Philip Morris International : 10 facts about the FDA's modified risk tobacco product authorization of IQOS

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.

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.