
FDA


Import tariffs on China unlikely to boost a US vape sector held back by FDA red tape
7th February 2025 - News analysis |
Tariffs on Chinese imports will not create any impetus for domestic production in the vaping sector, according to the American Vapor Manufacturers Association (AVM)

US FDA enforcement: an analysis of the warning letters issued in 2024
6th February 2025 - Regulatory reports , Topic regulatory reports |
This report examines the US Food and Drug Administration (FDA) enforcement measures taken in relation to unauthorised tobacco products, and analyses the warning letters sent out throughout 2024

US health secretary hearings: what could happen to vape industry under Kennedy
31st January 2025 - News analysis |
The first fiery hearing for the confirmation of Robert F Kennedy Jr. as US secretary of health and human services went on with plenty of fireworks but little of substance for the nicotine alternatives industry

Altria revises outlook amid Njoy patent battle, despite smoke-free segment gains
30th January 2025 - News analysis |
Altria released its fourth-quarter and full-year financial results today, revealing progress and ongoing challenges in its business strategy – particularly concerning the acquisition of its e-cigarette brand, Njoy

US Supreme Court case reveals key point: the FDA believes vaping could save lives
29th January 2025 - News analysis |
The US FDA vs RJ Reynolds case at the Supreme Court brought up an important point: the FDA believes vaping could save lives, as it represents a less risky product on a continuum of risk

Reynolds challenges FDA PMTA denial in Supreme Court case…
23rd January 2025 - Alerts | North America, United States |

Trump’s executive orders may impact the e-cigarette sector in the US and abroad
23rd January 2025 - News analysis |
Nicotine alternatives have gone unmentioned through the initial flurry of actions taken after the inauguration of US president Donald Trump, but several executive orders and proposals will have an impact on the sector

Does the plan to cap nicotine in cigarettes reveal cracks in US public health policy?
23rd January 2025 - Blogs , News analysis |
In something of a disconnect in US public health policy, the proposal for a rule to limit the nicotine content for most combustible tobacco products represents a major change from years of prior decisions

US FDA’s plan to cap nicotine in cigarettes approaches finalisation but faces hurdles
15th January 2025 - News analysis |
The US Food and Drug Administration’s proposed rule to slash nicotine levels in combusted tobacco products has cleared White House review, although it is still far from certain that the rule will come into force

FDA issues proposed rule reducing nicotine levels in tobacco products…
15th January 2025 - Alerts | North America, United States |

CTP releases overview of regulatory efforts in tobacco control…
15th January 2025 - Alerts | North America, United States |

FDA seizes 628,000 unauthorised e-cig products in Miami…
14th January 2025 - Alerts | North America, United States |

What to expect in e-cigs in 2025: is this the end for flavours and disposables?
10th January 2025 - News analysis |
The year 2025 is shaping up to be a significant one for vaping. ECigIntelligence predicts several long-anticipated policy developments will start to emerge as regulators attempt to catch up to the rapidly evolving vaping market

FDA import alert updates aim to stop entry of unauthorised products…
7th January 2025 - Alerts | North America, United States |

FDA issues warning letters for unauthorised disposable e-cigs…
20th December 2024 - Alerts | North America, United States |

Lawsuit claims vapour product directory violates FDA’s authority…
20th December 2024 - Alerts | Iowa, North America, United States |

Bans and taxes on disposables took centre stage in 2024, along with politics at play
19th December 2024 - News analysis |
“Disposables” was once again the word of the year in vaping – more specifically for 2024, “a ban on disposables” was the phrase of the year in the sector, with many governments passing prohibition laws in an effort to protect youth and the environment

Authorities announce new efforts to combat youth vaping…
9th December 2024 - Alerts | Illinois, North America, United States |

FDA sends warning letters to over 100 retailers for illegal sales…
9th December 2024 - Alerts | North America, United States |

Supreme Court hears dispute over FDA denial of flavoured vapes…
3rd December 2024 - Alerts | North America, United States |

Nicotine alternatives industry hopes lie with Trump’s US FDA commissioner pick
3rd December 2024 - News analysis |
Interest from the nicotine-alternatives industry in US president-elect Donald Trump’s pick for Food and Drug Administration (FDA) commissioner, Martin Makary, is less about who he is and more about who he is not

FDA fines retailers for continuing to sell unauthorised e-cigs
27th November 2024 - Alerts | North America, United States |

Trump critical of FDA in announcement of health secretary nomination…
15th November 2024 - Alerts | North America, United States |

FDA sends more warning letters emphasising its jurisdiction…
13th November 2024 - Alerts | North America, United States |

E-cig companies’ MDO-related court actions against the US FDA
11th November 2024 - Regulatory databases , Regulatory reports , Topic regulatory reports |
This report tracks and analyses the challenges brought to court by vape companies of their marketing denial orders (MDOs) of their premarket tobacco product applications (PMTAs)

What’s next for tobacco and nicotine regulation in the US under Trump?
8th November 2024 - News analysis |
Talking about the future of the novel nicotine sector in the United States – its biggest single market by a long way – just got a whole lot harder

FDA sends warning letters over vape technology and designs…
30th October 2024 - Alerts | North America, United States |

FDA sends warning letters to e-cig makers and sellers…
24th October 2024 - Alerts | North America, United States |

Big Tobacco’s brand-building recipe: what’s the missing ingredient for vapes?
24th October 2024 - Blogs , News analysis |
November will mark ten years since Iqos was launched in Japan. And as the third-quarter results of Philip Morris International show, the last ten years have been quite the story in the product’s global brand-building

Federal multi-agency task force seizes illegal e-cigs worth $76m…
23rd October 2024 - Alerts | North America, United States |

FDA adds new manufacturer to import red list…
21st October 2024 - Alerts | North America, United States |

FDA issues warning letters for unapproved e-liquid products…
9th October 2024 - Alerts | North America, United States |

Congressman urges for more enforcement action over illicit products…
7th October 2024 - Alerts | North America, United States |

US study suggests flavour restrictions could weaken reduced-nicotine policies
19th September 2024 - News analysis |
Banning popular flavours to discourage youth vaping may jeopardise efforts to curb smoking rates in adults at risk, according to a study published earlier this month in the Journal of the American Medical Association

Vaping among US teens drops to ten-year low, annual youth tobacco survey finds
10th September 2024 - News analysis |
The use of e-cigarettes among teenagers in the US has hit its lowest level in a decade, as the number of young vapers in the country dropped by half a million in the past year

New US FDA rule reinforces youth vaping prevention, causing minimal disruption
5th September 2024 - News analysis |
The US Food and Drug Administration (FDA) has introduced a new rule that increases age restrictions on tobacco and e-cigarette sales, continuing its mission to protect young people from tobacco addiction

Minimum age for certain restrictions on e-cig sales to increase…
2nd September 2024 - Alerts | North America, United States |

Altria and Njoy respond to ITC’s initial ruling in Juul patent infringement case
29th August 2024 - News analysis |
Altria Group and its subsidiary Njoy have expressed their disagreement with a recent ruling by the US International Trade Commission (ITC) concerning a patent infringement complaint filed by Juul Labs

Lead next-generation innovation with the consumer, not the regulator, CRO advises
23rd August 2024 - News analysis |
Businesses that lead product innovation with what the consumer wants will be one step ahead when it comes to taking a next-generation product to market – particularly when making PMTAs in the US

Will the new FDA import rule for ENDS products really streamline the process?
22nd August 2024 - Blogs , News analysis |
The US Food and Drug Administration (FDA) and Department of the Treasury have recently proposed a new rule that could significantly impact the importation process for electronic nicotine delivery systems (ENDS) into the country

Continuum of risk policy for tobacco and nicotine products in the US: status update
20th August 2024 - Regulatory reports , Topic regulatory reports |
This report looks at the US concept of the continuum of risk that not all tobacco and nicotine products are equally harmful, traces the evolution of policy based on it over the years, and looks at what has happened to it since

Will the ‘major questions doctrine’ be used in tobacco regulation in the US? August 2024
19th August 2024 - Regulatory reports , Topic regulatory reports |
This report analyses the potential impact of recent changes in the “major questions doctrine”, which addresses the issue of how far US federal agencies can go in making policy on their own initiative

Proposal for ENDS importers to put FDA tracking ref. in customs system…
16th August 2024 - Alerts | North America, United States |

Big Tobacco happy with growth, but no talk of impact from regulatory changes
8th August 2024 - Blogs , News analysis |
All Big Tobacco companies reported growth in their smoke-free segments, reflecting a trend towards diversification from traditional cigarettes, though none have addressed the regulatory environment and its potential impact on future earnings

Appeals court vacates five FDA MDOs…
6th August 2024 - Alerts | North America, United States |

FDA sends retailers warning letters about unauthorised disposables…
2nd August 2024 - Alerts | North America, United States |

Altria tripled Njoy’s footprint in Q2 and secured premium positioning at retail
31st July 2024 - News analysis |
Altria reported encouraging results for its e-cigarette brand Njoy, as well as rapid expansion of in-store distribution in the second quarter of 2024. It said it strengthened Njoy’s supply chain and tripled its footprint

Do lower nicotine content levels in vapes and cigarettes benefit public health?
31st July 2024 - News analysis |
Lower nicotine content levels make tobacco products less addictive, but in vapes, they may lead users to compensate their intake by increasing the pace and intensity of their puffs, according to a recent study
