Nov 15 2018

FDA Takes Aim at E-Cigarettes – And Pharmacists Take Note

According to the 2018 National Youth Tobacco Survey (NYTS), vaping increased nearly 80 percent among high schoolers and by 50 percent among middle schoolers in the past year, with one in five students saying they have used an e-cigarette in the past month.  These numbers represent 20 percent of all high school students, and five percent of middle school students.

These data indicate a reversal of years of success in the ongoing fight to prevent youth addiction to tobacco products.

  • Reversing this trend is at the heart of new measures proposed by the U.S. Food and Drug Administration (FDA) in early November.  As reported by The Wall Street Journal, these new actions include:
  • Sharp restrictions, set to take effect immediately, on the sale of sweet-flavored, cartridge-style e-cigarettes.  Sales will be restricted to areas of stores that minors can’t access, or to online sites with strict age verification procedures in place.
  • More than half (51.2 percent) of high-school vapers used mint or menthol e-cigarettes in 2018, up significantly from 42.3 percent reported in 2017.  However, NYTS data show those flavors are popular with teenagers as well.  Mint and menthol-flavored e-cigarettes are exempted from the restrictions because, according to FDA Commission Scott Gottlieb, those flavors are more popular with adults than with teens, and may affect adult smokers trying to switch to less harmful products. 
  •        A proposed ban on the sale of menthol cigarettes and flavored cigars.  This proposal has already been met with sharp opposition from the tobacco industry, and is likely to face a long legal battle.
  •       The FDA also reiterated its call for electronic nicotine delivery system (ENDS) manufacturers to revisit their marketing and sales practices, and initiate steps to reduce teen access to their products.  Several manufacturers have announced important steps including:
  •        Juul Labs Inc., manufacturer of the top-selling e-cigarette that is most widely used by teenagers, announced it has stopped selling fruit-flavored nicotine pods to stores, and shut down its U.S.-based Facebook and Instagram accounts.  Going forward, fruit-flavored pods will only be available through its website to age-verified customers.  As reported by Bloomberg, Juul accounts for 68 percent of all e-cigarette sales, and saw an 882 percent surge in sales over a recent four-week period.
  •        Altria, manufacturer of leading cigarette brands including Marlboro and Virginia Slims, announced it would discontinue most of its flavored e-cigarettes and stop selling some brands altogether.  According to The New York Times, Altria sells two types of vaping products through its Nu Mark subsidiary:  The MarkTen and Green Smoke brand, which resemble traditional cigarettes and the MarkTen Elite and Apex by MarkTen, which are larger and use an e-liquid pod inserted into a cartridge.  The company plans to stop selling the 20 percent of its MarkTen and Green smoke products that feature flavors other than menthol, tobacco and mint.  Flavors set to be discontinued include Mardi Gras, Apple Cider and Strawberry Brulee.

In announcing the restrictions on e-cigarettes, Dr. Gottlieb seemed to recognize the dilemma faced by retailers, including pharmacies, that sell the products as a way to assist adult smokers.  “This approach is informed by the potential public health benefit for adult cigarette smokers who may use these ENDS products as part of a transition away from smoking,” he explained.

CVS Health, which in 2014 became the first (and so far the only) national pharmacy chain to discontinue cigarette sales, and which has never sold e-cigarettes or vaping devices, was quick to praise the FDA’s initiatives, saying in a statement they represent “the most important step the agency has taken to date to curtail youth use of e-cigarettes and flavored nicotine products.”

Pharmacies that do sell e-cigarettes, as evidenced by research conducted among London community pharmacies, tend to carry the products as a way to help assist with smoking cessation efforts.  However, according to US Pharmacist, their success in this role is heavily debated. 

“Recent evidence regarding the efficacy of e-cigarettes for smoking cessation is conflicting,” the analysis reported.  “A systematic review and meta-analysis found that smokers using e-cigarettes as a cessation aid were 28 percent less likely to quit, whereas other studies have shown short-term, but not long-term, efficacy of e-cigarettes as a cessation aid.” 

Further, the analysis noted: “In a comparison of e-cigarettes and tobacco cigarettes, there was no significant difference in abstinence from tobacco after 24 months.  Patients using e-cigarettes may reduce the number of cigarettes smoked per day; however, they rarely abstain from the use of tobacco products, instead becoming dual users.”

Regardless of whether or not a pharmacy sells tobacco products, the FDA’s action reinforces the traditional role of the pharmacist as a key player in smoker cessation efforts.  This includes an integrated approach tailored to the unique characteristics of each patient.  While counseling and behavioral analysis are central to any cessation outreach, with possible treatments including nicotine gum and patches, the role of e-cigarettes as part of that strategy is debatable.

Pharmacists are no doubt watching the FDA’s recent actions carefully, and will continue to heed available e-cigarette-related research and findings as they become available.