PMI’s Moira Gilchrist, VP Scientific and Public Communications; Manuel Peitsch, Chief Scientific Officer; and Antonio Ramazzotti, VP Human Insights and Behavioral Research, presented on our Modified Risk Tobacco Products (MRTP) Applications for EHTP before the Tobacco Products Scientific Advisory Committee (TPSAC) in January 2018 as another step in the FDA’s review process. Gizelle Baker, Director Scientific Engagement, and Dr. Maurice Smith, PMI Scientific Fellow, were also available to answer questions during the presentation. The presentation covered EHTP, its heating technology and the results of our assessment program to date. In addition, a representative from Altria, which will sell EHTP in the United States if authorized by FDA, shared an overview of the company’s plans for the introduction of the product, including controls to minimize unintended use, as well as plans for post-market surveillance. We summarized our application in our November 2017 Issue.
The FDA then presented its own assessment and results on EHTP to date, and members of the public had an opportunity to present statements to the committee. At the end of the meeting, the members of the committee discussed and voted on specific questions for which the FDA requested the committee’s views. The committee’s votes and the discussion from the meeting will be taken into consideration by the FDA, together with all other inputs from their review.
The committee, which is established under US law, advises FDA on issues of tobacco regulation, including the review of Modified Risk Tobacco Product Applications. The committee consists of nine voting members from the scientific and public health communities and additional non-voting members, including industry representatives. The committee raised questions and probed the likelihood and magnitude of potential benefits as well as unintended use. Although it did not agree with some of the specific language of proposed risk and harm consumer communications, it confirmed that evidence supported the statement that switching completely to EHTP significantly reduces exposure to harmful chemicals as well as the low likelihood of users who quit smoking reinitiating nicotine use with EHTP.
Find out more about PMI’s presentations here.
NEUCHATEL, SWITZERLAND 7 MARCH, 2018
We have updated our PMI Science website to enhance sharing of the science, technology, and innovation behind our smoke-free products with interested stakeholders. The newly revamped website explains our smoke-free approach and includes new videos and infographics that explain key concepts. Initially launched in English, the site will be available in additional languages in the coming months.
The new PMI Science website showcases a range of introductory videos explaining why better alternatives to cigarettes have a role to play in public health, as well as explaining the various steps of our robust assessment program. Visitors can also explore our four smoke-free platforms by viewing interactive infographics, showing in detail how each of the products works, and quickly scan an up-to-date overview of scientific results to date on each. The website also includes an overview of our scientific assessment program and our over 250 peer-reviewed publications, as well as presentations and posters presented at scientific conferences.
To check out the updated website, go to: www.pmiscience.com.
BALTIMORE, US 21-24 FEBRUARY, 2018
This annual meeting includes an education-packed scientific program that allows more than 1,100 international attendees to stay current with the latest breaking research on nicotine and tobacco. PMI presented posters on topics that included the biological changes after six months of smoking abstinence (resulting from our one-year smoking cessation study), the relationship between intended use and perceived risks of heated tobacco products, and the reduced effect of EHTP use on dental resins and tooth enamel and dentin discoloration compared with cigarette smoke. This last poster by Filippo Zanetti et al. expands on the publication by Xiaoyi Zhao described on page 7.
Independent researchers also presented their latest studies on EHTP, including results on aerosol chemistry,18 toxicity,19 clinical research,20 and product awareness.21, 22
Find out more about PMI’s presentations at the event, including the posters and slide decks, here.
NEUCHATEL, SWITZERLAND
PMI’s investigator-initiated studies program was a pilot program to encourage investigator-initiated research on our smoke-free products. As more adult smokers switch to smoke-free products, we are pleased to see an increased number of independent scientific studies on our smoke-free products. As a result, there is less need to support investigator- initiated studies. Established in June 2016, the program has been used to support researchers who design, implement, and oversee their own research on PMI’s commercialized smoke-free products. PMI’s ongoing role to provide financial, technical or material support to these researchers as they expand the scientific and medical knowledge on our commercialized smoke-free products. Although the program stopped accepting new applications after January 1, 2018, the final committee meeting was held in February to evaluate the last of the proposals. Three studies are currently underway, and two further studies are pending implementation.
Find out more about the program and the research being supported here.
18 Talih, S. et al. SRNT poster POS5-118 “Is IQOS designed to convert combustible cigarette users? Investigation of free-base and total nicotine, and reactive species in IQOS.” American University of Beirut, Lebanon. 19 Leigh, N. et al. SRNT poster PA23-3 “Cytotoxic effects of a tobacco heat-not-burn system on human epithelial cells.” Roswell Park Cancer Institute, NY, USA. 20 Gale, N. et al. SRNT poster POS5-188 ”Changes in biomarkers of exposure on switching froma conventional cigarette to tobacco heating products: a randomized, controlled study in healthy Japanese subjects.” British American Tobacco Ltd. United Kingdom. 21 Diemert, L. et al. SRNT poster POS5-50 “Awareness, perceived risk, and policy perceptions of heat-not-burn products.” University of Toronto, ON, Canada. 22 Hammond, D. et al. SRNT poster POS4-108 “Awareness and interest in heat-not-burn IQOS among youth in three countries: Canada, USA, and England.” University of Waterloo, ON, Canada.
