LATEST ALERTS
To ban or not to ban, that is the question over e-cigs during COVID-19 pandemic
17th August 2020 - Blogs |
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
FDA issues warning to Puff Bar days after company drops all US sales
21st July 2020 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 , Topic 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 - News analysis |
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 - News analysis |
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 - News analysis |
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 , Topic 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 - News analysis |
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 , Topic 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 - News analysis |
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 - News analysis |
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 , Topic 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 - News analysis |
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 , Topic 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 - News analysis |
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 - Marketing & retailing , News analysis |
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 - News analysis |
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 - News analysis |
The US FDA has granted 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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 , News analysis |
“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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 , Topic 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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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
