{"id":977267,"date":"2026-06-30T12:32:30","date_gmt":"2026-06-30T16:32:30","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/"},"modified":"2026-06-30T12:32:30","modified_gmt":"2026-06-30T16:32:30","slug":"fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/","title":{"rendered":"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>FDA Issues Modified Risk Tobacco Product Orders for 20 <i>ZYN<\/i> Nicotine Pouch Products<\/b><\/p>\n<p class=\"bwalignc\"><i>FDA\u2019s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes<\/i><\/p>\n<p>STAMFORD, CT&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nPhilip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of <i>ZYN<\/i> nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized <i>ZYN<\/i> products: \u201c<i>Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis<\/i>.\u201d<\/p>\n<p><i>\u201cFDA\u2019s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,\u201d <\/i>said<i \/>Stacey Kennedy, PMI U.S. CEO. <i>\u201cToday\u2019s news ensures these adults<\/i><b \/><i>have access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer,\u201d <\/i>she added<i>. \u201cMore broadly, it reinforces the agency\u2019s science-based approach to evaluating products across the continuum of risk and communicating those findings transparently.\u201d<\/i><\/p>\n<p>\nThe FDA\u2019s action highlights a stark contrast: in the U.S., nicotine products undergo detailed scientific review before being authorized, while in many countries policymakers opt for bans rather than careful evaluation.<\/p>\n<p><b>Products covered by the FDA\u2019s MRTP orders include:<\/b><\/p>\n<p><i>ZYN<\/i> Cool Mint 3 mg<\/p>\n<p><i>ZYN<\/i> Cool Mint 6 mg<\/p>\n<p><i>ZYN<\/i> Peppermint 3 mg<\/p>\n<p><i>ZYN<\/i> Peppermint 6 mg<\/p>\n<p><i>ZYN<\/i> Spearmint 3 mg<\/p>\n<p><i>ZYN<\/i> Spearmint 6 mg<\/p>\n<p><i>ZYN<\/i> Wintergreen 3 mg<\/p>\n<p><i>ZYN<\/i> Wintergreen 6 mg<\/p>\n<p><i>ZYN<\/i> Citrus 3 mg<\/p>\n<p><i>ZYN<\/i> Citrus 6 mg<\/p>\n<p><i>ZYN<\/i> Coffee 3 mg<\/p>\n<p><i>ZYN<\/i> Coffee 6 mg<\/p>\n<p><i>ZYN<\/i> Cinnamon 3 mg<\/p>\n<p><i>ZYN<\/i> Cinnamon 6 mg<\/p>\n<p><i>ZYN<\/i> Smooth 3 mg<\/p>\n<p><i>ZYN<\/i> Smooth 6 mg<\/p>\n<p><i>ZYN<\/i> Chill 3 mg<\/p>\n<p><i>ZYN<\/i> Chill 6 mg<\/p>\n<p><i>ZYN<\/i> Menthol 3 mg<\/p>\n<p><i>ZYN<\/i> Menthol 6 mg<\/p>\n<p>\nIn January 2025, <i>ZYN<\/i> was the first nicotine pouch authorized for sale in the United States following rigorous scientific review. With today\u2019s decision, PMI holds MRTP authorizations for <i>ZYN, <\/i>the first nicotine pouch authorized by the FDA, versions of<i> IQOS <\/i>devices and consumables and eight <i>General <\/i>snus<i \/>products, underscoring the company\u2019s position as an industry leader and innovator.<\/p>\n<p><b>EDITOR\u2019S NOTE<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nFDA has authorized the <i>ZYN<\/i> MRTP claim, effective immediately.<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nFrom the FDA Modified Risk Granted Order: \u201c<i>Based on our review of your MRTPAs, we determined that the proposed modified risk tobacco products, as described in your applications and specified in Appendix A, have satisfied the requirements of section 911(g)(1)(A) and (B), including that they, as actually used by consumers, would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products. Therefore, we authorize marketing of the tobacco products as modified risk tobacco products with the following modified risk information: \u2018Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis<\/i>.\u2019\u201d<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nNicotine pouches, like <i>ZYN<\/i>, deliver nicotine through oral absorption and do not require the burning of tobacco, or inhaling of smoke. This significantly reduces exposure to harmful and potentially harmful chemicals compared to the use of combustible tobacco, such as cigarettes.<\/p>\n<\/li>\n<li>\nIn authorizing <i>ZYN<\/i> through the premarket tobacco product application (PMTA) pathway in January 2025, the FDA noted: \u201cthe agency\u2019s 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 authorized products [<i>ZYN<\/i>] pose lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and\/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.\u201d<\/p>\n<\/li>\n<\/ul>\n<ul class=\"bwlistdisc\">\n<li>\nWhen reviewing the <i>ZYN<\/i> applications, FDA considered extensive data showing that some adults who smoke and have started using <i>ZYN<\/i> products have reduced their cigarette use over time, with over half of those surveyed reporting no cigarette consumption in the past 30 days. Of those who continue to smoke cigarettes after starting to use <i>ZYN<\/i> products, the majority (80.7%) reduced their cigarette consumption, and over half (57.2%) reduced their cigarettes per day by more than 50%.<\/p>\n<\/li>\n<\/ul>\n<p><b>Philip Morris International: A Global Smoke-Free Champion<\/b><\/p>\n<p>\nPhilip Morris International is a leading international consumer goods company, actively delivering a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector. The company\u2019s current product portfolio primarily consists of cigarettes and smoke-free products, including heat-not-burn, nicotine pouch and e-vapor products. Our smoke-free products are available for sale in over 105 markets, and as of December 31, 2025, PMI estimates they were used by over 43 million legal-age consumers around the world, many of whom have moved away from cigarettes or significantly reduced their consumption. The smoke-free business accounted for 43% of PMI\u2019s first-quarter 2026 total net revenues. Since 2008, PMI has invested over $16 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise smoke, with the goal of completely ending the sale of cigarettes. This includes the building of world-class scientific assessment capabilities, notably in the areas of pre-clinical systems toxicology, clinical and behavioral research, as well as post-market studies. Following a robust science-based review, the U.S. Food and Drug Administration has authorized the marketing of Swedish Match\u2019s General snus and <i>ZYN<\/i> nicotine pouches and versions of PMI\u2019s <i>IQOS <\/i>devices and consumables &#8211; the first-ever such authorizations in their respective categories. Versions of <i>IQOS<\/i> devices and consumables, General snus and <i>ZYN<\/i> also obtained the first-ever Modified Risk Tobacco Product authorizations in their respective categories from the FDA. With a strong foundation and significant expertise in life sciences, PMI has a long-term ambition to expand into wellness areas.<\/p>\n<p>\nReferences to \u201cPMI\u201d, \u201cwe\u201d, \u201cour\u201d and \u201cus\u201d mean Philip Morris International Inc., and its subsidiaries. For more information, please visit <a rel=\"nofollow\" href=\"http:\/\/www.pmi.com\/\">www.pmi.com<\/a> and <a rel=\"nofollow\" href=\"http:\/\/www.pmiscience.com\/\">www.pmiscience.com<\/a>.<\/p>\n<p><b>About PMI U.S.: Invested In America<\/b><\/p>\n<p>\nPhilip Morris International Inc.\u2019s U.S. businesses are invested in America\u2019s future and advancing a smoke-free nation. The businesses are committed to providing the approximately 25 million legal-age consumers who smoke cigarettes with better, smoke-free alternatives and to ensuring the products are marketed responsibly. From PMI\u2019s global headquarters in Stamford, Connecticut, and other locations nationwide, PMI U.S. contributes leadership, jobs, investment, and innovation in the U.S. The U.S. businesses employ more than 3,000 people across America and operate product manufacturing facilities, including in Aurora, Colorado, Owensboro, Kentucky, and Wilson, North Carolina. For more information, please visit <a rel=\"nofollow\" href=\"https:\/\/www.uspmi.com\/\">www.uspmi.com<\/a>.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260630053034r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260630053034\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260630053034\/en\/<\/a><\/span><\/p>\n<p>\nCorey Henry<br \/>\n<br \/>Philip Morris International<br \/>\n<br \/>T. +1 (202) 679 7296<br \/>\n<br \/>E. <a rel=\"nofollow\" href=\"mailto:Corey.Henry@pmi.com\">corey.henry@pmi.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> United States North America Connecticut<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Oncology Retail Health FDA Tobacco Other Health Cardiology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260630053034\/en\/328938\/3\/PMI_logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products FDA\u2019s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes STAMFORD, CT&#8211;(BUSINESS WIRE)&#8211; Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: \u201cUsing ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.\u201d \u201cFDA\u2019s decision is an important moment for the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-977267","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products FDA\u2019s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes STAMFORD, CT&#8211;(BUSINESS WIRE)&#8211; Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: \u201cUsing ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.\u201d \u201cFDA\u2019s decision is an important moment for the &hellip; Continue reading &quot;FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-06-30T16:32:30+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260630053034r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"6 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products\",\"datePublished\":\"2026-06-30T16:32:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\\\/\"},\"wordCount\":1158,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20260630053034r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\\\/\",\"name\":\"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/","og_locale":"en_US","og_type":"article","og_title":"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products - Market Newsdesk","og_description":"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products FDA\u2019s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes STAMFORD, CT&#8211;(BUSINESS WIRE)&#8211; Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: \u201cUsing ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.\u201d \u201cFDA\u2019s decision is an important moment for the &hellip; Continue reading \"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/","og_site_name":"Market Newsdesk","article_published_time":"2026-06-30T16:32:30+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260630053034r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"6 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products","datePublished":"2026-06-30T16:32:30+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/"},"wordCount":1158,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260630053034r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/fda-issues-modified-risk-tobacco-product-orders-for-20-zyn-nicotine-pouch-products\/","name":"FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products - 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