Pouches Authorised for Sale in US
The U.S. Food and Drug Administration has authorised the sale and marketing of 20 different ZYN pouch products “following an extensive scientific review”
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by Dave Cross
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The U.S. Food and Drug Administration has authorised the sale and marketing of 20 different ZYN pouch products “following an extensive scientific review”. This marks the first time any nicotine pouches have been authorised through the premarket tobacco product application (PMTA) pathway and, predictably, has caused a meltdown in groups who have campaigned against the sale of vapes.
In authorising the sale of the nicotine pouches, the Food and Drug Administration declared: “Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorised products pose lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorised nicotine pouch products.”
Matthew Farrelly, director of the Office of Science in the Food and Drug Administration’s Centre for Tobacco Products, said: “To receive marketing authorisations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks. 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 American Lung Association (ALA) frequently makes deranged comments about vaping. Predictably, it sprang into action to attack the decision: “We are extremely disappointed that the FDA authorized these Zyn nicotine pouches – especially since the product has been on the market illegally up until now. While it has not been sold in the U.S. for long, we are already seeing very concerning levels of youth use.”
Maybe the ALA should have read the whole FDA press release before commenting as Brian King, director of the FDA’s Centre for Tobacco Products, stated: “It’s critical that the manufacturer market these products responsibly to prevent youth use. 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.”
What is it, American Lung Association, is youth use at “very concerning levels” or is it, as the FDA says, “that youth use remains low”?
The Bloomberg funded Campaign for Tobacco-Free Kids similarly made comment to protect its funding rather than focus on the truth, saying the FDA has “set a dangerous precedent that puts the nation’s kids at risk”.
President and CEO Yolonda Richardson attempted to link nicotine pouches to Juul vapes as they both use ‘kid friendly’ flavours such as…err…cinnamon, citrus and wintergreen. Oh, and “nicotine pouches are easy to hide”.
Wait till Yolonda hears about the flavoured nicotine gums and discovers how easy they are to hide.
Dave Cross
Journalist at POTVDave is a freelance writer; with articles on music, motorbikes, football, pop-science, vaping and tobacco harm reduction in Sounds, Melody Maker, UBG, AWoL, Bike, When Saturday Comes, Vape News Magazine, and syndicated across the Johnston Press group. He was published in an anthology of “Greatest Football Writing”, but still believes this was a mistake. Dave contributes sketches to comedy shows and used to co-host a radio sketch show. He’s worked with numerous start-ups to develop content for their websites.
