Philip Morris South Africa (PMSA) has expressed its excitement about the recent announcement from the U.S. Food and Drug Administration (FDA) granting authorisation for the marketing of 20 ZYN nicotine pouch products in the United States. This significant milestone follows an extensive scientific review under the premarket tobacco product application (PMTA) pathway.
Jonathan Kwak, Director of Smoke-Free Products at Philip Morris South Africa, highlighted the importance of this development, noting that PMSA launched ZYN in South Africa in the third quarter of last year. “Oral-smokeless products are a crucial part of our smoke-free portfolio, driving the transition away from smoking for adults who would otherwise continue. Scientists and public health experts increasingly recognise the role of smoke-free alternatives in addressing global smoking numbers,” Kwak said.
According to Kwak, no single smoke-free option appeals to all adult smokers, which is why a diverse range of science-based alternatives, like ZYN, is essential to encourage full switching. “Although not risk-free, these products present a significantly better choice for adults who still smoke,” he added.
The ZYN nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip, are the first products of their kind to be authorised by the FDA. The decision came after a comprehensive evaluation, where the FDA concluded that the ZYN products posed a lower risk of cancer and other serious health conditions compared to traditional cigarettes and smokeless tobacco products.
The FDA’s rigorous review showed that ZYN’s nicotine pouches contain significantly fewer harmful substances than cigarettes and other smokeless tobacco products, such as moist snuff and snus. The agency also determined that these products could benefit adults who completely switch from smoking or using smokeless tobacco products.
Matthew Farrelly, Ph.D., Director of the Office of Science at the FDA’s Center for Tobacco Products, explained: “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks. In this case, the data show that these nicotine pouch products meet that bar.”
While the FDA has authorised the marketing of these products, it emphasised that they are not “FDA approved” and should not be considered safe. It also warned that youth should not use tobacco products, and adults who do not use tobacco products should not start.
As part of its commitment to ensuring responsible marketing, the FDA has imposed stringent marketing restrictions for digital, TV, and radio advertisements to ensure they are targeted only at adults aged 21 and over. Additionally, the manufacturer must take steps to limit youth exposure and appeal through marketing tactics, such as using actors/models who are no younger than 35 years old.
