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Behavioral Studies
for Nicotine Products

Understanding Human Behavior Through Expertly Designed Studies

Understanding how people perceive and use your novel nicotine product in everyday life is essential for a Premarket Tobacco Product Application (PMTA) regulatory submission in the U.S. It is essential to build study designs capable of contributing to your product’s claims of being Appropriate for the Protection of the Public Health (APPH).

Woman using nicotine pouch

The Importance of Behavioral Studies  

A behavioral-based assessment of your product, including how it is perceived and used by people in their everyday lives, is one of the essential datasets generated to support claims of reduced risk, especially when considering a PMTA or MRTP regulatory submission for the U.S. 

Behavioral studies are significant, nationally representative surveys conducted online across different cohorts and age groups. They are conducted to demonstrate if your novel nicotine product, the associated product positioning, and marketing messages could lead to misuse by smokers, attract nicotine-naive users or appeal to youth. 

The ability to demonstrate that your product is unlikely to be used by youth and other vulnerable populations is essential when the U.S. Food and Drug Administration (FDA) considers if your product is Appropriate for the Protection of the Public Health (APPH) during a PMTA process. 

Behavioral Studies can also help improve product design, improve user communications, and prevent misuse or illegal access.

Speak to a behavioral studies expert to learn more about the importance of gathering behavioral data to improve product understanding and support a regulatory submission.

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Helping Build Compelling Scientific Evidence

Ensuring you have the most up-to-date consultancy about the behavioral studies your next generation nicotine product requires for a chosen regulatory pathway or to maintain compliance is critical for the commercial success of your business. Our experienced team of behavioral scientists has designed and executed studies across a wide range of novel nicotine products. Having worked on several successful regulatory PMTA submissions, they have the experience and insight to interpret data to build compelling narratives within your regulatory submission. 

We look to build long-term partnerships so our consultants can build study designs and programs that support your long-term commercial strategy across multi-product roadmaps and regulatory submissions.

Our Behavioral Studies Support Services

Perception of Risk Studies

Survey studies to determine, across a nationally representative cohort, what the risk perception of your novel nicotine product is compared to combustible cigarettes and other products within the nicotine category.

Intention to Use Studies

Survey studies to determine, across a nationally representative cohort, what the intention to use the product is if it were commercially available and marketed to consumers.

Prevalence of Use Studies

Survey studies are conducted once the product is authorized and on the market as part of ongoing post market compliance to gain insight and understanding into who is using the product and why. Is it being used as originally intended by the right target customer group?

Human Factor Studies

Human factor studies consist of small panels of human volunteers and simulated product use. These studies are designed to determine if users can use your product correctly, as per the instruction manual, thereby reducing the possibility of product misuse. They also ensure that product performance and therefore if the product’s claims of being appropriate for the protection of the public health (APPH), still apply when used by smokers in their normal lives.

Nicotine Consultancy Services Resources 

Learn more about how we can help bring your nicotine delivery product to market through our scientific and regulatory consultancy services.

Next-Generation-Nicotine-Products-Service-Guide

Next Generation Nicotine Products Service Guide

We help companies of all sizes through the product lifecycle stages, from concept innovation, product realization, and regulatory submission to post marketing surveillance. 

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PMTA-Guide-For-NGP-businesses

PMTA Guide For NGP businesses

At Broughton, our consultants have deep industry knowledge across all the elements required for a PMTA. We guide you through and generate the required data, to ensure that FDA finds your applications strong and compelling.

 

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Strategic-Insights-to-reignite-PMTA-confidence

Strategic Insights to reignite PMTA confidence

Dr. Nveed Chaudhary Chief Scientific and Regulatory Officer,  Paul Hardman Managing Consultant Chemistry and Manufacturing Controls, and, Libby Clarke Managing Consultant Toxicology share their thoughts on how to reduce costs and protect timelines while continuing to innovate.

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Nicotine Industry Insight and Expert Opinion

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The US Food and Drug Administration (FDA) has just announced an extension of its review of Premarket Tobacco Product Applications (PMTAs), as ....

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