Speaking of, ZYN has not received FDA approval. As of now, the FDA is still reviewing Philip Morris International's 2020 application for authorization to market Zyn nicotine pouches. While they have allowed Zyn to remain on the market while the application is being reviewed, there are some major concerns.
One significant issue is the potential for underage use. The FDA has recently taken action against retailers selling Zyn pouches to minors, issuing a series of warning letters. The agency is particularly concerned about the impact of nicotine on young people, as it can lead to addiction and negatively affect brain development.
And, their concerns are valid. According to the 2023 National Youth Tobacco Survey conducted by the FDA and CDC, 1.5% of middle school and high school students reported using nicotine pouches in the previous 30 days. As a fairly new product on the market, that statistic is alarming, especially considering the impact nicotine can have on a developing brain. We’ll get more into that in a moment. Social media videos showcasing Zyn use have also skyrocketed, racking up millions of views. Harmful trends are also a concern like “mouth stuffing” where video creators try to place as many Zyn pouches in their mouths as they can, disregarding the potential for nicotine overdose.
Government officials have also been adding their voices to the discussion. Senate Majority Leader Chuck Schumer (D-N.Y.) said in a press conference, “It’s a pouch packed with problems — high levels of nicotine. So today, I’m delivering a warning to parents, because these nicotine pouches seem to lock their sights on young kids — teenagers, and even lower — and then use the social media to hook ’em.”
Marketing practices also play a role. Zyn's advertisements have raised concerns because they may suggest that nicotine pouches are a safer alternative to traditional tobacco products without sufficient evidence—something we’ve mentioned a few times throughout this article. The FDA requires that product marketing accurately reflect the risks associated with use, and let’s be clear: They are not exactly the healthy, hip alternative they’re being marketed as.
Finally, nicotine pouches' regulatory status is complicated by their newness and lack of tobacco content, which means they don't fit into established categories of tobacco products. The FDA demands comprehensive safety and efficacy data before approving new products, and, again, the long-term health effects of nicotine pouches are not yet understood.