FDA
US regulatory report: synthetic nicotine products – what’s next?
27th April 2022 - Regulatory reports , Topic 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 - Blogs |
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 - News analysis |
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 - Blogs |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - Blogs |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - Blogs |
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 - News analysis |
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 - Blogs |
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 - News analysis |
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 - Blogs |
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 - News analysis |
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 - News analysis |
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 , Topic 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 - News analysis |
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 - News analysis |
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 - News analysis |
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 - News analysis |
“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 - Blogs |
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