Regulatory and market intelligence for the e-cigarette sector
The U.S. Centers for Disease Control and Prevention (CDC) has been asked to recommend e-cigarette bans in American workplaces.
Regulatory landscape: from regional to uniform regulation • Current regulatory framework • Comparison with tobacco regulation • Public use restrictions • Age restrictions • Packaging and point-of-sale requirements • Advertising restrictions • Medical claims • Enforcement • Case law • The missing pieces from the TPD jigsaw • The decreto ley option
The proposed regulations • FDA e-cigarette information requests • Analysis of SFATA submission • SFATA’s proposed alternative • Analysis of AEMSA submission and proposals • Analysis of Totally Wicked submission and proposals • Conclusions
The U.S. state of Missouri is to legally distinguish between e-cigarettes and tobacco products, following disagreement among law-makers which saw legislation passed, then vetoed, and finally reinstated.
Britain’s medicines regulator has issued a product licence for the nicotine inhaler Voke, which will be sold by British American Tobacco’s subsidiary Nicoventures and looks likely to be the closest pharmaceutically-approved competitor to the e-cigarette.
What the FCTC is • A global treaty • Broad scope of regulation • The regulatory framework • The FCTC in practice • No enforcement powers • Enforcement by signatories • Self-reporting • Shadow reporting • Influence on European legislation • Promoting tobacco regulation in the developing world • What does the FCTC mean for e-cigarettes • Current status of e-cigs • Political will to regulate • Structural barriers • Non-binding, but influential • Exclusion of e-cig firms • Regulatory options in detail
Queensland is set to become the first state in Australia subjecting e-cigarettes to the same laws as conventional tobacco products.
Thailand’s government is planning to clamp down harder on the import of e-cigarettes, seeking to close potential loopholes in the products’ confusing legal situation.
WHO’s basis for regulation • Political will to regulate • Regulatory proposals in detail • Likely impact of COP6 recommendations • Industry excluded from consultation? • Russia’s political situation and COP6 • Conclusions
France: influence on regulation and case law • France: influence on standards adoption • French and European associations’ influence on the TPD • UK: ECITA and the BSI e-cigarette standards • UK: developing manufacturing standards • French and British approaches compared • U.S.: industry self-regulation • U.S.: association regulatory and lobbying efforts
Consumer protection authorities in Utah are threatening online e-cig sellers with nearly $1m in fines over misleading claims and unauthorised credit card charges.
The law governing adoption of the TPD • Significant new rules for tobacco and e-cigs • Challenges before transposition • Pre-transposition challenges by member states • Poland’s TPD challenge • Pre-transposition challenges before the UK high court • PMI’s TPD challenge • Totally Wicked’s TPD challenge • Possible post-transposition challenges • Possible impacts on article 20 and e-cig regulation • Potential challenges by other e-cig stakeholders
Medical professionals should support but not promote the use of e-cigarettes in smoking cessation attempts, says the American Heart Association (AHA) in a new policy statement on the products.
A British e-cigarette supplier is the sector’s first independent to launch a legal challenge against the Tobacco Products Directive (TPD), the EU rules published this year that will regulate the e-cig market in European member states.
Prison inmates in North Carolina are to be allowed e-cigarettes, following an unusual law-making decision which implicitly gives official recognition to the products as substitutes for tobacco smoking.
The U.S. Food and Drug Administration (FDA) is likely to have received a deluge of comments in the run-up to the closing of the public consultation period on its e-cigarette regulations last Friday – among them a biting critique of the agency’s approach from a U.S. vapers’ group.
Italy’s Council of Ministers has approved a controversially high new tax on e-cigarettes, which would add an estimated 600% to the price of e-liquids.
E-cigs are not tobacco products • E-cigs are relatively unregulated • Standard consumer protection law applies • No product standards or requirements • Public use restrictions in significant cities • Limits on local government power • No tobacco taxes, or other special taxes – yet • Implementation of the TPD: scope • Implementation of the TPD: timeline and process • Implementation of the TPD: industry and NGO input • Implementation of the TPD: regulatory authority • Tobacco regulation in Poland
GMPs defined • Core principles: control and documentation • Enforcement • Evolution of GMPs: “current GMPs” and international harmonisation • The application of GMPs to tobacco and e-cigarettes • Industry groups and NGOs fill the regulatory void • How might the FDA formulate e-cig GMPs? • Conclusions
A new review of medical and public health research on e-cigarettes concludes that tobacco-style regulation is unjustifiably strict, but also suggests that further research is needed on health effects and the relationship of e-cigs to smoking.
Could handling e-liquid really be as safe as doing the dishes?
European regulations on classification, labelling and packaging (CLP) have been wrongly categorising nicotine as extremely toxic when it should be considered the equivalent of washing-up liquid, a new report claims.
While U.S. federal regulation of e-cigarettes creeps through a lengthy consultation and review stage, individual states and lower levels of government are trying to fill the legal vacuum.
The director of public health for Canada’s second-largest city has called for national regulation specifically covering e-cigarettes, which would clarify the country’s confusing mixture of proclaimed prohibition and actual tolerance.
An influential member of the U.S. Congress has urged the Food and Drug Administration (FDA) to mandate child-proofing for e-liquid containers, as the wrangling over whether e-cigarettes pose a threat to young people rumbles on.
A Swedish court has upheld attempts by the country’s medical products regulator to treat nicotine-containing e-cigarettes as pharmaceuticals, meaning that they must go through a licensing process and cannot be sold in outlets such as groceries and convenience stores.
Current regulatory framework • The “tabac” monopoly • Recent regulatory initiatives • Implementation of article 20 of the TPD
There is concern in the e-cigarette industry over the sale of the Blu e-cigarette brand to Imperial Tobacco as part of the merger of tobacco giants Lorillard and Reynolds.
Divisions among British pharmacists over whether to sell e-cigarettes, and who to, have been further highlighted this week by a survey showing that a substantial minority would support making the products available to under-18s.
Anne Arundel Medical Center (AAMC) in Maryland has elected to stop hiring nicotine users from 1 July, 2015.
An Australian e-cigarette retailer is attempting to crowd-fund an appeal after a court ruled that the e-cigarettes the company sold resembled conventional cigarettes – violating Australia’s Tobacco Products Control Act of 2006.
What the WHO FCTC is • The WHO FCTC in practice • What does the WHO FCTC mean for e-cigarettes?
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 • Deep dive: restriction of e-cig use in “public places” by state and local governments
Campaigners have accused two New York state senators of failing to see the wood for the trees after they introduced a bill that could prevent businesses from selling, offering to sell or giving away e-liquids.
E-cigarette regulation: lessons from another industry • Regulatory issues compared • Online gambling regulatory models • Lessons for the e-cigarette sector
Comments to the U.S. Food and Drug Administration (FDA) on its proposed e-cigarette regulations should focus on public health and skip business issues, an industry organisation has advised.
Edits made to e-cigarette proposal documents could significantly weaken the Food and Drug Administration’s final regulations.
Market intelligence • Market structure • Regulatory landscape
The proposed e-cigarette regulations of the U.S. Food and Drug Administration (FDA) could face legal challenges on at least five separate grounds if they are enacted without change, a new analysis from ECigIntelligence reveals.
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 of e-cigs as tobacco products • Challenges on the grounds that the regulations constitute a ban • Temporary suspension of the rules via injunctive relief • Potential loophole: nicotine not derived from tobacco
The U.S. Food and Drug Administration (FDA) has extended the period for industry and public comments on its proposed e-cigarette regulations by 30 days, to 8th August.
France appears to be edging closer to its long-awaited regulation of e-cigarettes.
Ten U.S. public health organisations have today asked the Food and Drug Administration (FDA) to move quickly on child-proofing of e-liquid containers, and extend its proposed e-cigarette regulations to cover flavourings and advertising.
Battle lines are drawing up around the World Health Organization (WHO) as it prepares to formulate policy on e-cigarettes which will powerfully influence most countries’ domestic regulation.
Market intelligence • Regulatory landscape
Efforts to cut tobacco use in Russia could lead to an increase in vaping for the country ranked the world’s second in tobacco consumption.
The American Medical Association (AMA) is urging the U.S. Food and Drug Administration (FDA) to restrict e-cigarette flavours and set standards for the child-proofing of products.
Market insight • Current regulatory framework
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 for deeming regulations
Market intelligence • Regulatory landscape • Advertising • EU law • Medical licensing
Law-makers in North Carolina are set to approve legislation imposing a tax on e-cigarettes far lower than that levied on conventional cigarettes.
Are you going to miss this opportunity?
Subscribe to any of our plans in August and receive 3-month free access to our sister publication CBD-Intel.
*Limited time offer - Available in August
Sign up to access to our business and regulatory briefings and get the most updated news, insights and our expert analysis to keep you on top of worldwide industry trends.
START TRIAL
By signing up you agree to our Terms and Conditions Please note trial access may take up to 24 hours to be granted as access must be qualified by a member of the ECigIntelligence team.