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 claims.
The confused picture of e-cig regulation in Canada, where provinces have established various partial regimes, is set to end with the likely passing of a federal law imposing a unified code
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 is unethical”.
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 White House as with Congress, and the FDA.
By contrast with other South American countries, which have a de facto ban on vaping, e-cigarettes have until now been virtually unregulated in Colombia. That could soon change, however, with a proposal before Congress to bring e-cigs under the umbrella of tobacco regulation.
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 law.
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 States.
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 product.
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 State.
A year and a half after the country’s Supreme Court overturned a fine on a vape salesman, e-cigarettes remain illegal in Mexico – but they also remain openly on sale, with no prosecutions in process.
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.
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.
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 issue.
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 wanting.
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 know.
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.
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.
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”?
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?
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?
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.
There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page. 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 » Continue Reading.
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.
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.
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