FDA grants first nicotine pouch marketing authorization to ZYN
ZYN's high profile presence at Dubai Duty Free may soon be replicated in the US
The US Food and Drug Administration has authorized the marketing of ZYN nicotine pouches, making it the first product in this category to receive authorization in the United States. The decision covers all 20 ZYN products currently marketed by Swedish Match in the US, encompassing ten menthol varieties and ten other flavors including citrus and coffee.
"An estimated 45 million Americans regularly consume nicotine and about 30 million of them smoke, the most harmful form of nicotine consumption," says Tom Hayes, president of Swedish Match North America, LLC. "The FDA's decision recognizes the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products."
The authorization follows an extensive FDA scientific review that began when Swedish Match, now an affiliate of Philip Morris International, filed its application in March 2020. The agency's evaluation showed that ZYN pouches contain substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products.
ZYN nicotine pouches are made from pharmaceutical grade nicotine derived from tobacco but contain no tobacco leaf. The products have been sold in the US since 2014, and the new authorization enables Swedish Match to continue marketing its full portfolio.
Studies suggest flavored smoke-free products play an important role in helping adult smokers transition away from cigarettes. Recent research published in JAMA Health Forum indicated that banning flavored smoke-free products led to "increased cigarette smoking, potentially offsetting public health gains."
The US Centers for Disease Control found youth nicotine pouch use remains low at 1.8% with no statistically significant change from the previous year, a point reiterated by the FDA in its authorization.
