NCHR’s Comments on FDA’s Proposed Rule on Tobacco Product Applications

National Center for Health Research, December 16, 2019

National Center for Health Research’s Public Comments on
FDA’s Proposed Rule for Premarket Tobacco Product Applications and
Recordkeeping Requirements 

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.

FDA’s proposed requirements for premarket tobacco product applications (PMTAs) defines the extent to which FDA is able to thoroughly evaluate the potential health effects of these products on consumers and, in particular, vulnerable populations such as children and adolescents.

  • As part of its review, it is important that FDA consider the health effects of these products on those actively consuming them, as well as the effects on non-users who are nearby during use or come in contact with residues from the products after they are used. This should therefore include not only the health effects of the chemical components of the product and those produced during use, but also those remaining on surfaces after use.
  • Additionally, the addictive potential of these chemical components as well as the likelihood that users would switch to risker products should be included in this review.
  • The FDA should also take steps to ensure that marketed tobacco products do not increase the likelihood that non-tobacco users would start using tobacco products.

When considering the addictive potential, it will be important for FDA to consider all of the many factors of the product that affect the likelihood of addiction, such as the amount, rate of effect, and potency of the nicotine delivered to the user. This includes different forms of nicotine, additives, and characteristics of delivery devices such as the amount of power and the heating temperature. Products with greater potential for addiction increase the risk for harm.

In addition, the design of products should be considered to prevent inappropriate use and unintentional exposures. In particular, because of the dangers that nicotine poses to children, liquid nicotine and e-cigarette devices need to incorporate appropriate child-resistant design features. And, these products should not be designed in such a way that it could be easily be mistaken by parents, teachers, and others as a flash drive, marker, or other benign product.

Flavored tobacco products should be banned. Even if a particular flavor does not increase the health risks of the product, the goal of flavoring is to make the product more attractive to children, adolescents, and adults. As such, it increases the likelihood of harm.

In addition to the products themselves, it will be important to consider how a product is marketed, how it is perceived, and how it is (or is expected to be) used. This affects the likelihood of use, and in particular, use by non-users. This should include all media channels, advertisements, as well as the intended audiences. For products that have been on the market, this should include all advertising, from the first advertisements and promotional materials to application submission. Studies on public opinion and usage are most informative if they are conducted on the intended population in the U.S. Cultural, regulatory, and demographic differences make it impossible to know how a study conducted in another country would relate to a U.S. population. Similarly, accurate data cannot be extrapolated to children or teens from adults, even young adults.

Because many early PMTAs will be for products already on the market, FDA can and should require the information related to the specific product’s users, health effects, addiction potential, advertising, marketing, and promotion in the U.S. market. There should be no need to base FDA evaluations on other products. Even for new, unmarketed products, use of “bridging studies” to estimate risks for a new product from another product should be excluded.

The health effects of a given product can differ dramatically because of individual differences among consumers. Since cancer and many other serious diseases can take decades to develop, it is premature to claim that an e-cigarette product, or other new tobacco product, is less dangerous than combustible tobacco products. For example, there are risks associated with inhaling toxic chemicals such as formaldehyde and heavy metals from e-cigarettes or other tobacco products. In addition, similar noncombustible tobacco products may have different risk profiles, and more dangerous profiles, even if less risky than cigarettes, which may make them unmarketable.

In many cases, important research about the use, safety and health effects of these products has been conducted by independent researchers not connected to the sponsors. FDA should welcome such research and other stakeholder input to provide scientifically and clinically solid information about tobacco products. Furthermore, it is essential that the FDA make public all data regarding products submissions, so that consumers and retailers know which products are in compliance and are legally marketed.

Given the epidemic of vaping and nicotine addiction, we believe that FDA should make public which products have pending applications. Once a marketing order for a product has been issued, the FDA should provide a public review of the data. This public understanding of the process and the information used as the basis of the FDA’s decision is invaluable in ensuring consistency and public confidence in the process. Producers, retailers and consumers need this information to ensure that marketed products have been rigorously reviewed and to understand the risk/safety profile of products.

National Center for Health Research can be reached at or at (202) 223-4000.