion, vomiting and loss of consciousness.

FDA commissioner Marty Makary stated: “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.”

The FDA is providing guidance to consumers on the safe storage of nicotine pouches to prevent accidental exposure.

It urged parents and caregivers to keep all nicotine products, including pouches, in secure locations, stored in their original packaging, and to seek immediate medical assistance if ingestion occurs.

The FDA believes that the introduction of child-resistant packaging is a critical measure to prevent the accidental ingestion of nicotine products by children.

Manufacturers with pending premarket applications for nicotine pouch products can reach the agency through their designated regulatory health project manager.