FDA urges child-resistant packaging for nicotine pouches

USA – The U.S. Food and Drug Administration has called on nicotine pouch manufacturers to adopt child-resistant packaging to protect young children from accidental exposure. 

According to data from April 1, 2022, to March 31, 2025, U.S. Poison Centers reported a steady increase in nicotine pouch exposure cases, with 72% involving children under five. 

These pouches, often flavored with fruity tastes and designed with bright, colorful packaging, can resemble candy, making them particularly appealing to young children.

Nicotine pouches contain high concentrations of nicotine, which can be dangerous or even fatal to children in doses as low as 1 to 4 milligrams. 

In a statement, FDA Commissioner Marty Makary expressed concern, saying, “The rising number of nicotine exposures in young children is alarming.” 

He urged manufacturers to take steps to prevent accidental ingestion, highlighting the candy-like appeal of these products.

To address the issue, the FDA has issued guidance for consumers on safely storing nicotine pouches. 

Parents and caregivers are advised to keep these products in their original packaging, stored in secure locations out of children’s reach, and to seek immediate medical help if ingestion occurs.

The agency emphasized that child-resistant packaging is a critical safety measure.

Manufacturers with pending premarket applications are encouraged to contact the FDA through their regulatory health project manager to discuss implementing such packaging.

Recent developments show progress in this area. In January 2025, the FDA authorized the marketing of 20 ZYN nicotine pouch products, all featuring child-resistant packaging. 

A spokesperson for ZYN’s manufacturer, Philip Morris International, noted that their packaging has been designed with child safety in mind since the product’s launch 11 years ago. 

This authorization followed an extensive scientific review, ensuring compliance with public health standards.

The push for safer packaging comes amid broader concerns about nicotine exposure. A July 2025 study in Pediatrics reported a 763% surge in nicotine pouch ingestion cases among children under six from 2020 to 2023, underscoring the urgency of preventive measures. 

The FDA’s call to action aims to reduce these risks, encouraging manufacturers to prioritize child safety while maintaining product integrity. 

As the nicotine pouch market grows, with U.S. adult usage reaching 2.9% in 2022, the focus on secure packaging remains a key step in safeguarding vulnerable populations. 

Immediate action, including calling Poison Control at 1-800-222-1222 in case of ingestion, is recommended for emergencies.

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