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E-Cigarette Brands Face Proposed FDA Regulations

By Matt McConnell

Friday April 25, 2014
FDA ecig regulations will finally sort out the tempestuous relationship between the FDA and vapers
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E-cigarette brands and industry watchers have been waiting for years to learn about how impending regulation will affect the industry.  There have been many worries considering the very powerful interests determined to see strict limitations imposed. Today, we learned about the proposed FDA regulations and while there are concerns, smokers can rest easy knowing that they will continue to enjoy access to a less harmful option.

First, the FDA will continue to regard the e-cigarette as a tobacco product.  From this point forward, the e-cigarette industry will operate under the following regulations:

  • Full disclosure of all ingredients.
  • A ban on sales to minors.
  • Product warnings (displayed on packaging in Ariel Bold or Helvetica in case you are interested!  The FDA is all about the little details)
  • No product giveaways (a reminder of the tobacco industry’s dark past when they would give cigarettes away, especially to soldiers, in order to addict generations of Americans).
  • All new products are subject to FDA review.

The FDA did not limit advertising nor did they propose limiting nicotine levels.  The FDA even acknowledged that, “several recent studies of limited numbers of users suggest that e-cigarettes may have the potential to help smokers, particularly those who have had limited success with currently approved cessation programs”.

“Several recent studies of limited numbers of users suggest that e-cigarettes may have the potential to help smokers, particularly those who have had limited success with currently approved cessation programs”. – FDA

The FDA cited research indicating that e-cigarette users had quadrupled in number between 2009 and 2010.  Other sources of statistical data indicate that those increases in use have continues to present day.  The FDA fell short of recommending e-cigs as smoking alternatives.

The FDA will consider any research that may indicate that the e-cigarette industry may provide a viable smoking cessation product.  Many of you already know how effective e-cigarettes are in this regard.

fda speculates more regulation and rules concerning ecigarettes

The FDA welcomes your comments about these proposed regulations and if you would like to submit a comment go to regulations.gov or submit your written comments citing docket #FDA-2014-N-0189 to:

Division of Dockets Management

Food and Drug Administration

5630 Fishers Lane, rm. 1061

Rockville, MD 20852.

Another piece of good news for consumers is the fact that potentially unsavory business people can no longer simply put a brand name on a generic e-cigarette and start selling them at gas stations near you.  ECCR has warned people about gas station ecigs for some time precisely because of the lack of regulation that allowed virtually anyone to sell e-cigarettes.

Bear in mind that any of the shady brands that already exist can continue to sell and will be able to do so for the next 2 years.  In the meantime, make sure that you stick to reputable brands.

Existing e-cigarette brands have 2 years for review and FDA compliance.  That means that all of the brands on our top-ten editor reviews will continue to be available.  Indeed this is good news for all of the reputable e-cigarette brands.

The less reputable brands should start to disappear from the landscape as the industry moves forward.

Today’s regulations were of particular interest to Jon Deak, ECCR CEO  “The FDA must play their cards correctly with this one because there are now 6 million people dying each year from smoking which equates to more deaths per year then car accidents, homicides, suicides and AIDS combined.  440,000 Americans die from smoking every single year. Another 1.2 Million people live with the illness and struggle each day just to be able to continue to breathe.” Deak explained.

tobacco billboard depicting the danger of tobacco cigarettes

“I certainly believe that the FDA should have some level of involvement to ensure that the quality of these products are safely manufactured for all parts of the world, not just the United States. The main focus should not be on the hardware but more specifically the Vaporizing Fluid aka E-Juice or E-Liquid.

“The vaporizing fluid mixtures are basic food compounds, asthma inhaler ingredients such as propylene glycol that have been FDA approved for over 50 years.  In fact propylene glycol is found in most foods, shampoos and even toothpaste.   Propylene glycol is also used to flood incubators for premature babies.

“As for the recent report released this month that small doses of E-liquid could potentially kill an infant if ingested, I completely agree that we should all be very cautious as to what we allow our children around and make sure we lock up anything hazardous to a child but in the same sense too much water or Nitrogen, Argon – Oxygen aka the air we breathe could also be hazardous in high doses to any human.”

Jon Deak also explained why we need access to as many options as possible when you consider how ingrained smoking has become in our society, “Smoking is not going away anytime soon, it’s been part of our global culture for close to 7,000 years.  The truth of the matter is that for the first time we have a device that has grown in popularity logarithmically in the last decade and it is a device that can save millions of lives.

The technology is no where near perfect and we have a long way to go before we can develop the perfect “Ecig” but the good news is that we don’t have to wait for that, its here on the shelves now.

“Its not going to take an FDA chemist to tell us that 3 ingredients that are non-combustible are healthier then 4,000 deadly carcinogenic chemicals in traditional cigarettes. I’ve been saying it since 2005 and I will continue to say it, it’s a no brainer!  Switching to e-cigarettes is a step you can take in a direction that will certainly change your life forever.”

Matt
Team ECCR

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