FDA Authorizes Zyn Nicotine Pouches for Sale While Proposing Limit on Nicotine in Cigarettes
The U.S. Food and Drug Administration has authorized Zyn nicotine pouches for sale following an “extensive scientific review" about their safety. The agency said in a press release it had found that the pouches posed lower risk of cancer and other serious health conditions compared to cigarettes and other smokeless tobacco products.
The FDA said that its findings about Zyn do not mean the products are ultimately safe or FDA- approved, but the agency does believe the pouches have the potential to benefit cigarette smokers, citing evidence that they can help them to quit.
Today, FDA authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. https://t.co/OcTXP7vCeX pic.twitter.com/58Hh4RODet
— U.S. FDA (@US_FDA) January 16, 2025
Jenny Vidrine, PhD, is a researcher in the Department of Health Outcomes and Behavior at Moffitt Cancer Center. She believes the approval can be a good thing for those trying to quit smoking.
“While it would be preferable for everyone to stop using nicotine altogether, nicotine is incredibly addictive and most people try to quit multiple times before they achieve long-term success,” Vidrine said. “In this context, less harmful products on the risk continuum have value. Nicotine pouches appear to offer a lower risk alternative to combustible cigarettes for nicotine delivery.”
In addition to the pouches, Vidrine says there are seven FDA-approved medications to help people quit smoking.
Jenny Vidrine, PhD
“All of these medications have efficacy for helping people quit smoking,” she said. “The best approach is the combination of some sort of behavioral counseling or support for smoking cessation combined with medication/nicotine replacement therapy.”
Earlier in the week, the FDA also announced a proposed rule that would make cigarettes and certain other combusted tobacco products minimally addictive or nonaddictive by limiting the level of nicotine in those products.
When it comes to combusted products like cigarettes, nicotine addiction leads to repeated exposure to a mix of toxic chemicals in the smoke that cause an increased risk of cancer and other deadly diseases.
The agency says the proposed nicotine level would be low enough to no longer create or sustain addiction.
“The actual reduced nicotine cigarettes will not be less harmful than standard cigarettes, but people are likely to stop using them because they don’t deliver much nicotine” said Vidrine. “Nicotine is actually one of the least harmful chemicals in cigarettes, but it’s what makes them addictive.”
The proposed rule would not ban cigarettes or any other tobacco products. The FDA is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the average concentration in these products on the market today.
