Modified risk tobacco product: Historic FDA decision and lessons for Africa
Following 43 months of evaluation, the U.S. Food and Drug Administration (FDA) on 7 July authorized the marketing of IQOS in the country, Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP).
This decision by the U.S. FDA marks the first time the agency has granted MRTP marketing orders for an electronic alternative to cigarettes. It found IQOS to be “appropriate to promote the public health and is expected to benefit the health of the population as a whole.”
While the FDA does not endorse IQOS, its decision followed a scientific review of more than one million pages of evidence submitted by PMI and took into account independent studies. The federal agency concluded that noncombustible tobacco products such as IQOS differ from cigarettes in reducing the body’s exposure to harmful or potentially harmful chemicals.
This is consistent with earlier conclusions of regulatory and scientific bodies, including in the United Kingdom, Germany, and the Netherlands, which have found that the product emits lower levels of harmful toxicants than lit cigarettes.
The finding recognizes the harm-reduction effects of the “heat-not-burn” technology, which provides smokers with nicotine, while substantially reducing the risks associated with the combustion of conventional cigarettes.
Considering that cigarette smoking kills more than seven million people worldwide each year, the USDA decision opens a public health opportunity in the fight against the global tobacco epidemic. Encouraging the rapid shift from smoking cigarettes to alternatives such as IQOS – for adult smokers who have been unable or unwilling to quit – could save many lives.
Cigarette smoking is rapidly growing in Africa and deaths are rising.
While rates of smoking have decreased in wealthy countries, they have grown in poorer nations. In sub-Saharan Africa, cigarette consumption increased by over 50 percent between 1980 and 2016. Of deaths among African adults caused by second-hand smoke, over 60 percent are among women who live and work with smokers.
Six lessons can be learned from the decision by the USFDA and similar regulatory bodies in Europe.
1. A dogmatic approach to tobacco control, which condemns all tobacco products as equally injurious to public health, has little chance of reducing the harm of cigarettes in today’s world;
2. Evidence-based regulation that recognizes new harm-reduction technologies could help shape effective public policies to curb the dangers of smoking;
3. The tobacco industry must move expeditiously towards ceasing to manufacture and to sell conventional cigarettes;
4. It should lower the cost of reduced risk products and make them available to adult smokers in Africa;
5. Countries should move to include harm reduction in their arsenal of tobacco-control measures and engage the tobacco industry to find the best ways to make the new products widely available to adult smokers unable or unwilling to quit, possibly including raising taxes on conventional cigarettes, while significantly lowering them on reduced risk products;
6. Across Africa, where the median age is under 25, very strict measures must be put in place to protect under-age youth from gaining access to the new products, considering that they have been shown to be only better alternatives but are not risk free.
In an ideal world, humans would avoid all unnecessary substances that have negative effects on their health. Unfortunately, that is not the case and will likely never be. It will require courage and political will, but it is a public health imperative to adopt measures to reduce risks to the more than one billion smokers worldwide.
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