The FDA has yet to approve any product for a “Modified Risk Tobacco Product” (MRTP) marketing designation since the first application was received in 2015. The MRTP designation may be awarded to tobacco products that are demonstrated to “(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”
Presumably, the purpose of this application pathway is to allow companies to market products that meet the rigorous standards set forth by the FDA, with the end goal of encouraging people who use or will use combustible cigarettes to switch to safer alternatives. Implicit in the decision to offer tobacco companies an exception to strict rules that prevent them from making any safety or health claims regarding mosttobacco products—all products that are on the market as of now—is that the FDA recognizes tobacco and nicotine products exist on a continuum of risk, with combustible cigarettes being the most dangerous product, and e-cigarettes, heat-not-burn devices and snus on the lower end of the spectrum.
The most talked-about product, the e-cigarette, has been determined to be at least 95 percent less harmful than combustible cigarettes. This estimate is based on a number of factors, including chemical analysis of e-cigarette vapor, human exposure to toxins and harmful chemicals, and actual and predicted health outcomes for those who switch from combustible cigarettes to vapor products. The conclusion that e-cigarettes are much less harmful than combustibles is supported by both Public Health England and the National Academies of Sciences, Engineering and Medicine. It estimated that e-cigarettes have the potential to save up to 6 million lives by 2100 if just one in 10 current smokers switches to e-cigarettes in the next decade.
Population studies also clearly show the reduced risk of snus, a smokeless tobacco product, compared to combustible cigarettes. A comprehensive review of snus use in Sweden demonstrates that a population-level shift from combustible cigarette use toward snus use is correlated with decreases in oral and lung cancer and heart disease. And studies also show that heat-not-burn devices, another reduced-risk tobacco product, emit over 50 percent less tar, carbon monoxide and nitrosamines carcinogens than combustible cigarettes.
Because all evidence shows that these products are safer than combustible cigarettes, it is a matter of time before the FDA approves MRTP status to products that are, in fact, safer alternatives.
But allowing tobacco and nicotine companies to make truthful claims about their products is only one part of the equation. One might assume that health preservation is incentive enough to encourage people to switch, but the cost of these products is equally important.
E-cigarette users are much more sensitive to price increases than combustible cigarette users, making them more likely to switch back to combustibles if vapor is highly taxed. Furthermore, populations of lower socio-economic status, who suffer higher rates of tobacco-related diseases and have a higher prevalence of smoking, will be less likely to take advantage of safer alternatives if taxes are increased on vapor products.
Many states are considering tax discounts for products with Modified Risk Tobacco Product designations. While reduced-risk and reduced-exposure marketing claims will certainly help consumers make informed decisions about safer products, reduced taxes provide a real economic incentive for smokers to switch.
It should be noted that, for a variety of reasons, the FDA has yet to grant an MRTP marketing designation to any products. The MRTP pathway is new and rather burdensome, and although there is compelling evidence for the products that have applied for approval, the FDA has unsurprisingly been cautious about granting these permissions. However, in anticipation of action from the FDA, state tax discounts put states at the forefront of incentivizing companies to produce safer products and helping smokers make the switch.
Considering the staggering number of tobacco-related illnesses and deaths that occur yearly, reduced-risk products have the potential to improve the health and welfare of a large part of our populace. Despite 30 years of intensive public health campaigns to warn us about the dangers of smoking, it continues to kill 480,000 Americans per year. To a large extent, abstinence-only approaches aren’t working. The FDA should recognize that harm-reduction approaches can mitigate many of smoking’s worst consequences, and use their MRTP designation to realize that potential.