Jonathan Kwak, Director of Smoke-Free Products at Philip Morris South Africa says this is an important milestone as PMSA launched ZYN in South Africa in the third quarter of 2024. 

PMSA says that the FDA has authorised the marketing of 20 ZYN nicotine pouch products in the United States, through the premarket tobacco product application (PMTA) pathway, following an extensive scientific review. 

This is the first time the agency has authorised products commonly referred to as nicotine pouches, which are small synthetic fibre pouches containing nicotine, designed to be placed between a person's gum and lip, PMSA adds.  

The FDA determined that the specific products receiving marketing authorisation met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole, says PMSA. 

Among several key considerations, the agency's evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorised products pose a lower risk of cancer and other serious health conditions than such products, adds PMSA.

"To receive marketing authorisations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks," says Matthew Farrelly, PhD, Director of the Office of Science in the FDA's Center for Tobacco Products.

PMSA says the FDA found that the applicant showed these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and / or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth. 

"It's critical that the manufacturer market these products responsibly to prevent youth use," says Brian King, PhD, M.P.H., Director of the FDA's Center for Tobacco Products.

"While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health," King adds.

PMSA adds the FDA explains that while these actions permit these specific tobacco products to be legally marketed in the US to adults 21 and older, it does not mean these tobacco products are safe, nor are they "FDA approved". 

PMSA says that the FDA will closely monitor the marketing and use of these products. To reduce the potential for youth exposure to advertising of these products, the authorisations impose stringent marketing restrictions for digital, TV and radio, including measures to ensure ads are carefully targeted to adults ages 21 and older and the demographics of the audiences reached by the ads are tracked and measured by the manufacturer. 

PMSA says that the products for which the FDA issued marketing granted orders are the following, each with two nicotine strengths (three milligrams and six milligrams):

  • ZYN Chill
  • ZYN Cinnamon
  • ZYN Citrus
  • ZYN Coffee
  • ZYN Cool Mint
  • ZYN Menthol
  • ZYN Peppermint
  • ZYN Smooth
  • ZYN Spearmint, and
  • ZYN Wintergreen.

PMSA says that, importantly, the actions are specific to these products only; the authorisations do not apply to any other nicotine pouch or other ZYN products. Additionally, the authorisation does not allow the company to make reduced risk claims about the authorised products, which would require a modified risk tobacco product application. 

PMSA concludes that this is the latest of many actions the FDA has taken to ensure all new tobacco products marketed in the US undergo science-based review and have received marketing authorisations from the agency. 

For more information, visit www.pmi.com/south-africa. You can follow PMSA on LinkedIn, Facebook, or on X.

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