Not Blowing Smoke’s submission of our comments in support of the MRTP application by PMI for its IQOS system has just been published by the FDA. You can find the four page comment on the FDA website or directly via this link. Note our strong case on the reduced risks inherent to vapor products.
Date: November 6, 2017
Scott Gottlieb, M.D.
Division of Dockets Management (HFA-305)
U.S. Food and Drug Administration (FDA)
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Not Blowing Smoke
2063 Main Street #131
Oakley, CA 94561
Re: Docket No. FDA-2017-D-3001, Modified Risk Tobacco Product Applications: Applications for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.
Note: Submitted via regulations.gov
Dear Dr. Gottlieb,
Not Blowing Smoke (“NBS”) is pleased to take advantage of the opportunity to submit our comments in support of the modified risk tobacco products applications (“MRTP applications”) submitted by Philip Morris Products S.A. (“PMI”) for its IQOS system and assorted consumables (“Heatsticks”); Marlboro Heatsticks, Marlboro Fresh Menthol Heatsticks, and Marlboro Smooth Menthol Heatsticks, collectively referred to as “IQOS”).
NBS is a 501(c)6 consumer-led and driven nonprofit organization that focuses on education for media, legislators, policy makers, and the public regarding tobacco harm reduction (“THR”). NBS also advocates for continued and affordable access to safer alternatives to smoking and was founded as a direct result of government funded media campaigns seeking to mislead the public regarding vapor products, such as California’s “Still Blowing Smoke” . As you are no doubt aware, there is a general consensus in the scientific community that vapor products represent a drastically reduced risk profile comparative to combustible cigarettes.
We would like to acknowledge the recent public statements and your paper in the New England Journal of Medicine titled “A Nicotine-Focused Framework for Public Health” regarding possible policy changes and direction of FDA to support a broader focus on harm reduction and how products known to be much safer than smoking, such as vapor products, should be regulated based on scientific evidence and proven merits.
Your commitment to encourage innovations that have the potential to make a positive public health impact represent mutual goals. Approving MRTP applications for IQOS would certainly fit within such proposed changes in policy and pave the way for other modified risk products to be marketed with appropriate and truthful information towards the public.
We have reservations on the merits of reducing nicotine levels in combustible cigarettes, but applaud FDA’s position of defining a framework based on tobacco-derived nicotine and incorporating the concept of THR within that framework. There are many products currently available, such as Electronic Nicotine Delivery Systems (“ENDS”) and other smokeless alternatives representing a significant level of harm reduction versus combustible cigarettes.
It is unfortunate that the Family Smoking Prevention and Tobacco Control Act (“TCA”) frequently uses terms such as “tobacco related disease” without having an appropriate delineation between the various products that either contain tobacco such as IQOS, or may merely be derived from tobacco such as nicotine containing e-liquids used in ENDS. We would hope Congress may also consider creating a separate definition for these products to better inform the public health discourse.
We believe there is consensus on the concept that a number of “tobacco products” present significantly lesser risk to consumers. We also find consensus that smoking combustible plant matter is a leading cause of much death and disease due to the tar and inhalation of smoke. While we also agree that a smoke-free world would be an ideal situation, we submit this is not the same as advocating for a nicotine-free world.
Nicotine is not the cause of what many public health and tobacco control organizations claim and science clearly reflects that. It is unfortunate to see so many groups rush to conflate the consumption of nicotine with smoking, given that most research on nicotine has occurred within the context of smoking cigarettes. Achieving a smoke-free world would be impossible without adequate, factual and truthful communications. Marketing of products that actively promote a smoke-free future through the MRTP process may represent a leap forward in shaping that future.
In our experience, smoking cessation is a very personal process that is greatly assisted by a diverse variety and availability of products that appeal to smokers. While flavored vapor products have shown to be an important and effective tool in helping millions of Americans to quit smoking, not every smoker starts off looking for flavored products and may indeed prefer a tobacco flavor that is similar or close to what they have grown accustomed to. IQOS most certainly meets this requirement and according to PMI has been a satisfying and safer solution for over 3 million smokers in Japan where it has been on the market since April 2016.
The Osaki Hospital Tokyo Heart Center also found that users were likely to completely switch to IQOS over traditional combustible tobacco and concluded that IQOS reduces exposure to harmful chemicals, leading to vast improvements to many of the measured indicators associated with smoking such as lung and heart disease. A similar 90-day clinical trial was conducted in the U.S. with similar results.
In addition to industry-funded research that has been provided as part of the MRTP application, there has also been non-industry research showing the harm reduction potential and vastly lower levels of toxicants via IQOS. We believe the combined data demonstrates that IQOS, though heating instead of burning combustible plant matter, provides an important opportunity the ongoing goal to eradicate smoking for those that seek to do so and substantiates the truthful modified risk claims PMI seeks approval for.
There appears to be a major difficulty in approving MRTP applications; since the introduction of the TCA, the agency has not approved a single application. In our review of the TCA, we feel that there is room for improvements that would allow for a more modern and forward-thinking approach to modified risk products such as vapor products, smokeless alternatives, and new heat-not-burn technologies such as IQOS. Being able to bring innovative solutions to the market in a timely and affordable manner would be in the best interest of public health.
It is of the utmost importance that the public is adequately protected and we acknowledge FDA’s role in that. However, refusal by FDA to allow the public to receive truthful and accurate information could prevent current smokers from seeking a path away from increased risk of death and disease caused by smoking combustible tobacco. We believe approval of MRTP applications will be a crucial step toward the goal of a smoke-free future. It is unfortunate that many public health and tobacco control organizations are ideologically opposed to safer alternatives that help combat the smoking epidemic. Approval of this and subsequent MRTP applications gives Americans a pathway to truthful information and will guard against misleading information to the public.
Absent MRTP approval, manufacturers of less harmful alternatives to smoking are enjoined from making accurate and truthful statements about their products. This compounds public confusion and prevents awareness by current smokers of alternative products representing reduced risk. We do not believe Congress intended for TCA to obfuscate fact, nor create a status quo in which less harmful products cannot be marketed to Americans.
This regulatory paralysis has the potential to be a guarantee of continued consumption of combustible tobacco.
It is our hope FDA will be able to look past ideological beliefs and focus on the scientific evidence, inclusive of PMI’s submissions for the IQOS products.
We respectfully request FDA approve the IQOS MRTP application so that adult smokers can be appropriately and honestly informed regarding the reduced risk of switching to a safer product that, based on the continuum of risk, may help lead to a huge leap forward in harm reduction and a welcome improvement to public health.
Stefan Didak, President, Not Blowing Smoke
Jason Downing, COO, Not Blowing Smoke
- Example of a government funded misleading media campaign: http://stillblowingsmoke.org/
- “A Nicotine-Focused Framework for Public Health” available at http://www.nejm.org/doi/full/10.1056/NEJMp1707409
- “FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death.” available at https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm568923.htm
- Farsalinos K, et al. “Impact of Flavour Variability on Electronic Cigarette Use Experience: An Internet Survey”. International Journal of Environmental Research and Public Health (December 2013) available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3881166/
- Frank Lüdicke, et al., “Effects of Switching to the Menthol Tobacco Heating System 2.2, Smoking Abstinence, or Continued Cigarette Smoking on Clinically Relevant Risk Markers: A Randomized, Controlled, Open-Label, Multicenter Study in Sequential Confinement and Ambulatory Settings (Part 2)”, Nicotine & Tobacco Research (April 2017) available at https://academic.oup.com/ntr/article-lookup/doi/10.1093/ntr/ntx028
- Frank Lüdicke, et al., “Reduced Exposure to Harmful and Potentially Harmful Constituents After 90 Days of Use of Tobacco Heating System 2.2 Menthol in the U.S.: A Comparison with Continued Cigarette Use or Smoking Abstinence” (March 2016), available at https://www.pmiscience.com/library/reduced-exposure-harmful-and-potentially-harmful-constituents-after-90-days-use-tobacco-2
- Farsalinos K, “Heated tobacco products vs. e-cigarettes” presentation at the Global Forum on Nicotine, Warsaw, Poland, (June 2017) available at https://gfn.net.co/downloads/Presentations_2017_/Dr%20Konstantinos%20Farsalinos.pdf
- Farsalinos K, et. al., “Nicotine delivery to the aerosol of a heat-not-burn tobacco product: comparison with a tobacco cigarette and e-cigarettes”, (June 2017) available at https://www.ncbi.nlm.nih.gov/pubmed/28637344