September 4, 2020
National Center for Health Research’s Public Comments on the Petition for Extension of Premarket Tobacco Product Application Filing Deadline from Keller and Heckman LLP
[Docket number FDA-2020-P-1797-0001]
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.
We strongly oppose the requested extension of the deadline for premarket tobacco product applications (PMTAs), and we urge the FDA to not grant this requested extension.
PMTAs are essential because they will allow the FDA to thoroughly evaluate the potential health effects of the tobacco products. The FDA and consumers need to know the health effects of these products for both those actively consuming them, as well as non-users who are nearby users or exposed to residue from used products. Further, there needs to be data regarding the addictive potential of these products, as well as the likelihood that these products would lead non-tobacco users to begin using tobacco products. In addition, if claims are being made that any of these products help people to quit smoking, that needs to be supported by strong, scientific evidence. Such evidence has been lacking, despite those claims.
Products are already on the market without having submitted PMTAs. The epidemic of adolescents using these products is well-documented, and is the result of earlier delays in requiring PMTAs. The implications for the health of these children and young adults are of great concern, and also has implications for future costs to the U.S. healthcare system. Further delaying the deadline for PMTAs means to further delay information that consumers urgently need to make informed decision