The U.S. Food and Drug Administration’s authorization of marketing of IQOS as a modified risk tobacco product should encourage other countries such as the Philippines to take a second look at innovative products as effective means to eradicate the smoking epidemic, according to two public health experts.
Prof. Tom Glynn, an adjunct lecturer at Stanford Prevention Research Center and a former director of International Cancer Control at the American Cancer Society in Washington D.C., said heat-not-burn tobacco products (HTPs) such as IQOS, electronic cigarettes and other less harmful products provide smokers with better alternatives to cigarettes, as studies show that smoking results in 100,000 deaths in the Philippines each year.
“More than 100,000 Filipinos die from cigarette smoking each year. Globally, more than 7 million people die from cigarette smoking annually. Cigarettes, when lit, produce more than 7,000 chemicals, at least 60 of which can cause cancer.
For more than 50 years, as the scientific and medical evidence about the dangers of cigarette smoking has accumulated, Filipino cigarette smokers, and cigarette smokers around the world, have been urged to quit their use,” said Prof. Glynn, a widely-published consultant on cancer and tobacco use prevention and control.
Prof. Glynn said that with the tobacco smoke being blamed for diseases and death of millions of smokers each year, less harmful products have been developed over the years including e-cigarettes, Swedish snus, and “heat-not-burn” products.
“The common thread among these products is that they offer a less harmful way of inhaling nicotine, the primary chemical that keeps smokers dependent on their cigarettes,” he said.
“Many public health experts believe that, by substituting these less harmful products for cigarettes, smokers can also reduce their vulnerability to the illnesses, and death, associated with cigarette smoking.” He said one of them is the heat-not-burn tobacco product called IQOS which received an authorization from the US Food and Drug Administration to be marketed as a modified risk tobacco product.
It was developed by Philip Morris International which received the authorization from FDA on July 7, 2020 to communicate the “reduced exposure” claim of IQOS, compared to cigarettes.
The authorization is the first and only for any existing electronic nicotine product.
“This is a significant advance for public health in the U.S., and globally, if other countries follow this lead (and some already have), since it offers smokers another opportunity to finally quit their cigarette use and its attendant death and disease,” he said.
“While the FDA was careful to avoid implying that they have approved IQOS for use, instead simply saying that the product produces significantly less harm than cigarette smoking, the FDA action does promote its long-standing position that there is a “continuum of risk” among nicotine-containing products and that IQOS is positioned well below cigarettes in that continuum,” said Prof. Glynn.
“This action is good for public health—smokers need less harmful alternatives to deadly cigarettes. Of course, it is vitally important to ensure that these IQOS and other nicotine-containing products do not become used by children and youth, and the FDA has taken, and will continue to take, strong actions to ensure that this does not happen,” he said.
The MRTP authorization shows that IQOS is a fundamentally different product than combustible cigarettes, and must be regulated differently, as the FDA has recognized.
The FDA’s decision is consistent with earlier conclusions of other leading regulatory and scientific bodies, including in the U.K., Germany, and the Netherlands, which have found that the product emits lower levels of harmful toxicants.
Prof. David Sweanor, a public health policy expert who chairs the advisory board of the Center for Health Law, Policy and Ethics at the University of Ottawa, said this is because it has been known since the 1970s that smoke, not nicotine, causes thousands of deaths among cigarette smokers each day.
“The science has clearly shown that it is the toxins in smoke rather than the nicotine that causes the harm.
We have also seen many examples of the ability of smokers to switch to smoke-free alternatives, including in our recent research on Japan where the availability of HTP has led to a massive decline in cigarette sales,” Prof. Sweanor said.
“Technology allows us to eradicate the pandemic of cigarette-caused disease. It is a matter of whether regulators can seize the opportunity. Also, whether an ironic combination of tobacco companies and abstinence-only anti-nicotine groups can be prevented from protecting cigarettes from disruptive technologies,” he said.
As of March 31, 2020, some 10.6 million adult smokers around the world have already stopped smoking and switched to electric cigarettes.