{"id":26606,"date":"2025-09-19T08:50:20","date_gmt":"2025-09-19T08:50:20","guid":{"rendered":"https:\/\/clearingtheair.eu\/?p=26606"},"modified":"2025-09-19T08:50:24","modified_gmt":"2025-09-19T08:50:24","slug":"nicotine-pouch-reviews-put-on-fast-track-under-fda-pilot","status":"publish","type":"post","link":"https:\/\/clearingtheair.eu\/en\/post\/nicotine-pouch-reviews-put-on-fast-track-under-fda-pilot\/","title":{"rendered":"Nicotine pouch reviews put on fast track under FDA pilot"},"content":{"rendered":"

The U.S. Food and Drug Administration (FDA) will fast-track reviews for a small group of nicotine pouch products, following pressure from the White House, according to meeting transcripts obtained by Reuters.<\/strong><\/p>

The pilot programme, which launched last week, will accelerate the premarket tobacco application (PMTA) process for four companies: Philip Morris International, Altria, R.J. Reynolds, and Turning Point Brands.<\/p>

The move marks a shift for the FDA Centre for Tobacco Products (CTP), which has been criticised for long delays and limited authorisations. <\/p>

To date, only one nicotine pouch brand – Zyn, owned by Swedish Match\/PMI – has received FDA marketing authorisation,<\/a> a process that stretched nearly five years from submission in March 2020 to approval in January 2025.<\/p>

A \u2018streamlined process\u2019<\/strong><\/h3>

Under the pilot, FDA officials said reviewers will focus only on \u201cinformation essential to start the scientific review of nicotine pouches, core product characterisation, manufacturing consistency and stability, and abuse-liability data,\u201d according to transcripts. <\/p>

The streamlined process will also include more frequent communication between the agency and applicants, with a goal of completing reviews by December.<\/p>

The products chosen are Zyn Ultra (Swedish Match\/PMI), on! and on! PLUS (Helix Innovations\/Altria), Velo mini (R.J. Reynolds), and Fre and Alp (Turning Point Brands). Some are not yet on the market while others are already sold without FDA authorisation.<\/p>

The \u2018safest way to consume nicotine\u2019<\/strong><\/h3>

Health and Human Services Secretary Robert F. Kennedy Jr. recently said nicotine pouches are \u201cthe safest way to consume nicotine\u201d and that \u201cvapes are second.\u201d He also claimed \u201cwe are fast-tracking approval\u201d of some vapes, although no vaping products are included in the pilot.<\/p>

The FDA\u2019s shift comes amid political pressure and industry lobbying. Agency staff were told the pilot was developed \u201cin response to pressure from leadership, including at the White House.\u201d Tobacco companies have also pushed for a faster, clearer authorisation process.<\/p>

Slow pace has caused friction<\/strong><\/h3>

Meanwhile, the FDA\u2019s slow pace has created friction with industry. Altria subsidiary NJOY sued the agency earlier this year over delays, while Altria and Reynolds have begun launching new products without authorisation, effectively daring CTP to act. <\/p>

Since the PMTA deadline five years ago, the FDA has authorised just eight e-liquid-based vaping devices \u2013 all tobacco or menthol-flavoured closed systems. No bottled e-liquid, refillable device, or flavoured vape has cleared review.<\/p>

Nicotine pouches, which are placed under the lip and do not contain tobacco leaf, are now the fastest-growing category of nicotine products in the U.S. PMI\u2019s Zyn leads the market, with quarterly shipment growth between 40 per cent and 80 per cent since January 2023.<\/p>

Some public health groups have urged caution about the latest move. \u201cThere should be no shortcuts when it comes to our kids\u2019 health,\u201d said Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids. <\/p>

But FDA officials noted in a recent meeting that current evidence \u201cdoes not show a significant uptake of these products among young people.\u201d<\/p>

Altria called the FDA\u2019s move \u201cencouraging and a positive step for harm reduction.\u201d Turning Point Brands said the plan reflects a commitment to \u201cefficiency, effectiveness and transparency.\u201d PMI said speeding reviews \u201ccould be a step in the right direction.\u201d Reynolds declined to comment.<\/p>","protected":false},"excerpt":{"rendered":"

The U.S. Food and Drug Administration (FDA) will fast-track reviews for a small group of nicotine pouch products, following pressure from the White House, according to meeting transcripts obtained by Reuters. The pilot programme, which launched last week, will accelerate the premarket…<\/p>\n","protected":false},"author":990002,"featured_media":26607,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[257],"tags":[186],"slider":[],"class_list":["post-26606","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-nicotine"],"_links":{"self":[{"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/posts\/26606","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/users\/990002"}],"replies":[{"embeddable":true,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/comments?post=26606"}],"version-history":[{"count":1,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/posts\/26606\/revisions"}],"predecessor-version":[{"id":26613,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/posts\/26606\/revisions\/26613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/media\/26607"}],"wp:attachment":[{"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/media?parent=26606"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/categories?post=26606"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/tags?post=26606"},{"taxonomy":"slider","embeddable":true,"href":"https:\/\/clearingtheair.eu\/en\/wp-json\/wp\/v2\/slider?post=26606"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}