You searched for (PMTA) - ECigIntelligence

Registration now open for meeting on PMTA processes…

Written by EcigIntelligence | 22nd September 2023

E-cigarette companies’ court actions against the US FDA: key arguments and decisions

Written by Berta Camps Bisbal | 20th September 2023

This report tracks and analyses the challenges brought to court by vape companies of their Marketing Denial Orders (MDO) of their premarket tobacco product applications (PMTA) ...

FDA launches new resources to help with PMTAs…

Written by EcigIntelligence | 8th September 2023

US FDA under scrutiny: the latest reports on PMTA progress

Written by Berta Camps Bisbal | 6th September 2023

This report discusses the background to this court decision requiring the FDA to submit status updates of the PMTA review, examines the timeline of these updates and provides analysis of...

US and UK studies search for reasons behind youth uptake of disposables

Written by ECigIntelligence | 15th August 2023

Youth preference for disposable vaping devices in the UK and the US could be driven by a combination of factors including price, style, packaging and flavour ...

Experts raise questions on Juul’s chances with its next-generation vapour system

Written by Antonia Di Lorenzo | 7th August 2023

Success for Juul with its premarket tobacco product application for its Juul2 next-generation vapour platform could lead to a complete reset of minimum youth prevention standards in the US, experts...

No place to Hyde as New York City goes to court in bid to stamp out flavoured vapes

Written by ECigIntelligence | 1st August 2023

New York City is taking legal action to stop four companies from selling flavoured e-cigarettes, accusing them of violating “nearly every law” related to the marketing, distribution and sale of...

BAT records ‘resilient’ H1 performance, remains confident about Vuse Alto PMTA

Written by Antonia Di Lorenzo | 28th July 2023

British American Tobacco (BAT)’s vapour brand Vuse was the key driver of the company’s positive performance in the first half of the year. The company also said it remains confident...

Juul submits the first PMTA for its next-generation vapour platform

Written by Antonia Di Lorenzo | 24th July 2023

Juul Labs has submitted a premarket tobacco product application (PMTA) for the company’s next-generation vapour platform to the US Food and Drug Administration (FDA) ...

Juul submits PMTA for its next-generation vape…

Written by EcigIntelligence | 20th July 2023

The most important upcoming elections – what do they mean for the industry?

Written by Pablo Cano Trilla | 19th July 2023

This report provides analysis of some of the findings from our Policy Radar, examining four countries on the brink of elections and exploring how the outcome will affect the tobacco...

Regulatory landscape of disposable e-cigarettes in the US – the new loophole?

Written by Berta Camps Bisbal | 11th July 2023

This report tackles questions about US federal regulation of disposable e-cigarettes, examines the regulatory loophole question, and looks into pressure from the public ...

What’s in a name? Another round begins in the fight for the right to be called Elf

Written by ECigIntelligence | 6th July 2023

In the latest twist in a bitter legal trademark battle between rival e-cigarette firms, the makers of Elf Bar disposable vapes are fighting the court order that prompted them to...

US FDA CTP takes ‘data-driven approach’ in response to Reagan-Udall report

Written by Freddie Dawson | 3rd July 2023

The US Food and Drug Administration Center for Tobacco Products has published milestones to expect as it continues to address issues brought up by the Reagan-Udall Foundation’s recent report ...

Can vaping legal framework be built on more than just slipshod bills, please?

Written by Freddie Dawson | 15th June 2023

It’s surprising the loopholes lawmakers can miss when writing, debating and passing bills. Or is it? With allegations that politicians don’t even read bills they vote on and of proposals...

NACS reiterates plea to FDA for a public list of legal e-cig products…

Written by EcigIntelligence | 6th June 2023

FDA plays Hyde and go seek in latest move against retail of disposables

Written by Freddie Dawson | 1st June 2023

Action against disposable e-cigarettes continues in the US, with the Food and Drug Administration (FDA) issuing warning letters to 30 retailers over sales of the popular Puff and Hyde brands...

The US FDA’s PMTA internal review process – a de facto ban on flavours?

Written by Berta Camps Bisbal | 19th May 2023

This report analyses an apparently change in the FDA's review process for PMTAs, and discusses a number of individual cases where companies have raised it following the issuing of an...

PMI ends interest in US vaping market, outsources manufacturing elsewhere

Written by Freddie Dawson | 28th April 2023

Philip Morris International will scale back and partially outsource its vaping business, instead focusing on other tobacco alternatives that can help it become a majority smoke-free revenue company by 2025...

US FDA proposed rule: requirements for tobacco product manufacturing practice

Written by Berta Camps Bisbal | 14th April 2023

This report examines the US Food and Drug Administration proposed rule that would establish a unified regulatory framework for tobacco product manufacturing practice requirements ...

The sale of e-cigarettes in duty-free stores in the US

Written by Kristina Iashina | 31st March 2023

This report examines the federal and general state requirements (though it does not analyse specific individual state requirements) that e-cigarette manufacturers need to comply with before selling their products in...

US FDA refuses 17m products for lack of environmental assessment with PMTA

Written by Antonia Di Lorenzo | 24th March 2023

The US Food and Drug Administration (FDA) has refused marketing authorisation for around 17m e-liquid products because the company behind the application did not provide the required environmental assessments ...

Altria cuts its losses on Juul, accepting a 98% collapse in its $12.8bn investment

Written by Antonia Di Lorenzo | 6th March 2023

Altria has swapped its 35% stake in Juul Labs for heated tobacco intellectual property rights, ending an investment which plummeted in value from $12.8bn to only $250m in just over...

Tobacco giant Altria ‘in $2.75bn bid to buy Njoy’ while preparing to pull out of Juul

Written by Antonia Di Lorenzo | 28th February 2023

Altria is reported to be in advanced talks to buy e-cigarette company Njoy for around $2.75bn and plans to divest its stake in Juul Labs. Nothing has been finalised, but...

US vape store survey 2022 – pessimism, PMTAs and product diversification

Written by Kate Havenga | 27th February 2023

ECigIntelligence’s annual survey of US vape stores finds a boost in monthly revenue; increases in product category diversification, disposables stocks and cannabis-derived products; and concerns over FDA requirements and other...

Mission Impossible? It’s sure to be tough at the top for new CTP science chief

Written by Antonia Di Lorenzo | 22nd February 2023

Matthew Farrelly will have a lot on his desk, and a lot of big calls to make, as the new director of the Office of Science at the US Food...

Importation and exportation of e-cigarettes in the US

Written by Kristina Iashina | 20th February 2023

This report provides a comprehensive summary of the import and export regulations in place for e-cigarette products in the US ...

BAT sees big growth across all three new categories, led by Vuse showing in US

Written by Antonia Di Lorenzo | 9th February 2023

British American Tobacco (BAT) enjoyed a 37% rise last year in revenues from novel products, with growing contributions across all three of its new categories, led by its vapour brand...

Nothing certain except flavour bans and taxes – that was the e-cig year that was

Written by Antonia Di Lorenzo | 30th December 2022

Bans on flavours and taxes on vaping products dominated the e-cigarette news agenda in 2022. Both could be seen as responses to still rising concern about youth vaping ...

Independent review of US FDA CTP recommendations sent…

Written by EcigIntelligence | 20th December 2022

PMTA, MRTP and SE: the main pathways to market for tobacco products in the US

Written by Berta Camps Bisbal | 22nd November 2022

This report examines the main pathways for tobacco products to enter the market in the US, covering PMTAs, MRTPs and SEs ...

Juul posts full details of its appeal against FDA MDO…

Written by EcigIntelligence | 25th October 2022

FDA warnings target smaller companies and leave the big boys alone, study finds

Written by Antonia Di Lorenzo | 20th October 2022

A recent study has revealed that the warning letters issued by the US Food and Drug Administration (FDA) target small online retailers rather than large e-cigarette brands or products most...

Triton requests rehearing before more judges over denied appeal against MDO

Written by ECigIntelligence | 17th October 2022

Disagreement among the judges who denied an appeal against a marketing denial order (MDO) issued by the US Food and Drug Administration (FDA) against Triton vaping products has allowed the...

Disposables to the fore as nearly one in ten US teens report as current vapers

Written by Antonia Di Lorenzo | 11th October 2022

Youth vaping remains high in the US, with 9.4% middle- and high-school students – around 2.5m teenagers – reporting current e-cigarette use, though changes in survey methods make it difficult...

New York: e-cigarette regulation, September 2022

Written by Berta Camps Bisbal | 27th September 2022

This report provides a detailed overview of the current regulatory framework in New York for e-cigarettes and related products, as well as possible future changes to the regime ...

Juul’s new suit against US FDA seeks materials withheld in suspended MDO

Written by ECigIntelligence | 23rd September 2022

Juul Labs is asking a judge to order the US Food and Drug Administration (FDA) to release information related to its now-vacated denial of the company’s premarket tobacco application (PMTA),...

Defeat for Gripum as US appeal court backs FDA’s marketing denial order

Written by ECigIntelligence | 13th September 2022

The early legal success of the vaping company Gripum against the US Food and Drug Administration (FDA) over its marketing denial order (MDO) has given way to a major defeat...

Court rulings focus on process, leaving the key question on vaping unaddressed

Written by Barnaby Page | 8th September 2022

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)...

Gripum loses its bid to overturn FDA marketing denial…

Written by EcigIntelligence | 31st August 2022

Why did Hawaii’s Democratic governor veto a bill to ban e-cigarette flavours?

Written by ECigIntelligence | 23rd August 2022

The Democratic governor of Hawaii appeared to take a step out of line with the US party’s common position when he vetoed a bill that would have introduced a ban...

Turning Point lowers its expectations in face of hostile US regulatory picture

Written by Antonia Di Lorenzo | 3rd August 2022

Turning Point Brands has blamed the hostile regulatory environment for vapour products in the US for the lowering of its sales and revenue expectations for 2022 ...

US FDA up against the ropes in fallout from PMTA denials and legal challenges

Written by ECigIntelligence | 1st August 2022

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...

Vuse uptake, PMTAs and innovation drive BAT’s new categories revenue up 45%

Written by Antonia Di Lorenzo | 28th July 2022

British American Tobacco (BAT) enjoyed a 45% rise in revenue from its new products category in the first half of the year, with strong momentum shown by its Vuse e-cigarette...

Independent review of US FDA’s tobacco centre met with scepticism from all sides

Written by Tiziana Cauli | 26th July 2022

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...

JWEI announces PMTA submission…

Written by EcigIntelligence | 21st July 2022

US appeal court denies plea for Myblu to remain on sale during MDO challenge

Written by ECigIntelligence | 20th July 2022

Myblu vaping products will not be allowed to be sold in the US market while a court reviews a marketing denial order (MDO) ...

US FDA wastes no time issuing first warning letters on synthetic nicotine

Written by Tiziana Cauli | 15th July 2022

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 under fire over synthetic nicotine uncertainty…

Written by EcigIntelligence | 13th July 2022

Last day for synthetic nicotine sales without a PMTA…

Written by EcigIntelligence | 12th July 2022

We know the UK is vape-friendly – but can Khan influence the rest of the world?

Written by Barnaby Page | 7th July 2022

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...

US FDA holds off on shutting down Juul sales to review ‘unique scientific issues’

Written by Antonia Di Lorenzo | 6th July 2022

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...

Court grants Juul temporary halt to ‘extraordinary and unlawful’ ban

Written by ECigIntelligence | 27th June 2022

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 will contest FDA order to remove all its vaping products from the US market

Written by Antonia Di Lorenzo | 23rd June 2022

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 ...

US FDA hands Njoy a Daily PMTA boost – but it’s strictly tobacco flavours only

Written by Antonia Di Lorenzo | 13th June 2022

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 ...

US FDA under fire after it forecasts work until June 2023 on final PMTA reviews

Written by ECigIntelligence | 25th May 2022

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...

Reynolds sees further PMTA success with six new product authorisations

Written by Freddie Dawson | 13th May 2022

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 ...

FDA authorises six new tobacco products…

Written by EcigIntelligence | 13th May 2022

Will FDA meet triumph or disaster over menthol – and how will it affect e-cigs?

Written by Barnaby Page | 9th May 2022

What are the implications of the FDA’s menthol plan for novel nicotine products such as e-cigarettes and heated tobacco? ...

It’s a yes from the FDA: Njoy granted PMTA for nicotine salts pod system

Written by Antonia Di Lorenzo | 27th April 2022

A modern pod system using nicotine salts from a non–Big Tobacco company has been authorised by the US Food and Drug Administration (FDA) through the premarket tobacco product application (PMTA)...

US regulatory report: synthetic nicotine products – what’s next?

Written by Berta Camps Bisbal | 27th April 2022

The new US federal legislation has brought synthetic nicotine products under the oversight of the FDA, so all synthetic nicotine products must go through a premarket tobacco product application (PMTA)...

Smoore puts faith in new testing lab to meet Chinese and export standards

Written by ECigIntelligence | 26th April 2022

Chinese e-cigarette company Smoore has opened what it is calling the vaping industry’s first laboratory to test for extractable and leachable (E&L) substances ...

Judge orders FDA to give quarterly reports on PMTA progress…

Written by EcigIntelligence | 19th April 2022

Los Angeles and San Francisco: flavour regulation in metropolitan areas, April 2022

Written by Kristina Iashina | 12th April 2022

This report will examine flavour restrictions in the San Francisco Bay Area and Greater Los Angeles, though it will also take into account wherever there is a total ban, since...

Durbin urges FDA to conclude PMTA review…

Written by EcigIntelligence | 6th April 2022

Synthetic and ‘natural’ nicotine – the real difference is just a matter of bureaucracy

Written by ECigIntelligence | 31st March 2022

While synthetic nicotine has become the focus of much controversy, demonised as a public health risk, its currently poor reputation derives more from bureaucracy than from the substance itself ...

US vape companies braced for the worst after rule change on synthetic nicotine

Written by Antonia Di Lorenzo | 22nd March 2022

Experts fear the decision to treat synthetic nicotine the same as tobacco products could devastate parts of the US vaping industry that have come to rely on it, with some...

US Congress passes omnibus bill, putting synthetic nicotine under FDA jurisdiction

Written by ECigIntelligence | 14th March 2022

Synthetic nicotine vaping products will likely require the same authorisations as those made with tobacco-derived nicotine – leading to a massive shake-up of the US vaping market – after Congress...

Turning Point blames US regulation for drop in vapour product sales and profit

Written by Antonia Di Lorenzo | 1st March 2022

The legal challenges faced by the vaping industry in the US impacted Turning Point Brands’ vapour portfolio in 2021, with a significant drop in the last quarter’s net sales and...

US vape store survey 2021 – revenues and confidence on the rise

Written by Tim Phillips | 22nd February 2022

ECigIntelligence's annual survey of US vape stores finds an increase in stores' revenues, greater confidence among store owners and customers, and a change in the range of products offered ...

US menthol cigarette ban is imminent – so what does that mean for e-cigs?

Written by ECigIntelligence | 17th February 2022

Flavours for other tobacco products will almost certainly become the major topic once a US ban on menthol cigarettes and flavoured cigars goes through ...

PMI sees bright future for Iqos Veev as it prepares to expand into more markets

Written by ECigIntelligence | 14th February 2022

Philip Morris International (PMI) has commited to continuing to support the sales and promotion of its Veev vaping product, with future expansion into more markets around the world ...

Where do we go from here? How new rules will affect world vape markets

Written by Freddie Dawson | 31st January 2022

Consumers will continue to increasingly spread usage out over different alternative nicotine products, partly driven by further, stricter vaping regulation across the globe throughout 2022, ECigIntelligence predicts ...

ECigIntelligence’s 2021 predictions reviewed: did our crystal ball work?

Written by Antonia Di Lorenzo | 27th January 2022

We look back at predictions ECigIntelligence published at the start of 2021. Real events and developments confirmed ECigIntelligence’s analysis in many cases, though Covid delayed things ...

Imperial remains bullish despite drop in revenue from next generation products

Written by David Palacios Rubio | 16th November 2021

Imperial Brands registered a dip in revenues from its next generation products (NGP) portfolio but said it looks forward to expanding product trials in new countries and consolidating European and...

Appeals court grants another company a stay of US FDA’s marketing denial order

Written by ECigIntelligence | 11th November 2021

A US court has granted another stay request to a company that sued the US Food and Drug Administration (FDA) after the agency issued a marketing denial order (MDO) for...

Manufacturer sues FDA for ‘irreparable harm’ despite PMTA reconsideration

Written by ECigIntelligence | 3rd November 2021

Florida-based e-cigarette manufacturer Bidi Vapor has taken the US FDA to court claiming “continued irreparable harm” from being given a marketing denial order (MDO) for its vaping products ...

Court allows firm to continue e-cig sales after ‘inadequate’ FDA denial order

Written by David Palacios Rubio | 29th October 2021

The US Court of Appeals for the Fifth Circuit concluded that the FDA “inadequately addressed or explained” a PMTA that resulted in a MDO, and decided to temporary allow a...

PMI on track to submit PMTA to market its new Iqos vapour device in the US

Written by ECigIntelligence | 21st October 2021

PMI is planning to submit a premarket tobacco product application (PMTA) to the US Food and Drug Administration (FDA) in the second half of next year for its new e-vapour...

A hammer to crack a nut: what the PMTA process reveals about US FDA approach

Written by Barnaby Page | 7th October 2021

Some light is now dawning on some truths long since suspected about the US Food and Drug Administration (FDA)’s evaluation of e-cigarettes ...

Regulatory report: US state-by-state regulation of CBD vaping products

Written by Anthony Traurig | 7th September 2021

This report from our sister site CBD-Intel covers, state by state, the question of whether each US state allows the sale of hemp-derived CBD vaping products and on what legal...

Disposables see heightened growth across four large vape markets

Written by Jose Gomez Luengo | 12th August 2021

Our trackers suggest that the overall disposables market has experienced strong growth since the beginning of the tracking period since 2019 ...

Market report: the growth of disposables – comparing US, UK, Russia and Canada

Written by Jose Gomez Luengo | 9th August 2021

This report provides insights and comparisons into the disposables e-cigarette segment in Canada, Russia, UK and the...

Juul in jeopardy? That’s how the press is billing the FDA’s upcoming PMTA verdict

Written by Aidan Semmens | 15th July 2021

The US press are calling it a “fight for survival” for the e-cigarette giant – but as one experts says, “The FDA has to evaluate this in a forward-looking way...

Imperial reaps significant benefit from its fresh approach to the vapour segment

Written by ECigIntelligence | 18th May 2021

Imperial Brands’ earnings for the first half of the year have jumped 6.1% to £15.57bn in the midst of a process to implement a new company strategy towards tobacco alternatives...

Covid-19: emergency regulations and affected legislative procedures

Written by ECigIntelligence | 16th April 2021

Find all of ECigIntelligence’s coronavirus-related regulatory alerts here, updated as they appear ...

Vape companies ask US Supreme Court to rule FDA deeming regulations invalid

Written by David Palacios Rubio | 8th April 2021

A group of eight vaping companies are escalating their legal fight against the US Food and Drug Administration (FDA)’s oversight of e-cigarette products, and in particular the premarket approval (PMTA)...

US representatives urge FDA to ban flavoured e-cigs and deny Juul PMTA

Written by ECigIntelligence | 29th March 2021

A group of 40 House Democrats have written to the US Food and Drug Administration (FDA) pressing it to remove from the market all flavoured e-cigarettes “fueling youth tobacco epidemic”...

FDA warning letters are the final straw for some as US businesses close

Written by ECigIntelligence | 15th February 2021

Vaping companies across the US are under pressure, with some going out of business and others saying they face a struggle to survive, as the Food and Drug Administration (FDA)...

Political changes in the US: the likely legal impact in 19 key states

Written by Berta Camps Bisbal | 10th February 2021

Our special report examines the potential impact of the recent political changes in the United States on e-cigarette legislation this year, with an in-depth look at 19 states, including those...

2020: the year of flavour bans, Juul cases, taxation, China – and that other thing

Written by Aidan Semmens | 30th December 2020

Who isn’t glad to see the back of 2020? ECigIntelligence looks back on what a generally cataclysmic year has meant for the world of e-cigarettes, from flavour bans to taxation,...

Market report: market and vaping product trends in the US

Written by Carlo Infurna | 9th December 2020

The US vaping market has recently experienced inputs and changes which are shaping new trends and transforming a market that generally is a bellwether for the rest of the sector...

Who will Biden pick for the top health jobs crucial to US e-cig regulation?

Written by ECigIntelligence | 30th November 2020

US president-elect Joe Biden has yet to name his candidates to lead the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), roles that will...

US vape stores survey, 2020 – impact analysis and outlook

Written by Eva Antal | 26th November 2020

ECigIntelligence has conducted a survey of US vape stores each year since 2016; here we present the findings of our 2020 survey in detail, including an analysis of how EVALI...

How will the US elections shape the future of the vaping industry?

Written by ECigIntelligence | 29th October 2020

Just a few days ahead of US elections, there is a lot of uncertainty about the approach that the next White House leader will have towards the tobacco-alternatives industry ...

Concerned US vape stores diversify in response to FDA’s PMTA regulation

Written by Lorraine Mullaney | 22nd September 2020

US vape stores are diversifying into CBD and oral nicotine, while others fear being blamed by customers for reduced choice as FDA premarket tobacco product regulations cause products to disappear...

Florida’s governor bucks the US trend by vetoing state ban on vape flavours

Written by ECigIntelligence | 15th September 2020

Florida governor Ron DeSantis has bucked a US national trend by vetoing regulations that would have banned flavoured vaping products in the state ...

As PMTA deadline passes, is it the point of no return for vaping in the US?

Written by Aidan Semmens | 11th September 2020

Is this week’s PMTA deadline the beginning of the end for the US vaping industry? No – but it’s probably the end of the beginning ...

Vape stores and PMTA – what’s coming next? ECigIntelligence US survey 2020

Written by Eva Antal | 9th September 2020

How many US vape stores have submitted PMTAs to the FDA – and what plans do they have for facing the post-PMTA future? ECigIntelligence presents the preliminary results of its...

US vape industry seeks PMTA deadline extension to 2021 for small businesses

Written by David Palacios Rubio | 25th August 2020

A group of manufacturers and vaping associations in the US have asked the FDA for a six-month extension to the premarket tobacco product application (PMTA) deadline for small companies ...

Juul submits 125,000-page PMTA application to the US FDA

Written by David Palacios Rubio | 31st July 2020

Juul has submitted a 125,000-page premarket tobacco product application (PMTA) to the US Food and Drug Administration (FDA) to continue selling its tobacco and menthol pods in the country ...

US representatives ask FDA to publish a list of vaping PMTA submissions

Written by ECigIntelligence | 10th June 2020

Members of the US Congress have asked the Food and Drug Administration (FDA) to produce “a public list” of vaping products for which premarket tobacco product applications (PMTA) have...

Altria takes Reynolds to court over alleged Vuse patent infringement

Written by ECigIntelligence | 5th June 2020

The Altria Group have filed a lawsuit for patent infringement against R. J. Reynolds Vapor Co., a subsidiary of Reynolds American Inc., over some of its Vuse e-cigarette products ...

Consumer survey: US flavour report

Written by Eva Antal | 23rd April 2020

This report, the first of a series of studies of current topics in the vaping world, looks at flavour preferences of open system users and what consumers will do if...

Cautious relief after US court grants four-month PMTA deadline extension

Written by ECigIntelligence | 7th April 2020

Vape businesses have generally welcomed a court’s decision to grant a four-month extension to the premarket tobacco product application (PMTA) deadline – but there are reservations ...

Juul suspends all sales in Indonesia, faces probe by coalition of US states

Written by David Palacios Rubio | 27th February 2020

Less than a year after launching in the country, Juul Labs is stopping selling all its products in Indonesia while it puts new measures in place to combat under-age purchases....

Trump plans to take e-cigarette and tobacco regulation out of FDA hands

Written by ECigIntelligence | 13th February 2020

The US Food and Drug Administration (FDA) is to lose its power to regulate tobacco and e-cigarette products if Congress passes president Donald Trump’s porposed budget for fiscal year 2021...

44% rise in HnB shipments drives a year of smoke-free growth for PMI

Written by ECigIntelligence | 6th February 2020

PMI saw its market share of heated tobacco units in IQOS markets, excluding the US, rise by 1.4 percentage points to 5% last year, with a 44.2% increase in HnB...

Q&A: US FDA enforcement on certain flavoured e-liquid products

Written by Berta Camps Bisbal | 3rd February 2020

The US FDA has recently implemented enforcement on (some) flavoured-e-liquid products, but what does this actually mean? This report provides answers to some of the important questions ...

Altria investment value in Juul drops by 65% in a year

Written by David Palacios Rubio | 31st January 2020

The investment value of Altria in e-cig company Juul fell by 65% in almost a year due to the recent developments in the US affecting the brand ...

FDA’s new clampdown on flavoured cartridges fails to satisfy either side

Written by David Palacios Rubio | 6th January 2020

The US FDA’s new policy of removing most e-cigarette cartridge flavours from the market has been greeted by scepticism and criticism from both the vaping industry and anti-tobacco groups ...

Good riddance to 2019 – vaping’s year of living even more dangerously

Written by ECigIntelligence | 30th December 2019

“The year just gone has been an intense one for the vaping industry – and don’t expect 2019 to be any less so.” So we said a year ago. We...

Vaping restrictions in and around Los Angeles and San Francisco metros

Written by Pablo Cano Trilla | 23rd December 2019

This report focuses on two of California's biggest cities – Los Angeles and San Francisco – and their vaping prohibitions and flavour bans. Local governments have decided to react to...

How Swedish Match snus finally got its FDA modified risk approval

Written by ECigIntelligence | 17th December 2019

How did Swedish Match USA manage to get eight General snus products approved by the US FDA as modified risk tobacco products after being previously unsuccessful? ...

PMTA raises concerns for business owners

Written by ECigIntelligence | 27th November 2019

ECigIntelligence’s 2019 survey of US vape stores highlights the ways in which store owners in the US expect the premarket tobacco product application (PMTA) process, laid down by the Food...

Proposed PMTA rule on labelling and marketing: FAQ

Written by ECigIntelligence | 18th November 2019

This report answers some of the questions a manufacturer may be asking in relation to the position of the proposed rule with regards to labelling and marketing ...

Global tobacco harm reduction policies: selected country overview

Written by ECigIntelligence | 11th November 2019

This report provides an overview of harm-reduction policies with regards to tobacco use from 18 selected countries from around the world ...

ECigIntelligence US vape store survey 2019 – the main findings

Written by ECigIntelligence | 5th November 2019

The 2019 ECigIntelligence survey of US vape stores explores the sector’s early reactions to the bringing forward of the PMTA deadline to May 2020, and what they expect to do...

In depth: the US FDA’s new PMTA rules

Written by ECigIntelligence | 5th November 2019

The US FDA's new proposed rule for PMTAs provides details of how to structure the application as well as what to include. This report looks at this rule in detail...

Los Angeles city council to consider e-cig ban ‘until FDA approval’

Written by ECigIntelligence | 24th October 2019

A motion from a Los Angeles councilmember is requesting the city attorney to prohibit the sale of all e-cigarettes and vaping devices in LA until they are approved by the...

Reynolds American files 150,000-page PMTA submission for Vuse

Written by ECigIntelligence | 15th October 2019

Reynolds American has submitted a premarket tobacco product application (PMTA) to the Food and Drug Administration (FDA) for authorisation to continue marketing Vuse e-cigarettes in the US ...

US industry alarmed for the vaping future; lung cases rise to over 800

Written by ECigIntelligence | 27th September 2019

While the CDC has raised the number of suspected lung disease cases to 805, key industry figures admit that vaping in the US is at a crossroads – and the...

Sharpless: ‘PMTA policy doesn’t mean flavoured e-cigs can never be sold’

Written by ECigIntelligence | 26th September 2019

Acting US FDA commissioner Ned Sharpless told a House hearing there would be no blanket e-cigarette flavour ban in response to the country’s outbreak of lung illness ...

BAT revenue rises; e-cigs and heated tobacco offset drop in cigarette sales

Written by ECigIntelligence | 1st August 2019

British American Tobacco’s (BAT) net revenue rose 4.6% in the first half of 2019, driven by growing demand for next-generation products such as e-cigarettes and heated...

San Francisco confirms city-wide ban on selling or manufacturing e-cigs

Written by ECigIntelligence | 26th June 2019

San Francisco has become officially the first major city in the US to ban the sale, distribution or manufacture of e-cigarettes ...

PMI moves on Bristol with four new IQOS stores opening this summer

Written by ECigIntelligence | 26th June 2019

Philip Morris International (PMI) is to expand its British heated tobacco presence with the opening of four new IQOS stores in Bristol this summer ...

US FDA proposes bringing PMTA deadline significantly forward

Written by David Palacios Rubio | 14th June 2019

The US FDA has suggested that the deadline for the submission of premarket tobacco product (PMTA) applications could be significantly advanced ...

So IQOS has PMTA approval – but what does that mean in practice?

Written by Pablo Cano Trilla | 23rd May 2019

PMI’s heated tobacco device IQOS and its associated consumables have been granted market authorisation by the FDA – here are the details ...

Federal judge tells FDA to hurry up, while North Carolina sues Juul

Written by David Palacios Rubio | 16th May 2019

A federal judge has ordered the US FDA to accelerate its reviewing of e-cigarettes currently on the market. Meanwhile, North Carolina’s attorney general is taking Juul to court ...

IQOS reaction: ‘Approval works for PMI, but what about the little guy?’

Written by Daniel Mollenkamp | 2nd May 2019

There have been mixed reactions from within the industry to the FDA decision to allow PMI’s heated-tobacco device IQOS and its associated consumables onto the US market ...

FDA gives the green light for IQOS roll-out onto the US market

Written by Daniel Mollenkamp | 30th April 2019

The US FDA has given its approval for Philip Morris International (PMI)’s IQOS in the US, along with its associated consumables ― the first heated-tobacco products to be so approved...

FDA budgets for $100m in user fees for CTP to keep up pressure on vaping

Written by David Palacios Rubio | 2nd April 2019

The US Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) budget for financial year 2020 has been set at $747m, a significant increase on this year’s figure of...

FDA and the US vapour industry watching each other’s moves closely

Written by ECigIntelligence | 25th March 2019

With an interim commissioner set to take over, the US FDA remains highly focused on the e-cigarette industry – while the industry itself is no doubt watching developments at the...

‘FDA flavour restrictions could devastate industry’, trade body warns

Written by ECigIntelligence | 15th March 2019

As much as 90% of the US e-cigarette market could be forced out of business by the FDA’s restrictions on flavours in e-liquids, according to an industry insider ...

FDA demands early PMTAs for flavoured e-cigs, sets limits on retail

Written by Daniel Mollenkamp | 13th March 2019

The US FDA has spelled out details of its planned crackdown on flavoured e-cigarettes, including retail restrictions and an earlier PMTA deadline for most flavoured...

Under grilling, Gottlieb tells House subcommittee e-cigs are a top priority

Written by ECigIntelligence | 28th February 2019

FDA commissioner Scott Gottlieb was peppered with questions about vaping during a House appropriations subcommittee hearing on the status of operations at the FDA ...

Gottlieb hints at harsh action ahead in the battle against youth vaping

Written by ECigIntelligence | 12th February 2019

The US vaping industry is waiting for the Food and Drug Administration (FDA) to offer guidance on how it plans to tackle e-cigarette usage by children. It may not like...

US FDA committee approves snuff reduced-risk claim

Written by Barnaby Page | 8th February 2019

A science committee at the FDA has approved a reduced-risk claim for snuff, a decision which may raise hopes that the agency is willing to accept some tobacco products as...

Q&A on the FDA’s flavour ban announcement

Written by Berta Camps Bisbal | 21st December 2018

US FDA commissioner Scott Gottlieb issued a statement in November outlining the agency’s new policy to prevent youth accessing flavoured tobacco products – but what did it really mean, and...

Mission accomplished: Altria confirms its $12.8bn investment in Juul

Written by David Palacios Rubio | 20th December 2018

The rumours have been confirmed: Altria is investing $12.8bn for a 35% percent stake in the Californian start-up Juul Labs, the company has announced ...

Altria to stop selling pods and many flavours in US

Written by Daniel Mollenkamp | 26th October 2018

Tobacco company Altria has told the US Food and Drug Administration (FDA) that it will stop selling e-cigarette pods and most non-tobacco flavours in the...

News analysis

FDA gets tough with big five: ‘Show us a plan to reverse youth uptake or else’

Written by Daniel Mollenkamp | 12th September 2018

The US Food and Drug Administration is threatening five major players in the US industry – Juul, Vuse, MarkTen XL, Blu and Logic – in an effort to get them...

ECigIntelligence brings you the latest from around the vaping world

Written by ECigIntelligence | 12th September 2018

Recent stories and reports brought to you by ECigIntelligence as summed up in last week's CEO Newsletter ...

It looks like the end of the road for Cole-Bishop grandfather reform

Written by ECigIntelligence | 16th August 2018

Appetite for changing US FDA e-cigarette regulations through congressional action may have dried up, with accusations that in its latest version the much-hoped-for Cole-Bishop amendment had been “turned into an...

Why BAT could get two HnB devices to the US market before IQOS

Written by Daniel Mollenkamp | 1st August 2018

British American Tobacco (BAT) may get two heated-tobacco products onto the US market before IQOS can be launched there, thanks to its decision to take a different route to FDA...

CBD as an ingredient in e-liquids: EU regulatory report

Written by Pablo Cano Trilla | 9th May 2018

What laws regulate the use of cannabidiol (CBD) in e-liquids across the European Union – and what regulatory regime is likely to apply in the future? Our report finds the...

Native American tribes try the vaping trade – but some have reservations

Written by ECigIntelligence | 9th May 2018

A few Native American tribes are moving into the e-cig business, some buoyed by tax advantages – while others remain sceptical at best. Among those moving into the vapour trade...

Relabelling and repackaging options could ease legal burden for US manufacturers

Written by Aidan Semmens | 24th April 2018

There could be some relief for manufacturers of “tobacco related” products for the US market who have been restricted by the complicated legal process of obtaining authorisation from the US...

Heated tobacco gaining ground: special market report

Written by Stavroula Anastasopoulou | 17th April 2018

In this special report, ECigIntelligence looks at how heated tobacco (heat-not-burn) and hybrid products are gaining ground in the world’s tobacco and vapour market ...

Cole-Bishop amendment fails once again to ride in on US spending bill

Written by Freddie Dawson | 22nd March 2018

Language changing the “grandfathering date” for vaping products has been dropped from the US Appropriations Bill as the government hurries again to avoid another shutdown ...

New and unapproved? FDA inspectors could have plenty to look at

Written by Daniel Mollenkamp | 7th March 2018

There may be widespread disregard of US FDA rules around the introduction of new vapour products and a new inspection regime may have its hands full, ECigIntelligence research suggests ...

Wholesale or volume taxes: a state-by-state analysis of US vapour taxation

Written by Berta Camps Bisbal | 7th March 2018

Eight US states currently tax e-cigarettes: five apply a volume tax, at a rate per ml of consumable product; three apply a wholesale tax, based on price sold at wholesale...

BAT ready to invest tax savings in HnB and e-cigs

Written by Freddie Dawson | 1st March 2018

British American Tobacco (BAT) has announced it will invest half the money it has saved from US corporate tax restructuring in next generation products ...

Substantial equivalence: Eclipse and Glo – same difference?

Written by ECigIntelligence | 1st March 2018

BAT has chosen to seek market authorisation in the US for its heat-not-burn product Glo on the basis of its “substantial equivalence” to a previous product, Eclipse – but what...

PMI execs promise to release raw data from IQOS trials, lambast media, praise FDA

Written by Daniel Mollenkamp | 22nd February 2018

Top executives of Philip Morris International (PMI) have promised at a major US analysts’ conference to make the raw data from clinical and non-clinical studies for the company’s reduced risk...

FDA committee rejects two IQOS MRTP claims, approves one

Written by Barnaby Page | 25th January 2018

Agency’s science committee agrees that PMI product decreases exposure to dangerous chemicals, but won’t accept broader claims of long-term risk reduction...

Israel set to tackle e-cig regulation with a clampdown on advertising

Written by David Palacios Rubio | 15th January 2018

Israel is in the process of taking a new approach to the advertising of new tobacco-related products, with a likely ban on all advertising of e-cigarettes and heated tobacco products...

Regulation, creativity and variety – that was the e-cig year that was

Written by ECigIntelligence | 27th December 2017

ECigIntelligence’s review of the year gone by reflects the big stories of the e-cigarette world in 2017, the trends in regulation, the developing and diverging markets, the science and innovation,...

The way ahead: Big Tobacco looks to a smoke-free next generation

Written by David Palacios Rubio | 20th November 2017

Big Tobacco is moving towards a smoke-free future, with all the leading companies indicating a focus in 2018 on next generation products, whether e-cigarettes or heated tobacco products ...

Uncertainty hangs over PMI application as FDA misses its own deadline

Written by Daniel Mollenkamp | 9th October 2017

The US FDA has missed its own 180-day deadline for replying to the premarket tobacco application (PMTA) by Philip Morris International for its IQOS heated tobacco products ...

French firm aims to roll out its nicotine dosage device in Europe and US

Written by Freddie Dawson | 2nd October 2017

Enovap, an innovative French hardware manufacturer, has announced plans to move into the US market, where it hopes to apply its technology to medicinal cannabis use ...

American Vaping Association urges FDA to approve iQOS

Written by Daniel Mollenkamp | 14th September 2017

The American Vaping Association has written to FDA commissioner Scott Gottlieb urging him to approve PMI’s heated tobacco product iQOS for sale in the US ...

PMTA and MRTP: navigating the path to FDA approval for reduced-risk products

Written by Berta Camps Bisbal | 14th September 2017

As PMI’s iQOS comes under consideration by the US FDA, we examine the hurdles it – and other – heated tobacco and e-cigarette products will have to clear to obtain...

Heated tobacco taxation in Europe – how it stands and what may emerge

Written by Pablo Cano Trilla | 6th September 2017

HnB products benefit from a more benign tax regime than traditional cigarettes, but with no broadly agreed classification, the picture across Europe remains for now inconsistent and...

From Russian elevators to US taxes, a change is gonna come

Written by David Palacios Rubio | 3rd August 2017

2017 has already been a significant year in the short history of e-cigarettes – and there is more to come in the remaining five months of a the year ...

FDA squeeze on nicotine in combustibles could hasten Big Tobacco move to HnB

Written by David Palacios Rubio | 3rd August 2017

A move by the US FDA to reduce the nicotine content in cigarettes to non-addictive levels could encourage Big Tobacco to put yet more effort into alternatives ...

Heated tobacco: expanding the market for reduced-risk nicotine?

Written by Stavroula Anastasopoulou | 23rd June 2017

Heat-not-burn could compete with e-cigarettes for consumer attention, but it may also attract new users. What progress has the recent spate of launches made, and what might the future hold?...

Substantial equivalence: the market approval process in detail

Written by Aidan Semmens | 19th April 2017

This report examines the current ways the e-cigarette industry in the U.S. has to get premarket approval from the FDA for new products, including detailed definitions of what constitutes a...

Frisco believes the future of synthetic nicotine could be a matter of taste

Written by Freddie Dawson | 6th April 2017

An American e-liquid company is looking to synthetic nicotine to improve flavour profiles but will have to convince consumers and retailers that the higher price-tag is worth...

PMI’s iQOS enters FDA process, edging closer to U.S. launch

Written by Daniel Mollenkamp | 3rd April 2017

Philip Morris International (PMI) has submitted its iQOS heat-not-burn system for approval by the U.S. Food and Drug Administration...

Nicotine-free and synthetic nicotine – some clarity from the FDA at last

Written by ECigIntelligence | 1st March 2017

Do nicotine-free and synthetic nicotine e-liquids come under the scope of the FDA's deeming regulations? It's a pressing question for the U.S. e-cigarette industry - and at last there is...

Altria ready to put millions behind digital U.S. launch of iQOS

Written by ECigIntelligence | 27th February 2017

Altria is set to take a digital approach to launching its iQOS heat-not-burn product in the U.S. but there will be significant costs along the way....

Cole-Bishop ‘could save the industry’ – but it’s not a done deal yet

Written by Freddie Dawson | 27th February 2017

The Cole-Bishop bill to bring forward the grandfathering date in the FDA deeming regulations could be a lifesaver for much of the U.S. e-cigarette industry - but it is...

FDA advises manufacturers and importers on listing of ingredients

Written by Aidan Semmens | 22nd February 2017

U.S. manufacturers and importers of “finished tobacco products” should submit full and detailed ingredients lists to the FDA - here's what they want to...

Pioneering U.S. manufacturer ProVape blames FDA for closure

Written by ECigIntelligence | 20th February 2017

ProVape has announced its decision to close down, citing the upcoming high cost of compliance with U.S. Food and Drug Administration (FDA) e-cigarette regulations....

FDA explains when it’s okay for vape stores to alter products

Written by Barnaby Page | 13th January 2017

The U.S. Food and Drug Administration has spelled out the limited circumstances where vape stores can modify e-cigarette products without seeking its...

FDA rejects snus as modified risk – but could reconsider some aspects

Written by Barnaby Page | 14th December 2016

Swedish Match has at last obtained some answers from the U.S. Food and Drug Administration (FDA) on its attempt to have snus products classified as modified risk – and they...

Totally Wicked to pull out of U.S. market, citing compliance burden

Written by Freddie Dawson | 14th November 2016

Totally Wicked will withdraw from the U.S. market by the summer of 2018 if no changes to the FDA deeming regulations are put in place before then....

FDA gives green light to scientific research with unapproved e-cigs

Written by Barnaby Page | 21st October 2016

The U.S. Food and Drug Administration (FDA) has confirmed that some unapproved e-cigarettes can be used in scientific research as long as their makers meet the deadlines for...

Deeming regulations and product packaging: key questions answered

Written by Aidan Semmens | 9th September 2016

New vapour products have been barred from entry to the U.S. market – but what impact will this have on those already on sale? How will the FDA’s final deeming...

Label changes do not require FDA approval, DC court rules

Written by Freddie Dawson | 22nd August 2016

Tobacco companies will be able to amend product labels without having to go through a federal review process, following a mixed victory by the industry in...

No summer break for FDA’s lawyers as deeming cases mount up

Written by Freddie Dawson | 12th July 2016

The U.S. Food and Drug Administration (FDA) this summer faces a welter of lawsuits against its deeming regulations, all of which have some features in common but also employ slightly...

The deeming rule and PMTAs: what it all means for manufacturers

Written by Aidan Semmens | 26th June 2016

There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page. Introduction On 10th May,...

PMTA applications: how the FDA’s policy has developed

Written by Aidan Semmens | 26th June 2016

Many questions remain over how the FDA will actually interpret the requirements for authorisation: how rigid a view it will take on the evidence required to support an application, for...

Deeming regulations in detail: the deadlines for initial compliance

Written by Aidan Semmens | 20th May 2016

In this ECigIntelligence report, we examine in detail the schedule for the U.S. deeming regulations’ major requirements affecting products that already exist on 8th August 2016, which will bring...

FDA expects many products to disappear as new regime takes effect

Written by David Attwood | 19th May 2016

The number of products on the U.S. e-cigarette market will contract sharply after the new deeming regulations come into full effect, according to their architect the Food and Drug Administration...

Some are sanguine, but PMTA fine print causes concern

Written by Freddie Dawson | 12th May 2016

Some larger independent e-cigarette companies support the new rules from the U.S. Food and Drug Administration (FDA), despite the debate over them being widely portrayed as an argument between Big...

PMTAs can use many kinds of scientific support, FDA says

Written by Barnaby Page | 10th May 2016

The U.S. Food and Drug Administration (FDA) believes most e-cigarette manufacturers will need to conduct fresh scientific research in order to obtain authorisation for their products under the newly-published deeming...

FDA will encourage sharing of scientific information on e-liquids

Written by Barnaby Page | 10th May 2016

Compliance with the new U.S. deeming regulations could be eased by the sharing of information among manufacturers and other stakeholders, says the Food and Drug Administration...

PMTAs: the road to FDA approval for e-cigarette products

Written by Aidan Semmens | 12th November 2015

Executive summary • Introduction • Why an electronic nicotine delivery system (ENDS) product requires a PMTA: distinction among ENDS products, components/parts, and accessories; three pathways to market approval; concerns about...

In depth: why the FDA treats vitamins easier than e-cigs

Written by Barnaby Page | 15th October 2014

Heavy-handed regulations for e-cigarettes • The DSHEA: a much lighter touch • Industry-friendly provisions for dietary supplements • Resisting tighter regulation for dietary...

In depth: e-cigs in the U.S. – market and regulatory analysis

Written by David Attwood | 24th September 2014

A comprehensive survey of the U.S. e-cigarette market and regulation, including: Market size • Consumption patterns • Online pricing • Distribution • Raw material supply • E-cigarette usage surveys •...

In depth: FDA deeming regs – the problems and solutions

Written by Barnaby Page | 19th September 2014

The proposed regulations • FDA e-cigarette information requests • Analysis of SFATA submission • SFATA’s proposed alternative • Analysis of AEMSA submission and proposals • Analysis of Totally Wicked submission...

In depth: potential legal challenges to FDA e-cig rules

Written by ECigIntelligence | 21st June 2014

Tobacco: precedents for challenge • Potential challenges to the deeming regulations • Challenges to scientific foundation • Challenges to pre-market approval and substantial equivalence • Challenges to health warning labels...

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