The fight is on for reduced harm tobacco products
Electronic cigarettes have their deeming regulations to contend with.
In Europe, they are fighting for snus to be sold in all EU countries. Currently, only Sweden can access it, along with the lowest smoking rates in Europe. It is however freely available here in the US.
Here in the US, the FDA is looking over the new heat not burn (HnB) device from Phillip Morris International (PMI), which is being promoted as a reduced harm device and selling well in Japan.
These are truly interesting times in the world of reduced risk products, where the same information is being interpreted differently by different nation states.
Initially, this blog was going to be a comparison of e-cigarettes vs heat not burn products. However, as we did more and more research into HnB, a curious trend emerged:
1) HnB are using ‘our’ language, as in being 95% less harmful
2) They don’t feel their product is a regular tobacco product, and as such, shouldn’t be regulated as one
“The tobacco plugs inserted into the device shouldn’t be classified as cigarettes because they do not burn or produce smoke. And the device itself, the company says, is an electronic product and so should not be regulated like tobacco.”
This is incredible because the HnB products contain tobacco. They are not like e-cigarettes that contain no tobacco whatsoever. PMI has the temerity to state that because it is an electronic device, the same as e-cigarettes, it should not be regulated as tobacco.
For vaping, any battery that is used to fuel an e-cigarette is considered a tobacco product. Anything within a 10-mile radius of an e-cigarette would be a tobacco product if the FDA had their way, yet, “A former Philip Morris employee in Bogota said the company’s position is that because the device itself does not include tobacco, unlike the inserts, marketing restrictions don’t apply to it.”
This means that PMI wants to be able to sell the HnB device, without the tobacco sheet, and for it not to be a tobacco product, so that it will not be subject to tobacco laws.
Can anyone else see the different playing fields emerging here? Is this because one company has applied for a license instead of many individual companies having to comply with rules made for them? Is PMI doing their level best to create the rules for themselves?
Another, probably just as obvious, question is, “how much does it have to do with the FDA?”
In July, the “newly appointed FDA Commissioner Scott Gottlieb proposed reducing nicotine levels in cigarettes to “non-addictive” levels while increasing development of lower-risk alternatives. The policy assumes that some percentage of the population will be unable or unwilling to give up nicotine.”
The article continues that, “To make the new strategy succeed, the agency needs a stable of vetted, reduced-risk alternatives to cigarettes. Philip Morris is one of the few companies that can finance such a long development process, spending close to $3 billion on reduced-risk products.”
Rulings will be made imminently regarding HnB, and they will be setting a precedent. This means that they will be setting a precedent for vaping too.
Vaping advocate Clive Bates has been quoted stating, “that if Philip Morris cannot win FDA clearance for a modified-risk product, no one will be able to.”
Currently, no tobacco/reduced risk company has succeeded in demonstrating that their product significantly reduces the risk of disease AND (this is the part they get ‘us’ on) does not encourage more smoking or delay quitting.
Think teens. If the FDA believes that vaping leads to teens smoking, despite information to the contrary, how will PMI’s new product fare?
“To date, the FDA has determined that only eight products meet that standard, all of them snus smokeless tobacco pouches made by Swedish Match AB. The agency has granted no company the right to specifically claim that their product is less risky than cigarettes.”
Now you understand the title of this post. PMI is either leading the charge or paving the way. This means that we should all be keeping a keen eye on how PMI fare. This could mean Totally Wicked things for our industry.