FDA “Approves” E-Cigarettes Acknowledging That They Can Help Smokers Quit
(Thursday, April 28, 2022)
This week FDA issued “marketing granted orders” (Order) for tobacco flavored e-cigarettes tacitly accepting that these devices can effectively help smokers quit conventional cigarettes and that they pose minimal risk of initiating new smokers. Despite the disclaimers in the announcement that “this does not mean these products are safe nor are they “FDA approved”, most readers of the Order would conclude that these products are safe, and FDA approved. FDA has traditionally opined that e-cigarettes should be treated as conventional smoking products, despite mounting evidence to the opposite. In many parts of the world, e-cigarettes are viewed as smoking cessation devices. These devices primarily use electrical heat to create water vapors or aerosols from aqueous fluids to create a sensation of smoke. The presence of nicotine in the vapor can be controlled. Unlike conventional cigarettes, they do not expose the users to harmful chemicals present in smoke from combustible cigarettes. Therefore, e-cigarettes are considered safer than combustible cigarettes. Most research on nicotine addiction is based on studies on smokers and not on e-cigarette users or users of purified or synthetic nicotine. However, it is generally accepted that e-cigarettes pose the same risk of nicotine addiction as conventional cigarettes, hence the regulators require limiting exposure to youths and new smokers. The FDA nod comes with strict restrictions on marketing of these products aimed towards reducing the use of these devices by the youth. Currently, marketing of e-cigarettes is restricted similar as combustible cigarettes but FDA’s own experience has shown that e-cigarettes are still quite popular with the youth. FDA attributes the popularity of these e-cig products in youth to fruity flavors. The Order states that FDA has concluded that tobacco flavored e-cigarettes would have a lower preference by youth. Additionally, the marketing restrictions proposed by FDA are intended to make any information about e-cigarettes hard to find by younger users. But it is hard to say if these restrictions would serve the purpose of preventing younger users from these devices. FDA documents will be likely used by proponents of e-cigarettes to contend their safety. And FDA likely knows that. It took FDA two years to approve the marketing of these devices, probably trying to figure out the best ways to avoid the above outcome. Now it has the tough task of monitoring the use of these devices in the youth with the FDA’s own documents saying that these are safe.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC