Regulatory and market intelligence for the e-cigarette sector
The ECigIntelligence FDA hub brings together all our briefings and reports that relate to the US Food and Drug Administration (FDA) and its regulation of e-cigarette and related products.
The US Food and Drug Administration (FDA) has rejected a call to “clear the e-cigarette market” during the COVID-19 crisis – eliciting an angry response from a House subcommittee
Vape businesses have generally welcomed a court’s decision to grant a four-month extension to the premarket tobacco product application (PMTA) deadline – but there are reservations
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
The US FDA has hinted that it might push back the deadline for e-cigarette PMTA applications, or offer flexibility to companies struggling to meet the May target while coping with coronavirus
The US Food and Administration (FDA) has decided to issue “a partial stop work order” for the external companies that are carrying out product compliance checks and vape store inspections
The US District Court in Washington DC has rejected the arguments of vape shop owners in five states that the US Food and Drug Administration (FDA)’s deeming rule was unconstitutional
The US Food and Drug Administration (FDA) is to lose its power to regulate tobacco and e-cigarette products if Congress passes president Donald Trump’s porposed budget for fiscal year 2021
The US FDA has recently implemented enforcement on (some) flavoured-e-liquid products, but what does this actually mean? This report provides answers to some of the important questions
The US FDA’s new policy of removing most e-cigarette cartridge flavours from the market has been greeted by scepticism and criticism from both the vaping industry and anti-tobacco groups
E-liquid cartridges with flavours other than tobacco or menthol are to be excluded from the US market at the end of this month, the FDA says, while advertising and marketing will come under scrutiny too
The US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have seized 44 websites they said were selling illicit vapour cartridges containing THC
How did Swedish Match USA manage to get eight General snus products approved by the US FDA as modified risk tobacco products after being previously unsuccessful?
The US Senate has confirmed cancer specialist Stephen Hahn as the new US Food and Drug Administration (FDA) commissioner
On 20th September, the FDA released its draft guidelines for PMTAs, spelling out in detail the information that e-cigarette makers will have to submit before next year’s deadline. This report provides information and related coverage regarding the process
President Trump has softened his position on a possible US flavour ban, and also endorsed a national minimum vaping age of 21
The US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) carried out 800 inspections in vape stores between 2016 and 2018, with thousands of warning letters have been issued to retailers for violations
This report answers some of the questions a manufacturer may be asking in relation to the position of the proposed rule with regards to labelling and marketing
US president Donald Trump has nominated lung cancer specialist Stephen Hahn to be the new full-time US Food and Drug Administration (FDA) commissioner
The US FDA’s new proposed rule for PMTAs provides details of how to structure the application as well as what to include. This report looks at this rule in detail cc
The White House has received the US Food and Drug Administration (FDA)’s final version of its guideline on flavoured e-cigarettes currently on sale without premarket authorisation
New Jersey e-liquid manufacturer Eonsmoke has been ordered by the US Food and Drug Administration (FDA) to remove from the market 96 products that do not have a marketing authorisation order
A motion from a Los Angeles councilmember is requesting the city attorney to prohibit the sale of all e-cigarettes and vaping devices in LA until they are approved by the US FDA
The US 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
Reynolds American has submitted a premarket tobacco product application (PMTA) to the Food and Drug Administration (FDA) for authorisation to continue marketing Vuse e-cigarettes in the US
The American public believes nicotine e-cigarettes to be more dangerous than THC vaping, even as official statements on the recent outbreak of lung disease start to emphasise the role of cannabis and play down the involvement of nicotine products
The US vapour industry is not happy with the FDA’s new guidelines for premarket tobacco product applications (PMTAs), with some fearing there may soon be no small manufacturers left to regulate
Acting US FDA commissioner Ned Sharpless told a House hearing there would be no blanket e-cigarette flavour ban in response to the country’s outbreak of lung illness
The FDA’s draft guidelines for PMTAs acknowledge a continuum of risk in tobacco products, while also placing much emphasis on youth protection
US president Donald Trump has announced that his administration is preparing new market restrictions on flavoured e-cigarettes
The possible addition of another 19 toxins to the US list of harmful and potentially harmful constituents (HPHCs) is generating uncertainty among vaping companies
Vaping advocates are seeking a legal injunction against the US FDA’s May 2020 deadline for submission of premarket tobacco applications (PMTAs) for e-cigarettes
The US Food and Drug Administration (FDA) wants to add up to 19 new chemicals to its list of harmful and potentially harmful constituents (HPHCs)
“Some people think that vaping is not a big deal, but that is just an illusion.” That’s the start of a new TV ad, one of a series featuring street magician Julius Dein launched on teen-focused networks by the US FDA
The US FDA has welcomed the ruling by a federal court that it must bring forward the deadline for submission of premarket tobacco applications (PMTAs) for e-cigarettes to 11th May 2020
11th May 2020 is the new deadline for US e-cigarette makers to submit their products to the FDA, following a federal court ruling
Acting US FDA commissioner Ned Sharpless has expressed his commitment to giving fair consideration to alternatives to smoking – but he still has doubts about vaping
The suggestion that the US FDA might bring forward the deadline for the submission of premarket tobacco product applications (PMTAs) has caused a wave of shock among small businesses
The US FDA has created a new digital age verification calendar to help retailers to avoid selling e-cigs and other tobacco products to under-age customers
The US FDA has suggested that the deadline for the submission of premarket tobacco product (PMTA) applications could be significantly advanced
The US FDA has published its long awaited guidance for premarket tobacco products applications (PMTAs) for e-cigarettes, including a number of non-binding recommendations for vaping manufacturers
Legislators in San Francisco have advanced a bill to ban the sale of e-cigs in the city until the US Food and Drug Administration (FDA) has reviewed the products
The US Food and Drug Administration (FDA) plans to visit vapour manufacturers in an effort to better understand the development, manufacturing, and testing of electronic delivery nicotine systems, as it pushes forward in its regulation of the category.
PMI’s heated tobacco device IQOS and its associated consumables have been granted market authorisation by the FDA – here are the details
A federal judge has ordered the US FDA to accelerate its reviewing of e-cigarettes currently on the market. Meanwhile, North Carolina’s attorney general is taking Juul to court
In the words of acting commissioner Ned Sharpless, the US FDA remains set on fighting the “epidemic of e-cigarette use by kids” and on “strategies to help those who are already addicted”
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
The US FDA has given its approval for Philip Morris International (PMI)’s IQOS in the US, along with its associated consumables ― the first heated-tobacco products to be so approved
The US FDA has written to 12 well-known convenience store chains – including Walmart, Kroger, and Family Dollar – accusing them of selling tobacco products to minors and ordering them to stop
Outgoing US Food and Drug Administration (FDA) commissioner Scott Gottlieb has linked e-cigarettes with a “potential emerging safety issue” after reports linking vaping with seizures, particularly among young people
The US Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) budget for financial year 2020 has been set at $747m, a significant increase on this year’s figure of $611m
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