7 July 2021
Below is the transcript of the video:
To maximize the reduction in exposure to a harmful or potentially harmful chemical and therefore maximize the potential to reduce the risk of disease, we need to minimize the exposure to these toxicants. And therefore this means switching completely, completely stopping cigarettes altogether. And therefore this is why both Phillip Morris thinks it's important, we put it in our message in the U.S. that you need to switch completely to these products to reduce the body's exposure to the harmful and potentially harmful toxicants as well as why the FDA is looking at this and saying it is important to make the switch. And we need to make sure that when this product is launched in the U.S. with these messages, that we monitor and make sure that people, one, understand they have to completely stop smoking to get the benefits, and, two, that they actually do so.
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.