ZYN Nicotine Pouches Receive FDA Marketing Approval

The U.S. Food and Drug Administration (FDA) has granted marketing authorization for 20 nicotine pouch products from ZYN, a brand of nicotine products from Philip Morris International Inc PM.

The ZYN nicotine pouches, small sachets containing nicotine meant to be placed between the gum and lip, are the first products of their kind to gain FDA approval.

This decision follows an extensive review, confirming that the ZYN nicotine pouches comply with the public health criteria set by the 2009 Family Smoking Prevention and Tobacco Control Act.

These standards assess the risks and benefits of tobacco products, especially concerning the overall population’s health.

The FDA’s assessment showed that these products present lower health risks than cigarettes and other smokeless tobacco items such as snus and moist snuff, due to their reduced levels of harmful chemicals.

FDA specialists noted that these products could be beneficial for adults who fully transition from cigarettes and smokeless tobacco.

The FDA also observed that, despite the rise in sales of these products in recent years, the likelihood of youth usage remains minimal.

Also Read: GM, Vianode Strike Multi-Billion Anode Graphite Supply Deal: Details

The 2024 National Youth Tobacco Survey revealed that just 1.8% of U.S. middle and high school students reported using nicotine pouches.

"It's critical that the manufacturer market these products responsibly to prevent youth use," said director of the FDA's Center for Tobacco Products, Brian King.

Strict rules have been established to guarantee that ZYN nicotine pouch ads are directed solely at adults aged 21 and over.

The FDA also specified further precautions, including restricting mass media advertising and mandating that actors in commercials be at least 35 years old or made to appear that age.

Additionally, the FDA emphasized that although these products are approved for sale, they are not deemed safe and the agency will keep monitoring their effect on public health.

The approved nicotine pouch products include flavors such as ZYN Chill, ZYN Cinnamon, ZYN Cool Mint and others, each available in 3 mg and 6 mg strengths.

The FDA’s approval applies solely to these products and does not cover other nicotine pouches or similar items made by ZYN.

The company is not allowed to assert reduced risk claims for these products unless it files a separate application for a modified risk tobacco product.

Price Action: PM shares closed higher by 1.08% at $119.80 on Thursday.

Photo: Shutterstock