The FDA also announces that existing scientific evidence shows that the content of harmful or potentially harmful substances (HPHC) in IQOS aerosol gas is lower than that of regular cigarettes. The agency has also cited scientific studies showing that a complete switch from smoking to using an IQOS system will significantly reduce the body's exposure to those chemicals, but on the condition that they have to completely switch to using them (taking IQOS). The FDA said the decision was based on the product's public health suitability for both smokers and non-smokers.
The FDA's announcement is considered by the world press to be one of the most noteworthy decisions related to the issue of tobacco. Mr. Andre Calantzopoulous, General Director of PMI and Ms. Moira Gilchrist - Deputy Director of Strategy & Science Communications of PMI had an online sharing session with the world press, including Vietnam, regarding these issues.
Moira Gilchrist said that this conclusion is not just made by the FDA alone, but this process is carried out transparently and widely to the public so that everyone can express their views on data or products on an open database made public by the FDA. All PMI data is published so that the community can refer to any document in their licensing application on the FDA's website.
This dossier received many different comments, accordingly, scientists and community health experts in the US as well as around the world contributed their opinions to the FDA throughout the agency's appraisal process before making a decision.
Regarding the concept of reducing exposure, Ms. Moira Gilchrist said that based on many clinical studies in adult smokers, the results showed that the exposure to harmful or potentially harmful chemicals when switching to using IQOS products was very close to the level measured in people who had quit smoking throughout the study period.
However, FDA also said that up to this point, IQOS does not have enough scientific basis to prove that this is a product that reduces health risks related to smoking. Explaining this, Ms. Moira Gilchrist said that when talking about risk reduction or harm reduction, it is a manifestation of smoking-related diseases after a long time and the disease can be measured. For example, lung cancer, it takes decades to see the progression of the disease and this progression can be measured in patients. Therefore, it is not possible to measure that data through short-term research. What we do is analyze the risk imprint index. These are marks that can be measured in blood and urine, the results will tell whether a person is at risk of a smoking-related disease increases or decreases. But to directly measure smoking-related diseases, we will need to go to the department of epidemiology, Ms. Moira emphasized.
Mr. Andre Calantzopoulous said that it is impossible to collect epidemiological data if the product is not on the market, because if there are no users of the product, there will be no data on their health over time. I think the most reasonable approach is to allow products to be available but with proper monitoring and supervision measures, not only marketing issues but also measuring over time, whether there is a reduction in diseases and premature deaths. Thus, after a period of time, we will have an absolute quantity of the level of benefits of the product for public health, Mr. Andre shared.
It is known that the above license is valid for 4 years, after which Philip Morris will need to continue to request an extension from the FDA.
