8 April 2021
"IQOS is the first and the only electronic nicotine product to receive authorization from the FDA. It is historic just because of that."
Below is the transcript of the video:
IQOS is the first and the only electronic nicotine product to receive authorization from the FDA. It is historic just because of that. But then also—you know I look at it as a scientist—it is also historic because it’s the first time that adult smokers can receive truthful information about a product like IQOS in the United States. That means almost 40 million adult smokers can now hear about why IQOS is fundamentally different to cigarettes, and I think that’s really exciting.
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.