Today, the Food and Drug Administration is expected to announce its historical decision on the fate of e-cigarettes in the United States. As a result of a review of millions of applications made by big and small e-cigarettes makers around the country, the agency will either recognize vaping products as “appropriate for the protection of public health”, or ban them from the market. Despite unequivocal evidence proving the safety of e-cigarettes, the odds are not in favor of e-cigarettes, especially when it comes to smaller companies.
E-cigarettes were actually invented to help smokers quit, and have been enormously successful in doing so. Since 2013, when vaping became popular in the United Kingdom, the adult smoking rate there has plummeted. In fact, in the UK, the smoking rate is at its lowest since 1974. The popularity of vape flavors among adults is one of the reasons smokers have switched to vaping. Vapers that use flavors are 2.3 times more likely to quit than those who use tobacco-flavored e-cigarettes.
Although not complete, the FDA market authorization review process has shown bias against flavored e-cigarettes. On August 26, the FDA denied 55,000 flavored e-cigarette products market access for failing to “provide evidence that they appropriately protect public health” despite the clear body of evidence that e-cigarettes do improve the health of smokers who switch to e-cigarettes. Instead of acknowledging this evidence, the FDA pivoted instead to the illegal use of e-cigarettes by those under 21 years old, saying “flavored tobacco products are very appealing to young people” and hence require close examination. Such reasoning doesn’t stand up to scrutiny and only hurts adult consumers who seek to switch.
A recent study by the Consumer Choice Center and World Vapers’ Alliance found that if the US was to put in place vape flavor bans, over 7.7 million vapers would go back to smoking. If the main goal behind the market authorization review process is to protect public health and prevent smoking-induced diseases, then e-cigarette flavor bans—which are popular with smokers seeking harm-reducing alternatives—are the wrong way forward.
Second, the application process has been unnecessarily bureaucratic and costly. The FDA itself estimated that building and submitting a market authorization application will take an average of 1,713 hours to compile and could cost several million dollars per product. For smaller vape companies, that is a heavyweight to bear.
Speaking to POLITICO, Dave Morris, the owner of Phoenix, Arizona-based Vape Gravy Brands, said that his company has spent nearly every penny to apply for market approval of his products. Many of the applications that have been submitted to the FDA have been issued “refuse to accept” or“refuse to file” notices as their applications were deemed incomplete, or as failing to meet technical requirements.
Small vape shops are essential to driving down smoking rates. A study published by BMC Health found that “vape shop staff play a central role in providing customers with product information, and many provide smoking cessation advice.” Therefore, preserving small vape shops is critical to reduce smoking.
Due to a high volume of applications, it seems likely that the FDA will postpone its decision further. However, the predictions are far from optimistic. The United States, a land of innovation and entrepreneurship, is set to crush a technology that—unlike taxes and various other tobacco restrictions—has helped millions of smokers quit. Many developing countries will follow America’s lead, so the fate of vaping globally is at stake. In the end, in pursuit of public health protection, the FDA will bring about a new smoking pandemic. Haven’t we had enough of pandemics?