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.
“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
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
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
The US Food and Drug Administration (FDA) has rescinded its marketing denial order (MDO) affecting 14 Turning Point Brands products, saying “relevant information that was not adequately assessed”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 (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”
A presentation given by Tim Phillips, ECigIntelligence managing director, to the ENDS US Workshop in October 2021
Some light is now dawning on some truths long since suspected about the US Food and Drug Administration (FDA)’s evaluation of e-cigarettes
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
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
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
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
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
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
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?
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)
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?
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
31 US state attorneys want to ban all non-tobacco flavours, including menthol, from e-cigarettes – but is their plea helpful, appropriate or logical?
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
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
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
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
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
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
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
An analysis of the long-awaited list of PMTA applications that was recently published by the US Food and Drug Administration
An analysis of the long-awaited list of PMTA applications that was recently published by the US Food and Drug Administration
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”
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
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
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
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
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
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
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
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
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.
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