Flavored e-cigarettes, FDA guidance and smoking cessation

Flavored e-cigarettes, FDA guidance and smoking cessation

Flavored cigars, aromatic pipe tobacco, and menthol cigarettes have always been enjoyed by adult smokers, although in recent months there has been some concern over whether flavored vape liquids are designed to encourage underage consumers to take up vaping.

Targeting underage consumers has always been a concern, both for vaping and for tobacco. Decades ago when cigarette companies were still allowed to advertise, television commercials featuring cartoon characters, most notably Fred Flintstone (who shilled Winstons) were prevalent. Popeye was never seen without his pipe. Ads featuring Santa Claus smoking Lucky cigarettes graced monthly magazines throughout the ’50s and ’60s, and of course, who can forget Joe Camel? It is that over-the-top and obvious targeting that, at least in part, led to the eventual advertising ban.

The biggest issue of 2018 was whether flavored tobacco and vape products, regardless of what advertising may or not be present, target underage consumers.

Striking a balance

In the FDA’s most recent November 2018 guidance, Commissioner Gottlieb offered a sane and balanced approach. Prior to this guidance, the vape industry was concerned that all flavors would be banned outright; the new guidance acknowledges that adults who use e-cigarettes often say that flavors make e-cigarettes a much more attractive alternative when they are trying to reduce or eliminate their consumption of traditional combustible cigarettes.

Research and guidance, including from the FDA itself, does indicate that using e-cigarettes is less harmful than using combustible cigarettes and can be useful as a smoking cessation device. In the UK, the Royal College of Physicians also issued a statement reinforcing the use of e-cigarettes as a harm reduction strategy for smokers of combustible cigarettes.

In the FDA guidance, Commissioner Gottlieb notes that there is a spectrum of nicotine delivery mechanisms, with combustible tobacco on one end (the most dangerous), and at the other end, medicinal nicotine products like gum and patches. However, he also acknowledges some of the positive aspects of e-cigarettes, stating, “I saw the opportunity to advance new technologies like electronic nicotine delivery systems (ENDS) as an alternative to cigarettes for adults who still seek access to satisfying levels of nicotine, without all the deadly effects of combustion. I believed then – and I continue to believe – that we must recognize the potential for innovative, less harmful products that can deliver satisfying levels of nicotine to adults who want them.”

Rather than banning flavors and menthol outright, the FDA kept open the use of flavored and mentholated e-cigarettes for adults, accurately reflecting that they are important to adult smokers who want to transition away from combustible cigarettes; while at the same time putting in place measures to keep them out of the hands of underage users. Those measures include imposing a new rule which requires flavored vape products to be sold in separate, age-restricted areas of stores; and also requires online vendors to implement stricter age verification measures. Many online vendors have championed the rule, and some, such as Vapor Authority, had already put in place ethical and reliable age-verification measures even before the FDA guidance. Vapor Authority, along with several other online vendors, uses a reputable third-party verification system to ensure compliance and keep vaping products out of the hands of minors. Manufacturers are similarly proactive with implementing their own voluntary actions which often exceed FDA mandates. Juul recently announced they would stop selling flavored e-cigarette pods in retail stores – a big step for the company, considering that the popular flavored pods account for 45 percent of their retail sales.

Clearly, the vaping industry has learned from the earlier actions of Big Tobacco and the days of Fred Flinstone puffing his Winstons that they need to be responsible. Retailers, online vendors and manufacturers alike today don’t want to do battle with the FDA, rather, they want to work with the regulators. It may be selfish – they don’t want to trigger a complete shutdown of the industry – but whatever the reason, the result of a more friendly relationship between the industry and regulators, for the consumer, is positive.


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