The US Food and Drug Administration has given the green light to the nicotine pouch brand ZYN, authorising its US sale in ten flavours and two nicotine strengths.
“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products.
“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 ten flavours FDA approved in both 3mg and 6mg nicotine concentrations are ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen.
While FDA says in its decision that the risk of young people using Zyn is low, prohibitionist campaigners the Center for Tobacco Free Kids – which receives much of its funding from Bloomberg Philanthropies – was unsurprisingly angry about the decision, saying it risked “another JUUL”. Juul has not received an FDA marketing authorisation.
As part of the FDA authorisation, there will be significant restrictions on how Zyn can be marketed, including limits on digital, TV and radio adverts designed to make sure that the audiences reached are over 21.
The approval comes hot on the heels of FDA’s announcement that it would propose a rule limiting the nicotine content of cigarettes to non-addictive levels. Helping smokers switch to safer nicotine products is a large part of the plan for making such a policy work.
ZYN is manufactured by Swedish Match, which was acquired by Phillip Morris International in 2023.
“An estimated 45 million Americans regularly consume nicotine and about 30 million of them smoke, the most harmful form of nicotine consumption,” said 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.”
