{"id":103850,"date":"2024-12-03T18:58:00","date_gmt":"2024-12-03T21:58:00","guid":{"rendered":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/releases\/releases-geral\/2one-labs-receives-second-fda-pmta-acceptance-notification-for-additionally-submitted-2one-branded-nicotine-pouch-products\/"},"modified":"2024-12-03T18:58:00","modified_gmt":"2024-12-03T21:58:00","slug":"2one-labs-receives-second-fda-pmta-acceptance-notification-for-additionally-submitted-2one-branded-nicotine-pouch-products","status":"publish","type":"post","link":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/releases\/releases-geral\/2one-labs-receives-second-fda-pmta-acceptance-notification-for-additionally-submitted-2one-branded-nicotine-pouch-products\/","title":{"rendered":"2ONE Labs Receives Second FDA PMTA &#8216;Acceptance&#8217; Notification for Additionally Submitted 2ONE\u00ae Branded Nicotine Pouch Products"},"content":{"rendered":"<p><b>2ONE LABS INC.<\/b><\/p>\n<p align=\"justify\">LAKE TAHOE, Nev., Dec.  03, 2024  (GLOBE NEWSWIRE) &#8212; 2ONE Labs Inc., is pleased to have received &#8216;Acceptance&#8217; of a second Premarket Tobacco Product Application (PMTA) for additional flavored 2ONE<sup>\u00ae<\/sup> nicotine product styles submitted to the U.S. Food and Drug Administration (FDA).<\/p>\n<p align=\"justify\">Welcoming receipt of this additional FDA Acceptance notification, Vincent Schuman, CEO of 2ONE Labs, said: Our strategy has always been to maintain a steady flow of supportable and responsible PMTA submissions for the 2ONE<sup>\u00ae<\/sup> nicotine pouch brand that reflect current adult consumer product demands. Our timely PMTA filings with the FDA reflect our company&#8217;s commitment to remaining at the forefront of product innovation in the nicotine pouch marketplace.<\/p>\n<p align=\"justify\">As with our previously &#8216;Accepted&#8217; 2ONE<sup>\u00ae<\/sup> PMTA submission, this application will move forward to the next stage of FDA review. 2ONE Labs aims to fund these submissions to a successful &#8216;Authorization&#8217; by FDA. Our wholesale, retail and sponsorship partners should take confidence in this additional Acceptance as a reflection of our ability to manage and navigate the complex PMTA process, and of our commitment to supporting the 2ONE<sup>\u00ae<\/sup> brand in the US market.<\/p>\n<p align=\"justify\">Schuman added: 2ONE<sup>\u00ae<\/sup> Tobacco-Free nicotine pouches are for adult users (21+), who want to switch from cigarettes, cigars or traditional oral tobacco chewing products. The 2ONE<sup>\u00ae<\/sup> brand has been in the market since early 2020 and has helped many thousands of adults move towards a better nicotine offering. We believe adults will continue to seek out 2ONE<sup>\u00ae<\/sup> as the best-in-class pouch product it has become. We remain encouraged by FDAs acceptance of the 2ONE<sup>\u00ae<\/sup> PMTA submission, and we look forward to continuing to support the needs of adult consumers making their journey away from tobacco.&#8221;<\/p>\n<p align=\"justify\">2ONE<sup>\u00ae<\/sup> nicotine pouch products are offered in a variety of nicotine levels and satisfying flavors at over 20,000+ retail outlets nationwide, including Circle K locations, and can be purchased online by adult consumers at: www.21Pouches.com.<\/p>\n<p align=\"justify\"><strong>About 2ONE<sup>\u00ae<\/sup> Nicotine Pouches<\/strong><\/p>\n<p align=\"justify\">2ONE Labs Inc.: Founded by pioneers in synthetic nicotine production, 2ONE Labs specializes in providing the most innovative tobacco-free nicotine products to adult consumers seeking an alternative to other tobacco products. For more information, contact 21Pouches.com.<\/p>\n<p>2ONE<sup>\u00ae<\/sup> is a registered trademark of 2ONE Labs Inc., Lake Tahoe, NV. All Rights Reserved.<\/p>\n<p><strong>Source<\/strong>: 2ONE LABS INC.<\/p>\n<p><strong>Contact<\/strong>: Press@21pouches.com<\/p>\n<p> <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTMxMzYzNSM2NjIxNDU2IzIyOTUzNzU=\" \/> <br \/><img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/MWY1ZDc1MzItMjA0MC00YjkzLTk0OTItOWYxMTQyYjBlMzVlLTEzMDY5MjU=\/tiny\/2ONE-LABS-INC-.png\" \/><br \/>\n<a href=\"https:\/\/www.globenewswire.com\/NewsRoom\/AttachmentNg\/e04acca1-ff38-4550-9918-847711111e76\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/e04acca1-ff38-4550-9918-847711111e76\/small\/2one-logo-png.png\" border=\"0\" width=\"150\" height=\"84\" alt=\"Primary Logo\" \/><\/a><\/p>\n<p>A <b>OESP<\/b> nao e(sao) responsavel(is) por erros, incorrecoes, atrasos ou quaisquer decisoes tomadas por seus clientes com base nos Conteudos ora disponibilizados, bem como tais Conteudos nao representam a opiniao da <b>OESP<\/b> e sao de inteira responsabilidade da <b>GlobeNewswire<\/b><\/p>\n","protected":false},"excerpt":{"rendered":"LAKE TAHOE, Nev., Dec.  03, 2024  (GLOBE NEWSWIRE) &#8212; 2ONE Labs Inc., is pleased to have received &#8216;Acceptance&#8217; of a second Premarket Tobacco Product Appli","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[34],"tags":[],"class_list":["post-103850","post","type-post","status-publish","format-standard","hentry","category-releases-geral"],"acf":[],"_links":{"self":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/posts\/103850","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/comments?post=103850"}],"version-history":[{"count":0,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/posts\/103850\/revisions"}],"wp:attachment":[{"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/media?parent=103850"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/categories?post=103850"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bluestudio.estadao.com.br\/agencia-de-comunicacao\/wp-json\/wp\/v2\/tags?post=103850"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}