FDA authorises ZYN nicotine pouches as modified-risk tobacco products

Authorisation covers 20 ZYN variants and allows a claim that using the products instead of cigarettes carries a lower risk of several tobacco-related diseases

The US Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouches, according to Philip Morris International (PMI).

The authorisation marks the first time the FDA has granted MRTP orders for nicotine pouch products.

Under the orders, PMI’s US business can market the authorised ZYN products with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

The FDA said its decision followed a review of the company’s Modified Risk Tobacco Product applications and determined that the products met the requirements for modified-risk authorisation. According to the FDA, the products, when used as intended by consumers, would significantly reduce harm and the risk of tobacco-related disease for individual tobacco users while benefiting population health.

As part of its review, the FDA considered data indicating that some adults who smoke and began using ZYN products reduced their cigarette consumption over time. More than half of those surveyed reported that they had not consumed cigarettes during the previous 30 days.

Among those who continued smoking after beginning to use ZYN, 80.7% reported reducing their cigarette consumption, while 57.2% reduced their daily cigarette use by more than half.

ZYN nicotine pouches deliver nicotine through absorption in the mouth rather than through the inhalation of smoke from burning tobacco. PMI said this results in substantially lower exposure to harmful and potentially harmful chemicals compared with cigarette smoking.

The company said the FDA authorisation represents another step in its efforts to develop and scientifically assess smoke-free alternatives for adults who would otherwise smoke.

The MRTP orders do not mean that ZYN products are risk-free. The FDA’s authorisation specifically permits the products to be marketed with the approved modified-risk information in comparison with cigarettes.