Mastering the Vape Space: FDA Regulation and Vapor Business

The following article is a guest post by Norm Bour. All opinions are solely those of the author. 

This Blog is supplied by Norm Bour and VapeMentorS, consultants to vape shops, on-line businesses and others in the Vape Space. This and other related reports can be viewed at http://www.VapeMentorS.com.

 

You have been bombarded by media reports about the recent FDA decision and I have been swamped with people wanting to know “what it really means.” So what does it really means?

Let’s step back for a second and take a look at how significant this “Vape Space” has become.

If you Google “Vape” right now you’ll get 3.1M hits; using “Vaping” will generate 1.7M hits. Those are significant numbers and means that people are talking about and writing about and curious about this industry. For as long as I have been in this business those are the highest numbers I’ve seen. And BTW, thanks to all of you for getting us on page one of both those SEO terms. [Editors note, Norm is referring to his site and show, not this one.  But I’m not jealous, nope not me -SK]

This vaping industry, once fringe, is now mainstream and weekly articles are reported in unexpected publications like the Wall Street Journal and even The Economist, a pretty lofty publication. There are media reports-usually negative and mostly inaccurate—that are clogging up the media, which by the way—loves controversy. If they smell something that people are curious about and want to know answers, they want to give it to them. Even if the information is wrong.

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Many E-cigarette advocates are relieved and even encouraged by the 241-page behemoth of a proposal. There has been a lot of political pressure from cities and states that are looking for some direction (i.e., someone to blame) and aside from the uncertainties of the business, what was even more important was sales to underage buyers. Some of that is addressed in this report.

Here are the most significant bullet points of the proposal:

• Sales banned to anyone under 18

• No ban on ads

• No ban or Internet sales

• No ban on the use of flavors

• Manufacturers will be required to disclose the chemicals

• Distribution of free samples banned

• New health warnings will note that the nicotine they contain can be addictive

• Evidence required from companies that claim e-cigs are healthier than tobacco cigarettes

• FDA review of products released or updated since February 2007

This list comes from the e-cig industry trade group SFATA (the Smoke Free Alternatives Trade Association). They’re likely to be in government halls arguing for sensible regulation alongside CASAA (Consumer Advocates for Smoke Free Alternatives) really soon. Support them both.

We are good with all of those items and most don’t affect the consumer, though much affects the Vape Shops and especially manufacturers.

The most significant piece, the last on the list, requires companies to submit an application for all technology and products released since February 2007. The FDA will review these applications and determine whether the products should be allowed on market. This effectively applies to all up to date electronic cigarettes. This application must happen within 2 years and the FDA will review the application at whatever pace it wants.

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FDA LogoSo what criteria does the FDA use? Again, this affects manufacturers much more than consumers, but it does impact juice producers. The biggest targets in that agenda is the Big Tobacco and similar producers of e-cigs. The technology involved is much more elaborate and complex than in batching up juice, so they will be spending millions of dollars to validate their materials and processes and prove that they have a “safe” product. This hamstrings technological advancement in the industry moving forward and could mean they will spend more time defending themselves than improving things that need improving.

It seems likely that the date of final regulation will get pushed forward in negotiation — probably to whenever the regulation officially becomes active. Maybe the FDA goal to use that date as a bargaining chip.

There is one bit of more good than bad news and that is the requirement that manufacturers require scientific evidence to substantiate any claims they make that e-cigs are safer than tobacco cigarettes. Most experts agree that there is no question on this fact and electronic cigarettes are safer than tobacco cigarettes, though the FDA could push for a ludicrously high standard to prove lower harm. However, this does mean that the FDA accepts some nicotine products are potentially safer than others and is open to allowing companies to make this claim.

The war is far from over and in real world terms the likelihood of any laws enacted any time “soon” is remote. Even so, take the higher ground and do the following:

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• No sales to minors

• Get involved in local politics

• Get involved with CASAA and SFATA

• Don’t be obnoxious vaping in public

• If you produce your own juice, please use sanitary conditions and ideally a Clean Room. No homemade brews, please.

• Do not make boastful claims in your passion and advocacy to spread the word Absolutely stay informed and involved.

I was able to interview RJ Reynolds tobacco recently and that will be part of the Vape News Radio Show, which is growing to twice per month. RJ Reynolds spun off an entire division of their company called “RJ Vapors” and are rolling out their own line of e-cigarettes called “Vuse.” It has been dominant in their two Beta states, Colorado and Utah and will be delivered to Indiana and Wisconsin by June, 2014 then into 15,000 retail stores, effectively giving them nationwide expansion. Calling it a “nicotine delivery device” rather than an e-cigarette, they seem to be heading in the right direction.

The two-part interview shares a lot of what is happening behind the scenes and interviews are scheduled or recorded for several other e-cig manufacturers along with lots of “Movers &  Shakers.”

Let us know if you would like to be part of the show: http://www.VapeNewsRadio.com. If you need information please contact the show host and writer of this article, Norm Bour at

norm@VapeMentorS.com.