ecently, the Canada Gazette published Health Canada’s proposed regulations on the plain and standardized appearance for tobacco products for public consultation. We do not oppose plain packaging for traditional combustible cigarettes, but we do believe that this regulation fails to recognize the strategic role of reduced harm products.

Below is the letter from our physicians that was submitted to Health Canada on the subject:

By way of introduction, we write as a team of Canadian physicians who have had a strong interest – for a long time – in the regulation of tobacco and nicotine products.

Although we come from different disciplines – you are regulators, we are physicians – we have much in common. We are focused on the health of the body, while you attend to the health of the body politic. That common responsibility motivates this letter on the subject of harm reduction, and how that essential public health benefit should manifest itself in enlightened regulations.

Let us first say that Canada has done the right thing with regard to both the regulation of the deadly cigarette, and also with more recent regulations that recognize that e-cigarettes and vaping are important steps forward on the harm reduction spectrum. There is a great deal of research on this topic, including the recently published paper “Managing nicotine without smoke to save lives now: Evidence for harm minimization” which lays out a harm minimization framework that focuses on “smoking control” – which is, significantly, separate and distinct from general tobacco control. This is a material difference which we shall discuss later in this letter.

We strongly urge Health Canada to recognize that there are other products on this continuum, beyond e-cigarettes and vaping options – and that these require a legislative framework that is both broader and more nuanced than what is represented by Bill S-5.

To be more specific – tragically, the bill made no provision for this next generation of products that can push harm reduction in even more beneficial directions. For example, the new regulatory regime treats anything derived from a tobacco product in the same way as a cigarette itself – with vape products as the only and overly-narrow exception. And it is silent on alternative delivery systems that are neither vaping nor e-cigarettes. These are lost opportunities to advance harm reduction and inspire innovation.

In the interests of disclosure, we write from the dual position of both physicians and founding entrepreneurs of a start-up life sciences company called Parallax Development. We are innovating one of those next-generation products through a collaboration with Philip Morris International (PMI). We are jointly pursuing a novel product for delivering nicotine in the safest ways possible.

This product is so unique that it doesn’t fit neatly into the current legislative definitions. It does not contain tobacco, nor does it qualify for the “exempted class” of vaping products as defined in Bill S-5. Our product involves no heat or burning, and produces no fumes or odour.

Thus, under the current law, there is no provision for our product and we run the risk of being defined as a tobacco product by default – simply because the regulatory framework is not nuanced enough to account for our innovation. This could potentially limit the harm reduction potential of our product, or other new products in the future.

S-5 also makes no distinction between the cigarette and heat-not-burn products, even though growing evidence supports the fact that heat-not-burn products are safer then cigarettes, should occupy a different place on the harm reduction continuum, and could save thousands of lives. Three heat-not-burn products are being marketed in Canada, and smokers are currently being thwarted in their ability to learn about and find them. This is unconscionable.

FDA Commissioner, Scott Gottlieb, in particular, has created a regulatory strategy that is a multiyear roadmap designed to strike an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes. Taken together, this regulatory architecture recognizes that innovative, potentially life-saving products on the harm reduction spectrum need to be encouraged and supported.

Canada’s failure to recognize and regulate the entire harm reduction continuum will have devastating implications for smokers, their families, and the Canadian health budget. Ginette Petitpas Taylor, the Health Minister, has noted that $80M has been set aside to encourage Canadians to stop smoking. We support that. It is tragic that 45,000 die each year from tobacco use. But education is not enough. We have seen that. In parallel with education, we need regulations that encourage the development of innovative harm reduction products for those who can’t quit – which is the vast majority of current smokers, who have tried multiple times.

Lastly, we want to weigh in on the subject of plain packaging – currently up for review. To be perfectly clear, we are not contesting your decision to impose plain packaging requirements on conventional cigarettes. We appreciate that this can discourage cigarette smoking – and see no downside to the regulations.

However, when you look more broadly at the relationship between plain packaging on non-combustible tobacco options, we believe that the principles of harm reduction should be applied here as well.

After all, when it comes to superior alternative delivery systems, we want consumers to be able to easily recognize and find those products. Plain packaging serves to mask them, thus putting obstacles in the way of harm reduction. Smokers should be able to easily find the better path, feel good about it, and get positive reinforcement from family, friends, and the larger culture.

Regulations should not force smokers to buy superior products in packaging that is no different than a conventional cigarette. That tells consumers that there is no difference when there is an enormous one. A difference that could save lives.

In short, Health Canada should be developing regulatory frameworks that can both inspire safer behaviour and encourage innovation; you should use market forces to effect positive change in the world.

While we have an economic stake in your regulatory decisions, we will only benefit as smokers abandon the fatal cigarette for our far superior alternative – which sits in what we believe is the most desirable spot on the harm reduction continuum.

“First do no harm” is the section of the Hippocratic Oath that is the most well known. But we want to close with a portion of the Oath that speaks to action, not passivity. “I will use treatment to help the sick according to my ability and judgment…”

Smokers are sick, and injury and wrongdoing will be done to them unless the principles of harm reduction are applied in a disciplined, scientifically informed, and forward-looking fashion.

Thank you for your time and attention.