7 July 2021
"From a toxicity perspective, they concluded there was a lower toxic potential from the IQOS aerosol compared to cigarette smoke."
Below is the transcript of the video:
The FDA reviewed our dossier which included, as you know, millions of pages of data. They also did a literature review of what was available in the literature that had been published since our submission, as well as doing some of their own tests. Example, they took samples of our product and did aerosol chemistry testing in their own lab. And with all of this data and the public comments that came in during the dossier review, they ended up making six major conclusions.
First, they concluded there was no combustion in IQOS. Second, they concluded that there was a reduction in the levels of toxicants emitted in the IQOS aerosol compared to cigarette smoke. Then they actually connected that and said that the reduced emissions lead to a reduced exposure to toxicants in people who switch completely from cigarettes to IQOS. From a toxicity perspective, they concluded there was a lower toxic potential from the IQOS aerosol compared to cigarette smoke. They also concluded that all of this evidence together would likely or is reasonably likely to lead to a reduction in morbidity and mortality in subsequent studies. And then, as part of the modified risk tobacco product authorization, they also have to look at the messages and how consumers understand these messages, and they concluded that it's reasonably likely that consumers would correctly understand the messages.
Through the MRTP pathway the FDA completed its scientific review of PMI's scientific evidence package—and independent studies—and decided that issuing an exposure modification order for IQOS is appropriate to promote the public health and is expected to benefit the health of the population as a whole. In reaching its decision, FDA had to consider not only the scientific evidence, but also the context and strictures imposed by U.S. law and regulations. The provisions of the 2009 Family Smoking Prevention and Tobacco Control Act set a standard specific to the U.S. and FDA must work within the framework that the law sets out.
The FDA's decision provides an important example of a government regulating smoke-free alternatives differently from combustible cigarettes based on their risk profile. The information in the video does not, and is not intended to, constitute legal advice.
Smoke-free products are for adult smokers who would otherwise continue smoking. They are not risk-free and contain nicotine, which is addictive. The best choice any smoker can make is to quit cigarettes and nicotine altogether.