Regulation and Legislation

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

12th November 2015 - Regulatory reports |

North America
United States
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Technology and Innovation
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

Q&A: what happens next with the deeming regulations?

6th November 2015 - Regulatory briefing |

North America
United States
Regulation and Legislation
Regulatory briefing

Introduction • Why is the OIRA required to review the final deeming rule before publication? • How many regulatory actions does the OIRA review at any given time? • When is the deadline for the OIRA to complete its review of the deeming regulations? • When will the OIRA most likely hand the regulations back to the FDA? • Why does ECigIntelligence believe the earliest date the final deeming rule will be published is in the spring of 2016? • What does the senators’ letter to the OIRA mean?

Regulatory report: UK gears up for fragmented TPD transposition

3rd November 2015 - Regulatory reports |

England
EU
Europe
Scotland
United Kingdom
Wales
Health
Market Research
Policy and Politics
Regulation and Legislation
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 |

Europe
Scotland
United Kingdom
Wales
Health
Market Research
Marketing and Retailing
Policy and Politics
Regulation and Legislation
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. […]

“Leaked deeming regulations” raise questions, offer few answers

29th October 2015 - Regulatory briefing |

North America
United States
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

An e-cigarette industry association this week claimed to be in possession of the U.S. Food and Drug Administration’s forthcoming deeming regulations, but the provenance and authenticity of the brief excerpts that it published remain unclear.

Washington state prosecutes e-cig firms over “organic” claims

29th October 2015 - Regulatory briefing |

North America
United States
Washington
Companies
Marketing and Retailing
Regulation and Legislation
Regulatory briefing

The state of Washington has brought charges against e-cigarette firms for wrongly claiming organic status on their products. This move is part of a wider trend by state attorneys general to crack down on marketing of e-cigarette products without e-cig specific legislation in place.

The UK e-cigarette market, October 2015

29th October 2015 - Market reports |

Europe
Scotland
United Kingdom
Wales
Market Research
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Market reports

The UK market in 2015 is estimated to be worth around £445million (€619m/$682m), with projected growth of 15% over the next two years. There has been a significant shift to tank, with usage of tanks now at 68% of the vaping population.

Presentation: the state of the e-cigarette industry

27th October 2015 - Business briefing |

Europe
North America
United Kingdom
United States
Market Research
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Business briefing

Exclusive insight for ECigIntelligence readers – download a detailed, data-rich presentation on the current state and future of the e-cig industry.

Video: municipal e-cig taxation in the United States

27th October 2015 - Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing

Why are local governments in the U.S. approving new taxes on e-cigarettes? ECigIntelligence’s regulatory analyst Carly Souther uncovers the reasons, identifies the trendsetters and discusses the outlook for municipal taxation of the vaping industry in our exclusive video presentation.

Deeming regulations reach their final hurdle: the White House

21st October 2015 - Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing

Federal control has come a step closer for the U.S. e-cigarette market this week, with the Food and Drug Administration (FDA) sending its proposed deeming regulations to the White House office responsible for their final review.

Opinion: why zoning is the next big threat to America’s vape stores

16th October 2015 - Regulatory briefing |

California
Florida
Georgia
Illinois
New York
North America
Oregon
United States
Utah
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

The gravest threat to the U.S. vapour industry comes from local government. While state-level attempts to regulate the industry have been largely unsuccessful, hundreds of local laws have come into force.

Italy opts for minimal regulation in draft TPD law

16th October 2015 - Regulatory briefing |

EU
Europe
Italy
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

The e-cigarette industry in Italy appears likely to receive gentle regulatory treatment from the government’s forthcoming implementation of the European Union Tobacco Products Directive (EU TPD).

Washington conferences to consider deeming regs, harm reduction

16th October 2015 - Regulatory briefing |

North America
United States
Virginia
Washington D.C.
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

As the U.S. e-cig industry and policy-makers alike await the final version of the Food and Drug Administration’s deeming regulations, two conferences will be held in the Washington area next week to discuss a spectrum of issues related to tobacco and nicotine policies.

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

14th October 2015 - Regulatory reports |

EU
Europe
Germany
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
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

Farsalinos: e-cigs need a fresh legal approach

2nd October 2015 - Regulatory briefing |

EU
Europe
North America
United States
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

Two of vaping’s most eminent scientific advocates have called for bespoke regulatory regimes that follow neither the tobacco nor the pharmaceutical model, but they acknowledge that formulating appropriate rules can be a “very challenging process”.

Tobacco product or medical? FDA spells out the difference

24th September 2015 - Regulatory briefing |

North America
United States
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Technology and Innovation
Regulatory briefing

The U.S. Food and Drug Administration (FDA) is this week proposing a new rule that will make it clearer when tobacco products should be considered as drugs or medical devices, and regulated accordingly.

FDA enforcement on e-cigarette suppliers: risks and strategies

23rd September 2015 - Market reports |

North America
United States
Companies
Health
Marketing and Retailing
Regulation and Legislation
Technology and Innovation
Market reports

Executive summary • Introduction • FDA enforcement authority • Development of FDA e-cigarette enforcement • Compliance strategies for the industry • Risk posed by patents

Ireland allows vaping in workplaces, but tightens ad rules

23rd September 2015 - Regulatory briefing |

EU
Europe
Ireland
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

The Irish government has decided not to extend the country’s smoking ban to e-cigarettes, citing the lack of evidence for harm – but the advertising self-regulatory body in Ireland has taken a slightly harder line.

Obama names deputy commissioner Califf to head FDA

16th September 2015 - Regulatory briefing |

United States
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

U.S. president Barack Obama has chosen Rob Califf, currently the deputy commissioner for medical products and tobacco at the Food and Drug Administration (FDA), to head up the agency.

Podcast: state regulation of public vaping in the U.S.

16th September 2015 - Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing

In this exclusive 20-minute podcast for ECigIntelligence, our U.S. regulatory analyst Carly Souther explores the current situation with state regulation of public vaping, and examines its potential implications.

Regulation key to success of tobacco alternatives, say PMI and Altria

11th September 2015 - Regulatory briefing |

Europe
Italy
North America
United States
Companies
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Technology and Innovation
Regulatory briefing

Tobacco giant Philip Morris International (PMI) wants to see alternative products take a large share of the nicotine market away from combustible cigarettes as soon as possible – with the help of appropriate regulation.

Portugal adds public vaping ban to new TPD law

7th September 2015 - Regulatory briefing |

Europe
Portugal
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

Portugal has become the latest European Union member state to implement the EU’s Tobacco Products Directive (TPD), hewing closely to its requirements but also introducing a public vaping ban with limited exceptions.

E-cigarette regulation in Portugal: TPD plans become clear

6th September 2015 - Regulatory reports |

EU
Europe
Portugal
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

Introduction • Regulatory landscape • Current regulatory framework • Product categorisation • Age restrictions • Product restrictions • Notification procedure • Public usage • Advertising and marketing restrictions • Cross-border sales • Taxation • Case law • Enforcement • Conclusions • Graphic: how Portuguese e-cigarette regulation will change

“Most online e-cig vendors make false claims,” says watchdog

4th September 2015 - Regulatory briefing |

United States
Marketing and Retailing
Regulation and Legislation
Regulatory briefing

The majority of U.S. e-cig vendors make unsupported claims on their Websites, a watchdog group has charged after surveying the online presence of 159 companies. Truth in Advertising (TINA), a nonprofit based in Connecticut, examined the firms’ online content including “social media, testimonials, [and] links to studies or media reports” – not just advertising in […]

E-cigarette regulation in Poland: the road ahead

2nd September 2015 - Regulatory reports |

EU
Europe
Poland
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

Executive summary • Introduction • Current national regulatory framework • Age restrictions • Product and packaging restrictions • Retail channels • Notification procedure • Public place usage • Advertising restrictions • Taxation • Case law • Enforcement • The missing pieces from the TPD jigsaw

E-liquid additives: untangling the testing dilemma

31st August 2015 - Business briefing |

Canada
EU
Europe
North America
United Kingdom
Health
Regulation and Legislation
Technology and Innovation
Business briefing

Differing limits set by e-cigarette manufacturing associations for diacetyl and acetylpropionyl in e-liquids seem likely to lead to confusion and acrimony.

FDA rebukes tobacco firms: don’t make modified-risk claims

27th August 2015 - Regulatory briefing |

North America
United States
Companies
Health
Marketing and Retailing
Regulation and Legislation
Regulatory briefing

The U.S. Food and Drug Administration (FDA) has warned tobacco companies including R.J. Reynolds and Imperial Tobacco to stop describing some of their combustible cigarettes as “additive-free” or “natural”.

Watch out, there’s a state attorney general about

24th August 2015 - Regulatory reports |

California
Indiana
Kentucky
Maine
New York
North Carolina
Ohio
United States
Washington
Policy and Politics
Regulation and Legislation
Regulatory reports

Executive summary • Introduction • The powers of attorneys general • AG attitudes to the e-cigarette industry • Advertising and marketing • Child-proof packaging • Age verification systems • Consumer protection • Attorney general co-operation

FDA grants more time for comments on child-proofing

21st August 2015 - Regulatory briefing |

United States
Policy and Politics
Regulation and Legislation
Technology and Innovation
Regulatory briefing

The U.S. Food and Drug Administration (FDA) has extended the deadline for commenting on its questions about e-cigarette warning labels and child-proofing, saying that prospective respondents have asked for additional time.

Developing nations advised to adopt pharma model

21st August 2015 - Regulatory briefing |

Africa
Asia
China
South America
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

Governments of poorer countries need to regulate e-cigarettes just as much as their wealthier counterparts, and ought to opt for a pharmaceutical model – but they may find it difficult, according to a new paper by two U.S. academics.

Uganda bans e-cigarettes in tough new tobacco law

18th August 2015 - Regulatory briefing |

Africa
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

The east African nation of Uganda appears to have become one of the small handful that ban e-cigarettes altogether, rolling a blanket prohibition into a stiff new tobacco control act.

E-cigarette regulation and outlook for Bulgaria, August 2015

18th August 2015 - Regulatory reports |

Bulgaria
EU
Europe
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

Regulatory landscape • Current national regulatory framework • Age restrictions • Packaging and product restrictions • Public usage • Advertising and marketing restrictions • Case law • Taxation • Enforcement • The future • Graphic: how Bulgarian e-cigarette regulation will change

British health charity calls for promotion of e-cigarettes

17th August 2015 - Regulatory briefing |

Europe
United Kingdom
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

A prominent British public-health charity has thrown its weight behind vaping, saying that the public needs educating on e-cigarettes’ health benefits compared with combustibles.

Spain to transpose TPD without full public vaping ban

16th August 2015 - Regulatory briefing |

EU
Europe
Spain
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

Spain appears to have abandoned plans to impose a blanket ban on indoor vaping, omitting the measure from its draft legislation to implement the European Union’s Tobacco Products Directive (EU TPD) in national law.

E-cigarette makers challenge Indiana’s manufacturing rules

14th August 2015 - Regulatory briefing |

Delaware
Florida
Indiana
Kentucky
North America
United States
Companies
Policy and Politics
Regulation and Legislation
Regulatory briefing

Four e-cigarette firms have filed a lawsuit challenging strict manufacturing regulations that are proposed for e-cigarettes in the state of Indiana – and their success or failure could have repercussions across the U.S.

E-cigarette regulatory outlook for Switzerland, August 2015

13th August 2015 - Regulatory reports |

Europe
Switzerland
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

Introduction • Regulatory landscape • National regulatory framework • Regulatory change • Timeline for the revised Federal Tobacco Products Act • Age restrictions • Packaging restrictions: current • Packaging restrictions: future • Product restrictions • Public usage • Advertising and marketing restrictions • Taxation • Enforcement • Looking ahead