PMI’s transformation builds upon a foundation of scientific facts and transparency to deliver a smoke-free future. In July 2020, we took a giant stride toward this goal when the FDA authorized our electronically heated tobacco system, IQOS, as a modified risk tobacco product (MRTP) by issuing exposure modification orders. The orders were accompanied by a more detailed scientific review document.
Our position is clear: smoke-free products are not risk-free and the best choice for any smoker is to quit tobacco and nicotine altogether. However, many don’t. PMI is developing smoke-free products, such as IQOS, for this large population.
Here are 10 important facts about our MRTP applications (MRTPAs) and the FDA’s exposure modification orders.
1) The FDA’s decision confirms that IQOS is fundamentally different from cigarettes.
With its decision, the FDA decided that the authorized reduced exposure information may be communicated to American men and women who smoke to help guide their choices. The decision also adds to the growing body of independent research (including government reviews) that, today, not all tobacco and nicotine-containing products are the same.
2) The FDA authorized the marketing of IQOS in the U.S. with the following information:
- The IQOS system heats tobacco but does not burn it.
- This significantly reduces the production of harmful and potentially harmful chemicals.
- Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.i
3) The FDA concluded that the issuing of exposure modification orders for the IQOS tobacco heating system is “appropriate to promote the public health.”
IQOS is the first and only electronic nicotine tobacco product to receive exposure modification orders from the FDA. The agency stated that “the available scientific evidence demonstrates that the issuance of an exposure modification order for IQOS would be appropriate to promote the public health and is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products.”ii
4) The FDA’s ruling follows a detailed regulatory and science-based review process.
We submitted over one million pages of documentation related to scientific findings to support the MRTPAs, which, among other things, included aerosol chemistry, non-clinical data, clinical data, consumers studies, and independent studies. This data package, along with the submissions made in public hearings, took the FDA more than three years to review. The applications were the result of many years of research and development, carried out by hundreds of world-class scientists, engineers and technicians as part of our rigorous assessment program.
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5) The FDA assessed 97 scientific studies from our five-step assessment program.
These included studies on aerosol chemistry, indoor air quality, standard and systems toxicology, perception, and behavior. Our studies were designed to compare the effects of cigarette smoking to switching to our heated tobacco product and smoking cessation.
6) The decision was made in absence of long-term studies.
FDA reached its conclusions even in the absence of long-term epidemiological evidence. FDA’s decision clearly demonstrates that there is already sufficient evidence to make decisions that enable adult smokers to access the product and receive accurate information to guide their choices. In our opinion, this also firmly rejects the notion of prohibition as a sensible precautionary measure.
7) PMI applied for both “risk modification” and “exposure modification” orders in December 2016.
While the FDA determined that “the evidence did not support issuing risk modification orders at this time,” it noted that it did “support issuing exposure modification orders for these products. This determination included a finding that issuance of the exposure modifications orders is expected to benefit the health of the population as a whole.” iii The FDA clarified that “although reduced risk has not been demonstrated, the totality of evidence presented suggests that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.”iv
8) As part of the MRTP orders granted by the FDA, we are required to monitor and report who is using the product in the U.S., including whether it is used by youth and young adults.
The agency looked at several published studies that contained estimates of IQOS use among youth in Japan and Italy and noted that those studies suggest that in those countries, youth use of IQOS is low. v. As part of the FDA’s ruling, we have an ongoing obligation to carry out post-market surveillance to ensure our product is not taken up by youth. vi. Keeping our products out of the hands of youth is something we take very seriously. Smoke-free alternatives are designed for existing adult smokers who would otherwise continue to smoke.
9) The FDA has not “approved” IQOS or declared it “safe.”
Rather, it has issued orders authorizing the marketing of the product to adult U.S. consumers with reduced exposure information. In his statement accompanying the authorization, Mitch Zeller, J.D., Director of the FDA’s Center for Tobacco Products, said: “It is important to note that these products are not safe, so people, especially young people, who do not currently use tobacco products should not start using them or any other tobacco product.”vii
10) The FDA’s decision to authorize IQOS as a modified risk tobacco product was made in the context of U.S. law.
The provisions of the 2009 Family Smoking Prevention and Tobacco Control Act set a standard specific to the U.S. The FDA’s decision is a function of both the totality of the scientific evidence PMI submitted, and also the law.
*The FDA authorization decision relates to IQOS 2.4.
i) U.S. Food and Drug Administration, “FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information,” press release, 7 July 2020, paragraph 5.
ii) U.S. Food & Drug Administration, “Scientific Review of Modified Risk Tobacco Product Application (MRTPA) Under Section 911(d) of the FD&C Act – Technical Project Lead,” July 2020, Page 13, paragraph 3.
iii) U.S. Food and Drug Administration, “FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information,” press release, 7 July 2020, paragraph 7.
iv) U.S. Food & Drug Administration, “Scientific Review of Modified Risk Tobacco Product Application (MRTPA) Under Section 911(d) of the FD&C Act – Technical Project Lead,” July 2020, page 44, paragraph 1.
v) U.S. Food & Drug Administration, “Scientific Review of Modified Risk Tobacco Product Application (MRTPA) Under Section 911(d) of the FD&C Act – Technical Project Lead,” July 2020, page 66, paragraph 3.
vi) U.S. Food and Drug Administration, “FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information,” press release, 7 July 2020, paragraph 9.
vii) U.S. Food and Drug Administration, “FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information,” press release, 7 July 2020, paragraph 2.
