Regulatory and market intelligence for the e-cigarette sector
Outdoor advertising and cinema will be the only mass media available to e-cigarette brands in England after May next year, the government expects.
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
James Higgs of Nicoccino shares his views on marketing, regulation, and education.
Regulators, health professionals and scientists are expected to converge in London this week for an update on research into vaping.
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?
The first convincing evidence of a causal link between under-age vaping and tobacco use has delivered a shock to those who favour banning sales to minors: e-cigarettes may actually reduce teen smoking.
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 […]
The U.S. has become the first major nation to officially ban e-cigarettes from checked-in baggage and prohibit charging them or their batteries during flights.
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. […]
European standards for e-cigarettes and e-liquids could be in place within two years.
Media reports of an e-cigarette ban in Malaysia sent waves through the industry. But is there really reason to panic?
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.
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 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.
Selling e-cigarettes without a medical licence is still not legal in Mexico, despite a supreme court ruling in favour of one retailer.
E-cigarette companies in the U.S. have been warned to expect federal rules on advertising and marketing, separately from the FDA deeming regulations.
Exclusive insight for ECigIntelligence readers – download a detailed, data-rich presentation on the current state and future of the e-cig industry.
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.
Key Democratic U.S. senators this week urged the Obama administration to take “immediate” action on pushing the deeming regulations for e-cigarettes through the final stage before enactment.
A French government agency found significant irregularities in tested e-liquid samples and e-cigarette chargers.
All aspects of an e-cigarette business could come under fire as the U.S. Food and Drug Administration (FDA) looks for novel ways to curtail unsubstantiated claims.
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.
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.
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).
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.
A new Welsh survey has found little use of e-cigarettes among consumers who have never smoked. But is the evidence enough to prevent a proposed public vaping ban from coming into force?
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
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”.
The Totally Wicked lawsuit seeking to strike down article 20 of the EU Tobacco Products Directive (TPD) goes to the Court of Justice of the European Union (ECJ) this week.
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.
Executive summary • Introduction • FDA enforcement authority • Development of FDA e-cigarette enforcement • Compliance strategies for the industry • Risk posed by patents
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.
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.
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.
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 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.
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
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 […]
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
Differing limits set by e-cigarette manufacturing associations for diacetyl and acetylpropionyl in e-liquids seem likely to lead to confusion and acrimony.
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”.
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
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.
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.
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.
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
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 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.
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.
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
New exclusive report: E-cigarettes in China: market, regulation and outlook
Looking for market trends and commercial opportunities in one of the fastest-growing e-cigarette markets in the world? If you want to identify the latest trends developing in the Chinese e-cigarette market, and ensure that products and business activities are fully compliant with Chinese regulation, then this new report is for you!
*Sample pages available
