Policy Studies Public Safety

E-cig tipping points vs. FDA deeming regulations

The attached policy study originally was published in Volume 8, Issue 1 of the Journal of Addiction Research & Therapy.

In 2002, writer Malcom Gladwell introduced the concept of “Tipping Point” into the American lexicon. A “tipping point” is the magic moment when an idea, trend or social behavior crosses a threshold, tips and spreads like wildfire, leading to a new and irreversible development.

E-cigarettes and related nicotine vapor products (e-cigs) have already “tipped” in two major ways. The first is popularity. According to the latest Reuters polls, e-cigs are now being used by about 10 percent of American adults, about 24.5 million people. About 30 percent of them continue to use them on an ongoing basis as a total substitute for cigarettes, with another 62 percent using them as a partial substitute. Only about 8 percent of vapers never smoked cigarettes. We now have advocacy groups representing manufacturers, vendors and millions of users. Thus, since their introduction in 2006, e-cigs have become a multibillion-dollar industry and a permanent part of the American scene.

The second tipping point was crossed last year. British authorities came out with the Public Health England report endorsing tobacco harm reduction using e-cig products to reduce tobacco-related illness and death. We now have American, Canadian and British reports showing that e-cigs are effective in helping smokers cut down and quit and doing so without recruiting significant numbers of nonsmoking teens to nicotine addiction. This tips e-cigs from a product seen as dangerous and highly addictive to a product that should be seen as having potential public health benefits well in excess of any potential harms; benefits not likely achievable by any other means.

British authorities and other responsible advocates do not claim that e-cigs are risk-free. They do claim that the potential benefits to smokers far outweigh the theoretical risks, and that the risk to nonusers is minimal.

While the crossing of the popularity tipping point is indisputable, American and British authorities differ on whether the public health benefits tipping point has been breached. This difference, in turn, appears to be rooted in how each side has framed the e-cigarette issue. The British carefully considered both potential harms and possible benefits, and concluded that the benefits will likely far outweigh any potential harms. The Americans have limited their consideration to potential harms. Rather than rely on published research by class of product, the Food and Drug Administration has challenged the manufacturers to generate new research, making the case for long-term benefit one product at a time. Current FDA regulations require product-specific studies to document that each combination of a device, flavor and strength of nicotine will not recruit nonsmoking teens to nicotine addiction and will not deter smokers from quitting.

The result is a regulatory burden so costly that it will eliminate more than 99 percent of current e-cig manufacturers due to the cost of application. The FDA not only recognizes this as the case, but states that one of its goals to be to sharply limit the number of applications they will have to review.

Pre-Market Tobacco Product Applications (PMTAs) are required of all tobacco-related products introduced into the market since Feb. 15, 2007. Thus, PMTAs are required of all American e-cig manufacturers. This ignores the fact that e-cigs are now a 10-year-old multibillion-dollar industry with thousands of manufacturers and millions of users. The FDA estimates the average cost of an e-cig PMTA at about $340,000. Industry estimates are in the range of $2 million to $5 million per individual application. The FDA estimate does not include all application-related costs. The industry estimates are likely too low because the FDA, while specifying the types of data they are requiring, offers no guidance as to the specific standards by which they will judge each element of the application, and no guidance as to what they will accept as evidence of long-term safety, nonrecruitment of teen nonsmokers and nondiscouragement of quitting. Thus, deeming regulations place a crushing application-related regulatory burden on e-cigs and on any tobacco-related product wishing to claim less risk than cigarettes. FDA regulations place no such burden on the currently marketed cigarettes that recruit 3,000 teens every day and kill an estimated half-million Americans every year.

A similar cost burden exists for any product that wishes to claim lower risk than cigarettes, a status referred to as a “Modified Risk Tobacco Product” (MRTP). For this designation, every single stockkeeping-unit (SKU) must separately demonstrate the difference in risk, compared to cigarettes. Even though we know, and the FDA readily admits that such differences exist by class of tobacco-related product, the manufacturer is required to duplicate an extensive body of such research for each individual product. While such a requirement may be reasonable for manufacturers to claim lower risk than other products within its class (like a lower risk combustible cigarette), such requirements make no sense when comparing a smokeless or e-cig product to cigarettes.

The result is a set of regulations that protects the most hazardous and most addictive of tobacco products, the cigarette, from competition from an array of far less hazardous and less addictive alternative products. In the case of e-cigs, eliminating almost all of them from the market, as currently planned by the FDA, will simply drive many current e-cig users back to cigarettes and drive others to hazardous contraband and homemade products.

Everything we know about the risk posed by tobacco-related products is by class of product. All commonly quoted data for tobacco-related illness and death are from a single class of tobacco product – the cigarette. The smokeless tobacco products available on the American and Scandinavian marketplaces and pharmaceutical nicotine products present substantially less risk. Except for American Cancer Society studies on light and low-tar cigarettes, we have no population-based studies that allege differences in either addiction or risk of potentially fatal tobacco-related illness by chemical or component of the tobacco smoke within a given class of tobacco-related products. By disregarding the studies by class of product, the FDA ignores the large and growing body of evidence that e-cigs, as a class, are likely to be far less hazardous and less addictive than cigarettes.

Securing the public health benefits that e-cigs and other relatively low-risk tobacco-related products can offer will require more than amendment of the deeming regulations. It will likely require congressional action to amend the Tobacco Control Act.

Image by Sarah2

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