Health and science

Harm-reduction strategies: how much action lies behind the talk?

1st June 2022 - Blog |

Most tobacco companies are keen to be seen supporting the concept of harm reduction, especially through reduced-risk products like e-cigarettes, heat-not-burn and pouches. But how far is their support for the idea actually having an effect on their activities right now, as well as their future direction?

MEPs Against Cancer highlight link between tobacco and beating cancer…

31st May 2022 - Alerts | Europe |

First Italian conference on tobacco harm reduction to be held…

6th May 2022 - Alerts | Europe, Italy |

New research suggests a link between vape heating mechanisms and EVALI

6th May 2022 - Business briefing |

The heating mechanisms of vaping devices may have played a part in the vaping-associated lung injury (EVALI) crisis, new research suggests. Initial theories on the August 2019 outbreak of EVALI in the US quickly linked the condition to the use of vitamin E acetate, a synthetic analogue of naturally occurring vitamin E such as would be found in food

An unwanted faceful of secondhand vapour meant a dash to hospital

19th January 2020 - Blog |

While feelings run high on both sides of the great debate over e-cigarette flavours, has one vital – potentially even life-threatening – factor been largely overlooked? My sister was recently rushed to hospital after being “vaped over” (her words) in a public car park. She says: “People would not dream of blowing cigarette smoke over […]

Austria beefs up regulatory stance with Non-Smoking Act

21st January 2019 - Regulatory briefing |

Austria has recently tightened up its regulatory stance with the Non Smoking Act (Nichtraucherschutzgesetz) restricting the purchasing age for e-cigs and similar tobacco products to 18 years old, from 1st January 2019. Previously, the minimum age for buying tobacco-related products was 16 years old.
The new age limit was voted into law in the federal parliament in April 2018, and now needs to be implemented by each state or land.

Experts, smokers and vapers to clarify UK research priorities

18th January 2019 - Regulatory briefing |

British smokers and vapers, as well as medical experts, are being asked to help define priorities for scientific research on e-cigarettes.
The E-cigarettes Priority Setting Partnership project is beginning its open consultation with an online survey consisting of just one query: “What question(s) about electronic cigarettes would you like to see answered by research?”

Industry and stakeholders react to US Surgeon General’s advisory

21st December 2018 - Regulatory briefing |

Tuesday’s advisory on e-cigarettes from US Surgeon General Jerome Adams sparked a response from relevant actors for the industry that fell along the usual lines; industry members indicated displeasure with the advisory, while some tobacco control groups and regulators parroted its talking points or generally indicated support.

Juul advances UK presence in deal with major supermarket chain

30th November 2018 - Business briefing |

Controversial US vaping firm Juul Labs has secured a deal to sell its vaping product in one of the UK’s largest supermarket chains.

The most publicised player in the US e-cigarette market started selling its vaping product in its UK stores in early November but now Juul will also be available in Sainsbury’s stores.

E-cig regulation issues are ‘not black and white’, says FDA’s Zeller

22nd October 2018 - Regulatory briefing |

Mitch Zeller, director of the Food and Drug Administration’s Center for Tobacco Products, gave a keynote address at an e-cigarette conference at New York University’s School of Law on Friday. The long-time tobacco hawk struck a surprisingly conciliatory tone, acknowledging that the issue of how to regulate e-cigs, “is not black-and-white,” and that there’s currently “a stalemate” on harm reduction strategies. Zeller also mentioned the Nasem Report, which reported reduced short-term negative health outcomes from e-cigs and that vape users are less likely to smoke cigarettes.

From cigarettes to vaping — the factors for change

26th September 2018 - Market reports |

In this report we compares data on six countries – the UK, France, Italy, the US, Russia, and Germany – to identify factors that impact consumer choice when switching to vaping, including the range of products available, distribution coverage, and affordability

Second highest notification fees in Europe: Denmark regulatory report

3rd September 2018 - Regulatory reports |

In our latest look at Denmark, we find that the country has the second highest notification fee in the EU, which amounts to about €4950 ($5771). The Danish Health Authority dismisses scientific evidence that e-cigarettes are an effective smoking cessation tool and even claims that e-cigarettes help to maintain the nicotine addiction and smoking habit.

FDA squeeze means more bad press for e-cigs

25th May 2018 - Regulatory briefing |

E-cigarettes have been hitting the headlines recently, thanks to recent actions by the US Food and Drug Administration (FDA), which has been battling against teen use, particularly Juul Labs’ Juul product. Juul has taken a large portion of the market, and it has been framed as the Pied Piper of e-cigs, supposedly luring teens to the products.

Video: Clearing the clouds: Reduced-risk and vaping regulation

27th April 2018 - Video |

EURACTIV organised a workshop to discuss the way forward in reduced-risk and vaping regulation. Pablo Cano, our head of legal analysis, has participated in the workshop that included the following questions: What are the main differences between e-cigarettes and heated tobacco products? What is the reduced risk potential in this category? What more can be […]

Hardware waste management in the EU

8th January 2018 - Regulatory reports |

The hardware and batteries used in e-cigarette products must be disposed of in line with EU legislation.
Packaging should display the crossed-out wheelie bin symbol, which indicates that hardware should be disposed of separately from normal household waste.

Finland: market grows despite strict regulation

22nd September 2017 - Market reports |

The EU’s Tobacco Products Directive (TPD) was transposed in Finland the form of the Tobacco Act, which made Finland one of the EU’s most strictly regulated countries. Market growth of 40% throughout 2016–2017 was mainly determined by increased numbers of vapers (+16%), growth of the share of daily users (30% in 2017 compared with 14% in 2016), plus an overall price increase in most e-cigarette categories.

Coming soon: deadline for product registration in the US

15th September 2017 - Regulatory briefing |

The deadline for the US Food and Drug Administration (FDA) product registrations for manufacturers is swiftly approaching. From 30th September, manufacturers need to register with the FDA and submit product lists, including labelling and advertisements, to the agency. This deadline was initially December 2016, but the FDA extended it for the industry. The deadlines differ for small and large-scale companies.

Light-touch regulation aids HnB over e-cigs in Japan

7th August 2017 - Regulatory reports |

In our latest look at Japan, we find the country is a favoured market for heated tobacco products because regulation is much lighter on tobacco than it is on nicotine-containing e-cigs. In a country where 20% of the population smoke, heated tobacco products are regulated in a similar way to tobacco in most policy areas.

Sweden’s new e-cig law transposes TPD

21st July 2017 - Regulatory reports |

E-cigarettes are regulated in Sweden by the Act on Electronic Cigarettes and Refill Containers (2017/425), which came into force on 1st July 2017. It transposed the EU’s Tobacco Products Directive (TPD) into Swedish legislation. Non-nicotine products are currently not regulated.

Indonesia: ban looks possible – when government makes its mind up

15th December 2016 - Regulatory reports |

The legal classification of e-cigarettes in Indonesia is far from clear – whether they come under regulations relating to tobacco, pharmaceutical or consumer products.
What does seem clear is that e-cigs continue to be legal for now, despite some reports last year to the contrary. It is possible they may become illegal in future. Our in-depth regulatory report looks at every aspect of e-cigarette regulation in Indonesia.

Surgeon general criticised and praised over youth vaping report

9th December 2016 - Regulatory briefing |

U.S. Surgeon General Vivek Murthy’s report on the use of e-cigarettes by young people has drawn both criticism and praise. Representatives of the industry claimed the report ignored the benefits e-cigarettes can provide to those trying to avoid cigarettes, while medical groups and other organisations praised it and its call
for action.

Vaping products under new classification in Belgium

8th December 2016 - Business briefing |

A few months after being suspended, a Royal Decree published on 28th October 2016 has finally transposed the European Tobacco Products Directive (TPD) – but with a very important change in the classification of vaping products in Belgium. From 17th January 2017, when the law comes into force, e-cigarettes and e-liquids containing nicotine will be considered consumer products, according to the latest ECigIntelligence regulatory report.

PMI bids to gain first ever FDA modified-risk approval for iQOS

6th December 2016 - Regulatory briefing |

Philip Morris International (PMI) this week submitted its iQOS technology for approval as a reduced-risk product by the U.S. Food and Drug Administration (FDA), a strategy which if successful would provide a tremendous boost to the credibility of heat-not-burn and perhaps pave the way for PMI’s partner Altria to dominate that market in the United States.

Heated tobacco in Europe: emerging regulation for a new category

26th October 2016 - Regulatory reports |

This report examines the regulation of heat-not-burn (HnB) or heated tobacco products in Europe, as well as some of the broader regulatory issues that they raise. It considers their treatment under the TPD; the question of whether they are smoking or smokeless products; and issues such as labelling, advertising and taxation. A detailed case study focuses on Italy.

Italy: light-touch TPD transposition with minimal restrictions

21st October 2016 - Regulatory reports |

Italy has adopted a light touch approach to implementing the European TPD regulations, with only minimum restrictions on the e-cigarette industry. There is only a limited ban on advertising, and no restriction on public use of e-cigs. Cross-border sales are prohibited, but domestic distance sales are allowed. Our report provides a full examination of all aspects of post-TPD e-cigarette regulation in Italy.

Netherlands: TPD followed closely, but some issues remain unresolved

20th October 2016 - Regulatory reports |

Regulation of vape products in the Netherlands follows closely the provisions of the European Tobacco Products Directive (TPD). But although the vaping industry is highly regulated, a few issues remain to be resolved, such as what laboratories will be accredited for product testing. This complete regulatory report examines in detail every aspect of e-cigarette regulation in the Netherlands.

FDA demands health documents from U.S. makers and importers

18th October 2016 - Regulatory reports |

Following the introduction this summer of the deeming regulations by the U.S. Food and Drug Administration (FDA), each vapour product manufacturer or importer is required to submit health documents describing the physiological, behavioural and toxicological effects of their tobacco products, current or future.

E-cigarette researchers outraged by charities’ “threatening” letters

11th October 2016 - Marketing & retailing , Regulatory briefing |

Scientists and researchers have said that anti-smoking charities are acting like the anti-Communist zealots of the 1950s McCarthy era in trying to keep them away from an international conference on tobacco and nicotine. One public-health expert said: “The tactic is to say ‘tobacco industry’ like senator Joseph McCarthy would once say ‘communist’ and assume that […]

Required warning statements on U.S. advertisements

23rd September 2016 - Regulatory reports |

The U.S. Final Deeming Rule requires that the advertisements of all covered tobacco products, including e-cigarettes, bear an addictiveness warning label statement. For tobacco products that do not contain nicotine, there is an alternative warning label statement for packages and advertisements.

Croatia regulatory report: TPD finally being transposed

23rd September 2016 - Regulatory reports |

E-cigarette products are in the process of being regulated in Croatia, by transposing the Tobacco Product Directive (TPD), once the government is established. We expect the Draft Act on Restriction of the Use of Tobacco Products to be passed by the end of 2016, or early 2017. The delay in transposition led the European Commission (EC) to take an infringement decision against Croatia.

Smoking, vaping, free will, demonic possession and tax

2nd September 2016 - Regulatory briefing |

Nearly all smokers would be better off moving to lower-risk alternatives than giving up nicotine completely; taxing e-cigs has no rational justification; society should be prepared for more non-smokers to take up vaping; and tobacco control is often built on a “demonic possession theory”. These are among the conclusions of a provocative new paper published by the Institute of Economic Affairs and written by Carl V. Phillips.

Russia: regulations expected by 2017

5th August 2016 - Regulatory reports |

  There may be more recent ECigIntelligence reports on this territory. Please visit the home page for Russia or the advanced search page.         Executive summary   • E-cigarette products are mainly unregulated in Russia, aside from general consumer and safety regulation. • Several initiatives to regulate policy are currently being discussed at the State Duma. […]

New Netherlands study reviews danger from exhaled vapour

2nd August 2016 - Regulatory briefing |

A recent study and review by the National Institute for Public Health and the Environment in the Netherlands has brought to the fore questions regarding e-cigarette vapour testing methods and the possible health risks of passive vaping. The rationale for banning e-cigs in enclosed public places falls into two main camps: ‘renormalisation’ of smoking and […]

Deeming regs: challenges to the sampling ban

29th July 2016 - Regulatory reports |

When the U.S. deeming regulations come into effect on 8th of August, the distribution of free e-liquid samples will be prohibited in the U.S. The U.S. Food and Drug Administration (FDA) justifies this ban as necessary for the protection of the public health but retailers believe it will undermine their profits without having a noticeable public health benefit. What challenges follow?

Making a myth: teens, e-cigs, science and the media

25th July 2016 - Regulatory briefing |

A new U.S. study claiming to show a link between youth e-cigarette use and tobacco smoking has not only been criticised by many scientists working in the field, but also demonstrates how misconceptions and misinformation on the topic of vaping spread through the media.

EU study finds “highest rate of smoking cessation ever”

27th June 2016 - Regulatory briefing |

However badly Britain’s skeptical Brexiters may feel the European Union has failed them, it appears to have delivered a big new prize to advocates of vaping: new research showing that 6.1m Europeans have given up smoking with the use of electronic cigarettes, with possibly the highest quit and reduction rates yet seen in a population survey.

The deeming rule and PMTAs: what it all means for manufacturers

26th June 2016 - Regulatory reports |

    There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page.       Introduction   On 10th May, the U.S. Food and Drug Administration (FDA) finalised its regulations that deemed tobacco products to be subject to the federal Food, Drug, and Cosmetic Act. […]

Third Indian state bans e-cigs, citing youth addiction

21st June 2016 - Regulatory briefing |

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.

Cessation evidence unclear, but second-gen devices may help

24th May 2016 - Regulatory briefing |

A new systematic review of e-cigarettes and smoking cessation is claimed to be the most comprehensive so far as it covers not only published, peer-reviewed studies – including observational research as well as RCTs – but also so-called “grey literature”, material published outside of peer review.

E-cig science: do meta-analyses really matter?

5th April 2016 - Regulatory briefing |

In the past year or so, scientists have conducted several systematic reviews that aim to analyse research evidence in order to find whether e-cigs help people quit smoking. The issue addressed by studies like these (which can also be known as meta-analyses) is, of course, one of the primary public-health and policy questions about the devices. But how much value should we place on their findings?

U.S. state and federal regulation: what to expect in 2016

10th February 2016 - Regulatory reports |

More vapour-related bills were introduced during the 2015 state legislative sessions than ever before, and ECigIntelligence expects even more vapour regulation to be proposed during the 2016 regular session. This report looks at the current regulatory situation across the U.S. in key areas such as manufacturing, labelling, advertising and marketing, public place usage, youth access and taxation, and forecasts the regulatory trends for 2016.

Updated: Germany’s draft TPD plans and beyond

19th January 2016 - Regulatory reports |

Introduction • Regulatory landscape • Current national regulatory framework • National regulatory framework post-TPD • Age restrictions • Product restrictions • Ingredients • Labelling and packaging • Product notification • Annual reporting • Vigilance • Retailing • Public usage • North Rhine-Westphalia • Bavaria • Baden-Württemberg • Lower Saxony • Hesse • Public usage: an inconsistent future? • Advertising and marketing • Taxation • Enforcement • Case law: e-cigarettes as medical products • Case law: e-cigarettes as tobacco products • Case law: tobacco advertising restrictions • The missing pieces from the TPD jigsaw • Graphic: how German e-cigarette regulation will change

CDC report on kids and e-cig advertising may be flawed

12th January 2016 - Marketing & retailing , Regulatory briefing |

As the advertising spend of U.S. e-cigarette suppliers escalates, they are continuing to use themes such as independence, rebellion and sex to sell their products – and their advertisements are prompting interest among the many young people who see them, according to a critical report from the Centers for Disease Control and Prevention (CDC). Yet some of the data relied upon by the CDC appears to raise questions of accuracy and relevance.

Big Tobacco encouraged by research on heat-not-burn

7th December 2015 - Business briefing |

Are big tobacco companies starting to favour heat-not-burn technology over e-cigarettes? While none has shown any signs of overtly stepping away from e-cigs, and such a move is unlikely, much enthusiasm and investment within the tobacco industry seems to be going toward heat-not-burn.

Flavour important for under-age U.S. vapers

29th November 2015 - Regulatory briefing |

Most underage vapers in America prefer the taste of mint, clove, fruit, chocolate, or alcohol to plain nicotine juice. More than 80 per cent of the 1,450 teenage respondents who had experimented with e-cigs said that their first ever puff was flavoured. The only products more likely to be flavoured when teens first tried them […]

Dual users experience significantly lower CO levels

29th November 2015 - Regulatory briefing |

It sounds like common sense: if people smoke fewer conventional cigarettes because they are using e-cigs as well, you would expect them to be exposed to fewer harmful substances. And that’s what a study has found after examining the effects on a group of smokers who were trying to quit by using e-cigs, although other […]

Hungary regulatory report: an end to mandatory pharma licensing

13th November 2015 - Market reports , Regulatory reports |

Hungary’s transposition of the EU Tobacco Products Directive will do away with the current mandatory pharmaceutical licensing requirement for e-cigarettes – which has resulted in no nicotine-containing products being legal in the country – and allow them to be sold as consumer products. As this great change approaches, our in-depth report on Hungary includes: Regulatory landscape • Current national regulatory framework • Age restrictions • Packaging and product restrictions • Notification requirements • Retailing restrictions (including cross-border and distance sales) • Public usage • Advertising and marketing restrictions • Taxation • Case law • Enforcement • The missing pieces of the TPD jigsaw • Graphic: how Hungarian e-cigarette regulation will change

PMTAs: the road to FDA approval for e-cigarette products

12th November 2015 - Regulatory reports |

Executive summary • Introduction • Why an electronic nicotine delivery system (ENDS) product requires a PMTA: distinction among ENDS products, components/parts, and accessories; three pathways to market approval; concerns about the grandfather date • Guidance for industry: information on premarket tobacco product applications (PMTA) and the submission process • Public health considerations: scientific evidence, comparative analysis, voluntary restrictions on sale and distribution, nicotine exposure warnings, child-resistant packaging, alternatives to new scientific studies, government-sponsored databases, non-U.S. randomised controlled clinical trials, literature reviews or reports • FDA enforcement for manufacturers and retailers: enforcement limited to finished tobacco products; independent vapour shops considered as tobacco product manufacturers • Appendix 1: definitions • Appendix 2: submitting a PMTA

Regulatory report: UK gears up for fragmented TPD transposition

3rd November 2015 - Regulatory reports |

  There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United Kingdom or the advanced search page.     Introduction The central government has started to transpose the Tobacco Products Directive (TPD). At the same time, the regional government of Wales wants to impose a smoking-style public place usage restriction while […]

E-cigarettes in the UK: regulations, politics, and consultations

2nd November 2015 - Regulatory reports |

  There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United Kingdom or the advanced search page.       To provide further insight on the developing UK regulatory scene for e-cigarettes, we have collated this in-depth companion to Regulatory report: UK gears up for fragmented TPD transposition for ECigIntelligence readers. […]

E-cigarette regulation in Germany: the draft TPD plans and beyond

14th October 2015 - Regulatory reports |

Introduction • Regulatory landscape • Current national regulatory framework • National regulatory framework post-TPD • Age restrictions • Product restrictions • Ingredients • Labelling and packaging • Product notification • Annual reporting • Vigilance • Retailing • Public usage • North Rhine-Westphalia • Bavaria • Baden-Württemberg • Lower Saxony • Hesse • Public usage: an inconsistent future? • Advertising and marketing • Taxation • Enforcement • Case law: e-cigarettes as medical products • Case law: e-cigarettes as tobacco products • Case law: tobacco advertising restrictions • The missing pieces from the TPD jigsaw • Graphic: how German e-cigarette regulation will change