pharmafileSeptember 20, 2018
FDA commissioner Scott Gottlieb was forthright in suggesting that e-cigarette use had reached crisis level proportions as he said in a statement that: "Unfortunately, I now have good reason to believe that it’s reached nothing short of an epidemic proportion of growth."
His plan, which aims to tackle the growing frequency with which e-cigarettes are used among young people in the United States, began in sending "1,100 warning letters to stores for the illegal sale of e-cigarettes to minors" as well as "131 civil money penalties to stores that continued to violate the restrictions on sales to minors."
The FDA commissioner continued in noting "We’re especially focused on the flavored e-cigarettes. And we’re seriously considering a policy change that would lead to the immediate removal of these flavored products from the market."
In addressing the problem directly however, Gottlieb commented: "Today, we sent letters to five e-cigarette manufacturers whose products were sold to kids during the enforcement blitz and that, collectively, represent more than 97 percent of the current market for e-cigs — JUUL, Vuse, MarkTen, blu e-cigs, and Logic. These brands will be the initial focus of our attention when it comes to protecting kids.
Given the magnitude of the problem, we’re requesting that the manufacturers of these brands and products come back to the FDA in 60 days with robust plans on how they’ll convincingly address the widespread use of their products by minors, or we’ll revisit the FDA’s exercise of enforcement discretion for products currently on the market."
Louis Goss
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