New powers in Washington suggest a whole new world for US vapour
22nd January 2021 - Blog |
North America
United States
FDA
Policy and Politics
Blog
Will a new political era in the US mean a new regulatory landscape for e-cigarettes?
FDA
The ECigIntelligence FDA hub brings together all our briefings and reports that relate to the US Food and Drug Administration (FDA) and its regulation of e-cigarette and related products.
Senators’ letter to FDA on PMTAs hints at tougher US policies on vapour products
18th January 2021 - Regulatory briefing |
North America
United States
FDA
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 |
North America
United States
FDA
Regulation and Legislation
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 |
COVID-19
FDA
Flavours
Health
Regulation and Legislation
Tax
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 |
North America
United States
FDA
Policy and Politics
Regulation and Legislation
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 |
North America
United States
FDA
Policy and Politics
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 |
North America
United States
FDA
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 |
North America
United States
FDA
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 |
North America
United States
FDA
Technology and Innovation
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 |
North America
United States
Companies
FDA
Health
Major brands
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 |
North America
United States
Consumers
FDA
Retail
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 |
Europe
North America
United Kingdom
United States
Consumers
FDA
Health
Science
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 |
North America
United States
FDA
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 |
North America
United States
FDA
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 |
North America
United States
Companies
FDA
Regulation and Legislation
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 |
North America
United States
COVID-19
FDA
Regulation and Legislation
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 |
Arizona
North America
United States
Companies
FDA
Regulation and Legislation
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 |
North America
United States
COVID-19
FDA
Health
Policy and Politics
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 |
North America
United States
Companies
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Policy and Politics
Regulation and Legislation
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 |
North America
United States
COVID-19
FDA
Policy and Politics
Regulation and Legislation
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 |
North America
United States
Companies
COVID-19
FDA
Regulation and Legislation
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 |
North America
United States
COVID-19
FDA
Regulation and Legislation
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 |
North America
United States
COVID-19
FDA
Health
Regulation and Legislation
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 |
North America
United States
Companies
COVID-19
FDA
Regulation and Legislation
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 |
North America
United States
Companies
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Policy and Politics
Regulation and Legislation
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 |
North America
United States
FDA
Flavours
Regulation and Legislation
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 |
North America
United States
FDA
Flavours
Policy and Politics
Regulation and Legislation
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 |
United States
FDA
Flavours
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
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 |
North America
United States
FDA
Health
Regulation and Legislation
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 |
North America
United States
FDA
Policy and Politics
Regulation and Legislation
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 |
North America
United States
FDA
Policy and Politics
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 |
North America
United States
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Flavours
Policy and Politics
Regulation and Legislation
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 |
North America
United States
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Flavours
Policy and Politics
Regulation and Legislation
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 |
North America
United States
FDA
Marketing and Retailing
Regulation and Legislation
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 |
California
North America
United States
FDA
Health
Policy and Politics
Regulation and Legislation
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 |
North America
United States
Companies
FDA
Health
Regulation and Legislation
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 |
North America
United States
Companies
FDA
Major brands
Marketing and Retailing
Regulation and Legislation
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 |
North America
United States
FDA
Health
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 |
North America
United States
Companies
FDA
Regulation and Legislation
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 |
North America
United States
FDA
Flavours
Health
Policy and Politics
Regulation and Legislation
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 |
North America
United States
FDA
Health
Regulation and Legislation
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 |
North America
United States
FDA
Flavours
Regulation and Legislation
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 |
North America
United States
FDA
Health
Regulation and Legislation
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