You had been anticipating MRTP designation for some time. What actions did you take in the run-up to authorization to prepare for increased production and sales? Please comment on the expansion of your low-nicotine, tobacco growing operations, the installation of new testing equipment, partnerships with retailers and your move to a new headquarters.
We were always highly confident that we would secure an FDA authorization, given the comprehensive scientific evidence base that has been established, both from our own research and the decades-long interest and clinical studies by health agencies and public health researchers. Moreover, we have established a strong regulatory and compliance function that has been fully supported by our executive team and board.
Drawing closer to the final marketing granted orders, we built out our commercial team, bringing on board highly experienced individuals with a unique blend of knowledge of the tobacco sector and emphatic support for how the product could help adult smokers. These hires include industry experts and disrupters for our commercialization team, including John J. Miller, previously with Swisher International and UST; John Ellegate, previously of Kretek International and R.J. Reynolds; and Sam Morales, previously [of] Cannadips, Swisher International and Drew Estate.
On the operations side, we’ve planted a record crop acreage this year to be able to support our national launch plans. We have also made substantial investments elsewhere in our manufacturing base. Our factory, for example, utilizes state-of-the-art manufacturing equipment, robust manufacturing processes and quality measures to be able to produce VLN reduced-nicotine tobacco cigarettes at the same speed and scale as conventional high-nicotine cigarettes.
Please describe your experience going through the MRTP process. What was good about it, and what parts need improvement? What would you advise other players considering an MRTP application?
Well, it wasn’t particularly easy—a classic British understatement—as those whom I worked with on the MRTP project know only too well. The modified-risk tobacco product application process is certainly the most rigorous and scientific process I’ve ever been a part of in my tobacco career. While it is a long and multistep process, we acknowledge that FDA had a vast amount of scientific literature to review—much of which was done whilst FDA managed the needs and disruption caused by Covid. This attention to detail and thorough review is essential because it allows the industry, the trade and—with product introduction—the adult consumer to have confidence and trust in the statements authorized by the FDA and how we describe our product.
Since launching, we’ve seen numerous points of view published by the trade in regard to our product and its proposition to adult smokers—the rigor of the MRTP application process is incredibly important because it allows the FDA to have the loudest voice in the room, so to speak, and helps trade partners and adult smokers receive and understand messages which are truly based in science. I particularly enjoyed working with a range of subject matter experts and seeing their shared enthusiasm for what we were working to achieve. The profound public health impact of cigarette addiction in the U.S. and elsewhere was and remains a significant motivation for me and for the team.
As for advice to other companies, I remain fully committed to reducing the harm caused by smoking, and [I] encourage all companies with appropriate products to utilize the MRTP application pathway. We are not a large company when compared to most U.S. tobacco interests and yet were able to navigate the complexities and challenges to bring something new and needed to adult smokers. Adults need access to and choice of alternative products that are supported by a robust evidence base, and we believe that having more MRTP-authorized products in the market will enable the industry to more rapidly move adult smokers to smoking less or to switch to using less harmful products [and] thus ultimately help end cigarette addiction.