{"id":51613,"date":"2025-12-26T17:09:02","date_gmt":"2025-12-26T09:09:02","guid":{"rendered":"https:\/\/www.abesmoke.com\/?p=51613"},"modified":"2025-12-26T17:09:02","modified_gmt":"2025-12-26T09:09:02","slug":"news-philippine-fda-e-cigarettes-and-new-tobacco-products-requiring-pharmaceutical-claims-need-licensing-to-enter-the-market-6-on-plus-nicotine-pouches-authorized-for-sale","status":"publish","type":"post","link":"https:\/\/www.abesmoke.com\/en\/a\/51613","title":{"rendered":"News | Philippine FDA: E-cigarettes and new tobacco products requiring pharmaceutical claims need licensing to enter the market; 6 on! PLUS nicotine pouches authorized for sale."},"content":{"rendered":"

Philippine FDA:\u00a0<\/span>E-cigarettes and new tobacco products with\u00a0<\/strong><\/span>medicinal\u00a0<\/span>or therapeutic claims require licenses to enter the market.<\/span><\/span><\/strong><\/p>\n

According to SunStar Philippines, the Philippine Food and Drug Administration (FDA) requires all businesses selling vaporized nicotine and non-nicotine products (VNNPs, e-cigarettes) and novel tobacco products (NTPs) to obtain the appropriate license to operate (LTO) if they involve medicinal or therapeutic claims.<\/span><\/p>\n

According to FDA Notice 2025-1487,\u00a0<\/span>companies providing pharmaceutical or therapeutic VNNPs and NTPs must apply for a license from the FDA, a division of the Philippine Department of Health (DOH).\u00a0<\/span>The FDA states that all manufacturers, traders, importers, exporters, wholesalers, and retailers involved in such products\u00a0<\/span>must apply for a license to operate as a pharmaceutical distribution entity.<\/span><\/strong><\/p>\n

The FDA states that \"all e-cigarettes and new tobacco products with claims of medicinal or therapeutic use must be registered before being marketed. Products intended for manufacture, distribution, and sale should be registered as drugs through the Center for Drug Regulation and Research (CDRR).<\/span><\/strong><\/p>\n

The FDA is urging all stakeholders to fully comply with the new regulatory requirements to ensure that e-cigarettes and new tobacco products with medicinal or therapeutic claims on the market meet standards in terms of safety, efficacy, and quality.<\/span><\/p>\n

FDA-authorized sales of 6\u00a0<\/span>\u00a0on! PLUS\u00a0<\/span><\/span>\u00a0nicotine pouch products<\/span><\/h1>\n
On December 19, the U.S. Food and Drug Administration (FDA) announced that it had authorized the sale of six on! PLUS nicotine pouch products in the U.S. market through the Premarket Tobacco Product Application (PMTA) pathway.<\/span>
\n<\/span><\/section>\n
This authorization marks the first review decision made by the agency since the pilot program was launched in September, aiming to streamline the review process for nicotine bag applications while maintaining the agency's stringent scientific standards. Through several improvements to the FDA review process, including real-time communication with applicants, the FDA was able to complete scientific reviews at record speed.\u00a0<\/span>The ON! Plus\u00a0<\/strong>nicotine bags\u00a0authorized\u00a0in\u00a0<\/span>\u00a0this instance<\/span>\u00a0are as follows:<\/span>\u00a0<\/span><\/section>\n
    \n
  • \n

    On! PLUS Nicotine Sachet 6 mg (Menthol)<\/span><\/strong><\/p>\n<\/li>\n

  • On! PLUS Nicotine Sachet 9 mg (Menthol)<\/span><\/strong><\/li>\n
  • On! PLUS Nicotine Bag 6 mg (Tobacco)<\/span><\/strong><\/li>\n
  • On! PLUS Nicotine Sachet 9 mg (Tobacco)<\/span><\/strong><\/li>\n
  • On! PLUS Nicotine Bag 6 mg (Wintergreen)<\/span><\/strong><\/li>\n
  • On! PLUS Nicotine Bag 9 mg (Wintergreen)<\/span><\/strong><\/li>\n<\/ul>\n
    The FDA stated that, following scientific review, these nicotine pouches met the legal standards for selling new tobacco products in the United States as set forth in the Home Smoking Prevention and Tobacco Control Act of 2009. These standards require the FDA to consider the risks and benefits to the entire U.S. population\u2014including the benefits to adults who currently use tobacco products and switch to potentially lower-risk products, ensuring these benefits outweigh the risks, and also the benefits to adolescents and adults who do not currently use tobacco products. \u00a0<\/span><\/span><\/section>\n
    British American Tobacco Italy, in partnership with Yoti, has implemented facial recognition age verification technology to strengthen the defenses against the sale of tobacco products to minors.<\/span><\/span><\/section>\n

    British American Tobacco Italy<\/span><\/span>\u00a0recently announced a partnership with\u00a0<\/span><\/strong>Yoti,\u00a0<\/span><\/strong>a company specializing in digital identity and age verification technology<\/strong><\/span>\u00a0. The partnership\u00a0<\/span>will utilize a facial scanning-based age verification system to enhance control over the sale of tobacco and nicotine products to minors.<\/span><\/span><\/p>\n

    The project's testing phase has begun in 119 pop-up stores<\/span><\/strong>\u00a0across Italy\u00a0<\/span>. Through this system, users scan a QR code with their smartphone camera to begin the testing process.\u00a0<\/span>The verification process analyzes facial feature parameters using a series of innovative algorithms,\u00a0<\/span><\/span>only determining whether the user is of legal age, without performing personal identification<\/span><\/strong>\u00a0. The system fully complies with relevant privacy regulations and does not store the user's facial image after verification, ensuring the security of personal information.<\/span><\/p>\n

    According to reports, data collected during the launch phase in Croatia several months ago has confirmed its effectiveness and reliability: the technology achieved an accuracy rate of 99% at points of sale using it. The\u00a0<\/span>tool's introduction in Italy marks a significant milestone for the country, reinforcing measures to prevent the sale of products to those under 18.<\/span><\/strong><\/p>\n

    \u201cToday, thanks to technological innovation,\u00a0<\/span>we can add an extra layer of security beyond routine ID checks, demonstrating not only compliance with current regulations but also a moral responsibility that goes beyond legal requirements<\/span><\/span>\u00a0.\u00a0<\/span>This initiative is significant in ensuring products are only for adult consumers, protecting minors, and driving ethical transformation across the industry<\/span><\/span>\u00a0,\u201d<\/span><\/em>\u00a0said Andrea Di Paolo\u00a0<\/span>,\u00a0<\/span>Vice President of BAT Italy .<\/span><\/p>","protected":false},"excerpt":{"rendered":"

    Philippine FDA:\u00a0E-cigarettes and new tobacco products with\u00a0medicinal\u00a0or therapeutic claims require licenses to enter the market. According to SunStar Philippines, the Philippine Food and Drug …<\/p>","protected":false},"author":2,"featured_media":51614,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2}},"categories":[1],"tags":[],"class_list":["post-51613","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"jetpack_publicize_connections":[],"_links":{"self":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/posts\/51613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/comments?post=51613"}],"version-history":[{"count":0,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/posts\/51613\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/media\/51614"}],"wp:attachment":[{"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/media?parent=51613"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/categories?post=51613"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.abesmoke.com\/en\/wp-json\/wp\/v2\/tags?post=51613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}