Safakish: Why FDA authorised commercialisation of our product

The United States Food and Drug Administration (US FDA) recently authorized the marketing of IQOS, the electronic tobacco heated system by Philip Morris International, one of the world’s tobacco manufacturing companies. Managing Director of the firm in Nigeria, Mr. Bahman Safakish, speaks on the FDA’s decision and what it implies for Nigeria and Africa

With the recent approval of a tobacco heated system, IQOS, as a Modified Risk Tobacco Product by the US FDA, what does this imply for your organisation?

Indeed, for more than a decade, Phillip Morris International (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 Organization 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 over three years for the agency to issue an authorization to commercialize 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

  • The IQOS system heats tobacco but does not burn it.

  • This significantly reduces the production of harmful and potentially harmful chemicals

  • 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.

It, therefore, recognizes that IQOS is substantially different from conventional cigarettes, and has added that it is expected that its commercialization will benefit population health. 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, what do you say about that?

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 ambitions of a smokefree future. IQOS is already commercialized 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 one 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 p u b l i c health.

All this is not a reality for Nigeria and some countries, which are less ad-vanced 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 programmes 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 not worried that the youths will be encouraged to take up the product because of the “Modified Risk Tobacco Product” claim and may become a worrisome case in future?

Youths must not use any tobacco or nicotine-containing product. The decision sets out clear commercialization guidelines, including marketing requirements that maximize the opportunity for adults to switch from cigarettes, while minimizing 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 commercialized. 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 commercialized 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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