LATEST ALERTS
France relents on rules for retailer signage and displays
21st June 2016 - News analysis |
France seems likely to mildly relax its rules on point-of-sale advertising for e-cigarettes.
Regulation and Legislation
Third Indian state bans e-cigs, citing youth addiction
21st June 2016 - News analysis |
The Indian state of Karnataka has become the third to ban e-cigarettes. It follows Maharahstra and Punjab in what appears likely to become a subcontinental trend, as India’s tobacco control tightens and grave concerns about the health risks of vaping are repeatedly pronounced by officials.
West Virginia politician is latest to contest deeming rule in court
19th June 2016 - News analysis |
The U.S. Food and Drug Administration (FDA) is facing another legal challenge to its new deeming regulation on e-cigarettes. Filed in the Southern District of West Virginia on 10th June, the action was taken by Larry W. Faircloth, a Republican member of West Virginia’s House of Delegates who is described as a user of e-cigarette devices and liquid nicotine.
All UK “lite” brands will have to change their names
17th June 2016 - Marketing & retailing , News analysis |
All British e-cigarette brands marketed as “lite” will have to change their names in order to comply with the EU Tobacco Products Directive (TPD), at an estimated cost of £23m (€30m, $33m).
Full version of EU’s Common Entry Gate is now online
16th June 2016 - News analysis |
The EU’s Common Entry Gate for e-cigarette product notifications is now fully up and running – and manufacturers who used the interim version launched in May have only until 24th June to transfer those submissions onto the new system.
Deeming regulations: many vapers ignorant, majority blissful
14th June 2016 - News analysis |
The majority of American vapers were unaware of the new deeming regulations for e-cigarettes from the U.S. Food and Drug Administration (FDA) until they were published last month – and many may remain so, a new survey seems to imply.
Could e-cigarettes be the next battleground for plain packaging?
10th June 2016 - Regulatory reports , Topic regulatory reports |
As the tobacco industry braces itself for a global epidemic of plain-packaging legislation, there have been calls for the controversial measure to be applied to e-cigarettes too.
Austrian online retailers prepare to do battle with government
9th June 2016 - News analysis |
Online e-cigarette retailers in Austria are challenging the country’s planned ban on distance sales.
European parliamentarians call for review of TPD science
7th June 2016 - News analysis |
Two British members of the European Parliament have asked the EU to take the first steps in reassessing the scientific information that supports its Tobacco Products Directive (TPD).
Sweden prepares for consumer regulation after court decision
6th June 2016 - Country regulatory reports , Regulatory reports |
Draft legislation to transpose Article 20 of the Tobacco Products Directive into Swedish national legislation will be in force by October 2016. The Swedish government is taking quite a lenient approach by allowing distance sales and omitting public place vaping provisions from their planned legislation.
Signs of policy relaxation in New Zealand, but Australia remains strict
6th June 2016 - News analysis |
The attitudes of New Zealand’s policy-makers to e-cigarettes seem to be growing more liberal than those of their counterparts in Australia, with the smaller nation edging toward greater tolerance of vaping while the larger maintains an unforgiving stance.
Germany’s post-TPD journey begins; further rules on the way
1st June 2016 - Country regulatory reports , Regulatory reports |
Contents1 Executive summary2 Regulatory landscape3 Previous regulatory framework4 National regulatory framework post-TPD5 Age restrictions6 Product restrictions7 Ingredients8 Labelling and packaging9 Product notification10 Annual reporting11 Vigilance12 Retailing13 Public usage14 Public usage: an inconsistent future?15 Advertising and marketing16 Taxation17 Enforcement18 Case law: e-cigarettes as medical products19 Case Law: e-liquid and nicotine20 The missing pieces from the TPD jigsaw21 Graphic: how German e-cigarette regulation » Continue Reading.
Second e-liquid company sues FDA over deeming regulations
25th May 2016 - News analysis |
E-liquid maker Lost Art Liquids has filed suit against the U.S. Food and Drug Administration (FDA), claiming that the deeming regulations violate two parts of the U.S. Constitution and two important statutes.
Plans for vaping ban in Wales are officially abandoned
24th May 2016 - News analysis |
The proposed Welsh public vaping ban is officially dead.
Greece decides to tax e-liquids, opts for flat-rate model
24th May 2016 - News analysis |
Greece is to become the fifth European country to tax e-liquids. A new levy of €0.10 per millilitre will go into effect on 1st January 2017.
PMTAs and substantial equivalence: the deadlines and the grace periods
24th May 2016 - Regulatory reports , Topic regulatory reports |
E-cigarette manufacturers will have more than two years to prepare premarket review applications for the U.S. Food and Drug Administration (FDA).
Infographic: deeming regulations compliance for existing products
20th May 2016 - Regulatory reports , Topic regulatory reports |
Infographic showing compliance dates for existing e-cigarette and ENDS products under the new FDA deeming regulations.
French government hammering out last details of transposition
20th May 2016 - News analysis |
The final shape of France’s TPD transposition is becoming clearer following the presentation this week of an ordonnance to the Council of Ministers.
Deeming regulations in detail: the deadlines for initial compliance
20th May 2016 - Regulatory reports , Topic regulatory reports |
In this ECigIntelligence report, we examine in detail the schedule for the U.S. deeming regulations’ major requirements affecting products that already exist on 8th August 2016, which will bring them into compliance with the regulations for the short term.
EU’s notification gateway is not ready in time for TPD
20th May 2016 - News analysis |
The EU may be resorting to Excel spreadsheets and email after failing to get its online gateway for e-cigarette manufacturers up and running by today’s deadline.
TPD does a good job on nicotine safety, says European Commission
20th May 2016 - News analysis |
The EU’s new Tobacco Products Directive (TPD) and national legislation are broadly sufficient to protect the public from nicotine poisoning, an official European study has concluded. But it does recommend further consumer education on the risks of ingestion, as well as tight control of industrial nicotine.
Most online vendors are disregarding distance sales bans
20th May 2016 - News analysis |
Europe’s online e-cigarette vendors are so far overwhelmingly ignoring new Internet sales bans where they exist, and taking full advantage of delays in legislation where they can.
Right on deadline, Ireland transposes the TPD
20th May 2016 - News analysis |
The Republic of Ireland has succeeded in transposing the EU’s Tobacco Products Directive (TPD) at the eleventh hour, with recently-appointed health minister Simon Harris signing the necessary regulations to come into force today.
The TPD: access all our latest news, reports and trackers
20th May 2016 - News analysis |
This page provides you with links to all ECigIntelligence coverage of the EU Tobacco Products Directive (TPD) since 1st January this year.
Almost half of member states are late with TPD transposition
20th May 2016 - News analysis |
Nearly half of EU member states look likely to miss today’s deadline for fully transposing the Tobacco Products Directive (TPD) into local law.
What it means for business: a non-lawyer’s guide to TPD compliance
20th May 2016 - News analysis |
We summarise the essential requirements of the EU Tobacco Products Directive for e-cigarette firms.
British e-cig industry reluctantly, resentfully ready for TPD
20th May 2016 - News analysis |
UK e-cig firms feel as prepared as they can be for the implementation of the EU Tobacco Products Directive (TPD), but many would still have liked to see it overturned by the European Court of Justice in the Totally Wicked case.
Only distant cousins: the TPD and the U.S. deeming regulations
20th May 2016 - News analysis |
Although the EU’s Tobacco Products Directive (TPD) and the U.S. deeming regulations are coming into effect almost simultaneously this summer, their approaches could hardly be more different.
Distance sales bans set to transform a €140m online market
20th May 2016 - Market reports , Topic market reports |
Eleven of the European Union’s 28 member states will ban online e-cigarette sales as part of their implementation of the EU Tobacco Products Directive (TPD). We explore the likely impacts.
The EU Tobacco Products Directive (TPD): essential facts
19th May 2016 - News analysis |
Essential facts about the new EU Tobacco Products Directive and its rules for e-cigarettes, which come into practical effect on 20th May 2016.
FDA expects many products to disappear as new regime takes effect
19th May 2016 - Market reports , Topic market reports |
The number of products on the U.S. e-cigarette market will contract sharply after the new deeming regulations come into full effect, according to their architect the Food and Drug Administration (FDA) – and its predictions suggest a sudden slowdown in innovation too.
Anger, disappointment and fear for the future in America’s vape stores
14th May 2016 - News analysis |
Small independent vape stores in the U.S. are almost universally negative in their reaction to the new deeming regulations.
Major changes to Europe’s e-cig sales channels imminent
13th May 2016 - Market reports , Topic market reports |
From May 2016, e-cig sales channels will be reduced in some European countries when the Tobacco Products Directive comes into force. This report looks at the details, including restrictions on distance sales, the imposition of age verification checks, licensing and registration of retailers, and limitations on retail outlets.
FDA to regulate zero-nicotine e-liquid, synthetic nicotine
13th May 2016 - News analysis |
How will the new U.S. deeming regulations cover nicotine-free e-liquids and synthetic nicotine?
The new deeming regulations: all our stories so far
13th May 2016 - News analysis |
This page provides you with links to all ECigIntelligence coverage of the U.S. deeming regulations published on 5th May.
Democrats welcome FDA regulations, and ask for more
12th May 2016 - News analysis |
Members of the U.S. Congress, mostly Democrats, continue to welcome the Food and Drug Administration’s deeming rule extending its authority over tobacco to e-cigarettes and other products.
Some are sanguine, but PMTA fine print causes concern
12th May 2016 - News analysis |
Some larger independent e-cigarette companies support the new rules from the U.S. Food and Drug Administration (FDA), despite the debate over them being widely portrayed as an argument between Big Tobacco and health organisations on one side versus indie e-cig firms on the other.
UK regulatory and medical bodies proffer broad views before TPD
11th May 2016 - Regulatory reports , Topic regulatory reports |
Contents1 Executive summary2 Introduction3 Medical organisations’ position towards e-cigs4 Politics and e-cigs in the United Kingdom5 Summary of consultation questions6 Information sought by the regulator in the UK consultation process There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United Kingdom or the advanced search page.
Executive summary » Continue Reading.
Thoughtful, puritanical, or just plain “huh”? How the media reacted
10th May 2016 - News analysis |
U.S. media reactions to the new deeming rule ran the gamut from praise for an FDA which had produced “sensible regulations”, to damning criticism for an agency which will supposedly do more to promote smoking than to stop it.
E-cig maker Nicopure files lawsuit against FDA deeming regulations
10th May 2016 - News analysis |
A U.S. e-cigarette maker has begun what may be the first of many lawsuits against the new deeming regulations from the Food and Drug Administration (FDA).
UK fragmented on regulation as TPD fast approaches
10th May 2016 - Regulatory reports , Topic regulatory reports |
Contents1 Introduction2 Regulatory landscape3 Devolved administrations4 National regulatory framework5 Near future situation in devolved administrations6 Product categorisation7 Information requirements8 Additional obligations in UK devolved countries9 Retail channels (cross-border sales)10 Age restrictions11 Product and packaging restrictions12 Labelling and information requirements13 Public usage14 Advertising and marketing restrictions15 Case law16 Taxation17 Enforcement18 Appendix 1 – Relevant consumer and safety laws19 Appendix 2 – » Continue Reading.
PMTAs can use many kinds of scientific support, FDA says
10th May 2016 - News analysis |
The U.S. Food and Drug Administration (FDA) believes most e-cigarette manufacturers will need to conduct fresh scientific research in order to obtain authorisation for their products under the newly-published deeming regulations – but not necessarily full-blown clinical studies.
FDA will encourage sharing of scientific information on e-liquids
10th May 2016 - News analysis |
Compliance with the new U.S. deeming regulations could be eased by the sharing of information among manufacturers and other stakeholders, says the Food and Drug Administration (FDA).
Two years of subtle change and clarification in the deeming rule
9th May 2016 - News analysis |
Differences between the FDA’s final deeming regulations and its 2014 draft version reveal many changes in areas ranging from retailing and health warnings to compliance timetables and product definitions.
Labelling is focus of conflict between federal and local law
9th May 2016 - News analysis |
The new deeming regulations from the U.S. Food and Drug Administration (FDA) will limit the regulatory authority of states and localities in a wide range of areas, with e-cigarette labelling proving to be one of the most contentious.
Deeming regulations: no more store-branded e-liquids?
6th May 2016 - News analysis |
The era of vape stores producing their own e-liquids is likely to come to an end after the introduction of the deeming regulations in the U.S., the agency responsible for them predicts. The Food and Drug Administration (FDA) says it “expects that most vape shops will stop mixing e-liquids“ because if they continue to do so they will fall under » Continue Reading.
The deeming regulations and the TPD: restrictive in different ways
6th May 2016 - News analysis |
While the U.S. deeming regulations and the EU’s TPD will come into effect almost simultaneously this summer, bringing some regulatory consistency and clarity to the world’s largest e-cigarette markets, their approaches could hardly be more different.
Washington reaction: “mystery chemicals” and “over-reach”
6th May 2016 - News analysis |
Several members of Congress welcomed what they view as a long-overdue rule by the U.S. Food and Drug Administration (FDA) to regulate e-cigarettes, but the initial responses also provided another opportunity for Democrats and Republicans to show how divided they are when it comes to adding new federal oversight.
Deeming regulations: mixed views from industry, health experts
6th May 2016 - News analysis |
Initial industry reaction broke down largely along expected lines – with many of the usual faces popping in with early assessments. Further reaction is expected as more people get to grips with the massive U.S. Food and Drug Administration (FDA) regulatory document.
FDA faced hard decisions, criticism in crafting regulations
5th May 2016 - News analysis |
Striving for science-based policy-making in the deeming regulations, the FDA faced a tough task in attempting to corral the rapidly-developing and often contradictory data on e-cigarettes at the same time as it was dealing with pleas and criticisms from the industry and pressure groups.
