FDA Committee Reviews ZYN Application Lower Health Risk Claim
On Jan. 22, 2026, the U.S. Food and Drug Administration's (FDA) Tobacco Product Scientific Advisory Committee (TPSAC) held a day-long public hearing to consider whether Philip Morris International would be allowed to advertise its Swedish Match Zyn nicotine pouches as a less-harmful alternative for adults who currently smoke cigarettes. The TPSAC is comprised of independent health experts and tobacco industry representatives.
The hearing was held in response to a Modified Risk Tobacco Product (MRTP) application that Swedish Match USA Inc. filed with the FDA for the company’s 20 ZYN nicotine pouch products. The MRTP application seeks FDA authorization to market the ZYN products with the following modified risk claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
Several days prior to the public hearing, the FDA’s Center for Tobacco Products (CTP), Office of Science, published a briefing document which included background on the ZYN MRTP application, the relative health benefits and risks of the Zyn products, and the consumer understanding of the product’s health benefits and risks.
In this briefing document, the CTP concluded the following: “FDA’s preliminary evaluation of the totality of the evidence described above suggests that the proposed modified risk claim ‘Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis’ is scientifically accurate.”
The TPSAC did not vote at the conclusion of the public hearing on whether to recommend that the FDA approve the ZYN MRTP application. The TPSAC is still expected to submit a report and final recommendation to the CTP regarding the ZYN MRTP application. If the FDA approves the ZYN MRTP application, then Philip Morris International would be permitted to use the modified risk claim in ZYN advertisements. Read more
here.