On July 7, 2020, the United States Food
and Drug Administration (US FDA) authorised the
marketing of IQOS, the
electronic tobacco heated system by Philip Morris International, one of
the largest tobacco manufacturing companies in the world. The Managing
Director of the corporation in Nigeria, Mr. Bahman Safakish, in this interview with Tobi Soniyi speaks on the implication of the FDA decision for Nigeria. Excerpts
For a few years now Philip
Morris has been promoting a smoke-free world by offering alternatives to
conventional cigarettes, reduced-risk products as you call them. On
July 7, the US FDA approved the marketing of your tobacco heated system
IQOS as a Modified Risk Tobacco Product. What does this decision really
mean?
Indeed, for more than a decade, PMI has
devoted many resources to the development and scientific substantiation
of alternatives to combustible cigarettes. We call these products
reduced risk products (RRP) because they present or have the potential
to present less risk of harm to smokers who switch to these products
versus continued smoking. It is important to note that the World Health
Organisation estimates that there will be over a billion smokers by 2025
and the goal is to reduce the prevalence of smoking by 30 per cent
then. One of the quickest and most effective solutions to reach the
overall goal of reducing non-communicable diseases would be to switch
from conventional tobacco products to less harmful products like
smoke-free products. The number one cause of smoking-related illnesses
is all of the toxic substances in cigarette smoke, most of which are
formed during the burning of tobacco. The U.S. Food and Drug
Administration (FDA) issued decisions on Modified Risk Tobacco Product
(MRTP) applications for IQOS and three HeatSticks variants (the IQOS
tobacco heating system) submitted by Philip Morris International (PMI)
since 2016. It took more than 3 years for the agency to issue an
authorisation to commercialise IQOS with a reduced exposure claim
because it takes some time to review the million plus pages of
scientific evidence and independent studies and be able to confirm that
switching completely from conventional cigarettes to the IQOS system
significantly reduces the body’s exposure to harmful or potentially
harmful chemicals. The decision of the FDA is a historic one as it marks
the first time that FDA has granted Modified-Risk Tobacco Product
(MRTP) marketing orders for a heated tobacco product. This decision
confirms three fundamental facts: That IQOS system heats tobacco but
does not burn it; that significantly reduces the production of harmful
and potentially harmful chemicals and; scientific studies have shown
that switching completely from conventional cigarettes to the IQOS
system significantly reduces the body’s exposure to harmful or
potentially harmful chemicals. Now is the time to rapidly shift smokers
away from cigarettes. Scientifically substantiated better alternatives
like IQOS represent a public health opportunity.
You are talking about change but you continue to sell cigarettes that still kill millions of people?
Discontinuing cigarette sales would
simply result in competitors and illicit trade filling the market space
and would do very little for the health of people who smoke and public
health. We are fully committed to doing everything we can to ensure that
smoke-free products replace cigarettes as soon as possible. We are
making tremendous progress toward our ambition of a smoke-free future.
IQOS is already commercialised in 53 markets, and we have already
encouraged over 10 million smokers to switch to IQOS and abandon
cigarettes, and four more million are currently adopting the product and
we expect them to abandon cigarettes soon.
Our ambition is that 30 per cent of our
volumes be represented by smoke-free products by 2025, which is
equivalent to approximately 40 million smokers that adopt them. However,
replacing cigarettes with smoke-free products will take time and does
not depend only on our efforts. For example, scientists and experts
should help by providing accurate information to the public about the
relative risks of these products versus continued smoking, governments
can work with manufacturers to encourage innovation in this space.
Governments have an important role to play by defining regulations that
encourage smokers to switch and smokers ultimately will have to decide
to quit cigarettes and, or switch to less harmful products.
This, of course, does not preclude
governments from continuing to prevent smoking initiation and to
encourage people to quit smoking. In fact, we too are publicly saying
that people should not start smoking and if they do smoke then the best
thing to do is to quit. However, the reality is that the vast majority
of smokers simply do not quit. Even WHO’s own predictions forecast that
there will continue to be more than 1 billion smokers by the year 2025,
roughly the same number as today. Providing these smokers with
science-based less harmful alternatives is therefore a commonsense
solution to improve public health.
All this is not a reality for
countries like Nigeria, which are less advanced and where most smokers
have a low purchasing power to access these alternatives, what about
affordability?
Consumers have the same needs and
concerns all around the world. Increasingly, consumers are looking for
alternatives to cigarettes. Our goal to replace cigarettes with
smoke-free products extends to all adult smokers of all income levels
and to all countries worldwide. Unlike cigarettes, adult smokers who
would like to switch to IQOS HEETS need to first purchase the IQOS
device. Still, supplying a reliable and scientifically substantiated
quality device is costly in this relatively new category, although we
have different programs in most countries where we commercialize IQOS to
make it easier for smokers to purchase the device. On the other hand,
the price of IQOS HEETS is in the same range as cigarettes, and in most
cases, lower than the premium priced cigarettes. We believe the cost of
both device and heated tobacco consumable will continue to drop over
time and governments will continue to provide tax differential and other
regulatory measures to accelerate adult smokers’ switching. IQOS was
launched in South Africa in 2017. We hope to launch in other African
countries as soon as possible.
Are you concerned that youth
will be encouraged to take up the novel product because of the “Modified
Risk Tobacco Product” claim?
Youth must not use any tobacco or
nicotine-containing product. The decision sets out clear
commercialisation guidelines, including marketing requirements that
maximise the opportunity for adults to switch from cigarettes, while
minimising unintended use. In addition, the decision also requires PMI
to conduct post-market surveillance and studies to determine the impact
on consumer understanding and perception, behavior and health. We are
also required to monitor youth awareness and use of the products to help
ensure that the marketing of the products does not have unintended
consequences for youth use. We take important steps that help to ensure
that unintended audiences, like youth, cannot purchase the product. We
are not aware of any reports of worrisome levels of youth use in any of
the markets where IQOS is commercialised.
We support monitoring of youth adoption
of nicotine products and swift action to correct any issues. This is
what the U.S. FDA did when it reviewed our application for IQOS to be
commercialised in the U.S., and concluded that “available data, while
limited, also indicate that few non-tobacco users would be likely to
choose to start using IQOS, including youth.”
At PMI we always ensure that our
products are not marketed to youth and non-smokers. We design all our
communications in a way that is not appealing to youths and implement
strict measures to limit youth interest and access to the product. Our
practices are governed by a set of internal rules—Good Conversion
Practices—that are often more restrictive than local laws.
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