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On Friday, July 28 the Food and Drug Administration (FDA) announced changes in their regulation of tobacco products, including electronic nicotine delivery systems (ENDS). FDA ascribed their Center for Tobacco Products the task of reconsidering “the aspects of the implementation of the final deeming rule.” Included in the reconsideration is an extension of four years for applications of ENDS products to be submitted, from November 8, 2018 to August 8, 2022.
FDA Commissioner Dr. Scott Gottlieb noted the importance of taking “a fresh look at nicotine itself, and how the addiction that it causes relates to the potential harm of its delivery mechanism.”
Gottlieb charged CTP to “advance rules that will lay out what needs to be in application for Substantial Equivalence, Modified Risk Tobacco Product (MRTP), and Pre-Market Tobacco Product (PMTA) applications.” Gottlieb notes that the agency will act “with an eye towards fostering innovation where innovation could truly make a public health difference.”
The deadline extension offers users and manufacturers of ENDS, and other tobacco harm reduction products, such as heat-not-burn (HNB) technologies, additional time to produce evidence affirming the health benefits these products offer. Of the approximate 39 million adult smokers in the United States, 480,000 will die each year. It is estimated that over 9.6 million Americans will die from smoking-related illnesses in the next 20 years. The announcement from FDA may help reduce those numbers.
Many policy experts have come out praising the FDA’s change in direction as it applies to vaping, tobacco control, and tobacco harm reduction.
Dr. Brad Rodu, professor of medicine at University of Louisville, calls the decision an “[endorsement] for tobacco harm reduction.” Rodu states “Dr. Gottlieb called for reduction of nicotine in cigarettes to non-addictive levels, an idea that I criticized in my 1995 book, For Smokers Only and more recently in my blog (here and here). However, I was critical because advocates of nicotine fadeout were deluded in thinking it would work in the absence of viable tobacco substitutes. Unlike them, Dr. Gottlieb embraces the harm reduction component…”
Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research “applaud[s] FDA Commissioner Scott Gottlieb.” Stier states the greatest significance of the announcement is “the FDA’s regulatory approach will now seek to implement a ‘tobacco harm reduction’ approach, recognizing that there’s a continuum of risk among different nicotine products. In other words, it will not impose onerous deadlines and ill-defined requirements for so-called pre-market tobacco applications. The FDA will first develop clear, science-based product standards before manufacturers would be required to submit applications.”
Jacob Sullum, senior editor at Reason magazine commented that “it looks like the FDA under Gottlieb will be taking a much more practical approach to e-cigarette regulation that recognizes the realities of the existing market and the relative hazards of different nicotine sources. Instead of wrecking an industry that seems to be accelerating the downward trend in smoking, the agency may actually embrace market-driven harm reduction.”
The extension applies to all products placed under the May 2016 deeming regulations including premium cigars and other tobacco-related products. It is important to note that the announcement does not change the predicate date of February 15, 2007. All products introduced to the market after that date must file the appropriate MRTP and PMTA applications by the newly established deadline in order to remain compliant with FDA regulations.
Unless the predicate date is changed, ENDS and HNB products still face an uncertain future. The announcement by FDA is hopeful. With this move FDA is acknowledging the potential for tobacco harm reduction, and allowing the necessary industries the time to prove the efficacy of their products’ role in the process of reducing harm from tobacco.