The Answers to FDA’s Tobacco Questions Are Obvious, But Perhaps Unwanted

In his recent Nicotine & Tobacco Research commentary, “The Future of Nicotine Regulation,” FDA Center for Tobacco Products director Mitch Zeller listed five “challenging questions.”  I offer the following answers.

1. How comfortable are we with long-term, or possibly permanent, use of less harmful nicotine delivery mechanisms by adults, if they help keep currently addicted smokers from relapsing to combustible tobacco products?

If addicted smokers stay smoke-free by using less harmful smoke-free alternatives, everyone who is not a tobacco prohibitionist is probably comfortable with long-term use.  The harm of permanent nicotine use is of the same magnitude as that of permanent caffeine consumption.  Most are comfortable with chronic consumption of caffeinated drinks, by adults and teens.

While the FDA does now acknowledge tobacco harm reduction, the agency still does not adequately distinguish the harm differential between smoke and smoke-free products, nor does it promote smokers’ transition to vastly safer products that have been on the market during the nine years of FDA regulation. 

2. How much weight should be placed on diminished interest in quitting nicotine altogether?

None.

3. Given the potential health impacts of dual use of tobacco, how acceptable is a short period of dual use while transitioning to less harmful nicotine-containing products? What if many current smokers engage in dual use on a long-term or permanent basis?

For smokers trying to quit, dual use of cigarettes and smoke-free products is a common practice which can occur over varying periods of time. 

Currently, owing to nonstop campaigning by federal authorities and health organizations, most American smokers believe incorrectly that smokeless tobacco and e-cigarettes are as dangerous as cigarettes (here and here).  Nine years ago I wrote in this blog: “In 2005, there were 1.4 million American men who were dual users of both cigarettes and ST [smokeless tobacco] products. These men consumed nicotine both from cigarettes and from ST, and the latter clearly resulted in lower consumption of the former. In both 2000 and 2005, every-day smokers who also used ST every day consumed significantly fewer cigarettes on average than exclusive smokers (13 cigarettes per day vs. 20 cigarettes). If these dual users knew that ST products were only 1% as hazardous as cigarettes, it is possible that many would have chosen to use only ST.” (here)

4. Can we revise labeling and indications for medicinal nicotine to increase quitting?

Of course, but this question is unrelated to tobacco harm reduction.  Medicinal nicotine is regulated by the FDA Center for Drug Evaluation and Research, not the Center for Tobacco Products, and the former has been futzing and diddling around with medicinal nicotine for decades (here).  In 1995, the Pittsburgh Tribune-Review published my open letter to FDA commissioner David Kessler, urging him to make medicinal nicotine products more available to smokers (here). The FDA did nothing to make them more effective or more affordable.

In February 2008, New York State Health Commissioner Richard Daines petitioned the FDA for revised package labeling and sales regulations for nicotine products – changes that would have greatly expanded product availability and consumer awareness. The petition was supported by numerous tobacco research and policy experts and organizations. The FDA failed to issue a response.

5. How might youth initiation be affected by the availability of different nicotine-containing products and how should we account for youth uptake of these products?

Teenagers have always been attracted to adult-oriented products and adult behaviors.  Teens are drawn to tobacco and alcohol, which are illegal for those under 21; many teens use marijuana, which is illegal for all or age-restricted in the various states (here).  It is not uncommon for teens to drive cars and have sex, two adult behaviors that can be high-risk.

Uniquely, tobacco use is regulated by a federal agency, the FDA, which now asserts that tobacco manufacturers are responsible for teen tobacco use. 

Everyone has a role to play in limiting teenage risk-taking, but focusing blame on manufacturers while ignoring other regulatory and information-sharing solutions ill serves the entire population.

October 24.  Clive Bates has just published his answers to Mr. Zeller's questions.  Please read them here.