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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.
With great fanfare, the US Food and Drug Administration has announced the rollout of its new artificial intelligence scientific review assistant, Elsa. But questions have been raised about the tool’s potential
US HSS decision-makers have been shuttling staff between employment and dismissal, much like the Grand Old Duke of York in the nursery rhyme marches troops up and down a hill
Packaging of US nicotine alternatives could face a major shake-up, thanks to First Amendment challenges against restrictions on what companies can say and do
The US FDA has issued a warning letter to manufacturer Nic Nac Naturals for selling unauthorised nicotine lozenges, described as “nicotine mints”, in both 3 mg and 6 mg strengths of nicotine and several flavours
The Reagan-Udall Foundation’s reports on the US Food and Drug Administration (FDA) provide “substantially different future policy implications” for the different FDA programmes investigated
Philip Morris International will focus on heated tobacco and nicotine pouches as the alternatives that can help it meet its goal of becoming a majority smoke-free revenue company by 2025
A US House of Representatives committee has launched an investigation into the Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) for alleged failure to effectively regulate tobacco products
What the US Food and Drug Administration (FDA)’s proposed new rule on manufacturing practices for tobacco products really means is an intriguing question. What can it tell us about the agency’s vision for future regulation?
Fears have been raised that new product standards proposed by the US Food and Drug Administration (FDA) may be costly to implement and overly burdensome for smaller companies
The US Food and Drug Administration (FDA) has announced its plans to address the recommendations put forward in a damning independent review of its Center for Tobacco Products (CTP)
The appointment of Matthew Farrelly as director of the Office of Science at the US Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) comes at a potentially critical time for tobacco alternatives
Flavours continue to be the main target of the Food and Drug Administration (FDA) in the US when it comes to novel nicotine products, it seems – and that could give heated tobacco an edge over e-cigarettes
The US Food and Drug Administration has authorised the marketing of three new tobacco-flavoured heated tobacco products from Philip Morris Products’s supplemental PMTAs
The US Food and Drug Administration’s Center for Tobacco Products (FDA CTP) is “reactive and overwhelmed”, staff are “fatigued”, the industry and public health advocates are “frustrated”, and litigation has “upended” the CTP’s plans
With the 8th November US midterm elections getting closer by the day, it looks like Republicans will seize control of Capitol Hill – overall good news for the tobacco and vaping industries
Another day, another judgement in the saga of the US vapour industry’s cases against the Food and Drug Administration (FDA) – but what might the conflicting decisions mean for other smoking alternatives?
Cristine Delnevo, the new chair of the US FDA’s Tobacco Products Scientific Advisory Committee (TPSAC), has been hailed as an “objective, thoughtful scientist” with an understanding of research into harm reduction
The US Food and Drug Administration (FDA)’s warning over flavoured nicotine gummies has been welcomed by public health organisations, while it has not gone down well with representatives of the vaping industry
The tobacco industry has little faith that the upcoming external review of the Center for Tobacco Products (CTP) will help fix faults in the US FDA department’s regulation of new tobacco and alternative products
US Food and Drug Administration (FDA) commissioner Robert Califf has authorised an external review of the Center for Tobacco Products (CTP), citing a “series of challenges that have…stressed the agency’s operations”
You can almost hear the judge’s sigh as he wrote his latest opinion in the long-running litigation between the FDA and the cigar industry over the latter’s treatment by the 2016 final deeming rule. Here we go again…
This report asks and answers questions regarding US federal regulation on nicotine pouches, reviewing current law, looking at what stands to change, and clearing up what could happen if state and federal legislation clash
The US Food and Drug Administration (FDA) has appointed epidemiologist Brian King as head of the Center for Tobacco Products (CTP) – an appointment that has not gone down well among advocates of tobacco alternatives
The long-mooted proposal to prohibit menthol is the most dramatic step the US Food and Drug Administration (FDA) has taken since the 2009 Tobacco Control Act exempted menthol from a general ban on flavoured tobacco
The new US federal legislation has brought synthetic nicotine products under the oversight of the US Food & Drug Administration (FDA), meaning all synthetic nicotine products have to go through a premarket tobacco product application (PMTA) process
What will Michele Mital’s reign as acting director of the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) mean in terms of policy?
TobaccoIntelligence has put together a timeline outlining the major points to look out for over the summer as the US FDA brings synthetic nicotine into the premarket tobacco product application (PMTA) process
The US Food and Drug Administration (FDA) is allowing Philip Morris International (PMI) to market its Iqos 3 heated tobacco device with some reduced risk claims
The US Food and Drug Administration (FDA) has confirmed that a plan to ban menthol in combustible smoking products by the end of spring 2022 “remains on track”
22nd Century Group is to announce its full year results on 1st March, after confirming the launch of its two low-nicotine cigarettes as modified risk tobacco products
Acceptance by the US FDA of very-low-nicotine cigarettes as a modified risk product may be controversial, even bizarre, but it will be worth seeing how they perform in the market – and how that may affect future regulation of alternatives
2021 may have been a downer in many other areas but the year saw phenomenal growth across tobacco alternatives, including in the oral segment, heated tobacco and nicotine pouches
The prospect of very-low-nicotine cigarettes becoming the next alternative product on the US market has come a significant step closer, with the FDA issuing modified risk orders for two products from 22nd Century Group
Robert Califf’s expected return to head the US FDA has excited plenty of attention in the world of e-cigarettes, but there’s been much less talk about the likely impact on heated tobacco, pouches and other novel nicotine products
This report answers your questions on the US Food and Drug Administration (FDA)’s recently issued final rules on the requirements for Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) reports
The US Food and Drug Administration (FDA) has issued marketing authorisation for four mint-flavoured oral tobacco products that were withdrawn from the US market in 2019
While the decision to give marketing authorisation to some RJ Reynolds relates specifically to e-cigarette products, it’s highly likely that much the same priorities will govern official thinking on other alternative products
Some light is now dawning on some truths long since suspected about the US Food and Drug Administration (FDA)’s approach to tobacco-alternative products of all kinds through its cumbersome evaluation of e-cigarettes
As the US Food and Drug Administration’s deadline to pass or reject e-cigarette premarket tobacco product applications (PMTAs) arrives, where does it leave the market and what might it mean for tobacco alternatives?
Both the House and Senate are intent on increasing the US Food and Drug Administration (FDA) budget for next year, but the figure is likely to be far short of the $6.5bn initially requested by president Joe Biden
Are we really in the midst of a “pandemic” of oral nicotine use by young people, and if so is the answer a flavour ban? 31 US attorneys general have some answering of their own to do
A group of 31 US state attorneys general have accused the Food and Drug Administration (FDA) of failing to impose rules setting “acceptable levels of nicotine” for oral nicotine products and called for a flavour ban
The US Food and Drug Administration (FDA) has posted a list of over 6m deemed new tobacco products for which it received Premarket Tobacco Product Applications (PMTAs) by the 9th September 2020 deadline
The US FDA considers that the Modified Risk Tobacco Product Application (MRTP) for Philip Morris International (PMI)’s Iqos 3 holder and charger is “sufficiently complete” to start a substantive review
The big news from the US Food and Drug Administration last week was a ban on menthol in combustible cigarettes, closing off a loophole that had allowed this one flavour to be marketed even after all others were forbidden. It may not happen any time soon – the agency’s cautiously-worded announcement said only that it is “working toward issuing proposed product standards » Continue Reading.
The US Food and Drug Administration (FDA) has announced plans to ban menthol tobacco in 2022, a “significant step” towards increasing smoking cessation and reducing youth uptake
The US Food and Drug Administration (FDA) is looking to appoint a new company to provide public communication services to the agency’s Center for Tobacco Products (CTP)
Apart from the obvious, what has 2020 brought us? And in particular, what has it brought to the world of alternative tobacco and tobacco alternatives?
The US Food and Drug Administration (FDA) has issued a marketing order authorising the sale of Philip Morris International (PMI)’s IQOS 3 holder and charger
Nicotine and CBD are perceived as the bad guy and the good guy of health and wellness – but could putting the two together make commercial sense if it can help smokers break the habit?
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