When the Tobacco Control Act was enacted in 2009, it established a predicate date of February 15, 2007 for products subject to the Act: namely, cigarettes and smokeless tobacco. While any new brands introduced to the market would have to file complex and burdensome applications with the Food and Drug Administration (FDA) for pre-approval, all existing cigarette brands—which includes every cigarette currently on the market—were given a free ride. This means that every cigarette brand on the market is allowed to continue being sold, without any changes in nicotine content, without eliminating menthol—which is known to appeal to youth—and without lowering the levels of any of the more than 60 known carcinogens in these products.
Therefore, it may come as a surprise to many to find out that despite the lack of any safety regulations for deadly cigarettes, the FDA has sent for executive branch approval a set of regulations for electronic cigarettes—devices that contain no tobacco, involve no combustion, and have been shown to be orders of magnitude safer than cigarettes—that require every electronic cigarette product to submit burdensome, expensive, and technically near-impossible applications just to stay on the market.
The FDA has apparently decided that electronic cigarettes pose a much greater threat to the health of the public than the extremely toxic tobacco cigarettes that are killing more than 400,000 Americans each year. While tobacco cigarettes are given a free ride – they can stay on the market without submitting any application and without satisfying any safety requirement—much safer electronic cigarettes must go through a nearly impossible, expensive, and burdensome application process that will decimate the industry.
In 2007, e-cigarettes were in their infancy and it was unclear as to how they would be regulated. Over the last couple of years that has changed. Thus, as the FDA moves to regulate e-cigarettes, it should establish a predicate date based upon the date when FDA’s deeming regulations go into effect, rather than trying to rely on a date that is close to eight years old and which would give the cigarette market a decisive advantage.
In terms of science and technological advancement, today's products are light years ahead of what was on the market in 2007. As one major tobacco control organization has stated, we should be seeking to 'maximize e-cigarette benefits and minimizing their potential harms.’ Why should the most toxic consumer products on the market—combustible cigarettes—have to do absolutely nothing to stay on the market, while much safer, tobacco-free electronic cigarettes have to file burdensome and prohibitively expensive applications?
It seems that the issue of ‘descriptive flavors’ targeted at ‘children’ is the clarion call from anti-smoking groups like the Campaign for Tobacco-Free Kids for the use of the 2007 date, and it’s an easy argument for members of Congress to latch on to.
But the anti-smoking groups’ views are short-sighted. Preventing e-cigarettes from competing with real cigarettes is the best possible outcome for continued high rates of cigarette sales. By taking e-cigarettes off the market, the cigarette industry will enjoy an unfettered profit stream via the elimination of any serious competition. And changing the predicate date for e-cigarettes would not in any way inhibit the FDA’s oversight of candy-flavored e-cigarettes. The agency is free, at any time, to promulgate safety standards for all electronic cigarettes, something that it has—ironically—not done for tobacco cigarettes.
We believe that the FDA deeming regulations should be the focal point for directly dealing with e-cigarette safety issues by establishing product standards, labeling and marketing controls, and restrictions on flavorings such as diacetyl, that are known to be toxic to humans. Using the 2007 predicate date would result in the removal of at least 99 percent of electronic cigarettes from the market, turning back the clock on all of the technological advancements that have taken place. Such an approach protects the cigarette industry while stifling companies willing to invest in products that could have a significant impact on the health of this nation.
We have spent decades working on tobacco-related issues in the advancement of public health, including working with members of Congress on FDA oversight of tobacco products. We believe that the federal government needs a more rational approach to the regulation of tobacco and nicotine products that regulates all products based on their risks and relative risks. Protecting the cigarette industry while stifling innovation of new and much safer products does not achieve that goal and will damage public health efforts.
Siegel is a professor in the Department of Community Health Sciences, Boston University School of Public Health. Ballin is a health policy consultant and former vice president and legislative counsel for the American Heart Association. Both are 30-year veterans of the tobacco control movement.