The US Food and Drug Administration (FDA) has authorised the marketing of 11 new ZYN ULTRA nicotine pouch products, including an 11mg variant, following scientific review under its premarket tobacco product application (PMTA) pathway.
The products, manufactured by Swedish Match USA, a subsidiary of Philip Morris International (PMI), comprise ten 9mg variants and one 11mg variant. They include Smooth, Cool Mint, Spearmint, Wintergreen, Peppermint, Citrus, Chill, Menthol, Deep Freeze and Wintergreen Chill.
The authorisations take the total number of nicotine pouch products cleared by the FDA to 43, with 23 authorised through its nicotine pouch pilot programme, which aims to streamline the PMTA review process.
The FDA said its assessment found the newly authorised products contained lower levels of most harmful and potentially harmful constituents (HPHCs) than other oral and smokeless tobacco products, with many constituents too low to be quantified.
It also assessed nicotine exposure based on each product's characteristics, rather than relying solely on its labelled nicotine content. Factors considered included product design, formulation and materials, as well as the amount and rate of nicotine delivered to users.
According to the FDA, product-specific evidence indicated that the products appealed to adults who would benefit most from switching to them – namely current cigarette and smokeless tobacco users.
The agency also said the products could deliver enough nicotine to reduce cravings and withdrawal symptoms, potentially supporting substitution among adults who currently use more harmful tobacco products.
“[The] authorizations are another important step to provide greater access to potentially less harmful alternative tobacco products for existing adult tobacco users,” the FDA said.
PMI said the authorisations would strengthen its position in the US smoke-free category and extend ZYN's presence among legal-age nicotine consumers.
“We are delighted with the FDA’s decision to authorise a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI US CEO.
“We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.”
ZYN ULTRA has a higher moisture content than the existing ZYN range and, like the flagship ZYN pouches, does not contain tobacco leaf.
The FDA has previously authorised 20 ZYN nicotine pouch products in a range of flavours and at 3mg and 6mg strengths.
PMI said additional 11mg ZYN ULTRA variants remain under scientific review.