Last week the FDA Commissioner called out the manufacturers of electronic cigarettes for their clear efforts to market to teenagers and put them on notice that additional regulations could be on the way. You probably heard about this in the media this week. When I went to the FDA website to get the details, I discovered that the media had overstated FDA’s intervention commitments.
Apparently, the FDA is at least considering removing certain flavored e-cigarettes from the market and shortening the time to market review for most cigarettes now being sold. At a press conference last week, he acknowledged that his agency has failed to recognize the extent of the problem. Here’s a direct quote from him.
The quote did strike me as unusual from a member of this administration for its candor: “We didn’t predict what I now believe is an epidemic of e-cigarette use among teenagers, and today we can see that this epidemic of addiction was emerging when we first announced our plan last summer. Hindsight, and the data now available to us, reveal these trends. And the impact is clearly apparent to the FDA.”
The FDA issued more than 1,300 warning letters and civil money penalty complaints to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide. Last week’s action also included a request to 5 e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends toward marketing to teens or face a potential decision “to reconsider extending the compliance dates for submission of premarket applications”.
At least it’s a start.