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What are the US Food and Drug Administration’s (FDA)’s final rules for taking new tobacco products to market in the US? Our legal experts have compiled an in-depth regulatory report to guide you through the complex requirements for Premarket Tobacco Product Applications (PMTAs). Meanwhile, our news briefings update you on the latest developments. Access all of our FDA-related content from this page.
Reynolds American has submitted a premarket tobacco product application (PMTA) to the US Food and Drug Administration (FDA) for its Velo nicotine lozenges to remain on the market after September
California is edging closing to banning flavoured tobacco products – and despite industry lobbying, state lawmakers will not make an exception for tobacco-alternative products that have modified-risk approval
The US FDA’s granting of modified risk status to PMI’s IQOS system suggests possible future competition in the tobacco alternatives market, experts have told TobaccoIntelligence
The US Food and Drug Administration (FDA) has granted Philip Morris International (PMI) modified risk tobacco product (MRTP) status for Iqos and its associated HeatSticks
This report covers the US role as a modern oral tobacco product player, examining snus, tobacco-free nicotine pouches and all-free products
This reports takes on a Q&A structure, providing a comprehensive overview of US regulations of oral nicotine products
The US Food and Drug Administration (FDA) has asked a judge to postpone the effective date of its new rule imposing graphic health warnings on cigarette packaging
The US tobacco industry is resisting another attempt by the FDA to impose graphic health warnings, claiming in a lawsuit that mandatory warnings would violate their rights under the First Amendment
The US Food and Drug Administration (FDA) has been granted a 120-day extension to the deadline for premarket tobacco product applications (PMTAs)
The US Food and Drug Administration (FDA) has requested a 120-day extension to the deadline for premarket tobacco product applications (PMTAs) due to the challenges that the coronavirus outbreak is posing to companies
Further evidence that reducing the amount of nicotine in combustibles does not lead to heavier smoking may provide encouragement for those who want to see reductions legally mandated
What benefit might there be in very low nicotine combustible cigarettes? That is the essential question the US FDA must answer in assessing a modified risk tobacco product (MRTP) application from 22nd Century Group for its VLN products
Recent action by the US Food and Drug Administration (FDA) against a maker of nicotine-infused toothpicks highlights an obscure corner of the tobacco-alternatives business – consisting of products which are not vapour, heated tobacco or snus
The US Food and Drug Administration (FDA) is to lose its power to regulate tobacco products if Congress passes president Donald Trump’s budget proposal for fiscal year 2021
The US Food and Drug Administration (FDA) has granted its first modified risk order for eight snus smokeless tobacco products to be sold with certain modified risk claims by Swedish Match USA
The US Food and Drug Administration (FDA) has grated its first ever modified risk orders to eight snus products from Swedish Match, which can now be advertised as less harmful than traditional cigarettes
TobaccoIntelligence considers the effects the possible re-merger of Philip Morris International (PMI) and Altria might have on the combustible and alternatives markets in the US and beyond
PMI’s heated tobacco device IQOS and its associated consumables have been granted market authorisation by the FDA
There have been mixed reactions from within the industry to the FDA decision to allow PMI’s heated-tobacco device IQOS and its associated consumables onto the US market
British American Tobacco (BAT) may get two heated-tobacco products onto the US market before IQOS can be launched there, thanks to its decision to take a different route to FDA approval
British American Tobacco (BAT) has a chance to steal a march on its Big Tobacco rivals in the heated-tobacco market after the company became the first to receive approval to sell a heat-not-burn device in the US
Heated tobacco is grabbing headlines, but what else will it seize? We examine a number of market and regulatory scenarios with greatly differing outcomes for both heat-not-burn products and e-cigarettes
The US FDA has taken a step closer to regulating nicotine levels in combustible cigarettes, but excluded vapour products from its proposals, even predicting a low-nicotine regime might encourage smokers toward electronic alternatives
BAT has chosen to seek market authorisation in the US for its heat-not-burn product Glo on the basis of its “substantial equivalence” to a previous product, Eclipse – but what are the pitfalls and the advantages in this approach? …
The US FDA has made some public amendments to PMI’s reduced risk applications for IQOS and three types of Marlboro HeatSticks products
British American Tobacco claims to be the largest reduced-risk product company in the world following its acquisition of Reynolds American and says it will build on this through a variety of HnB, moist tobacco and oral tobacco brands
The latest evidence review by Public Health England credits e-cigs with helping 20,000 people a year quit smoking, and blames distorted media reporting for that figure not being a lot higher
As the US FDA gets to grips with its new focus on nicotine as a single marketplace, it is planning to take a fresh look at one of the longest-established non-combustible forms of the substance – nicotine replacement therapy
ECigIntelligence’s review of the year gone by reflects the big stories of the e-cigarette world in 2017, the trends in regulation, the developing and diverging markets, the science and innovation, and peers into the crystal ball to consider where it all goes from here
The US FDA has missed its own 180-day deadline for replying to the premarket tobacco application (PMTA) by Philip Morris International for its IQOS heated tobacco products
The American Vaping Association has written to FDA commissioner Scott Gottlieb urging him to approve PMI’s heated tobacco product iQOS for sale in the US
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.
A move by the US FDA to reduce the nicotine content in cigarettes to non-addictive levels could encourage Big Tobacco to put yet more effort into alternatives
2017 has already been a significant year in the short history of e-cigarettes – and there is more to come in the remaining five months of a the year
Scott Gottlieb, commissioner of the US FDA, appeared on Friday to go further than any federal official – or most politicians – previously had in supporting alternative nicotine products for harm reduction
New research shines a little light on how Japanese consumers are reacting to iQOS, and how HnB products compare with both combustibles and e-cigarettes on the crucial question of nicotine delivery.
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”
Swedish Match has at last obtained some answers from the U.S. Food and Drug Administration (FDA) on its attempt to have snus smokeless tobacco products classified as modified risk
Philip Morris International (PMI) this week submitted its iQOS technology for approval as a reduced-risk product by the U.S. Food and Drug Administration (FDA)
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