Decision-driven Data: FDA investigates e-cigarettes

Decision-driven Data: FDA investigates e-cigarettes

A few weeks ago, Hong Kong recently proposed a total ban on e-cigarettes citing health concerns, particularly amongst young people. Only one month earlier, the US FDA announced it was considering a ban on flavored e-cigarettes in response to what it warned was an “epidemic” of young people using the devices. As regulatory bodies further examine the subject, what kind of data or research will they be focusing on?

FDA submissions and decisions

The Tobacco Control Act requires that manufacturers of new tobacco products demonstrate to the FDA that the marketing of said products would be appropriate for the protection of public health. This is determined by weighing the risks and benefits to the net population as a whole, including adults and youth, tobacco users and non-users. In addition, the FDA is duty bound to base their approval decision based on the net outcome of both the impact of size of risk and size of benefit.

Further, in order for a vapor product manufacturer to convince the FDA that their product helps people to quit smoking, they will need to submit a 12-month prospective behavioral data. This will include a description of what category of person is using the product, as well the impact on smoking behavior (for example, a provision of evidence that people are not smoking for a time period between 6-12 months after using the product). Essentially, a behavioral study will take into account three transitions: (1) What proportion of current smokers quit smoking by using the new product?; (2) What proportion of former smokers relapse to smoking through use of the new product?; and (3) What proportion of ‘never-smokers’ initiate smoking through the use of the new product?

One such behavioral study done and presented by our expert at the Centre for Substance Use Research, showed that 64% of people who were smoking daily or non-daily when they first used the popular e-cigarette JUUL no longer smoked, 45% of people who quit smoking by using a JUUL did so within 30 days, and 49.5% of people who buy online quit smoking by using JUUL. For those duel users (i.e. smoking both JUUL and traditional cigarettes), around 50% have reduced their daily cigarette consumption by between 50% and 99%. In terms of relapse rates, only 7.6% of former smokers had relapsed back to smoking since starting to use a JUUL, whereas as little as .3% began using JUUL as a gateway product, meaning that they began smoking traditional cigarettes after using JUUL for the first time.

In addition to the above behavioral data, supplementary data will also need to be submitted by manufacturers with regards to exposure of harmful and potentially harmful constituents of vapor in comparison to cigarette smoke.

Politics vs science

The perception that younger people are increasing their usage of e-cigarettes has led to the

FDA demanding that vape manufacturers present a plan on reduction of teen usage of these devices in school. While a correlation between the timing of this announcement and the midterm elections can potentially be made, scientifically there is currently no systematic data on which to base any regulatory action. In fact, age-related research so far shows that a large percentage of 21-30 year olds are switching away from cigarettes to JUUL, which is important because the switching before the age of 35 demonstrates a prevention benefit, as well as a cessation benefit. Because the FDA can only base regulatory action on evidence, vape manufacturers should press ahead with studies measuring the extent of youth regarding vape machines and cigarettes.

Due to the regulator’s concern with youth take-up of flavored e-cigarettes, however, precautionary action by manufacturers could still yet be taken. Whilst it has been proven that JUUL and other e-cigarettes have demonstrated that aerosol emissions reduce user exposure to HPHCs by between 90-95% on average, the FDA has warned that brands may well need to remove some or all of their flavored products from the market until they receive premarket authorization and otherwise meet all of their obligations under the law. Nonetheless, regulatory action on restricting access to flavors would need to be supported by scientific data showing that a certain flavor could cause more harm than good. That level of detail simply does not exist at this point in time.

Public policy based on data

Overall, there is no evidence suggesting many teens use JUUL, only anecdotal observation of this behavior publicized in the media, from parents, school teachers and public health officers. Public policy, however, can only be based out of systematic data collection. What has been evidenced so far is that not only does JUUL have a massive effect on people quitting, but also a substantial effect on cigarette reduction among people who continue to smoke as well. The detail is in the data.

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