When I take a step back and think about what it must be like to work for the American nicotine-delivery industry, it’s actually difficult not to feel at least a tiny pang of something approaching…sympathy. It’s nearly impossible to imagine there’s anybody left in the developed world who isn’t aware that smoking is harmful to human health, and yet many families’ economic lives and futures currently depend on maintaining demand for tobacco products. At the same time, the prevalence of smoking continues to fall: According to the United States Centers for Disease Control, just 14% of Americans were current smokers by 2017 (a percentage that still represents 34 million people).
It’s a conundrum. How do you create (or even maintain) demand for something that’s objectively harmful?
It is within this difficult context that I greeted the news that the US Food and Drug Administration will be permitting the sale of a novel tobacco delivery system that heats, but does not burn, tobacco, creating and delivering an aerosolized form of nicotine instead of smoke, and that may reduce some harm (as with vaping, we likely will not know the extent or the full, true risks for decades).
The FDA’s Premarket Tobacco Product Application (PMTA) pathway requires manufacturers to demonstrate that a new product’s marketing (not necessarily the product itself) will appropriately protect public health, including the health of current tobacco users, current non-users, and (importantly), youth. For now, it seems, Phillip Morris has satisfied these requirements, and the agency has pledged to monitor the marketplace and the marketing of the new delivery system to protect public health.
In fact, FDA’s greenlight to sell the new IQOS “Tobacco Heating System” in the United States included an emphatic reminder that permission to market the products “does not mean these products are safe or ‘FDA approved.’” But limited data suggest at least some of the harmful components of combusted tobacco are reduced in the new delivery system.
Under PMTA pathway approval standards, FDA determined “IQOS delivers nicotine in levels close to combustible cigarettes suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively. Available data, while limited, also indicate that few non-tobacco users would be likely to choose to start using IQOS, including youth.”
Still, with all we know about the history of the tobacco industry and its history of providing less than full, transparent data when faced with opposition to its products, I always advocate caution. It would be premature to begin celebrating yet another “cigarette alternative” before all the facts are in. The new devices do, in fact, still meet the Federal Food, Drug, and Cosmetic Act definition of “cigarettes.” Furthermore, a secondary application under a different standard (MRTP—modified risk tobacco product), which would allow Phillip Morris to claim reduced health risks or exposure to harm, is still under consideration, so if word-of-mouth or “informal” social influencers start to chat up the fact that “heated” tobacco is “safer” than combustible tobacco, DON’T FALL FOR IT.
The FDA said it best in their press release:
All tobacco products are potentially harmful and addictive and those who do not use tobacco products should continue not to.