Dive Brief:
- The U.S. Food and Drug Administration has issued modified risk granted orders to Swedish Match USA for 20 Zyn nicotine pouch products, the agency announced on June 30.
- The order allows these Zyn branded nicotine pouches to be marketed as a safer alternative to cigarettes. The pouches must use the claim that “using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis,” according to the announcement.
- The decision comes about a year and a half after the FDA first authorized the marketing and sale of these 20 Zyn products, marking the first time the administration had granted such rights to any nicotine pouch items.
Dive Insight:
The FDA’s latest risk granted orders may spark an even greater lift in sales for nicotine pouches, which continue to gain popularity in convenience retailing. Sales in the U.S. are expected to grow at a compound annual growth rate of almost 25% through 2033, according to research from Grand View Research.
However, the FDA emphasized in its announcement that the order only refers to the 20 specific Zyn products and not an entire class of items. The products receiving modified risk granted orders include 3- and 6- milligram pouches of Zyn flavors Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint and Wintergreen
“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “Today’s decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”
The authorization requires Swedish Match to conduct postmarket surveillance and studies of consumers who purchase the 20 Zyn pouches. The orders will expire in five years, before which Swedish Match may request to continue marketing the products. The FDA said it can withdraw the orders at any time.
