On Oct 27, FDA’s Office of Science and Office of Regulation in the Center for Tobacco Products released new guidance for industry – Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies. Arriving approximately six weeks after the Sept 9 deadline, this guidance offers a window into FDA’s thought process as they review current ENDS PMTAs (Electronic Nicotine Delivery Systems, vape products like e-liquids and devices; PreMarket Tobacco Product Application). The new guidance shows a preference for comprehensive consumer behavior research and interest in the details of how that research is performed.
With the intense media focus on ENDS product marketing, it’s not surprising that FDA is paying more attention to consumer behavior research. At Blackbriar Regulatory Services (BRS), we were delighted to discover that the program we crafted for our ENDS submissions aligns neatly with the new guidance (over 70 SKUs in substantiative review as of Nov 6 with no rejections). Read on for highlights from the FDA’s Oct 27 draft and the thought process that shaped BRS’s consumer behavior program for PMTA.
GET SPECIFIC
FDA isn’t going easy on new tobacco products, ENDS in particular. While a comprehensive review of current ENDS behavior literature is essential in building support for your products, a book report will not cut it if you want market authorization. FDA is looking for product-specific research, ideally for each of your SKUs. The new guidance warns against applications that fail to provide a sound justification for leaving a particular product out of consumer behavior research. Applications that make it to substantiative review but fail to include complete perception and intent data are likely to receive requests for additional data – now is the time to prepare.
For each PMTA application, BRS custom-tailored our perception and intent to use studies to our client’s products. Our goal is comprehensive coverage without breaking the bank. That means we only bridge data across gaps we can defend with solid reasoning, not across critical SKUs. Our clients get a robust dataset and a comprehensive understanding of how consumers interact with each product.
A SURVEY ISN’T ENOUGH
Historically FDA has focused on quantitative behavior studies. However, the new guidance makes it clear that when it comes to vaping, they’re looking for more depth than a single survey can provide (it explicitly says so on page 6). Well designed qualitative studies, like focus groups or user testing, offer more nuanced insights into how consumers perceive a product and how they might interact with it in real life. These studies also lay the groundwork for a meaningful quantitative survey. Without a qualitative component, consumer behavior research is likely to miss critical insights into how current ENDS users started their journey and how potential users might pick up vaping. Further, FDA has high expectations for quantitative studies and wants to see surveys designed with research in mind.
The BRS approach includes a suite of interrelated qualitative and quantitative studies, thoughtfully designed to build upon one another and the body of tobacco and vape literature. Our program allows us to glean deep personal insights from our participants and tie them back to large datasets and academic research.
CURRENT CUSTOMERS ARE ONLY ONE PIECE OF THE PUZZLE
While pre-deadline communications indicated a strong interest in current vapers’ habits, the new guidance clarifies that FDA also wants to understand how new products impact all consumers. As FDA gets to know the ENDS industry, they have three big questions they want answered:
- How do consumers view this product?
- Do they want to try it?
- Do they understand the associated risks?
They aren’t only interested in learning about vapers, they also want insights into how current smokers and non-smokers see ENDS products. If you’re only asking your existing customers, your program is going to fall short.
BRS’s research program pulls from a wide swath of the US population, bringing in participants that are diverse geographically, demographically, and in their tobacco use histories. The resulting data paints a more complete picture of ENDS product perceptions and potential use in the US.
YOU NEED SCIENTISTS IN THE MIX
The guidance is clear – your research team matters. You wouldn’t have your lawyer throw together your HPHC testing, likewise your consumer research needs an expert at the helm.
As the head of BRS’s Consumer Research division, I bring over a decade of behavioral research and marketing experience to the table. Our team works to develop customized research programs for ENDS products that meet FDA’s wish list while respecting our client’s budget and timeline. Reach out to info@bb-rs.com to learn more about filling the gaps in your consumer research.
Article written by MARA UNKEFER – Director of Consumer Research at Blackbriar Regulatory Services