Magic Beer and Magic Wands
The FDA’s Electronic Cigarette Deeming Regulations effect on small business and consumers.
Imagine for a moment that there was Magic Beer.
Imagine it tasted great, came in hundreds of flavors, and didn’t have any of the drawbacks associated with alcohol. No short or long term health effects, no drunk driving accidents or the 80,000 or so deaths attributed to excessive alcohol use per year. Imagine it didn’t cost the country $200 billion in lost productivity, healthcare costs and criminal justice system costs, just by drinking it. Imagine if you might live longer if you drank it.
Imagine this Magic Beer was only made by the 2,500 craft brewers in the USA. They could brew it, and sell it with minimal interference from governing agencies. Happily making their Magic Beer because they enjoyed it, and they knew their customers enjoyed it too.
Magic Beer would be the end of mass produced light beer.
Now imagine that the FDA was allowed to impose regulations that required every brewer to submit an expensive application any time they created a new beer or a new bottle shape, unlike the simple process currently handled by the Alcohol and Tobacco Tax and Trade Bureau.
Even the tiniest nuance of flavor adjustment or smallest change to alcohol content would require filing an application. That application would be sent off, with a check for a very large amount of money, to the FDA, along with samples of the beer, for testing. The brewer would then wait, up to six months, but possibly even longer before they could sell their new beer. If there were any errors in the application, or at the FDA’s discretion, the beer couldn’t be sold, and the application process would have to start all over again.
If you were a magic beer consumer, you’d be upset about this.
If you were a brewer of magic beer, you’d be upset about this.
This could put you out of business.
This could put all of your employees out of work.
We all know there is no such thing as Magic Beer, I just made that up.
There is something similar though. Magic Wands. Electronic cigarettes, personal vaping devices, call them what you will, they’re magic because they save lives.
There are two sides to the electronic cigarette or vaping industry. On one side, we have small companies who hand craft and sell amazingly flavored e-liquids, and small companies who build and sell personal vaping devices in many shapes and sizes, at all levels of technology and functionality. Like the beer industry, these are the “craft brewers” of the vaping industry.
On the other side, we have the mega-companies who churn out disposable e-cigarettes like Green Smoke and Vuse and Blu, with such varied flavors as “tobacco” and “menthol”. They spend millions on marketing and advertising their cig-a-likes, mass produced, and sold in every conceivable location, from gas stations and truck stops, to grocery stores and pharmacies, to kiosks at your local mall. They are discarded into a landfill when used up. These companies are the “light beer makers” of the vaping world. It’s not at all surprising that many of them are owned by Big Tobacco.
On Friday, April 25th, 2014, the FDA released their draft deeming regulations for electronic cigarettes. It’s 241 pages of bullet points, roman numerals, and big words—many of which seem written with the sole purpose of putting small, craft vaping companies out of business.
Back in 2009, the Family Smoking Prevention and Tobacco Control Act was passed, which gave the FDA regulation over tobacco products. Electronic cigarettes were exempt when it was enacted, but will be within reach if these new regulations go into effect.
These new regulations will require every vaping industry manufacturer to go through a lengthy and expensive process for every new item they want to bring to market.
Every. New. Item.
Every new flavor of e-liquid, every new tank, every new mod. Any device used to vape. Oh, and all the ones currently on the market.
Lengthy. 180 days, or longer (up to 2 years), per submission, for the FDA to look at it.
Expensive. $300,000 or more per item.
If a product passes the process, the vendor will still be facing estimated yearly fees in excess of $400,000. The FDA will use these fees to test all these products, many of which, like e-liquids, already containing nothing but FDA approved ingredients.
This will kill the small, “craft” vaping businesses, that so many people rely on daily for e-liquids, advanced vaporisers, batteries, and accessories.
Imagine a small brick and mortar store with 10 employees, making and selling two dozen flavors of e-liquid. Imagine their sales at $200,000 a year. They would spend an estimated $7.2 million just to submit those 24 flavors at 3mg nicotine strength to the FDA. Now multiply that by 6 different strengths.
These proposed regulations will have a far smaller effect, if any, on Big Tobacco, and the e-cig businesses they now own, simply due to their lack of innovation in product and flavor development. Oh, and their wallets, their big fat wallets, stuffed with uncountable dollars for situations just like this.
With the craft vaping market gone, Big Tobacco will then have free will to do as they please with the industry, even going as far as killing it entirely because cigarettes will still be profitable for them.
This makes one wonder who is behind all this.
The Family Smoking Prevention and Tobacco Control Act of 2009 was designed to help consumers understand that cigarettes and other combustible tobacco products were bad for them. It was not designed to make it harder for cigarette smokers to find an alternative.
What the act does not allow them to do, is ban certain specified classes of tobacco products.
You don’t need to ban something though, if you can simply force it out of existence through exorbitant fees and long delays in bringing new products to market.
The FDA even states that they expect this to happen in their report on Economic Effect on Small Entities.
Premarket tobacco applications, discussed above in section II.B, are expected to be the most burdensome requirement for electronic cigarettes. We expect to see adjustment through additional product consolidation and exit from the U.S. market, compared with what we would expect without regulation.
That’s a direct contradiction to one of the goals the FDA vowed to uphold in 2009, how best to encourage companies to develop innovative products that help people stop smoking.
Innovative Products.
Like electronic cigarettes.
That help people stop smoking.
Wouldn’t this also hurt Big Tobacco? Of course not. They hedged their bets five years ago, buying up e-cig companies for as little as $10 a customer. If the craft vaping industry goes away, they still have their e-cig customers. If the e-cig industry goes away, they still have their cigarette customers, plus all the previous smokers who have no choice but go back, or quit.
The FDA has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. These regulations don’t protect anyone except Big Tobacco.
Is the FDA even qualified to regulate the electronic cigarette industry?
I don’t think so, and you may agree with me.
Judge for yourself based on comments they have released to the public, it seems they lack the knowledge and understanding required to regulate something so different than simply “tobacco products”.
The FDA has had a surplus of almost half a billion dollars each year since the Family Smoking Prevention and Tobacco Control Act was passed in 2009. Dollars earmarked for research.
Yet the FDA doesn’t know how many companies are involved in the vaping industry.
Most electronic cigarette manufacturers are also small, though the number of small domestic manufacturers is uncertain.
The FDA, in 5 years, hasn’t managed to research what effects vaping has on the public health.
we do not currently have sufficient data about e-cigarettes and similar products to determine what effects they have on the public health.
The FDA, in 5 years, hasn’t figured out that vaping isn’t as bad as smoking cigarettes.
Many consumers believe that e-cigarettes are “safe” tobacco products or are “safer” than cigarettes. FDA has not made such a determination and conclusive research is not available.
Yet the FDA continues to approve the sale of cigarettes, and will continue to do so as it moves forward to what may be the elimination of electronic cigarettes and other safer alternatives to smoking.
The whole thing stinks—like a Big Tobacco Lobbyist’s cigarette smoke.
I wish my vaping device was a Magic Wand, to go with my Magic Beer.
