FDA Nicotine Regulation in 2026: PMTAs, Enforcement Discretion, and State Sales Restrictions
FDA Nicotine Regulation in 2026: PMTAs, Enforcement Discretion, and State Sales Restrictions
The starting point is federal law. The Tobacco Control Act generally prohibits the marketing of a new tobacco product without FDA authorization....
www.jdsupra.com
August 24, 2026 at 7:17 PM
FDA Nicotine Regulation in 2026: PMTAs, Enforcement Discretion, and State Sales Restrictions
nicotineinsider.com/2025/06/26/t...
Yes it's last year. But relevant given recent news. An app and "random biometric check-ins during usage" 🙄 not to mention giving up a scan of your ID, how long before there is a "data breach." E-cigarettes, more access controls than a firearm, *Now FDA Approved!"
Yes it's last year. But relevant given recent news. An app and "random biometric check-ins during usage" 🙄 not to mention giving up a scan of your ID, how long before there is a "data breach." E-cigarettes, more access controls than a firearm, *Now FDA Approved!"
The Right Stuff: Glas Focuses on its PMTAs
Glas’s PMTA process began long before its application landed at FDA headquarters.
nicotineinsider.com
May 6, 2026 at 3:16 AM
nicotineinsider.com/2025/06/26/t...
Yes it's last year. But relevant given recent news. An app and "random biometric check-ins during usage" 🙄 not to mention giving up a scan of your ID, how long before there is a "data breach." E-cigarettes, more access controls than a firearm, *Now FDA Approved!"
Yes it's last year. But relevant given recent news. An app and "random biometric check-ins during usage" 🙄 not to mention giving up a scan of your ID, how long before there is a "data breach." E-cigarettes, more access controls than a firearm, *Now FDA Approved!"
FDA Issues Draft Guidance on Flavored ENDS PMTAs
FDA Issues Draft Guidance on Flavored ENDS PMTAs
On March 9, the U.S. Food and Drug Administration (FDA) released a draft guidance document describing the agency’s perspective on premarket...
www.jdsupra.com
March 23, 2026 at 7:17 PM
FDA Issues Draft Guidance on Flavored ENDS PMTAs
#$MO on! Plus PMTAs currently being reviewed by FDA:
12mg mint, wintergreen and tobacco flavors
6 additional flavors across 3 nicotine strengths
"The new flavor applications are not included in the FDA's pilot program"
12mg mint, wintergreen and tobacco flavors
6 additional flavors across 3 nicotine strengths
"The new flavor applications are not included in the FDA's pilot program"
February 19, 2026 at 5:35 PM
#$MO on! Plus PMTAs currently being reviewed by FDA:
12mg mint, wintergreen and tobacco flavors
6 additional flavors across 3 nicotine strengths
"The new flavor applications are not included in the FDA's pilot program"
12mg mint, wintergreen and tobacco flavors
6 additional flavors across 3 nicotine strengths
"The new flavor applications are not included in the FDA's pilot program"
#$MO believes Mint/Wintergreen and 6/9mg varieties "aligned with preferences of ~60% of pouch consumers"
But "interest in strengths 9mg and above also continues to rise and higher nicotine strengths appeal to certain dippers"; PMTAs for additional varieties already filed
cc: #$PM
But "interest in strengths 9mg and above also continues to rise and higher nicotine strengths appeal to certain dippers"; PMTAs for additional varieties already filed
cc: #$PM
February 19, 2026 at 5:29 PM
Both start-ups are backed by venture capital
Sesh: 8VC (started by PLTR co-founder Joe Lonsdale)
Lucy Nicotine: Y Combinator, Greycroft
Both seem to have submitted PMTAs prior to FDA 2022 deadline
Sesh: 8VC (started by PLTR co-founder Joe Lonsdale)
Lucy Nicotine: Y Combinator, Greycroft
Both seem to have submitted PMTAs prior to FDA 2022 deadline
December 31, 2025 at 9:40 AM
Both start-ups are backed by venture capital
Sesh: 8VC (started by PLTR co-founder Joe Lonsdale)
Lucy Nicotine: Y Combinator, Greycroft
Both seem to have submitted PMTAs prior to FDA 2022 deadline
Sesh: 8VC (started by PLTR co-founder Joe Lonsdale)
Lucy Nicotine: Y Combinator, Greycroft
Both seem to have submitted PMTAs prior to FDA 2022 deadline
Congress allowing FDA to charge a small user fee on PMTAs would thwart such tactics. The new legislation now requires FDA to divert user fees from other programs, further degrading its mission.
November 15, 2025 at 2:25 PM
Congress allowing FDA to charge a small user fee on PMTAs would thwart such tactics. The new legislation now requires FDA to divert user fees from other programs, further degrading its mission.
As of 2023, the e-cigarette industry has submitted 26 million (!!!) e-cigarette PMTAs to FDA, a systematic assault on the agency to make it look ineffective. Just one company submitted 17 million PMTAs.
November 15, 2025 at 2:25 PM
As of 2023, the e-cigarette industry has submitted 26 million (!!!) e-cigarette PMTAs to FDA, a systematic assault on the agency to make it look ineffective. Just one company submitted 17 million PMTAs.
What the legislation doesn't do is enabling FDA to collect user fees from the e-cigarette industry for Premarket Tobacco Product Applications (PMTAs) or Modified Risk Tobacco Product (MRTP) applications.
November 15, 2025 at 2:25 PM
What the legislation doesn't do is enabling FDA to collect user fees from the e-cigarette industry for Premarket Tobacco Product Applications (PMTAs) or Modified Risk Tobacco Product (MRTP) applications.
They are fast-tracking the review of these products too.
FDA Launches Program to More Efficiently Review Nicotine Pouch Applications
FDA Launches Program to More Efficiently Review Nicotine Pouch Applications
FDA Launches Program to More Efficiently Review Nicotine Pouch PMTAs
FDA launched a pilot program that aims to increase efficiency and streamline the review process for PMTAs for nicotine pouch products.
www.fda.gov
October 17, 2025 at 1:20 AM
They are fast-tracking the review of these products too.
FDA Launches Program to More Efficiently Review Nicotine Pouch Applications
FDA Launches Program to More Efficiently Review Nicotine Pouch Applications
Philip Morris $PM's ZYN is the only nicotine pouch with PMTA authorization, but only for 3mg and 6mg; these seem the main varieties available
Other pouches grandfathered from 2016 can be sold legally in the US while PMTAs are pending
It is not clear if $TPB's new pouch is one
Other pouches grandfathered from 2016 can be sold legally in the US while PMTAs are pending
It is not clear if $TPB's new pouch is one
October 9, 2025 at 6:58 AM
Philip Morris $PM's ZYN is the only nicotine pouch with PMTA authorization, but only for 3mg and 6mg; these seem the main varieties available
Other pouches grandfathered from 2016 can be sold legally in the US while PMTAs are pending
It is not clear if $TPB's new pouch is one
Other pouches grandfathered from 2016 can be sold legally in the US while PMTAs are pending
It is not clear if $TPB's new pouch is one
I think someone has messed up because all 20 of the nicotine pouches on the list are ZYN
They have confused products which have Marketing Granted Orders (only ZYN) and products which can legally be sold (which include products with pending PMTAs, notably on! and Velo)
cc: $PM $MO $BATS $BTI $IMB
They have confused products which have Marketing Granted Orders (only ZYN) and products which can legally be sold (which include products with pending PMTAs, notably on! and Velo)
cc: $PM $MO $BATS $BTI $IMB
September 30, 2025 at 2:38 PM
I think someone has messed up because all 20 of the nicotine pouches on the list are ZYN
They have confused products which have Marketing Granted Orders (only ZYN) and products which can legally be sold (which include products with pending PMTAs, notably on! and Velo)
cc: $PM $MO $BATS $BTI $IMB
They have confused products which have Marketing Granted Orders (only ZYN) and products which can legally be sold (which include products with pending PMTAs, notably on! and Velo)
cc: $PM $MO $BATS $BTI $IMB
#Scratch #PenguinMod #スクラッチ #ペンギンモッド #スクアニ #ScratchAnimations #PMTAS #ペンギンモッダーズ
祝! SATO-PLUS+一周年!
それを祝して新作アニメ、ペンギンモッダーズが7月8日に公開!
PenguinModでは最速で二か国語で視聴できるぞ!
祝! SATO-PLUS+一周年!
それを祝して新作アニメ、ペンギンモッダーズが7月8日に公開!
PenguinModでは最速で二か国語で視聴できるぞ!
July 6, 2025 at 4:42 AM
#Scratch #PenguinMod #スクラッチ #ペンギンモッド #スクアニ #ScratchAnimations #PMTAS #ペンギンモッダーズ
祝! SATO-PLUS+一周年!
それを祝して新作アニメ、ペンギンモッダーズが7月8日に公開!
PenguinModでは最速で二か国語で視聴できるぞ!
祝! SATO-PLUS+一周年!
それを祝して新作アニメ、ペンギンモッダーズが7月8日に公開!
PenguinModでは最速で二か国語で視聴できるぞ!
This was the argument (from the FDA) that I expected, and it seems it's going to carry the day.
No justices voiced support for the e-cigarette companies on the merits (of their PMTAs) -- as the 5th Circuit had -- and at least 5 expressed skepticism that the FDA had truly changed its position.
No justices voiced support for the e-cigarette companies on the merits (of their PMTAs) -- as the 5th Circuit had -- and at least 5 expressed skepticism that the FDA had truly changed its position.
December 3, 2024 at 3:31 AM
This was the argument (from the FDA) that I expected, and it seems it's going to carry the day.
No justices voiced support for the e-cigarette companies on the merits (of their PMTAs) -- as the 5th Circuit had -- and at least 5 expressed skepticism that the FDA had truly changed its position.
No justices voiced support for the e-cigarette companies on the merits (of their PMTAs) -- as the 5th Circuit had -- and at least 5 expressed skepticism that the FDA had truly changed its position.
Interpet 2024 reúne estudantes da Ufam e do Ifam para debates sobre a inter-relação de saberes. x.gd/pmtas
October 8, 2024 at 5:41 PM
Interpet 2024 reúne estudantes da Ufam e do Ifam para debates sobre a inter-relação de saberes. x.gd/pmtas
Our take on the results:
Little reason to act against ZYN
Reason to speed up e-cig PMTAs
Good news for $PM and $BATS $BTI overall
Little reason to act against ZYN
Reason to speed up e-cig PMTAs
Good news for $PM and $BATS $BTI overall
September 5, 2024 at 6:56 PM
Our take on the results:
Little reason to act against ZYN
Reason to speed up e-cig PMTAs
Good news for $PM and $BATS $BTI overall
Little reason to act against ZYN
Reason to speed up e-cig PMTAs
Good news for $PM and $BATS $BTI overall