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Vaping treated as if it was tobacco in California

24 March, 2017 | Regulatory reports |

California
North America
United States
Regulation and Legislation
Regulatory reports

In this March 2017 look at regulations in California, we find that nicotine-containing products are subject to a wholesale tax of 27.3%. This tax rate will be revised periodically. Vaping in the state is treated as tobacco in regards to public usage.

FDA moves to restrict distribution of free samples

9 March, 2017 | Regulatory reports |

North America
United States
Regulation and Legislation
Regulatory reports

Under the Food And Drug Administration’s Code of Federal Regulations Title 21, distribution of free samples of tobacco products is prohibited. For now, the FDA has published draft guidance on the subject, in order to aid compliance with the law.

Impacts of regulatory changes on the global e-cigarette market

20 February, 2017 | Regulatory reports |

EU
Europe
North America
United States
Regulation and Legislation
Regulatory reports

Is regulation always a bad thing for the vapour industry? In a report based on a presentation given to industry experts in Washington, ECigIntelligence’s international legal analyst Pablo Cano Trilla weighs up the evidence for and against.

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

18 October, 2016 | Regulatory reports |

North America
United States
Public Health and Medicine
Regulation and Legislation
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.

Required warning statements on U.S. advertisements

23 September, 2016 | Regulatory reports |

North America
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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.

Deeming regulations and product packaging: key questions answered

9 September, 2016 | Regulatory reports |

North America
United States
Marketing and Retailing
Regulation and Legislation
Regulatory reports

New vapour products have been barred from entry to the U.S. market – but what impact will this have on those already on sale? How will the FDA’s final deeming rule impact the packaging of e-cig products considered “safe”?

Deeming regs: challenges to the sampling ban

29 July, 2016 | Regulatory reports |

Arkansas
Georgia
Iowa
Kentucky
Massachusetts
New Hampshire
New Mexico
North America
Oklahoma
Rhode Island
South Dakota
Tennessee
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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?

Will U.S. vapour taxes apply to synthetic nicotine?

29 July, 2016 | Regulatory reports |

Kansas
Louisiana
Minnesota
Missouri
North America
North Carolina
Pennsylvania
United States
West Virginia
Policy and Politics
Regulation and Legislation
Regulatory reports

Six U.S. states have enacted an excise tax on e-cigarettes and vapour products. Within these states – Kansas, Louisiana, Minnesota, North Carolina, Pennsylvania, and West Virginia – will synthetic nicotine be subject to tax?

Challenging the U.S. deeming rule: the legal options and their chances

1 July, 2016 | Regulatory reports |

North America
United States
Regulation and Legislation
Regulatory reports

The U.S. FDA’s final deeming rule is likely to be the subject of a number of legal challenges if finalised in its current form. This could delay the application of any final regulations by several years, and could ultimately lead to a court setting the deeming rule aside – at least with regard to e-cigs.

This report examines the “next steps” for industry, the current and potential challenges, as well as the possibility of congressional relief.

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

26 June, 2016 | Regulatory reports |

North America
United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory reports

        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. This rule extended the FDA’s authority to include the regulation of electronic nicotine delivery systems (ENDS) such as e-cigarettes and vape […]

PMTA applications: how the FDA’s policy has developed

26 June, 2016 | Regulatory reports |

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

Many questions remain over how the FDA will actually interpret the requirements for authorisation: how rigid a view it will take on the evidence required to support an application, for example. Comparing a leaked earlier version of the regulations with the final published version provides some clues.

Could e-cigarettes be the next battleground for plain packaging?

10 June, 2016 | Regulatory reports |

Africa
Asia
Australasia
Australia
Belgium
Brazil
Europe
Finland
France
Hungary
Ireland
New Zealand
North America
Norway
Singapore
Slovenia
South Africa
South America
United Kingdom
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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.

Deeming regulations in detail: the deadlines for initial compliance

20 May, 2016 | Regulatory reports |

North America
United States
Marketing and Retailing
Regulation and Legislation
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.

E-cig advertising in the United States: defining the boundaries

16 March, 2016 | Regulatory reports |

North America
United States
Marketing and Retailing
Regulation and Legislation
Regulatory reports

      Executive Summary   In the U.S., there are laws in place to regulate misleading marketing claims, which apply to e-cigarettes. However, the advertising requirements related to tobacco products are much broader in scope – several laws and regulations prohibit broadcast advertisement, limit print advertising, and require health warnings on labels. Anti-nicotine advocates […]

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

10 February, 2016 | Regulatory reports |

North America
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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.

Vapor Industry Regulation in the United States: 2016 Outlook

21 December, 2015 | Regulatory reports |

North America
United States
Regulation and Legislation
Regulatory reports

ECigIntelligence has published its comprehensive 106-page end-of-year guidebook on the regulatory landscape for e-cigarettes and the vapor industry in the United States. Titled “Vapor Industry Regulation in the United States: 2016 Outlook” the guide is a full review of federal- and state-level regulatory development for the sector in 2015, and what can be learnt from this […]

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

12 November, 2015 | Regulatory reports |

North America
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
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

Watch out, there’s a state attorney general about

24 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

Deeming regulations vs state law: who wins?

17 July, 2015 | Regulatory reports |

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

Introduction • The deeming regulations: express pre-emption of state laws • Where pre-emption does not apply • Pre-emption in practice: California’s Prop 65 • How pre-emption can prevent state-level litigation • Appendix: the doctrine of pre-emption • Appendix: Tobacco Control Act provisions

Defusing the deeming regs: Congress, courts, and the FDA

9 July, 2015 | Regulatory reports |

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

Legislative solution: giving the FDA discretion • Legislative solution: changing the grandfathering date • Legislative solution: amending the Tobacco Control Act • Judicial challenge: the Tobacco Control Act’s purpose • Judicial challenge: scientific evidence • Judicial challenge: free speech • Judicial challenge: are e-cigs really tobacco products? • Judicial challenge: injunctive relief • Solutions from the FDA

In depth: U.S. state e-cig tax laws and proposals, May 2015

21 May, 2015 | Regulatory reports |

Alabama
Arizona
Arkansas
Hawaii
Indiana
Iowa
Kentucky
Louisiana
Maine
Minnesota
Montana
Nevada
New Jersey
New Mexico
New York
North America
North Carolina
Ohio
Oregon
Rhode Island
United States
Vermont
Virginia
Washington
Washington D.C.
Policy and Politics
Regulation and Legislation
Regulatory reports

Introduction • State tax models • Varying impacts of tax models • State tax policy approaches analysed • State-by-state tax proposals in detail

In depth: more safety worries over e-liquid flavourings

27 April, 2015 | Regulatory reports |

Europe
North America
United Kingdom
United States
Public Health and Medicine
Regulatory reports

E-cigarette flavours are causing concern again, but this time not over their purported appeal to youth. The latest study to stoke up worries about harmful substances in e-cigs is “Flavour chemicals in electronic cigarette fluids”, another from a group at Portland State University in the U.S.