Summary Recommendations:

  • FDA should redefine smoking as a behavior, not a disease, and regulate all tobacco-related and nicotine-delivery products accordingly.
  • FDA should migrate all regulation of tobacco-related and nicotine-delivery products to the Center for Tobacco Products (CTP), with the partial exception that those choosing to be marketed as drugs must also meet the safety, efficacy, research and documentation requirements of the Center for Drug Evaluation and Research (CDER).
  • If implementation of these recommendations is deemed inconsistent with the current text of the FDA tobacco law, action should be taken to amend the law as needed to implement these recommendations for the purposes articulated in this comment to FDA.

Introduction:

The current division of regulatory responsibility between the FDA Center for Tobacco Products (CTP) and the Center for Drug Evaluation and Research (CDER) has fostered a dysfunctional and scientifically unsound regulatory process by which tobacco products regulated by CTP are deemed to have harms, but no potential benefits, and products regulated by CDER are deemed to be unattractive to teens and other non-smokers, safe and effective, no matter how strong the evidence to the contrary.

E-cigarettes and related vapor devices (e-cigs) are most likely responsible for the recent record reductions in both teen and adult smoking in the United States, United Kingdom and Poland. These data are fully consistent with the hypothesis that most, if not all of the major reductions in cigarette use by teens are most likely due to the ever-increasing popularity of e-cigarettes for both current smokers and potential smokers experimenting with tobacco-related products. The fact that this same phenomenon is being observed in three very different countries with very different cultures and regulatory environments further supports the premise that these record reductions are, indeed, due to the skyrocketing use of e-cigs.

Despite this evidence, public health authorities continue to condemn e-cigarettes. FDA has even proposed deeming regulations which, if implemented, would likely eliminate the entire American e-cig industry by imposing requirements that would be physically impossible for any e-cig manufacturer to meet in the context of a pre-market application. This action, if successful, could reverse the recent record reductions in both teen and adult smoking.

The implications of FDA continuing to think of smoking as a disease are substantial. The current situation is one in which CTP thinks only in terms of potential harms of tobacco-related products, and CDER only considers benefits that can be documented by means of randomized clinical trials of individual substances to secure short-term smoking cessation. This leaves no place within FDA to consider benefits such as harm reduction and population health impacts that cannot be addressed by randomized clinical trials. This leaves no place within FDA that can consider benefits of a class of products, rather than one stock keeping unit (SKU) product at a time. Reframing smoking as a behavior, not a disease, and placing all regulation of all tobacco-related products in a single center with the flexibility to design and research and evaluation studies other than randomized clinical trials is a necessary first step if we are to ever enjoy the benefits that THR can offer.

The only partial exception to this rule would be to allow manufacturers who desire to market their nicotine delivery products as drugs to continue do so. Those who chose this option should also be required to meet all CTP requirements relative to marketing, impact on users and non-users, post-market surveillance, etc. This partial exception envisions regulation by CTP with CDER oversight to assure their requirements have been met.