FDA
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 - Regulatory briefing |
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 - Regulatory briefing |
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 - Regulatory briefing |
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
Will FDA meet triumph or disaster over menthol – and how will it affect e-cigs?
9th May 2022 - Blog |
What are the implications of the FDA’s menthol plan for novel nicotine products such as e-cigarettes and heated tobacco?
FDA issues more warning letters…
5th May 2022 - Alerts | North America, United States |
First of US FDA’s court-ordered status reports on pending PMTAs expected
29th April 2022 - Regulatory briefing |
The first report on the status of US Food and Drug Administration (FDA) premarket tobacco product applications (PMTAs) is expected today, 29th April, following an order from a federal judge
FDA announces two proposed product standards…
29th April 2022 - Alerts | North America, United States |
It’s a yes from the FDA: Njoy granted PMTA for nicotine salts pod system
27th April 2022 - Regulatory briefing |
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) pathway
FDA authorises marketing of four new tobacco products…
27th April 2022 - Alerts | North America, United States |
US regulatory report: synthetic nicotine products – what’s next?
27th April 2022 - Regulatory reports |
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) process
Judge orders FDA to give quarterly reports on PMTA progress…
19th April 2022 - Alerts | North America, United States |
Change at the top – but expect no change of direction at US CTP under Mital
13th April 2022 - Blog |
What will Michele Mital’s reign as acting director of the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) mean in terms of policy?
FDA sends out more warnings on unauthorised e-liquids…
13th April 2022 - Alerts | North America, United States |
FDA’s marketing denials for Myblu ‘very ominous news’ for US vaping industry
11th April 2022 - Regulatory briefing |
The company that makes the Myblu vaping pod has a 30-day window to challenge the US Food and Drug Administration (FDA)’s denial of premarket tobacco applications (PMTAs) for the device and flavoured refills
FDA issues marketing denials to several Myblu products…
11th April 2022 - Alerts | North America, United States |
What will changes at the US CTP and CDC mean for the e-cigarette industry?
8th April 2022 - Blog |
Michele Mital’s appointment as acting head of the Center for Tobacco Products (CTP) is not bad news for the industry, even if it’s not quite good news. And there may be bigger change at the Centers for Disease Control and Prevention (CDC)
FDA issues more warnings over unauthorised e-liquids…
7th April 2022 - Alerts | North America, United States |
Durbin urges FDA to conclude PMTA review…
6th April 2022 - Alerts | North America, United States |
Synthetic and ‘natural’ nicotine – the real difference is just a matter of bureaucracy
31st March 2022 - Business briefing |
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
FDA issues more warning letters over unauthorised products…
31st March 2022 - Alerts | North America, United States |
Mital to take over from Zeller at FDA…
31st March 2022 - Alerts | United States |
FDA’s decision on Logic gives way to concerns over pending PMTAs
30th March 2022 - Regulatory briefing |
The recent decision by the US Food and Drug Administration (FDA) on Logic’s products has raised some concerns among experts on how the federal agency will address the pending premarket tobacco product applications (PMTAs)
FDA requests nearly 34% budget increase for FY 2023…
29th March 2022 - Alerts | North America, United States |
FDA OKs some tobacco-flavoured vape products…
25th March 2022 - Alerts | North America, United States |
FDA authorises some tobacco-flavoured Logic vape products, but denies others
25th March 2022 - Regulatory briefing |
The FDA has authorised the marketing of several tobacco-flavoured e-cigarette products from Logic Technology Development, under the brands Logic Power and Logic Pro, but the agency also issued marketing denial orders for other products from the same company, owned by Japan Tobacco International
Mital likely to step up from No 2 role when Zeller retires as CTP director
25th March 2022 - Regulatory briefing |
Michele Mital, deputy director of the US Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) since 2018, looks the most likely candidate to take the CTP reins from retiring director Mitch Zeller
FDA issues more warning letters…
23rd March 2022 - Alerts | North America, United States |
Milestones ahead as the US FDA takes charge of synthetic nicotine regulation
23rd March 2022 - Regulatory briefing |
ECigIntelligence has put together a timeline outlining the major points to look out for over the summer as the US Food and Drug Administration (FDA) brings synthetic nicotine into the PMTA process
US vape companies braced for the worst after rule change on synthetic nicotine
22nd March 2022 - Business briefing |
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 businesses forced to close and others praying for FDA discretion
One judge of three seems receptive to Triton’s argument against FDA decision
17th March 2022 - Regulatory briefing |
E-liquid provider Triton Distribution may have made some progress in its attempt to convince a court that the US FDA was “arbitrary and capricious” in denying its flavoured vaping products application
FDA sends warnings about ‘new tobacco products’…
17th March 2022 - Alerts | North America, United States |
It’s hard to unpick, but there’s good news lurking in the detail of CDC vaping report
17th March 2022 - Blog |
The headline conclusions of the CDC are not surprising: tobacco products remain a menace to America’s kids, e-cigarettes particularly, flavoured ones most of all. But that is not the whole story
Senator accuses FDA of e-cig delay…
16th March 2022 - Alerts | North America, United States |
FDA gives OK to market Iqos 3 with special information…
14th March 2022 - Alerts | North America, United States |
US Congress passes omnibus bill, putting synthetic nicotine under FDA jurisdiction
14th March 2022 - Regulatory briefing |
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 passed its omnibus spending bill
FDA issues new warning letters…
2nd March 2022 - Alerts | North America, United States |
FDA sends out more warnings…
21st February 2022 - Alerts | North America, United States |
New FDA commissioner Califf urged to tackle vaping and synthetic nicotine
21st February 2022 - Regulatory briefing |
The US Senate has confirmed Robert Califf to be the next commissioner of the Food and Drug Administration on a tight vote
US menthol cigarette ban is imminent – so what does that mean for e-cigs?
17th February 2022 - Regulatory briefing |
Flavours for other tobacco products will almost certainly become the major topic once a US ban on menthol cigarettes and flavoured cigars goes through
Senate confirms FDA choice…
16th February 2022 - Alerts | North America, United States |
Senate in a hurry to finalise FDA appointment…
15th February 2022 - Alerts | United States |
Good Vuse for BAT as vapour growth helps offset dip in overall revenue
14th February 2022 - Business briefing |
Vuse and vapour were the primary driver of a 42.4% year-on-year increase in British American Tobacco (BAT)’s new category portfolio revenue, according to the company’s latest results
Altria keeps fingers crossed on Juul PMTA but ‘will not invest further in vaping’
1st February 2022 - Business briefing |
US tobacco giant Altria has announced that it will not invest any further in the vapour category for the foreseeable future
Where do we go from here? How new rules will affect world vape markets
31st January 2022 - Business briefing |
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
Robert Califf’s FDA nomination is approved at committee stage
19th January 2022 - Regulatory briefing |
Califf’s bid to be the first permanent FDA leader under president Joe Biden comes amid ongoing calls by politicians for more regulation of tobacco and the cigarette industry
Officials on both sides of the Atlantic caught in an old nicotine delusion
13th January 2022 - Blog |
Is nicotine really the big baddie when it comes to tobacco products and their alternatives? Some people in positions of authority – people you might think ought to know better – still seem to think so
2021 reviewed: false dawn for vaping, or some light showing at the tunnel’s end?
10th January 2022 - Business briefing |
Could 2021 be remembered as the year we first started to see some light at the end of the tunnel? Only time will tell for sure, but there were clues
How smokers with no plans to quit may hold the key to e-cigs’ future regulation
5th January 2022 - Blog |
An original and potentially highly significant piece of peer-reviewed research published last week could – and should – have an impact on the way e-cigarettes are regarded and regulated in the US
Company goes to Supreme Court after judge rejects stay of US FDA denial order
26th November 2021 - Regulatory briefing |
Breeze Smoke is asking the US Supreme Court to stay a Food and Drug Administration (FDA) marketing denial order (MDO) after the Court of Appeals rejected such motion
Will Califf and the Biden administration really heed the science on e-cigarettes?
18th November 2021 - Blog |
Robert Califf, US president Joe Biden’s choice to take up leadership of the FDA again, has unfinished business with the agency – and with e-cigarettes in particular
Flavour ban advocate Califf picked by Biden to take charge of US FDA again
15th November 2021 - Regulatory briefing |
A 70-year-old cardiologist who has backed a flavour ban on vaping products has been nominated by president Joe Biden to return to the role of commissioner of the US Food and Drug Administration (FDA)
Appeals court grants another company a stay of US FDA’s marketing denial order
11th November 2021 - Regulatory briefing |
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 its flavoured vaping products
Regulatory report: Q&A – US FDA final guidance on PMTAs and SE reports
3rd November 2021 - Regulatory reports |
This report answers your questions on the US Food and Drug Administration (FDA)’s recently issued final rules on the requirements for Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) reports
Manufacturer sues FDA for ‘irreparable harm’ despite PMTA reconsideration
3rd November 2021 - Regulatory briefing |
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
29th October 2021 - Business briefing |
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 company from Texas to keep its flavoured products on the market until it resolves the case
FDA technical review throws light on agency’s priorities for e-cigarettes
20th October 2021 - Regulatory briefing |
While some of the biggest players in the US vapour market wait for the Food and Drug Administration (FDA) to decide whether their products can remain on sale, the agency has provided some insight into its processes and priorities
PMTAs: after the Reynolds approvals, which way will the FDA go next?
15th October 2021 - Regulatory briefing |
“The importance of the FDA authorising a vaping product as ‘appropriate for the protection of public health’ should not be understated,” said Greg Conley, president of the American Vaping Association
FDA’s views on Vuse have potential to change the whole vaping landscape
14th October 2021 - Blog |
The granting of RJ Reynolds’s PMTAs for its Vuse Solo e-cigarette device and two of its pods is very big news for the US vaping industry, its supporters, its customers, and its opponents
First PMTA success for Reynolds’s Vuse products – but tobacco flavours only
13th October 2021 - Regulatory briefing |
The US Food and Drug Administration (FDA) has issued its first marketing authorisations for e-cigarette products, following the rejection of millions of others. The authorisations cover RJ Reynolds’s Vuse Solo device and two 4.8% nicotine tobacco-flavoured pods
Turning Point withdraws legal action after FDA back-tracks on PMTA refusal
12th October 2021 - Regulatory briefing |
The US Food and Drug Administration (FDA) has rescinded its marketing denial order (MDO) affecting 14 Turning Point Brands products, saying “relevant information that was not adequately assessed”
Turning Point Brands seeks emergency court ruling against FDA denial order
8th October 2021 - Regulatory briefing |
Turning Point Brands (TPB) is challenging in court the Marketing Denial Order (MDO) issued by the US Food and Drug Administration (FDA) to its premarket tobacco product applications (PMTAs) as it considers the decision “arbitrary”
The post-PMTA US vape market: trends, disposables and nicotine alternatives
7th October 2021 - Market reports |
A presentation given by Tim Phillips, ECigIntelligence managing director, to the ENDS US Workshop in October 2021
A hammer to crack a nut: what the PMTA process reveals about US FDA approach
7th October 2021 - Blog , Regulatory briefing |
Some light is now dawning on some truths long since suspected about the US Food and Drug Administration (FDA)’s evaluation of e-cigarettes
US FDA questioned about pending PMTAs and enforcement for non-compliance
1st October 2021 - Regulatory briefing |
US senators have urged the FDA to implement a timeline to decide on the pending PMTAs and to reveal how it will ensure that there are no non-compliant products on the market
Vaping experts see integrating science and innovation as the way forward
27th September 2021 - Business briefing |
Representatives of the vaping industry have urged a broader collaboration with scientists and agreed that integrating technological innovations is key to encouraging transition to tobacco alternatives
FDA marketing denial orders spread fear and confusion among US vaping retailers
23rd September 2021 - Business briefing |
The US FDA’s rejection of premarket tobacco product applications (PMTAs) has sown confusion among vape retailers, who are urging the agency to make public which vaping products have been approved for sale
‘Significant progress’ – but the US FDA’s biggest decisions are still to come
15th September 2021 - Blog , Regulatory briefing |
The dog didn’t eat all the FDA’s homework – just 7% of it. But there will be those who argue that the missing 7% was the crucial bit all along
FDA’s PMTA denials get a warm political welcome – but not the delay over Juul
13th September 2021 - Regulatory briefing |
The US Food and Drug Administration (FDA)’s denial of premarket tobacco product applications (PMTAs) has been welcomed by politicians and public health bodies – with severe reservations about the delay over Juul and others
US FDA rejects 5.5m PMTAs; Juul’s application still under review
9th September 2021 - Regulatory briefing |
The US Food and Drug Administration (FDA) has rejected most of the 6m premarket tobacco product applications (PMTAs) it received for vaping products, but Juul’s intently-watched application remains under review
Into the great unknown as US FDA’s deadline to decide on PMTAs arrives
9th September 2021 - Blog , Regulatory briefing |
As the US Food and Drug Administration’s deadline to pass or reject e-cigarette premarket tobacco product applications (PMTAs) arrives, where does it leave the market and the as-yet undetermined applications?
US FDA denies more PMTAs a week before the final deadline – ‘more will follow’
2nd September 2021 - Regulatory briefing |
The US Food and Drug Administration (FDA) has issued a number of “additional” marketing denial orders (MDOs) for flavoured e-cigarettes, denying their premarket tobacco product applications (PMTAs)
The FDA can’t win on PMTAs. But should it really be taking the fight to flavours?
2nd September 2021 - Blog |
It’s hard to argue against the view that packaging and advertising e-cigarette products in a “kid-friendly” way is irresponsible. But are flavours in themselves innately kid-friendly?
US Congress looks set to cut Biden’s proposed budget for the FDA by half
31st August 2021 - Regulatory briefing |
Both the House and the Senate are intent on increasing the US Food and Drug Administration (FDA) budget for next year, but the figure is likely to be well short of the $6.5bn proposed by president Joe Biden
State attorneys’ knee-jerk interjection is no sound basis for federal regulation
27th August 2021 - Blog |
31 US state attorneys want to ban all non-tobacco flavours, including menthol, from e-cigarettes – but is their plea helpful, appropriate or logical?
US FDA denies marketing authorisation for 55,000 flavoured vapour products
27th August 2021 - Regulatory briefing |
The US Food and Drug Administration (FDA) has ruled out premarket tobacco product applications (PMTAs) for 55,000 flavoured vapour products after concluding that on balance they pose a threat to public health
State AGs join in calling on FDA to deny PMTAs for flavoured vaping products
24th August 2021 - Regulatory briefing |
A group of 31 US attorneys general has joined together in urging the Food and Drug Administration (FDA) to deny premarket tobacco product applications (PMTAs) for vaping products
As FDA faces a paperwork tsunami, big firms may come out of it best
19th August 2021 - Blog , Business briefing |
The number of applications thrown in the metaphorical dumpster is huge, but so is number of outstanding applications, and the question remains how the FDA can possibly deal with all of them
US lawmakers look to establish a $100m e-cigarette user fee scheme for 2022
13th August 2021 - Regulatory briefing |
A bipartisan group of federal senators have reintroduced a bill in Congress that would force e-cigarette manufacturers to pay user fees to the FDA in a bid to fund the federal agency
How will the US FDA resolve the 1.5m pending PMTAs?
11th August 2021 - Regulatory briefing |
After the recent announcement that FDA rejected 4.5m of the total 6m PMTAs filed, experts believe that this decision is a clear path for enforcement
US FDA rejects 4.5m PMTA applications from one single manufacturer
10th August 2021 - Regulatory briefing |
A small manufacturer from Texas must remove millions of vaping products from the US market after the FDA issued a Refuse to File (RTF) letter rejecting most of its PMTAs
Behind the scenes of the 6m PMTA submissions – the ‘top five’
6th August 2021 - Regulatory briefing |
Five US companies are top of the list with the most PMTAs submitted, and represent five out of the 6m total applications by the September 2020 deadline
PMTA applications reveal key roles for tobacco, fruit and menthol flavours
15th July 2021 - Charts and infographics |
An analysis of the long-awaited list of PMTA applications that was recently published by the US Food and Drug Administration
E-cig hardware under scrutiny in the US
15th July 2021 - Charts and infographics |
An analysis of the long-awaited list of PMTA applications that was recently published by the US Food and Drug Administration
Juul in jeopardy? That’s how the press is billing the FDA’s upcoming PMTA verdict
15th July 2021 - Blog |
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 and can’t really punish Juul”
Analysis of FDA data suggests big US vape brands will grow, as smaller ones decline
12th July 2021 - Business briefing |
E-cigarettes manufactured by large companies may soon dominate the US vape market while many of those produced by smaller players disappear, new research by ECigIntelligence suggests
An analysis of PMTA applications: what they reveal about the US market
12th July 2021 - Market reports |
What do the 6m-plus premarket tobacco product applications (PMTAs) received by the US Food and Drug Administration (FDA) reveal about the current state of the US e-cigarette industry? We assess the FDA data
Experts still see hope for future legal challenges to US FDA authority
22nd June 2021 - Regulatory briefing |
The US Food and Drug Administration (FDA)’s authority to regulate e-cigarettes could face further legal scrutiny after the recent refusal by the Supreme Court to hear a challenge initiated by a vape shop
Was freeing e-cigarettes from FDA rule ever really a straw worth reaching for?
11th June 2021 - Blog |
It was always a long shot – such a long shot that no one, surely, was surprised that the US Supreme Court refused to review the case
US Supreme Court refuses challenge to FDA authority over vaping products
8th June 2021 - Regulatory briefing |
The US Supreme Court has rejected a challenge to the Food and Drug Administration (FDA)’s authority to regulate e-cigarettes, refusing to review a case that relied on a constitutional doctrine last applied in 1935
US FDA at last publishes full PMTA list, featuring more than 6m products
24th May 2021 - Business briefing |
The US Food and Drug Administration (FDA) has posted a list of over 6m deemed new tobacco products for which it received Premarket Tobacco Product Applications (PMTAs) by the 9th September 2020 deadline
Washington attack on nicotine in smokes could be good news for e-cigarettes
23rd April 2021 - Blog |
News that the Biden administration is considering reducing nicotine levels in combustible cigarettes in the US has affected stock prices in the UK – and has potentially interesting implications for the vaping market
Product placement in music videos is the way to make vaping look cool to kids
9th April 2021 - Blog |
New research suggests “exposure to e-cigarette product placement in music videos is associated with vaping among young adults”. Meanwhile, back in the Marvel universe, something strange is stirring
Vape companies ask US Supreme Court to rule FDA deeming regulations invalid
8th April 2021 - Regulatory briefing |
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) process
US representatives urge FDA to ban flavoured e-cigs and deny Juul PMTA
29th March 2021 - Regulatory briefing |
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” and to make an example of Juul
US flavour bans: analysis and current trends
9th March 2021 - Regulatory reports |
This special report details the e-cigarette flavour bans or restrictions in place in four US states, and analyses those under consideration at state level elsewhere across the nation
FDA warning letters are the final straw for some as US businesses close
15th February 2021 - Business briefing |
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) tightens the regulatory screw
New powers in Washington suggest a whole new world for US vapour
22nd January 2021 - Blog |
Will a new political era in the US mean a new regulatory landscape for e-cigarettes?
Senators’ letter to FDA on PMTAs hints at tougher US policies on vapour products
18th January 2021 - Regulatory briefing |
Twelve US senators, including 11 leading Democrats, have called on the Food and Drug Administration (FDA) to enforce tougher reviews of premarket tobacco product applications (PMTAs)
US agents seize 33,000 fake Puff e-cigarettes flown in from China
14th January 2021 - Regulatory briefing |
More than $700,000 worth of counterfeit e-cigarettes arriving from China have been seized in the US as part of a joint-agency operation to crack down on fraudulent vaping products
2020: the year of flavour bans, Juul cases, taxation, China – and that other thing
30th December 2020 - Business briefing |
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, with Juul in the dock and China on the rise
Why the US vapour industry should fasten its seat-belts for a bumpy ride
5th December 2020 - Blog |
Everyone from Big Tobacco to the small vape store will have a keen eye on who president-elect Joe Biden picks to be the next chief of the FDA, the US agency with responsibility for regulating tobacco and e-cigs
Who will Biden pick for the top health jobs crucial to US e-cig regulation?
30th November 2020 - Regulatory briefing |
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 be crucial to e-cigarette regulation
Tobacco or not? The nicotine may be synthetic, but the question is real enough
21st November 2020 - Blog |
Can synthetic nicotine possibly be classified as tobacco? At the most straightforward level, the answer has to be “no”. But it’s a bit more complicated than that
Regulatory report: synthetic nicotine in the US – ‘tobacco product’ or not?
12th November 2020 - Regulatory reports |
Synthetic nicotine, created from chemicals in a lab, not derived from tobacco, is not a specifically regulated product in the US so its legal status is subject to interpretation, as outlined in detail in this report
US representative asks the FDA to work with small vape firms on PMTAs
19th October 2020 - Regulatory briefing |
A US congressman has called on Food and Drug Administration (FDA) commissioner Stephen Hahn to work with small vaping businesses that submit premarket tobacco applications (PMTAs) “in good faith”
US lawsuits against Juul pile up, but where are they all headed?
13th October 2020 - Regulatory reports |
Juul is being sued in courts across the US. Most of the cases brought by individuals, states, or school districts have many allegations in common – and the consequences could affect the whole e-cigarette industry
Concerned US vape stores diversify in response to FDA’s PMTA regulation
22nd September 2020 - Business briefing |
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 from the shelves
How EVALI, and the way it was reported, damaged perceptions of vaping
18th September 2020 - Business briefing |
Many smokers believe vaping is at least as harmful as combustible cigarettes, despite e-cigarettes’ lower production of toxicants and carcinogens; researchers in England have been examining why
As PMTA deadline passes, is it the point of no return for vaping in the US?
11th September 2020 - Blog |
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
E-cigarette use by US school students falls by a third in a year, CDC reports
10th September 2020 - Business briefing |
New official data shows that the number of young people in the US who are current e-cigarette users has fallen sharply, from 5.4m in 2019 to 3.6m this year
Wednesday 4pm: final countdown to the PMTA deadline
7th September 2020 - Regulatory briefing |
The final deadline for premarket tobacco product applications (PMTAs) for e-cig products in the US is now imminent, with the US Food and Drug Administration (FDA) officially setting it at 4pm on 9th September
US vape industry seeks PMTA deadline extension to 2021 for small businesses
25th August 2020 - Regulatory briefing |
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
Arizona granted $22.5m judgement against out-of-business Eonsmoke
18th August 2020 - Business briefing |
US e-liquid manufacturer Eonsmoke, which recently announced that it had ceased all operations, has been ordered to pay $22.5m to the state of Arizona for selling unapproved vapour products
To ban or not to ban, that is the question over e-cigs during COVID-19 pandemic
17th August 2020 - Blog |
Would it be appropriate to ban e-cigarettes for the duration of the COVID-19 pandemic? That’s what some US Congress members are calling for
FDA issues warning to Puff Bar days after company drops all US sales
21st July 2020 - Regulatory briefing |
The US Food and Drug Administration (FDA) has issued warnings to Puff Bar and nine other companies demanding they withdraw unapproved vapour products from the market
US representatives ask FDA to publish a list of vaping PMTA submissions
10th June 2020 - Regulatory briefing |
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 been submitted
FDA angers US House subcommittee by refusing to stop all e-cigarette sales
21st April 2020 - Regulatory briefing |
The US Food and Drug Administration (FDA) has rejected a call to “clear the e-cigarette market” during the COVID-19 crisis – eliciting an angry response from a House subcommittee
Cautious relief after US court grants four-month PMTA deadline extension
7th April 2020 - Regulatory briefing |
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
US FDA requests extension of PMTA deadline due to coronavirus problems
31st March 2020 - Regulatory briefing |
The US Food and Drug Administration (FDA) has requested a 120-day extension to the deadline for premarket tobacco product applications (PMTAs) due to the challenges that the coronavirus outbreak is posing to companies
US FDA may relax PMTA deadline for firms facing coronavirus problems
24th March 2020 - Regulatory briefing |
The US FDA has hinted that it might push back the deadline for e-cigarette PMTA applications, or offer flexibility to companies struggling to meet the May target while coping with coronavirus
US FDA suspends all vape store inspections for at least a month
20th March 2020 - Regulatory briefing |
The US Food and Administration (FDA) has decided to issue “a partial stop work order” for the external companies that are carrying out product compliance checks and vape store inspections
US judge throws out vape stores’ case against FDA deeming rule
18th February 2020 - Regulatory briefing |
The US District Court in Washington DC has rejected the arguments of vape shop owners in five states that the US Food and Drug Administration (FDA)’s deeming rule was unconstitutional
Trump plans to take e-cigarette and tobacco regulation out of FDA hands
13th February 2020 - Regulatory briefing |
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
Q&A: US FDA enforcement on certain flavoured e-liquid products
3rd February 2020 - Regulatory reports |
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
FDA’s new clampdown on flavoured cartridges fails to satisfy either side
6th January 2020 - Regulatory briefing |
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
FDA will remove most cartridge flavours from US market
2nd January 2020 - Regulatory briefing |
E-liquid cartridges with flavours other than tobacco or menthol are to be excluded from the US market at the end of this month, the FDA says, while advertising and marketing will come under scrutiny too
FDA and DEA shut down 44 websites selling illicit THC vaping products
23rd December 2019 - Regulatory briefing |
The US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have seized 44 websites they said were selling illicit vapour cartridges containing THC
How Swedish Match snus finally got its FDA modified risk approval
17th December 2019 - Regulatory reports |
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?
Senate confirms Stephen Hahn as new FDA commissioner
13th December 2019 - Regulatory briefing |
The US Senate has confirmed cancer specialist Stephen Hahn as the new US Food and Drug Administration (FDA) commissioner
An overview of the US FDA’s premarket tobacco applications (PMTAs) for e-cigarettes
25th November 2019 - Regulatory reports |
On 20th September, the FDA released its draft guidelines for PMTAs, spelling out in detail the information that e-cigarette makers will have to submit before next year’s deadline. This report provides information and related coverage regarding the process
Trump warns of black market if flavour ban is adopted; backs minimum age of 21
23rd November 2019 - Regulatory briefing |
President Trump has softened his position on a possible US flavour ban, and also endorsed a national minimum vaping age of 21
FDA inspects 800 vape stores in two years, seeks tobacco experts for panel
20th November 2019 - Regulatory briefing |
The US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) carried out 800 inspections in vape stores between 2016 and 2018, with thousands of warning letters have been issued to retailers for violations
Proposed PMTA rule on labelling and marketing: FAQ
18th November 2019 - Regulatory reports |
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
Trump chooses lung cancer specialist to be the new FDA commissioner
6th November 2019 - Regulatory briefing |
US president Donald Trump has nominated lung cancer specialist Stephen Hahn to be the new full-time US Food and Drug Administration (FDA) commissioner
In depth: the US FDA’s new PMTA rules
5th November 2019 - Regulatory reports |
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 cc
White House reviewing new FDA guidance on flavoured e-cigs
29th October 2019 - Regulatory briefing |
The White House has received the US Food and Drug Administration (FDA)’s final version of its guideline on flavoured e-cigarettes currently on sale without premarket authorisation
FDA orders Eonsmoke to remove nearly 100 products from US market
25th October 2019 - Business briefing , Marketing & retailing |
New Jersey e-liquid manufacturer Eonsmoke has been ordered by the US Food and Drug Administration (FDA) to remove from the market 96 products that do not have a marketing authorisation order
Los Angeles city council to consider e-cig ban ‘until FDA approval’
24th October 2019 - Regulatory briefing |
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 US FDA
FDA approves its first modified risk tobacco order for eight snus products
23rd October 2019 - Regulatory briefing |
The US FDA has grated its first ever modified risk orders to eight snus products from Swedish Match, which can now be advertised as less harmful than traditional cigarettes
Reynolds American files 150,000-page PMTA submission for Vuse
15th October 2019 - Business briefing |
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
CDC and FDA shift emphasis to THC, but public still believes nicotine more dangerous
4th October 2019 - Business briefing |
The American public believes nicotine e-cigarettes to be more dangerous than THC vaping, even as official statements on the recent outbreak of lung disease start to emphasise the role of cannabis and play down the involvement of nicotine products
As PMTA deadline approaches, US industry fears the end may be nigh
2nd October 2019 - Business briefing |
The US vapour industry is not happy with the FDA’s new guidelines for premarket tobacco product applications (PMTAs), with some fearing there may soon be no small manufacturers left to regulate
Sharpless: ‘PMTA policy doesn’t mean flavoured e-cigs can never be sold’
26th September 2019 - Regulatory briefing |
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
FDA outlines what PMTAs must include: youth protection, comparative risk are key
21st September 2019 - Regulatory briefing |
The FDA’s draft guidelines for PMTAs acknowledge a continuum of risk in tobacco products, while also placing much emphasis on youth protection
Trump declares flavours ‘off the market’ until approved by FDA
12th September 2019 - Regulatory briefing |
US president Donald Trump has announced that his administration is preparing new market restrictions on flavoured e-cigarettes
FDA’s proposed additions to harmful constituents list spread confusion
27th August 2019 - Regulatory briefing |
The possible addition of another 19 toxins to the US list of harmful and potentially harmful constituents (HPHCs) is generating uncertainty among vaping companies
New legal action aims to overturn FDA’s latest PMTA deadline
16th August 2019 - Regulatory briefing |
Vaping advocates are seeking a legal injunction against the US FDA’s May 2020 deadline for submission of premarket tobacco applications (PMTAs) for e-cigarettes
FDA proposes increasing list of harmful toxins in e-cigarettes
2nd August 2019 - Regulatory briefing |
The US Food and Drug Administration (FDA) wants to add up to 19 new chemicals to its list of harmful and potentially harmful constituents (HPHCs)
FDA’s new TV campaign aims to turn teens off vaping by magic
23rd July 2019 - Marketing & retailing , Regulatory briefing |
“Some people think that vaping is not a big deal, but that is just an illusion.” That’s the start of a new TV ad, one of a series featuring street magician Julius Dein launched on teen-focused networks by the US FDA
Sharpless: court’s deadline ruling sets ‘a rapid pace’ for PMTA reviews
16th July 2019 - Regulatory briefing |
The US FDA has welcomed the ruling by a federal court that it must bring forward the deadline for submission of premarket tobacco applications (PMTAs) for e-cigarettes to 11th May 2020
Judge moves PMTA deadline to May 2020; praises FDA, criticises industry
13th July 2019 - Regulatory briefing |
11th May 2020 is the new deadline for US e-cigarette makers to submit their products to the FDA, following a federal court ruling
Acting FDA chief Sharpless says the case for e-cigs is still unproven
11th July 2019 - Regulatory briefing |
Acting US FDA commissioner Ned Sharpless has expressed his commitment to giving fair consideration to alternatives to smoking – but he still has doubts about vaping
‘Go under or go underground’ – PMTA threat sows gloom among small firms
4th July 2019 - Business briefing |
The suggestion that the US FDA might bring forward the deadline for the submission of premarket tobacco product applications (PMTAs) has caused a wave of shock among small businesses
FDA offers retailers digital calendars to help with age verification
19th June 2019 - Regulatory briefing |
The US FDA has created a new digital age verification calendar to help retailers to avoid selling e-cigs and other tobacco products to under-age customers
US FDA proposes bringing PMTA deadline significantly forward
14th June 2019 - Regulatory briefing |
The US FDA has suggested that the deadline for the submission of premarket tobacco product (PMTA) applications could be significantly advanced
The waiting’s over as FDA produces its guidance on PMTA submissions
12th June 2019 - Regulatory briefing |
The US FDA has published its long awaited guidance for premarket tobacco products applications (PMTAs) for e-cigarettes, including a number of non-binding recommendations for vaping manufacturers
San Francisco moves towards e-cig sales prohibition ‘until FDA acts’
10th June 2019 - Regulatory briefing |
Legislators in San Francisco have advanced a bill to ban the sale of e-cigs in the city until the US Food and Drug Administration (FDA) has reviewed the products
Seeking enlightenment, FDA plans to visit vape factories
24th May 2019 - Regulatory briefing |
The US Food and Drug Administration (FDA) plans to visit vapour manufacturers in an effort to better understand the development, manufacturing, and testing of electronic delivery nicotine systems, as it pushes forward in its regulation of the category.
So IQOS has PMTA approval – but what does that mean in practice?
23rd May 2019 - Regulatory reports |
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
16th May 2019 - Regulatory briefing |
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
Sharpless keeps the FDA on its chosen path against youth vaping ‘epidemic’
16th May 2019 - Regulatory briefing |
In the words of acting commissioner Ned Sharpless, the US FDA remains set on fighting the “epidemic of e-cigarette use by kids” and on “strategies to help those who are already addicted”
IQOS reaction: ‘Approval works for PMI, but what about the little guy?’
2nd May 2019 - Business briefing |
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
30th April 2019 - Business briefing |
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 orders 12 major store chains to stop selling tobacco products to kids
17th April 2019 - Regulatory briefing |
The US FDA has written to 12 well-known convenience store chains – including Walmart, Kroger, and Family Dollar – accusing them of selling tobacco products to minors and ordering them to stop
FDA announces seizures may be linked with e-cigarettes – or maybe not
4th April 2019 - Business briefing |
Outgoing US Food and Drug Administration (FDA) commissioner Scott Gottlieb has linked e-cigarettes with a “potential emerging safety issue” after reports linking vaping with seizures, particularly among young people
FDA budgets for $100m in user fees for CTP to keep up pressure on vaping
2nd April 2019 - Regulatory briefing |
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 $611m
Gottlieb reaches out to vape industry with new rule on SE requirements
28th March 2019 - Regulatory briefing |
The US FDA has issued a proposed rule to establish requirements for the content and format of substantial equivalence (SE) reports for tobacco products
FDA offers vape stores guidance on what counts as ‘modification’
26th March 2019 - Regulatory briefing |
The US FDA has issued guidance to help vape shops that sell newly deemed products navigate the agency’s enforcement of the federal Food, Drug, and Cosmetic Act (FD&C) and its specific requirements
FDA and the US vapour industry watching each other’s moves closely
25th March 2019 - Regulatory briefing |
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 just as closely
San Francisco considers e-cig ban, FDA looks at stopping the sale of pods
20th March 2019 - Regulatory briefing |
Pressure on the US vapour industry has increased yet again. Local legislators in San Francisco are attempting to ban e-cig sales entirely, while the FDA commissioner is pondering more action against pods
‘FDA flavour restrictions could devastate industry’, trade body warns
15th March 2019 - Business briefing |
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
13th March 2019 - Regulatory briefing |
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 products
Cancer Institute head Sharpless to follow Gottlieb as acting FDA chief
12th March 2019 - Regulatory briefing |
The next head of the US FDA has been named. Norman “Ned” Sharpless, director of the National Cancer Institute, will take over when Scott Gottlieb steps down next month – but only as acting commissioner
FDA’s $6.1bn funding request includes $100m in user fees for e-cig regulation
12th March 2019 - Regulatory briefing |
Outgoing US FDA commissioner Scott Gottlieb’s $6.1bn funding request for fiscal year 2020 includes for the first time an element aimed specifically at the development of e-cigarette regulation
‘Trump did right hiring Gottlieb to lead FDA,’ say Washington watchers
8th March 2019 - Regulatory briefing |
For once, Democrats and Republicans are in agreement: President Donald Trump was right to hire Scott Gottlieb to lead the US FDA. Politicians and policymakers reacted to Gottlieb’s resignation announcement on 5th March
Mixed responses to Gottlieb’s departure from the FDA hot-seat
7th March 2019 - Regulatory briefing |
The news that Scott Gottlieb would be stepping down as FDA commissioner has elicited a predictably mixed response from those involved in US public health, tobacco control and the vaping industry
Exit Gottlieb, the ‘friend of vaping’ who became its outspoken foe
6th March 2019 - Regulatory briefing |
Almost all news coverage of Scott Gottlieb’s shock resignation as FDA commissioner depicts him as the enemy of e-cigs and speaks of his “unfinished fight against vaping” – but it wasn’t always that way
Scott Gottlieb, frequent critic of vaping, resigns from FDA
6th March 2019 - Regulatory briefing |
Scott Gottlieb, commissioner of the US Food and Drug Administration (FDA) and vocal critic of e-cigarettes, has resigned and will leave office in about a month; no successor has been named
Gottlieb names chains accused of flouting rules on sales to youth
5th March 2019 - Regulatory briefing |
FDA commissioner Scott Gottlieb has announced new action against retailers selling tobacco products to minors and e-cig manufacturers who fail to comply with labelling and advertising regulations
Under grilling, Gottlieb tells House subcommittee e-cigs are a top priority
28th February 2019 - Regulatory briefing |
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
12th February 2019 - Regulatory briefing |
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 it when it comes
US FDA committee approves snuff reduced-risk claim
8th February 2019 - Regulatory briefing |
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 safer than others
FDA seeks ‘no sale of tobacco’ orders against Walgreens and Circle K
8th February 2019 - Regulatory briefing |
The US Food and Drug Administration (FDA) is seeking no tobacco sale orders (NTSO) against Walgreens and Circle K for selling combustibles and cigars to minors
Youth vaping ‘an existential threat’ to US e-cig industry, warns Gottlieb
16th January 2019 - Regulatory briefing |
The entire US e-cigarette industry could be wrecked by the country’s youth vaping “epidemic”, US Food and Drug Administration (FDA) commissioner Scott Gottlieb has warned
Q&A on the FDA’s flavour ban announcement
21st December 2018 - Regulatory reports |
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 what will it add up to in practice?
FDA guides on product labelling: US regulatory report
2nd May 2018 - Regulatory reports |
In this latest report on American regulations, ECigIntelligence highlights the fact that all electronic vaping devices will have to comply with FDA label requirements from August 2018
Relabelling and repackaging options could ease legal burden for US manufacturers
24th April 2018 - Regulatory reports |
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 Food and Drug Administration (FDA) in the form of a premarket tobacco product application (PMTA).
Substantial equivalence: Eclipse and Glo – same difference?
1st March 2018 - Regulatory reports |
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 are the pitfalls and the advantages in this approach?