Regulatory reports

The medical route to market approval in the UK – the pros and cons

Written by Elba Manzanilla Zapata || 21st March 2018 || Regulatory reports |

EU
Europe
United Kingdom
Public Health and Medicine
Regulation and Legislation
Regulatory reports
The MHRA, Britain’s pharmaceutical regulator, is currently encouraging and supporting companies to submit medicines authorisation applications for e-cigarette products. Here we explain what that process entails ...

Shake and vape and the law in the EU

Written by Elba Manzanilla Zapata || 16th March 2018 || Regulatory reports |

EU
Europe
Market Research
Marketing and Retailing
Regulatory reports
As shake and vape products increase in popularity in Europe in response to the restrictions imposed by the EU’s TPD, we take a close look at country-by-country regulation ...

Ukraine regulatory report: TPD beyond the EU?

Written by Marija Obradovic || 12th March 2018 || Regulatory reports |

Europe
Ukraine
Policy and Politics
Regulation and Legislation
Regulatory reports
Ukraine's current regulatory setup is lenient on e-cigs but with politicians keen to foster stronger links with the EU, and with acts now in force to strengthen existing relations, it's only a matter of time before the European...

Wholesale or volume taxes: a state-by-state analysis of US vapour taxation

Written by || 7th March 2018 || Regulatory reports |

California
Delaware
Hawaii
Indiana
Kansas
Kentucky
Louisiana
Massachusetts
Michigan
Minnesota
New Jersey
New Mexico
New York
North America
North Carolina
Pennsylvania
United States
Utah
Vermont
Washington
West Virginia
Regulation and Legislation
Regulatory reports
Eight US states currently tax e-cigarettes: five apply a volume tax, at a rate per ml of consumable product; three apply a wholesale tax, based on price sold at wholesale in the state – and several other states...

Substantial equivalence: Eclipse and Glo – same difference?

Written by Paula Cazes || 1st March 2018 || Regulatory reports |

North America
United States
Companies
Regulation and Legislation
Regulatory reports
BAT has chosen to seek market authorisation in the US for its heat-not-burn product Glo on the basis of its “substantial equivalence” to a previous product, Eclipse – but what are the pitfalls and the advantages in this...

US tribal territories – a unique opportunity for the vaping trade?

Written by || 22nd February 2018 || Regulatory reports |

North America
United States
Regulation and Legislation
Regulatory reports
There are more than 320 tribal territories (Indian reservations) in the US, administered by federally recognised tribes – subject to federal, but not state laws. This affects the tobacco trade in various ways and may have interesting implications...

Norway regulatory report: nicotine e-cigarettes will soon be legal

Written by Marija Obradovic || 5th February 2018 || Regulatory reports |

Europe
Norway
Policy and Politics
Regulation and Legislation
Regulatory reports
Norway is likely to end its ban on e-cigarettes in mid-2018. However, vapour products are subject to detailed regulations and the Norwegian authorities have extended the EU’s TPD to cover nicotine-free products ...

A question of balance – do health benefits outweigh possible harms?

Written by Barnaby Page || 30th January 2018 || Regulatory reports |

North America
United States
Public Health and Medicine
Regulation and Legislation
Regulatory reports
Given the complexity of all the possibilities, how can you forecast the long-term effect of e-cigs on smoking-related harms? That was the challenge taken on by the National Academies of Sciences, Engineering, and Medicine (NASEM) ...

Online sales now banned: Italy regulatory report

Written by Elba Manzanilla Zapata || 25th January 2018 || Regulatory reports |

Europe
Italy
Regulation and Legislation
Regulatory reports
In our latest look at the Italian market, we see that distance sales, including domestic and cross-border, are now banned under the latest amendment (known as the “Vicari amendment”) approved in the Italian parliament ...

Proposed tax rate increase: North Carolina regulatory report

Written by || 12th January 2018 || Regulatory reports |

North America
North Carolina
United States
Regulation and Legislation
Regulatory reports
North Carolina's current regulatory status is explained by the ECigIntelligence team of analysts: decisions are made at state level for state-wide uniformity; vapour products are included in the definition of tobacco products; and the taxable rate of e-liquids...

Hardware waste management in the EU

Written by Marija Obradovic || 8th January 2018 || Regulatory reports |

EU
Europe
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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...

Mexico: a new bid to legalise e-cigs

Written by || 5th January 2018 || Regulatory reports |

Mexico
North America
Policy and Politics
Regulation and Legislation
Regulatory reports
The PRI party’s Senator Marcela Guerra Castillo has presented a new bill to legalise e-cigarettes in Mexico, in response to their continuing popularity. It is a bid to control the quality of products on the market. The bill legalises...

Los Angeles: proactively restricting e-cigarettes

Written by || 11th December 2017 || Regulatory reports |

California
North America
United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory reports
Los Angeles takes an active approach towards electronic cigarettes, including them in the definition of tobacco products for purposes of the Tobacco Retailing License and public smoking restrictions ...

Could the TPD allow for reduced-risk claims?

Written by Elba Manzanilla Zapata || 6th December 2017 || Regulatory reports |

Europe
Policy and Politics
Regulation and Legislation
Regulatory reports
Nearly all EU member states have interpreted article 13 of the European TPD to ban all claims related to health in the absence of a medical certificate. However, there may be a pathway to a reduced-risk...

New regulatory initiatives create uncertainty in Italian e-cigarette market

Written by || 17th November 2017 || Regulatory reports |

Europe
Italy
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports
Uncertainty surrounds the Italian e-cigarette market, following a number of recent regulatory decisions and initiatives. These include a court decision on the long-running issue of whether to tax nicotine-free e-liquids; proposals to ban online sales and limit offline...

Scare stories get more attention than calmly issued research findings

Written by Marc Beishon || 1st November 2017 || Regulatory reports |

Europe
North America
United Kingdom
United States
Public Health and Medicine
Regulation and Legislation
Regulatory reports
A research paper which led to the headline claim that e-cigs can trigger lung disease “just like cigarettes” was picked up by the media more eagerly than other studies which came to less alarmist conclusions ...

South Africa regulatory report: vaping in legal limbo

Written by Marija Obradovic || 23rd October 2017 || Regulatory reports |

Africa
South Africa
Policy and Politics
Regulation and Legislation
Regulatory reports
Nicotine e-cigs can only be sold legally in South Africa at pharmacies under medical licence. There is, however, a thriving black market, and a government promise – yet to be acted on – to regulate e-cigs in the...

Two possible paths to e-cig legalisation: Mexico regulatory report

Written by Elba Manzanilla Zapata || 4th October 2017 || Regulatory reports |

Mexico
North America
Policy and Politics
Regulation and Legislation
Regulatory reports
The sale of e-cigarette products is banned in Mexico under the General Tobacco Control Law, although a modest e-cigarette market does exist. In 2015 Mexico’s highest court unanimously held that the regulator’s interpretation of Mexico’s Tobacco Control law is...

New incoming rules will mean further restrictions in Portugal

Written by Marija Obradovic || 27th September 2017 || Regulatory reports |

Europe
Portugal
Policy and Politics
Regulation and Legislation
Regulatory reports
New legislation regulating nicotine-containing e-cigarettes came into force on 1st January 2016 in Portugal. Current taxes on nicotine e-liquids are €0.30/ml, but a new budget law is due for vote in November 2017 when it will become clearer if the...

Q&A: how cross-border distance sales are regulated across the EU

Written by Elba Manzanilla Zapata || 12th September 2017 || Regulatory reports |

EU
Europe
Regulation and Legislation
Regulatory reports
Based on questions that have arisen in conversations with the e-cigarette industry, our Q&A considers the different regulatory problems that may arise with cross-border distance marketing within the EU or from other countries to Europe ...

Shake and vape: the legal implications in the EU

Written by Marija Obradovic || 24th August 2017 || Regulatory reports |

EU
Europe
Regulation and Legislation
Regulatory reports
The sale of ingredients for shake and vape – enabling users to mix their own nicotine and non-nicotine e-liquids – is a legal grey area for sellers in many European countries, as it can be a way to...