The U.S. Food and Drug Administration formally authorized Zyn nicotine pouches for sale after conducting an ‘extensive scientific review’ about their safety.
In a release Thursday, the agency said it had found that the popular pouches posed lower risk of cancer and other serious health conditions compared with cigarettes, as well as in relation to other smokeless tobacco products.
The agency also found that the pouches even had the potential to benefit cigarette smokers amid evidence that they can get them to quit.
‘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,” Matthew Farrelly, director of the office of science in the FDA’s Center for Tobacco Products, said in a statement.
Zyn use has exploded in recent years in the wake of a viral online meme trend, even prompting a shortage last year. Yet the product had been operating in a legal gray area while it underwent official FDA review about its health effects and uptake among young users.
To that latter point, the FDA found that, so far, Zyn use among youths appeared to be relatively low, though it was continuing to monitor the trend.
A spokesperson for Philip Morris International Inc., which owns the U.S. rights to Zyn, did not immediately respond to a request for comment.
Swedish Match, the developer of Zyn, said in a statement, “The FDA’s authorization of all ZYN nicotine pouches currently marketed by Swedish Match in the U.S. is an important step to protect the public health by providing better alternatives to cigarettes and other traditional tobacco products for adults 21+.”
The Campaign for Tobacco-Free Kids slammed the FDA’s decision in a separate statement.
‘The FDA today has set a dangerous precedent that puts the nation’s kids at risk by authorizing the sale of 20 Zyn nicotine pouch products with flavors that clearly appeal to kids, including chill, citrus, cool mint and peppermint,’ it said.
‘The FDA’s decision is deeply troubling given the extensive scientific evidence that flavored tobacco products appeal to kids and the fact that nicotine pouches were the only category of tobacco product that saw an increase in youth use last year. The FDA is sanctioning a flavored tobacco product that is already increasing in popularity with kids and repeating the mistakes it made with Juul that resulted in the youth e-cigarette epidemic.’
In the release, the FDA emphasized that its findings about Zyn did not mean the products are ultimately safe or “FDA approved.”
‘There is no safe tobacco product,’ the agency said. ‘Youth should not use tobacco products and adults who do not use tobacco products should not start.’