Synthetic nicotine analogues appeared on the US market in vaping and oral products, marketed as exempt from the FDA’s PMTA requirements. This report examines nicotine analogues and their regulation at both the federal and state...

The report analyses enacted law and proposed bills that require tobacco products and e-cigarettes to be included in the tobacco directories before they can be distributed or sold in US states ...

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 ...

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) ...

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...

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 ...

This report looks at the US federal multi-agency task force to curb the distribution and sale of illegal e-cigarettes, examines options companies have, and summarises the Senate Judiciary Committee hearing on illicit e-cigs ...

This report provides analysis of the current regulatory regime for e-cigarettes in the US, covering all aspects from labelling and product restrictions, to retail and advertising regulations ...

This report provides an update on the progress of the US Food and Drug Administration's review of the PMTAs, and whether it has met its targets ...

This report examines the challenge brought to court by Triton and Vapetasia, against the MDOs issued by the US FDA in response to both companies’ premarket tobacco product applications (PMTAs) ...

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 2023 ...

In May 2023, the US FDA issued import alerts on multiple vape products and said any that do not have marketing authorisation will be detained at the border. This report looks at the process, implications...

This report provides detailed analysis of the US Department of Health and Human Services (HHS) report, which assessed the FDA’s efforts regarding online tobacco retailers’ compliance with the Tobacco Control Act ...

This report examines the challenge brought to court by Avail Vapor against the marketing denial order issued by the US Food and Drug Administration in response to the company’s premarket tobacco product application ...

This report discusses the background to this court decision requiring the FDA to submit status updates of the PMTA review, examines the timeline of these updates and provides analysis of the FDA's progress ...

This report analyses an apparently change in the FDA's review process for PMTAs, and discusses a number of individual cases where companies have raised it following the issuing of an MDO ...

This report examines the US Food and Drug Administration proposed rule that would establish a unified regulatory framework for tobacco product manufacturing practice requirements ...

This report examines the main pathways for tobacco products to enter the market in the US, covering PMTAs, MRTPs and SEs ...

This report analyses whether any of the upcoming tobacco-related regulations may be challenged under the major questions doctrine, including the menthol ban and the policy relating to nicotine levels ...

The new US federal legislation has brought synthetic nicotine products under the oversight of the FDA, so all synthetic nicotine products must go through a premarket tobacco product application (PMTA) process ...

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 ...

This special report details the e-cigarette flavour bans or restrictions in place in four US states, and analyses those under consideration at state level elsewhere across the nation ...

Synthetic nicotine, created from chemicals in a lab, not derived from tobacco, is not a specifically regulated product in the US so its legal status is subject to interpretation, as outlined in detail in this...

Juul is being sued in courts across the US. Most of the cases brought by individuals, states, or school districts have many allegations in common – and the consequences could affect the whole e-cigarette industry...

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 ...

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? ...

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...

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 ...

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 ...

PMI’s heated tobacco device IQOS and its associated consumables have been granted market authorisation by the FDA – here are the details ...

US FDA commissioner Scott Gottlieb issued a statement in November outlining the agency’s new policy to prevent youth accessing flavoured tobacco products – but what did it really mean, and what will it add up...

In this latest report on American regulations, ECigIntelligence highlights the fact that all electronic vaping devices will have to comply with FDA label requirements from August 2018 ...

There could be some relief for manufacturers of “tobacco related” products for the US market who have been restricted by the complicated legal process of obtaining authorisation from the US Food and Drug Administration (FDA)...

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...