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.

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

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.

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