Written by Berta Camps Bisbal | 14th September 2017
As PMI’s iQOS comes under consideration by the US FDA, we examine the hurdles it – and other – heated tobacco and e-cigarette products will have to clear to obtain authorisation for commercialisation and reduced-risk...
PMI has responded forcefully after a Swiss research team claimed its iQOS heat-not-burn system released “the same harmful constituents of conventional cigarette smoke” and said “dancing around the definition of smoke to avoid indoor-smoking bans...
While the election of Donald Trump was greeted as a cause for some optimism in the US e-cigarette industry, hopes for the easing of regulation at the federal level lie not so much with the...
ECigIntelligence explores e-cigarette regulation in the state of New York, which is showing signs of taking a hard line toward vaping despite little existing...
Exclusively for ECigIntelligence Platinum subscribers, you can now download a free PDF of the most recent ECigIntelligence report on e-cigarette regulation in the United...
This report examines the current ways the e-cigarette industry in the U.S. has to get premarket approval from the FDA for new products, including detailed definitions of what constitutes a new...
ECigIntelligence guides you through the thicket of bureaucratic requirements faced by retailers engaging in either face-to-face or distance sales of vapour products in the Lone Star...
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...
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 For now, the FDA has published draft guidance on the subject, in order to...
Do nicotine-free and synthetic nicotine e-liquids come under the scope of the FDA's deeming regulations? It's a pressing question for the U.S. e-cigarette industry - and at last there is some clarity emerging on the...
A study claiming to have added to evidence that vaping can be "a one-way bridge to smoking" by young people has been subjected to critical analysis – and found to be seriously...
U.S. manufacturers and importers of “finished tobacco products” should submit full and detailed ingredients lists to the FDA - here's what they want to...
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...
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...
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...
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...
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...
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...
Contents1 Introduction2 Why an ENDS product requires FDA approval3 Pathways to approval4 The FDA guidance on PMTAs5 PMTAs, public health, and scientific studies There may be more recent ECigIntelligence reports on this territory....
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...
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...
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...
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...
There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page. ECigIntelligence has published its comprehensive 106-page end-of-year guidebook on the regulatory landscape for e-cigarettes and...
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...
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...
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...
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 •...
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”,...
Introduction • The matrix of authority • State government regulation • Local government regulation • Regulation by quasi-governmental institutions • Regulatory trends • Appendix: state law – health and safety codes and consumer protection...
A comprehensive survey of the U.S. e-cigarette market and regulation, including: Market size • Consumption patterns • Online pricing • Distribution • Raw material supply • E-cigarette usage surveys • Current U.S. e-cigarette regulation •...
The multi-layered, multi-jurisdictional regulatory landscape • The structure of federal and state e-cig regulation • Trends in state government regulation • Trends in local government regulation • Case study: regulation of e-cigarettes in California •...
Tobacco: precedents for challenge • Potential challenges to the deeming regulations • Challenges to scientific foundation • Challenges to pre-market approval and substantial equivalence • Challenges to health warning labels • Challenges to the deeming...
FDA 9-step regulatory process • Public comment • FDA e-cigarette information requests • FDA case studies: previous FDA efforts to regulate tobacco products • Impact of public comment submissions • Extension of public comment period...
Five years after the U.S. Food and Drug Administration (FDA) finally gained the legal authority to regulate certain tobacco products, the agency is in the middle of what could be a landmark effort to extend...