FDA announcement: a policy change of endorsing harm reduction?

Saturday, 29 July 2017 08:39



FDA announcement: a policy change of endorsing harm reduction?


By Dr Farsalinos

Yesterday (July 28), the FDA made an unexpected announcement about their future policy and strategy for tobacco control. The announcement started with a brief presentation about the burden of smoking-related morbidity and mortality in the US and then had two main sections:

Very low nicotine cigarettes. There is an ongoing debate, especially in the US, about the mandatory reduction of nicotine levels in tobacco cigarettes to levels so low that “cigarettes would no longer create or sustain addiction”. I am skeptical about this approach for two reasons. One is that nicotine is not the only determinant of dependence on smoking, and this approach does not deal with the behavioral aspect of smoking dependence. A study evaluating low-nicotine cigarettes for 6 weeks found lower cigarette consumption in the groups assigned to using such cigarettes, but in reality they did not reduce their normal daily consumption. Compensatory smoking was minimal, but the big concern is that if smoker’s continuously use low-nicotine cigarettes and don’t quit, they will have the same health risks as smoking regular cigarettes since they will be exposed to the same combustion chemicals. Such a policy could create other problems too. If nicotine is allowed in smokeless tobacco products, people could just buy smokeless tobacco and use it to smoke. Illicit trade could also sky-rocket, creating a huge black market of nicotine cigarettes. I am open-minded in this aspect (as in any other aspect of science and policy), and I will be waiting some more convincing evidence that this will work.

E-cigarettes (and other harm reduction products). For start, the important decision is the plan to extend the deadline for submitting applications for e-cigarettes to August 8, 2022. The manufacturers will be allowed to market the products while the FDA reviews the product applications. The announcement mentions that “The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes.”. While this is an important step, the FDA needs to realize that the current regulatory framework achieves the exact opposite. The predicate date allows the sales of old products only, which are both less effective as smoking substitutes and more harmful in terms of exposure to potentially toxic chemicals. Additionally, the regulatory requirements are so extensive and burdensome that innovation by small and medium-sized enterprises, which has transformed the e-cigarette market in the last few years, is basically discouraged. Imagine how long it would take to transition from silica to cotton wicks and from plastic top coil to stainless steel and glass bottom coil atomizers if all companies had to pass such extensive regulatory requirements. Another part of the FDA statements mentions the issue of flavors, with specific reference to “obviously kid-attracting flavors“. This is a very hot topic, especially in the US. I have previously discussed the issue of irresponsible marketing, which creates a perfectly avoidable problem since I seriously doubt that the real intention of anyone in the e-cigarette industry is to attract kids to vaping. I think it is crucial that flavors variability is maintained (including sweet flavors), and my survey in 2013 has clearly shown that. We might perform a new survey, specifically addressing the US situation, to explore the experience of US vapers in relation to flavors in e-cigarettes.

In conclusion, this FDA announcement is definitely a positive step, but there should be a follow up. The current regulatory framework is extremely expensive and complex, and will largely create an oligopoly and stifle innovation. Unless changes in the process and requirements of acquiring a license are implemented, the change in the deadline for submissions will just delay the virtual elimination of the e-cigarette market as we know it today. Of course regulation and product standards are needed, but the FDA needs to find the ideal balance in preparing a reasonable, realistic and proportionate regulatory framework.