FDA’s E-Cigarette Regulations Manage to Disappoint People on All SidesBy: Josh Wolford - April 25, 2014
The U.S. Food and Drug Administration currently regulates your traditional forms of tobacco–cigarettes, cigarette tobacco, and smokeless tobacco. Of course, some new players have joined the nicotine party as of late-the most notable being the electronic cigarette, or e-cig (or vape pen), which has been unregulated for years now. We’ve all known it was coming for some time, and Thursday the FDA finally revealed their proposals on how to regulate the multi-billion dollar e-cig industry.
And what do you know, they have found a way to irk all sides of the e-cig issue. Imagine that.
First, what did the FDA actually say?
The administration wants to extend its tobacco authority to put other “tobacco” products, such as e-cigs, under their regulatory umbrella. E-cigs are tobacco-less products, remember, but the FDA would still like to classify them as an alternative tobacco product.
In doing so, e-cig makers, e-liquid makers, and vape accessory makers would be forced to register their products with the FDA and could only market their products after an FDA review and approval process.
Herein lies one of the main issues that the vaping community has with FDA regulations–that oftentimes lengthy approval process.
Some fear it could stifle innovation within the industry, and prevent better products from hitting the market in a timely fashion. You can find some discussion on this over on reddit’s e-cig subreddit.
That’s where you can find a discussion on the a White House petition that opposes the newly proposed FDA restrictions. It asks for a veto (?) of the proposed (and not yet adopted) FDA guidelines for electronic cigarettes.
“The FDA has classified E-Cigarettes as ‘Tobacco Products’ and will now severely restrict their use. These regulations are not like those of tobacco, but instead all manufactures will be required to complete a lengthy and expensive application just for putting new products on the market. This includes Mechanical Mods, Variable Voltage, tanks, drippers,etc. Any new ‘Model’ after 2015 will be required to complete this application. The FDA has over stepped their boundaries. E-Cigarettes CAN NOT be classified as a ‘Tobacco Product’ as there is no tobacco in it. They fret about the nicotine, but there is nicotine in many plants including tomatoes. They fret about the flavors, yet allow Smirnoff Vodka to advertise candy and fruit flavors. DoNot, allow the FDA to take control of a life saving prod…”
If you ignore the grammatical errors, you can see the crux of many anti-regulation advocates’ concern.
Of course, this only represents a certain selection of e-cig users. Some have welcomed FDA oversight, and have so for a while.
Another proposal by the FDA attempts to ban the distribution of “free samples,” which could impact so-called “vape lounges.”
The Consumer Advocates for Smoke-free Alternatives Association (CASAA), which has been an advocate of the electronic cigarette industry, had this to say about the FDA proposal:
“On its face, it appears that it is not as bad for consumers as it might have been, but there are still serious concerns. The FDA approval process is very complicated, and the details matter. Unlike some commentators, we are not prepared to say much more until we have a chance to examine them and consider them in the context of existing institutions.”
CASAA said that they would be reviewing the documents and then issuing a “Call to Action” for its members.
CASAA’s official position on electronic cigarettes is that they support FDA classifying and regulating them as a tobacco product.
Now, if we take a look at the other side of the aisle, we have those who are miffed that the FDA hasn’t gone far enough–specifically when it comes to advertising. The FDA’s proposals do not take aim at e-cig advertising.
“It’s very disappointing because they don’t do anything to rein in the wild-west marketing that is targeting kids,” Stanton Glantz, a professor at the Center of Tobacco Control Research and Education at the University of California, San Francisco, told Reuters.
The FDA’s proposal also fails to mention any restriction on flavorings, which some groups lament as the kid-magnet aspect of the industry. Of course, placing bans on e-liquid flavorings would cripple the industry.
“Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”
“The window is still open for a more draconian approach,” Jason Healy, president blu eCigs, told Reuters. “I think the proposal shows a good science-based reaction here from the FDA, but there is a lot we have to go through during the public comment period.”
But it’s no really blu, which holds the majority of the e-cig market, that has the most to worry about from regulatory control. It’s the upstarts, the new guys on the block, and even the modding community that have the most to lose.
There will be a public comment period (75 days), so expect a cacophony over the next few months. These will be highly-debated regulations, and you can be sure that everyone from the vaping community to health advocates, from children’s groups to big tobacco, will chime in with their two cents.
Image via Wikimedia Commons