WASHINGTON -- Philip Morris International (PMI) has filed an extensive number of documents with the U.S. Food and Drug Administration in an effort to gain approval to sell its new heat-not-burn iQOS device in the United States. And while the FDA recently published much of the material, product research largely remains blacked out.
The word “redacted” has been in national headlines recently with regard to FBI investigations into last fall’s presidential elections. The term referred to people’s names being blacked out, or redacted, from documents made public. Similarly, documents that New York-based PMI filed with the FDA to get approval to market iQOS in the United States were largely blacked out. The files had titles such as Comparability Report, Comparability Study and Scientific Report—Carbonyls.
Much of what is revealed speaks to scientific methodology, like what standards researchers will adhere to and what metrics will be used. The available language revealed little about what was being compared to what, or if proving a health benefit or any reduced-risk quality was the goal of any particular report. However, the available language did refer to clinical trials, “potentially harmful and quantifiable constituents,” and carcinogens.
One document described the testing of the product’s storage time and shelf life. It addressed testing methods to see if samples of product would function the way they were supposed to after a certain amount of time had passed.
While heavily edited, the documentation also revealed the body of research that has gone into the development of iQOS and appeared to support many industry claims that the FDA's new-product application process for tobacco can be extensive and costly.
The published material revealed many other aspects of the heat-not-burn device, including an extensive product description and proposed advertising materials. Watch CSP Daily News for details.