This week, Food and Drug Administrator Scott Gottlieb, MD, announced a series of policy actions intended to respond to the dramatic increase in youth use of e-cigarette products.  In announcing his action, Commissioner Gottlieb stated, “…we see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger.”

The FDA is giving the five largest e-cigarette manufacturers 60 days to respond with a plan to, “immediately and substantially reverse these trends.”  The Agency warns that to address youth e-cigarette use, they may reconsider the six-year extension it gave the e-cigarette industry to avoid pre-market product review and further, “..may restrict flavored e-cigarettes to address youth epidemic.” 

The FDA also announced the results of a nationwide “sting” operation that revealed e-cigarettes sales to minors in stores across the U.S.  Monetary fines were issued to several chain convenience and drugstores for underage sale violations.

ATS Tobacco Action Committee chair Harold Farber, MD, noted, “That the tobacco industry would market and sell e-cigarette products to kids was predictable. The tobacco industry business model has always been to lure kids into nicotine addiction to create life-long nicotine users. Given the tobacco industry’s long history of marketing products to kids, to expect that the e-cigarette industry would responsibly limit the sales and marketing of e-cigarette products to adults only, was, to put it generously, naive.  The FDA’s previous inaction -- including failure to regulate e-cigarette flavorings and a six-year delay in pre-market review of e-cigarette products --   significantly contributed to the epidemic. 

Dr. Farber added: “While I am pleased that the FDA is finally taking some action, I remain concerned that the Agency is poised to make the same mistake again.   Why is the FDA relying on industry to stop sales to kids?  The tobacco industry has already shown they are unwilling and incapable of self-policing.  It is the FDA’s responsibility to act now and act decisively – not wait for industry to take the next move.”