On Friday, the new FDA Commissioner - Dr. Scott Gottlieb - saved the day for the public's health by officially embracing a harm reduction approach
to tobacco control. Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA's previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.
Previously, the FDA had simply lumped e-cigarettes into the exact same category as tobacco cigarettes and in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all cigarettes were exempted. The old approach would have destroyed about 99% of the existing vaping product market, leading to a major reduction in smoking cessation in the U.S. and with that, an increase in smoking-related morbidity and mortality.
Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process. At the same time, the FDA will - for the first time - actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms. And, to top it all off, the agency will consider - also for the first time - actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.
Commissioner Gottlieb also, for the first time, tied implementation of a harm reduction approach based on vaping products to the idea of making combustible cigarettes less addictive through substantial nicotine reduction, thus reducing the demand for real cigarettes but at the same time, making a viable alternative available to smokers to help ease them through the transition to the tobacco-free, smoke-free cigarettes.
Dr. Gottlieb emphasized that while nicotine is largely responsible for the addictive potential of cigarettes, the nicotine itself is not what kills smokers. As he stated: "the nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year. Yes, it got them all addicted and kept them addicted for the long term. And it got most of them addicted when they were still teenagers. But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine."
Commissioner Gottlieb unveiled his vision of " a world where cigarettes lose their addictive potential through reduced nicotine levels. And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them."
Specifically, the strategy outlined by Commissioner Gottlieb involves the following:
1. Implementation of the requirement for pre-market applications for electronic cigarettes will be delayed until 2022, giving vaping product manufacturers another four years to remain on the market and to prepare the necessary application materials.
2. New guidance for the pre-market applications will be developed, which will presumably greatly simplify the requirements and reduce the burden and expense of preparing these applications.
3. Safety standards for electronic cigarettes will be developed, addressing issues such as battery safety, e-liquid ingredients, and flavorings.
4. The agency will examine the effectiveness and feasibility of requiring a reduction of nicotine levels in real, tobacco cigarettes to a non-addictive level.
5. Ideally, the reduction of nicotine levels in real cigarettes would be paired with the development and promotion of electronic cigarettes and vaping products as a viable alternative to smoking.The Rest of the Story
This is truly a great day for public health. For the first time since 2009, when the FDA began regulating tobacco products, we now have a rationale approach to their regulation. This approach explicitly acknowledges the differential in risk between smoking and vaping and proposes to regulate these products according to the level of risk they present. It acknowledges that while nicotine is a critical contributor to the addiction potential of tobacco products, it is not what actually kills smokers. It aims to maximize the benefits of electronic cigarettes while minimizing their harms by both embracing e-cigarettes for harm reduction and easing their ability to stay on the market and setting safety standards to make these products as safe as possible. Finally, it aims to reduce the attractiveness of cigarettes and facilitate a transition from combusted to non-combusted nicotine products by reducing the addictive potential of cigarettes, thus promoting a shift to safer forms of nicotine delivery.
More than anything else, the greatest contribution of this new approach is that it is evidence-based, rather than based on ideology or political concerns. Instead of punishing smokers by depriving them of potentially life-saving alternatives, it embraces the idea of giving them much lower-risk choices that have already been shown to help millions of smokers quit.
The greatest risk to successful implementation of this sensible approach comes from the anti-tobacco groups themselves. Already, the Campaign for Tobacco-Free Kids is complaining about the pre-market tobacco application deadline extension for e-cigarettes. In a statement released Friday by the Campaign, it attacked the agency for attempting to save the e-cigarette industry, arguing that: "it is a serious error for the FDA to significantly delay critical deadlines for complying with the FDA’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products. This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight."
This complaint is complete crap. There is nothing in the deeming regulations that directs the agency to eliminate "kid-friendly" flavors. To do that, the agency would almost certainly have had to formally consider the issue and make a decision regarding the overall public health impact of such a restriction. It would have also had to carefully consider exactly how to define "kid-friendly" flavors. It is almost inconceivable that such a decision would have been made arbitrarily through the process of approving or denying pre-market tobacco applications. Moreover, in the approach outlined by Dr. Gottlieb on Friday, he specifically stated that the agency would examine the issue of "kid-friendly" flavors and make a decision about whether and how to implement such a policy. In contradiction with the Campaign's false claims, the FDA has full authority and oversight over e-cigarette flavorings and can regulate these flavorings completely independently of the pre-market application process.
It is great to see this major change in the FDA's approach to the regulation of tobacco products and especially, to see the shift from an ideologically-driven approach to an evidence-based one. It is time for the anti-tobacco groups to make such a change as well. The ideological crap that is coming out of these groups has to end. Frankly, that crap is the greatest threat to the successful implementation of the sensible, evidence-based public health approach to tobacco control that the FDA has now embraced.
Original author: Michael Siegel