FDA
FDA launches NTN website for premarket review progress…
9th September 2022 - Alerts | North America, United States |
Court rulings focus on process, leaving the key question on vaping unaddressed
8th September 2022 - Blogs |
Another day, another judgement in the saga of the US vapour industry’s cases against the Food and Drug Administration (FDA) over its handling of the premarket tobacco product application (PMTA) process
Prohibition Juice fails with court claim that US FDA overstepped its authority
6th September 2022 - News analysis |
Prohibition Juice has failed in an attempt to get the US Food and Drug Administration (FDA)’s authority over vaping products curtailed
A ‘groundbreaking’ ruling as appeal court orders US FDA to reconsider PMTA denial
5th September 2022 - News analysis |
In a big win for the vaping industry, a federal appellate court has ordered the US Food and Drug Administration (FDA) to reconsider its denial of premarket tobacco product applications (PMTAs) for six companies
‘Thoughtful scientist’ Delnevo a popular choice to chair FDA advisory committee
1st September 2022 - News analysis |
Cristine Delnevo, the new chair of the US FDA’s Tobacco Products Scientific Advisory Committee (TPSAC), has been hailed as an “objective, thoughtful scientist” with an understanding of research into harm reduction
CTP issues new warnings over unauthorised e-liquid sales…
1st September 2022 - Alerts | North America, United States |
Gripum loses its bid to overturn FDA marketing denial…
31st August 2022 - Alerts | North America, United States |
US FDA warning on flavoured nicotine gummies brings out mixed responses
31st August 2022 - News analysis |
Vaping industry representatives have accused the US Food and Drug Administration (FDA) of “creating a fake panic” with a warning over illegal flavoured nicotine gummies
Appeals court orders FDA to reconsider marketing denial orders…
25th August 2022 - Alerts | North America, United States |
FDA e-liquid warnings cover ‘nicotine from any source’…
24th August 2022 - Alerts | United States |
FDA issues warning letter for flavoured nicotine gummies…
19th August 2022 - Alerts | North America, United States |
Will the ‘major questions doctrine’ be used in tobacco regulation in the US?
11th August 2022 - Regulatory reports , Topic regulatory reports |
This report will analyse if any of the upcoming tobacco-related regulations may be challenged under the major questions doctrine, including the menthol ban and the policy relating to nicotine levels
CTP initially intended to approve ‘a greater number’ of PMTAs…
11th August 2022 - Alerts | North America, United States |
Professor named chair of FDA tobacco science advisory committee…
10th August 2022 - Alerts | North America, United States |
FDA ‘working diligently’ to process PMTAs…
8th August 2022 - Alerts | North America, United States |
Campaign leader tells FDA to ‘enforce the law’ on synthetic nicotine…
5th August 2022 - Alerts | North America, United States |
How Triton’s PMTA hopes were dashed as appeal court sided 2-1 with US FDA
4th August 2022 - News analysis |
A potentially key but temporary legal win for a vaping company challenging the US Food and Drug Administration (FDA)’s PMTA review process has been transformed into a resounding loss
US FDA up against the ropes in fallout from PMTA denials and legal challenges
1st August 2022 - News analysis |
Uncertainty is mounting over the US Food and Drug Administration (FDA)’s premarket tobacco application (PMTA) process after the agency shifted its position on Juul Labs’ application, leading to searching questions
Altria suffers Juul troubles in first half of 2022 at ‘pivotal point’ in the industry
29th July 2022 - News analysis |
Altria is pessimistic about the future of Juul and its investment in the company but does not think the time has come to pull the plug just yet
CTP science chief quits to join PMI…
27th July 2022 - Alerts | North America, United States |
Independent review of US FDA’s tobacco centre met with scepticism from all sides
26th July 2022 - News analysis |
The vaping industry has little faith that the upcoming external review of the Center for Tobacco Products (CTP) will help fix faults in the US FDA department’s regulation of new tobacco and alternative products
CTP issues more warning letters over unauthorised e-liquids…
25th July 2022 - Alerts | North America, United States |
JWEI announces PMTA submission…
21st July 2022 - Alerts | North America, United States |
FDA chief puts CTP under external review…
20th July 2022 - Alerts | North America, United States |
Court rejects Fontem plea to keep selling Myblu until MDO case resolved…
20th July 2022 - Alerts | North America, United States |
US appeal court denies plea for Myblu to remain on sale during MDO challenge
20th July 2022 - News analysis |
Myblu vaping products will not be allowed to be sold in the US market while a court reviews a marketing denial order (MDO)
FDA chief Califf orders external review of ‘stressed’ Center for Tobacco Products
20th July 2022 - News analysis |
US Food and Drug Administration (FDA) commissioner Robert Califf has authorised an external review of the Center for Tobacco Products (CTP), citing a “series of challenges that have…stressed the agency’s operations”
Do Pop and Bidi Vapor cases indicate how judges are likely to view MDO appeals?
19th July 2022 - News analysis |
Arguments in a US appeal court could demonstrate how judges are likely to perceive arguments from vaping companies contesting US Food and Drug Administration (FDA) decisions on pre-market tobacco applications (PMTAs)
Flavoured e-liquid makers denied a review of marketing denial…
19th July 2022 - Alerts | North America, United States |
US FDA wastes no time issuing first warning letters on synthetic nicotine
15th July 2022 - News analysis |
The US Food and Drug Administration (FDA) took immediate action against unauthorised vaping products made with synthetic nicotine still found on the US market after the grace period expired
FDA issues warning letters about synthetic nicotine…
14th July 2022 - Alerts | North America, United States |
Truth Initiative wants FDA to stand by decision on Juul…
8th July 2022 - Alerts | North America, United States |
We know the UK is vape-friendly – but can Khan influence the rest of the world?
7th July 2022 - Blogs |
Could the UK’s Khan review of tobacco policy have lessons for the rest of the world in its enthusiastic endorsement of vaping, even for countries where there is far more hostility toward novel tobacco products?
US FDA holds off on shutting down Juul sales to review ‘unique scientific issues’
6th July 2022 - News analysis |
The US Food and Drug Administration (FDA) has temporarily suspended the marketing denial order (MDO) it served on Juul Labs last month demanding the company remove its e-cigarettes from the US market
US FDA appeals against court ruling that Myblu can remain on sale pending review
30th June 2022 - News analysis |
The US Food and Drug Administration (FDA) has hit back at a court-issued stay allowing Fontem’s Myblu vaping products to continue to be legally sold in the US
FDA brief opposes stay allowing legal sales of Myblu…
30th June 2022 - Alerts | North America, United States |
Court grants Juul temporary halt to ‘extraordinary and unlawful’ ban
27th June 2022 - News analysis |
Juul Labs has been granted a temporary administrative stay while it asks a federal appeal court to halt the Food and Drug Administration (FDA)’s order requiring the removal of all Juul products from the US market
Juul will contest FDA order to remove all its vaping products from the US market
23rd June 2022 - News analysis |
Juul Labs says it will contest a marketing denial order (MDO) issued by the US Food and Drug Administration (FDA), effectively ordering all its products off the US market
Njoy wins some, loses some in Daily PMTA verdict…
13th June 2022 - Alerts | North America, United States |
US FDA hands Njoy a Daily PMTA boost – but it’s strictly tobacco flavours only
13th June 2022 - News analysis |
The US Food and Drug Administration (FDA) has passed its first premarket tobacco product application (PMTA) for a disposable e-cigarette, authorising two tobacco flavours of Njoy Daily
FDA announces launch of new e-cig prevention campaign…
9th June 2022 - Alerts | North America, United States |
FDA issues more warning letters…
8th June 2022 - Alerts | North America, United States |
FDA under fire after admitting another year’s PMTA delay…
25th May 2022 - Alerts | North America, United States |
FDA issues more warnings over unauthorised e-liquids…
25th May 2022 - Alerts | North America, United States |
US FDA under fire after it forecasts work until June 2023 on final PMTA reviews
25th May 2022 - News analysis |
The US Food and Drug Administration (FDA)’s first court-ordered update on the premarket tobacco product application (PMTA) progress has not gone down well with health lobbyists or a group of senior US senators
New man at the helm of tobacco control…
24th May 2022 - Alerts | North America, United States |
King’s appointment to head CTP rings alarm bells in US e-cigarette industry
24th May 2022 - News analysis |
The US Food and Drug Administration (FDA) has appointed epidemiologist Brian King as director of the Center for Tobacco Products (CTP) – an appointment that has not gone down well with the US vaping industry
FDA issues new warning letters…
19th May 2022 - Alerts | North America, United States |
Reynolds sees further PMTA success with six new product authorisations
13th May 2022 - News analysis |
RJ Reynolds has received a second round of authorisations for devices and cartridges from the US Food and Drug Administration (FDA) for its Vuse vaping brand