The U.S. Food and Drug Administration (FDA) has approved the use of a differentiated risk claim for 20 varieties of ZYN nicotine pouches. These are the first approvals granted for nicotine pouches as modified-risk tobacco products (Modified Risk Tobacco Product Application—MRTPA), allowing Philip Morris International (PMI) to make the following claim about the authorized ZYN products: “Using ZYN instead of conventional cigarettes reduces the risk of oral cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
“The FDA’s decision marks a significant milestone for the more than 45 million adult nicotine users in the United States,” said Stacey Kennedy, CEO of PMI USA. “This decision ensures that adult smokers have access to accurate, science-based information, including FDA-approved evidence, which show that switching from conventional cigarettes to ZYN reduces the risk of smoking-related diseases, such as heart disease and lung cancer,” she added. “More broadly, it reinforces the Agency’s science-based approach to evaluating products across the entire risk spectrum and communicating these findings transparently.”
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The products covered by the FDA’s MRTP decisions include: ZYN Cool Mint 3 mg, ZYN Cool Mint 6 mg, ZYN Peppermint 3 mg, ZYN Peppermint 6 mg, ZYN Spearmint 3 mg, ZYN Spearmint 6 mg, ZYN Wintergreen 3 mg, ZYN Wintergreen 6 mg, ZYN Citrus 3 mg, ZYN Citrus 6 mg, ZYN Coffee 3 mg, ZYN Coffee 6 mg, ZYN Cinnamon 3 mg, ZYN Cinnamon 6 mg, ZYN Smooth 3 mg, ZYN Smooth 6 mg, ZYN Chill 3 mg, ZYN Chill 6 mg, ZYN Menthol 3 mg, ZYN Menthol 6 mg.
With this recent decision, PMI now holds an MRTP license for ZYN, the first (pouch) approved by the FDA, for IQOS devices and their consumables, as well as for eight General snus products, underscoring the company’s position as a leader and pioneer in the industry.
