Human studies play an important role in assessing whether the marketing of an Electronic Nicotine Delivery Systems (ENDS) product is Appropriate for the Protection of Public Health (APPH), a key contributor in a Premarket Tobacco Application (PMTA) submission to the US Food and Drug Administration (FDA).

How Human Studies can help

Human studies are a pivotal component in the submission of a PMTA to the US Food and Drug Administration. Broughton Nicotine Services provide an end-to-end support service with leading industry specialists and a network of experienced Contract Research Organisation's (CRO) to ensure your data are acceptable to FDA and can inform an APPH assessment, in these key areas:

  • Performing clinical studies to assess puffing profiles, nicotine uptake and abuse liability of ENDS products
  • Conducting rigorous literature reviews to assess the potential health impact of ENDS products, for submission as a component of a PMTA
  • Undertaking behavioural studies to assess the prevalence of use, perceptions of use, appeal, and intentions to use ENDS products in nationally representative samples of the US population
  • Performing human factors studies to assess whether people understand how to use an ENDS product and that its use presents no immediate safety concerns and that any potential hazards are mitigated

What do Human Studies involve?

Several different types of human studies are required to demonstrate to FDA that marketing of an ENDS product is Appropriate for the Protection of Public Health. The overall aim of these studies is to demonstrate that an ENDS product poses no safety or health risks to users, and that a particular product's appeal is towards its target user and not towards unintended users.

Broughton Nicotine Services provide a turn-key service in the design, conduct and reporting of human studies in four core areas:

Clinical Studies

  • Nicotine pharmacokinetics – how much nicotine is delivered and how quickly when someone uses an ENDS product
  • Abuse liability assessment – how addictive is an ENDS product relative to combustible cigarettes
  • Puffing topography – what are the puffing patterns in users of an ENDS product, and how does this impact inhalation of toxicants and impact on health

Literature Reviews

  • Rigorous assessment of whether the use of an individual or a type of ENDS product is known to impact human health

Behavioural Studies

  • Cross-sectional, large-scale surveys to assess the prevalence of use and demographics of users of an ENDS product, and what was their prior use of other tobacco and nicotine products
  • Assessments of whether an ENDS product, its packaging, or its marketing appeal to current users of tobacco products, and whether it appeals to unintended populations such as non-tobacco users or adolescents
  • Longitudinal user surveys to examine changes in tobacco product use behaviour after starting to use an ENDS product

Human Factors Studies

  • Simulated use studies to assess whether an ENDS product can be used safely and operated correctly by both naive and experienced ENDS users
  • Examination of whether the instructions for use of an ENDS product can be understood and that this leads to its safe use

 

Broughton Nicotine services integrates all the information gathered by these studies to generate a narrative in a PMTA submission, which demonstrates whether the marketing of an ENDS product is Appropriate for the Protection of Public Health.

A fully integrated approach to Human Studies

Broughton Nicotine Services offer a wide range of services, combined with a network of internal experts and partners, exclusively dedicated to supporting companies operating in the ENDS sector. This full-service, when integrated with our other ENDS-focused analytical and scientific services provided, supports regulatory submissions and enables new product development to advance a smoke free future.

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Resources

Leaflet

Overview of our full-service PMTA compliance solution, from planning through to compilation and submission.

Guide

Understand what’s involved in a PMTA and how the recommendations relate to your ENDS business.

Leaflet

Download our leaflet for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.