Swedish Match MRTP Application Denied, Deferred
by Michael Huml
Swedish Match, the company responsible for the General brand of Swedish snus, has finally received the results of its MRTP application, and they're not good. This MRTP was an important document, as it was one of the first submitted to the FDA for approval, and would have provided a template for other products in the future. With its denial, those trying to submit either PMTAs or MRTPs in the future are still canaries in a coal mine when it comes to figuring out how to navigate complicated FDA regulatory requirements.
First, what is snus? Snus is oral tobacco. Unlike standard chewing tobacco, which has been dried in a kiln, snus is pasteurized and put into a pouch. It doesn't require the user to spit, and has been used in Sweden for over 100 years. It has undergone much more scientific analysis, and has much more evidence based on population studies than vapor products. In that time, no correlation between snus usage and negative health effects has ever been established.
When attempting to comply with FDA regulations, there are 3 avenues that a tobacco product can take: substantial equivalence (SE), modified risk tobacco product (MRTP), and premarket tobacco application (PMTA). SE must prove that a new or modified tobacco product is basically the same (substantially equivalent) to a product that was available on the market before 2007. MRTPs are for tobacco products that wish to claim that they pose less risk than another tobacco product, such as cigarettes. PMTA is the only path relevant to vaping, which is a new product, and legally a tobacco product as of May 10, 2016. Snus, on the other hand, has been around much longer, and Swedish Match is attempting to submit an MRTP so that they can start legally making claims that snus is safer than smoking.
Swedish Match was hoping to achieve 3 things by submitting the 130,000-page MRTP application:
• Remove the gum disease and tooth loss warning
• Remove the oral cancer warning
• Remove the “not a safe alternative to smoking” warning
The first item requested was flat-out denied, while items 2 and 3 were deferred, giving Swedish Match the opportunity to rework and resubmit its application. Whether they can, financially or logically, is the next question they need to consider.
Decades of research pertaining to snus was provided to the FDA, yet somehow did not meet the required standards, which were not made clear before or during the crafting of the application. FDA did, however, provide reasoning afterward as to what it was looking for.
The FDA maintains that in order to remove the current warning labels, Swedish Match must scientifically prove that snus cannot ever cause oral cancer, and provide evidence that consumers will not misinterpret the warning labels to mean that snus is harmless. It has to be clear that not using snus is always less risky than using it, even though it's safer than smoking.
If it sounds difficult, it's because it is. So difficult, in fact, that it's impossible. You can't prove a negative. If a snus user does develop oral cancer, there is no way to prove that snus was not the cause. People who never use tobacco still develop cancer, so it's impossible to draw a conclusion as to which tobacco users would have developed cancer anyway, regardless of tobacco usage. The years of snus research can only prove that the cancer rates of snus users is equivalent to that of non-users. But that's not enough for the FDA.
In addition, the FDA wants Swedish Match to prove that the public won't misinterpret the warning labels. Again, this is impossible. There are so many variables, perspectives, intelligence levels, etc., that nothing that exists in real life is 100% immune from misinterpretation. Nobody can control the way people perceive anything, so when I say that these requirements are impossible to meet, I don't mean that anecdotally. I literally mean that they are logically and conceptually impossible to meet.
So what does this all mean? For one thing, it tells us one of two things about the FDA. Either they don't understand how science and logic work, in which case they are unqualified and therefore incompetent, and in no position to be in the business of protecting public health. Or, they have no intention of protecting public health and underneath their public image, they have another agenda. Either way, it doesn't inspire much hope for the future of the vapor industry or public health.
For the vapor community in general, it again leaves us without any sort of precedent as to how to comply with FDA regulation. Swedish Match's MRTP would have been a great starting point had it been approved. In addition, snus has had a decades-long head-start when it comes to research compared to vapor products. The chances of anything other than a handful of cigalikes being approved by the FDA is, honestly, very slim. That means getting the regulations changed is the most pragmatic approach.
Unfortunately, we are all still subject to FDA's ruling, which means we need to play by the rules until the rules are changed. Many companies, including Madvapes, are working tirelessly to comply with FDA regulation. In the meantime, consumers and vendors alike can challenge the regulation through legislation. Contact your representatives, and make as much noise as possible. There are currently 2 bills in the works that would dramatically help the situation: HR2058 and the Cole-Bishop Amendment.
For more detailed information, head over to www.casaa.org or www.august8th.org to find out exactly what to do in order to help. CASAA makes it extremely easy to get involved, and it can take as little as 2 minutes. We encourage you to do more if you can, but the worst thing you can do is nothing at all. Ask friends and family to help as well, even if they don't vape. This issue goes beyond vaping, and affects everybody not only in terms of public health, but also in relation to regulatory overreach, the spread of misinformation, and the power of government to control consumer choice.
For CASAA's full analysis on Swedish Match's MRTP ruling, click on the link below:
http://casaa.org/news/swedish-match-gets-trapped-in-the-fdas-regulatory-house-of-mirrors/