Regulatory and market intelligence for the e-cigarette sector
The US Food and Drug Administration (FDA) regulates the manufacture, import, packaging, labelling, advertising, promotion sale and distribution of electronic nicotine delivery systems (ENDS) so it plays a key role in the US e-cigarette industry.
Keep up to date with the latest developments at the ECigIntelligence FDA hub, where we keep all of our briefings and reports on the FDA and its regulation of e-cigarettes.
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
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
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
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
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
Will a new political era in the US mean a new regulatory landscape for e-cigarettes?
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)
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
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
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
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
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
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
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”
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 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?
The US Senate has confirmed cancer specialist Stephen Hahn as the new US Food and Drug Administration (FDA) commissioner
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
President Trump has softened his position on a possible US flavour ban, and also endorsed a national minimum vaping age of 21
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
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
US president Donald Trump has nominated lung cancer specialist Stephen Hahn to be the new full-time US Food and Drug Administration (FDA) commissioner
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
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
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
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
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 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
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
The Food and Drug Administration is responsible for protecting the public health by regulating tobacco products and reducing tobacco use by minors.
Before any product the FDA defines as tobacco – which includes ENDS – can be marketed in the US, the manufacturer has to submit a premarket tobacco product application (PMTA) to the FDA. The application needs to show that placing the product on the market would be “appropriate for the protection of the public health”.
This application is then reviewed by the FDA and either approved or rejected. The FDA has been cracking down on all vaping products that are not PMTA approved and issuing warning letters to manufacturers that are not compliant with regulations.
However, now there is a new administration in the White House and it’s yet to be seen what impact that Biden will have on the FDA’s stance towards ENDS. And how long will the FDA take to look through the thousands of PMTA applications that it has received?
Watch this space for further details.
Sign up to access our business and regulatory briefings and get the most updated news, insights and our expert analysis to keep you on top of worldwide industry trends.
By signing up you agree to our Terms and Conditions Please note trial access may take up to 24 hours to be granted as access must be qualified by a member of the ECigIntelligence team.
