The U.S. Food and Drug Administration (FDA) has approved the use of a modified risk claim for 20 varieties of ZYN nicotine pouches. These are the first Modified Risk Tobacco Product Application (MRTPA) decisions ever granted for nicotine pouches, allowing Philip Morris International (PMI) to communicate the following claim for its authorized ZYN products: “Using ZYN instead of cigarettes reduces your risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
“The FDA’s decision is a landmark moment for more than 45 million adult nicotine consumers in America,” said Stacey Kennedy, CEO of PMI USA. “This decision ensures that adult smokers have access to accurate, science-backed information — including FDA-authorized evidence 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 risk spectrum and communicating those findings with transparency.”
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 latest decision, PMI now holds MRTP authorization for ZYN — the first nicotine pouch ever approved by the FDA — as well as for IQOS device versions and their consumables, and for eight General snus products, further cementing the company’s position as a leader and pioneer in the industry.
This FDA action highlights a striking contrast. In the United States, nicotine products undergo rigorous scientific evaluation before receiving market authorization, while in many other countries, policymakers opt for outright product bans rather than careful, evidence-based assessment.
In line with this science-driven approach, Greece has already made its own mark on the world stage. It became the first country outside the United States where — following a recommendation by the competent Scientific Committee for assessing the harmfulness of new tobacco products — the Ministry of Health authorized a science-backed claim for 7 TEREA variants: “The concentration of chemicals with recognized toxicity, other than nicotine, produced during use of IQOS ILUMA with TEREA tobacco sticks is lower compared to conventional smoking. It is important to note that a reduction in the concentration of chemicals with recognized toxicity does not mean a corresponding reduction in health risk. The aerosol of this tobacco product contains nicotine and other harmful chemicals, is harmful to your health and is addictive. The best choice is to quit using tobacco and nicotine products altogether.”
