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Infographic showing compliance dates for existing e-cigarette and ENDS products under the new FDA deeming regulations.
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.
There are more recent ECigIntelligence reports on this territory. Please visit the home page for Canada. Executive summary The federal government’s regulatory stance on e-cigs is unclear, which is causing confusion in the industry and among regulatory bodies. The federal Health Canada agency has issued an advisory regulating the sale and marketing of e-cigarettes, » Continue Reading.
There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page. 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 – » Continue Reading.
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.
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 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 » Continue Reading.
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
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
Executive summary • Introduction • The multi-layered regulatory framework • Tobacco regulation – the multi-layered model in action • No federal regulation of e-cigs • The role of Health Canada • Provincial regulation • Municipal regulation • Trade associations and industry standards • Appendix 1: provincial and territorial tobacco regulation in Canada • Appendix 2: market authorisation in Canada
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
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
Regulatory landscape • Current national regulatory framework • Product categorisation • Age restrictions • Packaging and product restrictions • Public usage • Advertising and marketing restrictions • Case law • Taxation • Enforcement
ECigIntelligence is breaking down the complex potential layers of federal, state and local legislation.
Introduction • State tax models • Varying impacts of tax models • State tax policy approaches analysed • State-by-state tax proposals in detail
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.
Executive summary • Introduction • Zoning – key facts • Utah zoning law • Local zoning laws • Potential legal challenges
A new study is the first to cautiously find no link between e-cigarette use in U.S. middle- and high-school students and harm reduction.
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 laws
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 future of e-cigarette regulation in the United States • Potential challenges to the deeming regulations • Taxation of e-cigs • State and local government regulation case study – California • Public place restrictions by state and local governments • Challenging the deeming regulations – precedents • The FDA regulatory process • The role and influence of trade and consumer associations
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
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
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
After a friendly confirmation process, Margaret Hamburg became the 21st commissioner of the U.S. Food and Drug Administration on 18th May 2009.
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 that power to the skyrocketing e-cigarette industry.
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