FDA’s E-Cigarette Regulations Manage to Disappoint People on All Sides

    April 25, 2014
    Josh Wolford
    Comments are off for this post.

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

  • UrMom

    Its not about the kids. They will do sh*t just like we use to do in our younger days. Bad seeds will be bad seeds and good seeds will be good seeds. Time to be more free.

  • StandUpAndPissLikeAMan

    FDA approval? Please, spare me! The FDA doesn’t care about safety or regulating an industry for health purposes any more than a monkey cares about the moon. All these greedy bastards care about is money and getting a piece of the pie. Plain and simple. Pharmaceuticals must be FDA Approved, yet millions of people die from using them and every time you turn around there is another law suit because of the horrible side effects people are experiencing from using FDA Approved drugs. Boys growing breasts from using FDA Approved Resperidol, people dying of heart attacks from using arthritis medication like Celebrex or Vioxx etc. The list is nearly endless and ALL of these things are ‘FDA Approved’. These people need to get their filthy legislative hands off of viable, beneficial products and stay the hell away from good people who simply want to make a living and be at peace with the products they choose to use. Pretty soon we’re going to need a license or FDA Approval to take a piss. “Excuse me, but is that an FDA-Approved bush you’re pissing behind?” “Pardon me, but do you have a license to piss standing up?” There is FAR too much government intervention in every aspect of American’s lives and it needs to stop. Most people are too damn apathetic, though to even give a damn. When regulatory agencies need to be regulated, themselves, that is absurd and a huge waste of MORE tax-payer’s money. These kinds of things are reminiscent of the Boston Tea Party which was over a simple tax on tea! Have we become the ‘frog in the pot’ that is boiling because the temperature has been turned up ever so slowly, so we don’t even know it? Maybe another revolution is what is needed, as the government certainly no longer gives a damn about the citizens and keep sucking everyone dry and flexing their legislative muscle at every turn. Enough is enough. If you agree…Get off your goddam cell phone and say SOMETHING!

  • http://www.eliquids.ie/ Kate Stone

    Electronic cigarettes are not a 100% healthy alternative to traditional smoking. However there is no doubts that comparing to analog cigarettes are less harmful.

    The most important is to use good quality liquids from checked source. I am using e liquid Eirhorse BH. These e liquids were tested by CMA Trinity Dublin so I know what I am inhaling.

  • debek

    I agree with ‘StandUp…” and Kate Stone and maybe even UrMom here. Frankly, after trying for over 20 years to quit smoking – hypnosis, wellbutrin, classes, cold turkey, nicotine gum, lozenges, I accept my addiction to the habit. I switched to vaping over a year ago and find I do not like real cigarettes anymore. Can’t be around them, hate the smell, taste, they do nothing for me. I am a vapor. My greatest concern about the new FDA regulation is that the person from whom I purchase 100% certified organic liquid from will be forced out of business. There are certainly some safer, healthier liquids than others.

    I can not buy the arguement that vape pens are marketed to children as a reason to regulate – no one is protesting the massive flavored beer displays in the supermarket, gas stations, and drug stores as marketed to children – and they often have cute blow-ups or cut-outs to draw attention to them! You can buy hard lemonade in the supermarket in the beer section. This product is packaged so that unless one sincerely srutinizes the can it is not clear that it contains alcohol. (I almost purchased it for my 15 year old!)

    I am not smoking. I am vaping. please don’t call my vape pen an e-cigarette. I believe that people want to ban these simply because they don’t like the visual. Well frankly, I don’t like a lot of what I see, but I don’t think I have the right to have it banned! My water vapor disapates very quickly. Unless you are standing right next to me deliberated attempting to inhale the water vapor, you’re not going to even smell it. And frankly, I don’t always like the smell of the person I’m standing next to! But I don’t thinnk it’s my right to have them removed from the building!