Dive Brief:
- The U.S. Food and Drug Administration has authorized the marketing of nicotine pouches for the first time, the agency announced on Thursday.
- The marketing authorization covers 20 Zyn-branded nicotine pouch products. These items — which are tobacco free — are small synthetic fiber pouches containing nicotine that can be placed between a person’s gum and lip.
- Nicotine pouches have become popular in convenience stores as cigarette sales plunge, and the FDA’s first marketing approval of these products sets the stage for continued growth.
Dive Insight:
Sales of nicotine pouches grew 50% from 2022 to 2023, and were expected to surge by another 50% to 60% last year, according to data from Don Burke, who recently retired from his role as senior vice president of Management Science Associates. Sales of Zyn surged so much that production could not keep up with demand in 2023, resulting in supply shortages and leading Philip Morris International, owner of the brand, to invest in expanded production.
Burke said in an interview last year that the “modern oral” category — which includes nicotine pouches — could soon become one of the largest nicotine categories in retail if this growth continues. He called it an “exciting opportunity” for c-stores.
When it came to Zyn’s marketing approval, the FDA determined that these items met the public health standard required by the 2009 Family Smoking Prevention and Tobacco Control Act, which considers the risks and benefits of products to the general population.
Additionally, the administration found that since Zyn’s pouches contain significantly smaller amounts of harmful substances than cigarettes and other smokeless tobacco products, they pose a lower risk of cancer and other serious health conditions.
“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, said in the announcement. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”
The FDA emphasized that Zyn nicotine pouches must be marketed responsibly to prevent youth use. The administration also said Zyn’s approval does not mean these products are necessarily safe.
“While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health,” Brian King, director of the FDA’s Center for Tobacco Products, said in the announcement.
