7 July 2021
Below is the transcript of the video:
As part of our assessment process for making sure that we had all of the evidence to support our messages and claims that were submitted to the FDA as part of our modified risk tobacco product application, we included an extensive program looking at consumers' perceptions of the product, and behaviors, which included understanding of the messages. From this, the FDA was able to conclude the consumers generally understood the message and that they understood it properly in the context of their total health. And, if you read through their findings and scientific review, you see the pieces that really helped them come to that conclusion.
They found that consumers generally understood that these products weren't risk-free. They also go to the fact that consumers very much understood that quitting was still the best option for them. And they also concluded that consumers understood that IQOS was less harmful than a cigarette.
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.