The Food and Drug Administration (FDA) addressed the “epidemic” of minors using electronic cigarettes and announced it is cracking down on the manufacturers, calling the action “the largest coordinated tobacco compliance effort in FDA’s history.”
FDA Commissioner Dr. Scott Gottlieb said if the companies do not come up with a plan to address e-cig sales to minors in 60 days, they may have to stop selling some or all of their products entirely.
“This may require these brands to revise their sales and marketing practices, including online sales; to stop distributing their products to retailers who sell to kids; and to remove some or all of their flavored e-cig products from the market until they receive premarket authorization and otherwise meet applicable requirements,” Gottlieb wrote.
I’m glad the FDA has agreed with my repeated calls to crack down on e-cigarette companies that peddle kid-appealing flavors. This is a health epidemic, and FDA must follow through with today’s announcement to protect youth from these dangerous and addictive products. https://t.co/2nlAOWK2xC
— Senator Dick Durbin (@SenatorDurbin) September 12, 2018
“In the meantime, we’ll be investigating their marketing and sales practices, including with boots on the ground inspections. The FDA is going to continue to work to find out why so many kids are using and abusing these products.”
Five companies that currently account for more than 97% of e-cig sales nationwide were contacted directly: JUUL, Vuse, MarkTen, blu e-cigs, and Logic.
Today #FDA took a series of critical actions to address the epidemic of youth e-cigarette use. We also intend to take new, significant steps to stem this challenge, including re-examining our compliance policy regarding flavored e-cigarettes: https://t.co/I4YjHxD110 pic.twitter.com/2dP1ZgtqTq
— Scott Gottlieb, M.D. (@SGottliebFDA) September 12, 2018
Over the last few years, e-cig use among teens has sharply increased. According to research published in the New England Journal of Medicine, high schoolers who reported using e-cigs within the previous month went from less than 2% in 2011 to 16% by 2015. The Surgeon General’s Report on e-cigarette use among young people reported, “Besides increasing the possibility of addiction and long-term harm to brain development and respiratory health, e-cigarette use is associated with the use of other tobacco products that can do even more damage to the body. Even breathing e-cigarette aerosol that someone else has exhaled poses potential health risks.”
The FDA’s correspondence pertains to a number of products on the market, according to Gottlieb.
“We’re also re-examining the enforcement discretion we currently exercise for other e-cig products currently on the market without authorization. Today’s letters target the five dominant e-cig manufacturers, including those whose products were purchased by kids in our enforcement blitz. But the policy reconsiderations apply to the entire category,” Gottlieb wrote.
“JUUL Labs will work proactively with FDA in response to its request,” a spokeswoman for JUUL told The New York Times in an email. “We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people.”
The FDA also sent over 1,100 letters to stores that sell e-cigs, as well as issued 131 civil money penalties to ones that did not follow protocol on sales to minors.