US FDA clears ZYN nicotine pouches for lower-risk claim

Following an extensive scientific review, the US Food and Drug Administration (FDA) has issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products, allowing Philip Morris International US (PMI) to market these products in the United States (US) with a specific modified risk claim.

The US FDA’s MRTP order, dated June 30, applies only to the 20 ZYN products reviewed by the FDA and does not extend to other nicotine products.

As per an official statement, the FDA issued the MRTP orders following its scientific review of Swedish Match USA, Inc.’s.

“Based on this review, FDA concluded that Swedish Match had demonstrated that the specific modified risk claim is scientifically accurate with respect to these 20 ZYN products, that consumers understand the claim, and that marketing the products with the authorised claim would benefit the population,” read the statement.

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The products, which were authorised for sale in the US earlier this year, may now be marketed with the FDA-authorised claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

“FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products so that they can make informed choices,” said Bret Koplow, PhD, J.D., acting director of the U.S FDA’s Centre for Tobacco Products.

He further stated that the “decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”

This is the first time the agency has granted MRTP orders for nicotine pouches.