Status of PMI’s Modified Risk Tobacco Product Application
On December 5, 2016, Philip Morris International (PMI) submitted an application for FDA authorization to market its Tobacco Heating System (THS) as a Modified Risk Tobacco Product (MRTP).
On May 24, 2017, FDA initiated the substantive scientific review of PMI’s application. The agency published the executive summary and research summaries supporting PMI’s application. On June 15, 2017, FDA also published a notice in the Federal Register establishing a formal docket for public comments on PMI’s application.
FDA will post additional documents related to the application on a rolling basis and plans to issue subsequent communications when these materials are made public.
An abbreviated 10-page summary of PMI’s application is available here.
FDA’s Review of MRTP Applications is a Multi-Step Process
Once an MRTP application is submitted to FDA, the agency conducts an administrative review to determine whether it has jurisdiction to review the application. The application then goes through a filing review whereby the agency determines whether the application is complete.
If FDA determines an application is complete, the agency begins a substantive scientific review. FDA initiated the substantive scientific review of PMI’s application on May 24, 2017. PMI’s application was made available for public comment on June 15, 2017.
Also during FDA’s substantive scientific review, a meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) was convened on January 24–25, 2018 to review the application, provide recommendations, and answer specific questions set out by FDA.
The TPSAC is a body established by the statute, comprised of nine public health experts and three non-voting tobacco industry representatives, appointed by FDA Commissioner to provide recommendations on tobacco matters from a public health perspective. The TPSAC hearing is open to the public and interested parties may present data, information or views, orally or in writing, on applications pending before the Committee. While TPSAC’s recommendations related to an application may inform FDA’s ultimate decision, they are non-binding.
Following the substantive scientific review period, FDA will determine whether the evidence presented demonstrates that a product reduces individual risk and benefits the health of the overall population, and whether the claims for which authorization is sought by the applicant are substantiated. FDA takes into account all aspects of the application, public comments, and TPSAC’s recommendations. FDA has issued non-binding guidance stating it intends to review MRTP applications within 360 days.
An FDA order permitting commercialization of an MRTP is not permanent; it is for a fixed period of time as specified in the order, and requires manufacturers to conduct ongoing post-market surveillance. To market a modified risk tobacco product after the term set in the original order, a manufacturer must seek renewal of the order and FDA will need to determine that the requirements to market an MRTP continue to be satisfied.
The Tobacco Control Act of 2009 Gave FDA Authority to Regulate Tobacco Products and Created a New Pathway to Designate and Market Certain Tobacco Products as “Modified Risk”
The Tobacco Control Act (TCA) grants the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products and establishes a regulatory pathway for new products to enter the market. Under this authority, FDA is required to consider the effects of each new tobacco product not just on smokers, but on the general population as a whole, weighing the risks with the potential public health benefits of bringing a new product to market.
Acknowledging the principle of harm reduction to lessen the impact of smoking on individual and public health, the TCA established a process for FDA to determine if candidate products meet the standards to be designated as a Modified Risk Tobacco Product (MRTP) and thus marketed as such. This process and the FDA draft guidance requires manufacturers to submit extensive scientific research including clinical studies to demonstrate that a product reduces individual risk or exposure to harmful chemicals and benefits the health of the overall population.
About Tobacco Heating System
Using patented heat-not-burn technology, Tobacco Heating System (THS) heats tobacco to less than 570°F, compared to cigarettes that burn tobacco at temperatures that can exceed 1600°F. The heating process releases an aerosol with tobacco taste to provide current adult smokers with a familiar experience and ritual without smoke.
PMI’s application presents extensive scientific evidence to substantiate the requested claims. It includes the results of eight clinical trials, a series of in vitro and in vivo systems toxicology and standard toxicology studies, U.S.-based perception and behavior assessment, and population impact modeling.
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