Last week, the FDA announced a new, two-part plan for tobacco and nicotine regulation. It cracks down on combustible cigarettes by aiming to reduce their nicotine content to non-additive levels, while giving newly regulated combustible (e.g., cigars and pipe tobacco) and non-combustible (e.g., e-cigarettes) tobacco products a reprieve in the form of extended deadlines to apply for tobacco product review.
According to the announcement, the FDA endeavors to increase "awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes."
To learn more about the nuances and implications of the FDA's plan, I contacted tobacco expert Robert Jackler, MD, a professor and chair of otolaryngology at Stanford Medicine.
In a nutshell, what does the FDA announcement say and mean?
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which empowered the FDA to require reduction of the nicotine content of cigarettes but explicitly prohibits 'requiring the reduction of nicotine yields of a tobacco product to zero.' On July 28, the FDA announced commencement of a what is likely to be a lengthy process to explore the possibility of reducing the nicotine content in traditional combustible cigarettes to non-addictive levels. Initially this entails a period of public commentary to gain varied perspectives from the public health community, the tobacco industry, and the public at large. Such processes can drag on for years and have an uncertain resolution, particularly given the potent political influence of the tobacco industry, their penchant for delaying litigation, and use of highly compensated experts to manufacture doubt about the scientific facts even though none exists regarding the central role of nicotine addiction in the suffering and premature deaths resulting from tobacco use.
Do you think that reducing nicotine levels in combustable cigarettes while postponing review deadlines for other tobacco products is a deliberate effort to steer combustible cigarette users towards these “less harmful” tobacco products?
The FDA announcement endorses innovation in harm reduction — satisfaction of nicotine addiction by means other than burning tobacco leaf. (The products of tobacco leaf combustion are the principle causes of tobacco-related cancer, lung disease and heart disease.) Nicotine replacement therapies have long been on the market in the form of patches and gums. While is it controversial, some advocate that e-cigarettes, which deliver nicotine in a vapor of glycerin and propylene glycol, may be a healthier alternative for current smokers. An emerging product category is heated rather than burned tobacco (e.g., Philip Morris International’s IQOS) which is being promoted by major tobacco companies as a harm reduction alternative.
What’s your reaction to the FDA’s announcement and proposed plan?
The FDA under the Obama administration announced a series of much-needed regulations of e-cigarettes, intended to take effect in the near future, which were much needed to counter the notable excesses among purveyors of vapor products. I'm disappointed by the delay in enacting regulation of the e-cigarettes industry until 2022. A generation of America’s youth will remain vulnerable to youth oriented marketing of e-cigarettes on social media in flavors such as glazed donut, pink bubblegum, and mint chocolate chip.
Flavored tobacco products are of differential appeal to adolescent starter smokers. I certainly support the FDA focus on eliminating flavors, which was done for cigarettes (except for menthol) by act of Congress in 2009, from all tobacco products. I'm disappointed that we're now eight years following the flavor ban for cigarettes and the FDA still has not expanded this policy to encompass cigars, mini-cigars, smokeless tobacco, pipe tobacco and vapor products.
Do you think this proposed plan could successfully reduce the number of people addicted to tobacco products?
The single most effective measure the FDA could enact would be reducing the nicotine content of combustible tobacco products to non-addictive levels. Most established smokers would either quit or migrate to less toxic means of satisfying their addiction. Teen experimenters wouldn't get ensnared by nicotine addiction into becoming lifelong smokers.
Previously: E-cigarette brands make unvalidated claims their product helps people quit smoking, New landscape for e-cigarettes: Stanford tobacco expert weighs in on new FDA regulations, Med School 101 class on e-cigarettes gives teens a crash course in critical thinking and A conversation about the FDA's new graphic health warnings for cigarettes.
Photo by Joe Foley