I worked at Swedish Match from 2012 to 2020 and since then they have been a client of my firm JMS Scientific Engagement. JMS Scientific Engagement provides private sector clients guidance for understanding and engaging in the regulatory science process. The firm specializes in finding opportunities for clients to interact with non-industry scientists and science- based institutions and to foster dialogue and understanding of common principles. I will address my experiences while with the company and in my current role, but I am not a spokesperson for the company.
I have worked in Washington, DC since 1982, starting with the National Governors’ Association (1982-1994), then the American Chemistry Council (1994-2006), and the consulting firm ENVIRON (2007-2012) where Swedish Match was a client. For most of that time I was involved in risk assessment: assessing the risk posed by a product (chemical product, for example) or occurrence (such as a natural disaster) and suggesting how best to manage the risk. I have also always been involved in the role of science in the regulatory decision-making process and advocating for regulatory reform by ensuring decisions are based on science.
FDA and the Tobacco Control Act
The 2009 Tobacco Control Act authorizes FDA to regulate tobacco and nicotine products. One of the provisions of the Act was to allow companies to submit a Modified Risk Tobacco Application (MRTP) making a health claim that a product is appropriate to the protection of public health.
The first product FDA authorized as an MRTP was the Swedish Match line of snus products marketed in the US as General Snus. The products were granted this distinction because they have low levels of harmful and potential constituents. And because the epidemiology – long-term human health studies—from Sweden demonstrated that snus does not cause smoking-related diseases such as oral cancer and heart disease.
For new products, such as the Swedish Match nicotine (no tobacco) in a pouch product ZYN, companies must go through the Premarket Tobacco Application (PMTA) process. A product may remain on the market awaiting the PMTA decision provided the company has submitted a credible application.
With your long background in government affairs at Swedish Match, please tell us about your work including the duration and difficulty of the regulatory process entailing getting nicotine products approved in the U.S.
One difficulty has been overcoming the view that nicotine causes cancer and other diseases; it does not, but according to a recent Rutgers University study, approximately 80% of physicians believe nicotine does cause cancer and other diseases.
Nicotine use is not harmless, it is addictive, but it is combustible tobacco –cigarettes- that cause disease. In Sweden and Norway, people use nicotine at about the same rate as other European countries, but they use snus rather than cigarettes (Sweden has by far the lowest smoking rate of EU countries) and thus doesn’t suffer from smoking-related diseases.
Considering Swedish Match's longstanding tradition and superior position on the Swedish market, how do you transfer that to the U.S. market and integrate into a country with presumably more extensive regulations for nicotine products?
Swedish epidemiological (long-term human health) studies demonstrate that snus users do not get smoking-related diseases. Since Swedish Match dominated the snus market during the time of these studies, in its MRTP application, Swedish Match was able to claim that Swedish studies were directly applied to Swedish Match products.
In other words, the Swedish long-term health studies contributed greatly to Swedish Match’s General Snus products receiving the first MRTP.
ZYN has proven to be a successful Swedish Match product in the U.S. - how do you envision the future for Swedish Match in general and tobacco-free products in particular, on American soil?
To successfully move smokers off cigarettes to a much less risky product there should be a variety of products available to meet consumer demand and give the consumer a choice. In Sweden and Norway, snus has been that product. But in the US ZYN has been that product. In much of the US and throughout the world, vape has been the harm-reduction product of choice.
Switching from cigarettes to vape, snus, and nicotine-pouched products like ZYN all greatly (by more than 90%) reduce individual risk. But vape is still a new product and thus there are no long-term human health studies. ZYN is also a new product, but it is very similar to snus, for which there is a considerable amount of long-term human health evidence.