The Food and Drug Administration (Fda) has given the green light for the Philip Morris Iqos system to be marketed in the United States as Risk Modified Tobacco Product (MRTPS), only electronic device with tobacco or nicotine to receive such an authorization. From now on, therefore, the Iqos device can be sold with the wording "with modified exposure" or with reduced exposure with respect to the damage caused by smoking traditional cigarettes.
The FDA will continue to monitor the data to verify that the sale of the product continues to be appropriate, including assessments of the potential increase in use among young people.
However, the agency assessed that according to the scientific evidence available, Iqos could be less harmful than normal cigarettes and could therefore bring "a benefit to the health of the population as a whole". "In any case, the FDA has specified that this does not mean that Iqos is risk-free or approved by the FDA", specifies the note from Philip Morris Italia.
Commenting on the FDA announcement, André Calantzopoulos, CEO of Philip Morris Italy, he said: “The FDA has determined that scientific studies show that switching completely from conventional cigarettes to Ios reduces exposure to harmful or potentially harmful chemicals. Iqos is a materially different product than conventional cigarettes and needs to be regulated differently, as recognized by the FDA."
The FDA's decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote public health. We are thrilled that this important decision will help guide the choices of adult smokers in the United States. The best choice for health is to never start smoking or to quit altogether. For those who don't quit, the best thing they can do is switch to a smoke-free product backed by scientific evidence."
As at March 31, 2020, according to Philipp Morris Italia estimates there are about 10,6 million smokers who have switched from traditional cigarettes to Iqos. "The data show that marketing these particular products with the licensed information could help addicted adult smokers switch from traditional cigarettes and reduce their exposure to harmful substances, but only if the switch is done completely," he said. Mitch Zeller, director of the FDA's Center for Tobacco Products.
