# Wall Street Journal:The FDA’s Vaporous Thinking About E-Cigs



## Alex (7/5/16)

*The FDA’s Vaporous Thinking About E-Cigs*
*The new rules won’t benefit public health and will force thousands of small businesses to shut down.*
Boston University Public Health Professor Dr. Michael Siegel says the Federal Drug Administration’s new rule will stunt anti-smoking efforts. Photo credit: Getty Images.
By
Michael B. Siegel
May 5, 2016 6:34 p.m. ET
 57 COMMENTS 
The Food and Drug Administration on Thursday finally released its regulations on electronic cigarettes. The rules, intended to sharply restrict the use of e-cigarettes—which deliver nicotine via a propylene glycol and/or glycerin-based smokeless aerosol—were immediately lauded by many health groups. But these new FDA regulations will actually protect tobacco-cigarette sales at the expense of the public’s health. They will also destroy thousands of small businesses and effectively hand the e-cigarette market over to a small number of large companies, including the tobacco companies.

Why? Because the regulations require every electronic-cigarette product on the market (the devices and the liquids that give them taste and vapor) to submit a premarket application to the FDA demonstrating that the product is beneficial to the public’s health. To do this successfully under the statute, a company must show that its e-cigarette product is safer than regular cigarettes; that it helps smokers to quit; and that the above benefits won’t be outweighed by the adoption of the product by nonsmokers, including young people.

It is a test that the agency cannot expect the e-cigarette makers to pass. I happen to disagree with those public-health experts who believe that “vaping” e-cigarettes may be more dangerous than smoking, and that vaping may make it harder to quit tobacco or even induce young people to start smoking. But if some public-health professionals don’t believe that electronic cigarettes are beneficial for the public’s health, how can an e-cigarette company expect to convince the FDA that its products are beneficial?

The FDA itself has acknowledged that the premarket applications are a burdensome requirement that will take more than 5,000 hours to complete and will cost a minimum of $330,000 per product. Since few of the e-cigarette-product makers—most of which are small businesses—can afford to stay in business and pay for this level of resources or expertise, the majority of these companies will shut down. That will leave the market open only for e-cigarette products made by the largest of companies, some of which have already begun buying what once were small-company e-cigarette brands. For example, R.J. Reynolds now owns Vuse.

Even worse, by creating a huge preapproval barrier to product innovations, the new regulations remove the incentive to pursue e-cigarette improvements that are the most effective in getting people to quit smoking tobacco by better mimicking the experience of smoking, such as the taste and the sensation of puffing, and improvements to make e-cigarettes even safer. Some tobacco financial analysts have predicted that such innovations could result in a 50% decrease in cigarette consumption over the next decade. Instead the FDA seems bent on blocking what might have been one of the most substantial public-health victories of our lifetimes.

And if improving public health is the goal, why is the FDA regulating e-cigarettes more stringently than the real tobacco cigarettes that are killing more than 400,000 people each year—while e-cigarettes have helped hundreds of thousands of smokers quit over the past five years? Because cigarette-makers don’t have to submit burdensome and expensive applications to stay on the market, the FDA has in effect protected them from competition from a product that could have cut their cigarette sales in half.

But what is by far the most shameful aspect of these regulations is that the new regulations will do nothing to actually help make e-cigarettes safer. For instance, the FDA isn’t banning the use of a kind of battery used in some brands that has a small but proven risk of exploding. The new regulations don’t ensure that e-liquids cannot be overheated in a way that can produce carcinogens like formaldehyde—another rare but documented risk. And they don’t ban potentially harmful ingredients in some brands, such as diacetyl, a chemical once used in popcorn-butter flavoring that has been associated with “popcorn lung” disease.

The only way out of this mess is for Congress to take matters into its own hands and enact legislation that would force the FDA to change its regulations in a way that will actually protect, rather than harm, the public’s health. This could be done by requiring the FDA to set safety standards directly for vaping products instead of requiring premarket applications that create a huge federal bureaucracy while destroying small businesses and doing nothing to protect the public’s health.

_Dr. Siegel, a professor at the Boston University School of Public Health, has conducted tobacco-policy research for 25 years and has advocated for antismoking policies._

source: http://www.wsj.com/articles/the-fdas-vaporous-thinking-about-e-cigs-1462487690

Reactions: Informative 9


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## Lord Vetinari (7/5/16)

This is all so crazy and sad.


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## Silver (7/5/16)

Thanks @Alex
Very well said by Dr Siegel


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## Petrus (7/5/16)

If you want to vape you WILL no matter what. If they want to outsource Vaping they must shut down the Internet. I will and shall still buy my goodies even if I had to import from Timbuktu. I can't understand why a government can't rather focus on getting it's country in order. So to put it plain and simple..... **** them.
Sorry for my language guys, but this is my honest opinion.

Reactions: Agree 2 | Can relate 1


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## Lord Vetinari (7/5/16)

Petrus said:


> If you want to vape you WILL no matter what. If they want to outsource Vaping they must shut down the Internet. I will and shall still buy my goodies even if I had to import from Timbuktu. I can't understand why a government can't rather focus on getting it's country in order. So to put it plain and simple..... **** them.
> Sorry for my language guys, but this is my honest opinion.


I think we are all feeling a bit foul today. And we all feel cheated. Bad language is going to be par for the course in vaping circles right now. Legal weed and illegal mods. Good one World.

Reactions: Like 1 | Agree 1


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## Nightwalker (7/5/16)

Just how big is our favourite brands? On a global market?
Can jaybo stay in the game?
Can our Griffin stay in the game?

Reactions: Informative 1


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## Lord Vetinari (7/5/16)

Nightwalker said:


> Just how big is our favourite brands? On a global market?
> Can jaybo stay in the game?
> Can our Griffin stay in the game?


My mates in Switzerland and the UK and Germany run the same gear as us. Vaping is global. I think mostly we will get stuck with clones though.

Reactions: Like 1


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## ReeZ (7/5/16)

"FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation."
Source http://www.fda.gov/AboutFDA/WhatWeDo/

The above statement is ironic given the items over the years that have been banned or endorsed by the FDA that have nothing to do with public health safety but rather who gets rich by such bans/endorsements.
Look at genetically modified foods-high level Monsanto employees take up decision making positions at the FDA, and approve Monsanto's products as being safe. That's just one example. 

If you look at the pharmaceutical industry it's the same, thousands of drugs with no long term studies conducted have been approved by them.
Where there is a natural cure that can't be patented (because no one can make money from this), chances are it's either banned or not recognised by the FDA such as cannabis oil or vitamin B17 which thousands of people have claimed has cured their cancer. Pharmaceutical companies however, are allowed to sell drugs based on cannabis extracts.

Sad thing is that the FDA is seen as the leader for other governing bodies like it around the world so it won't be long before other countries adopt the same stance to vaping.

Reactions: Agree 1


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## Jan (7/5/16)

It is all about the $$$'s don't think for one moment they care about your health

Reactions: Agree 1


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## Byakko (19/5/16)

Money talks...would be mindblowing to see what kind of bribes and kickbacks the big shots at the FDA must be getting from tobacco companies.
Worst of all is that if these ridiculous regulations go through it will probably only be a matter of time until we are slapped with similar restrictions.Our government tends to jump on the bandwagon of what first world countries do so I hope it doesn't come down to that.I for one am enjoying the health benefits of switching to vaping and it makes me sick knowing these clowns value money over human life.

Sent from my LG-D855 using Tapatalk


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## Jan (19/5/16)

Byakko said:


> Money talks...would be mindblowing to see what kind of bribes and kickbacks the big shots at the FDA must be getting from tobacco companies.
> Worst of all is that if these ridiculous regulations go through it will probably only be a matter of time until we are slapped with similar restrictions.Our government tends to jump on the bandwagon of what first world countries do so I hope it doesn't come down to that.I for one am enjoying the health benefits of switching to vaping and it makes me sick knowing these clowns value money over human life.
> 
> Sent from my LG-D855 using Tapatalk


I don't think it is the tobacco companies. Try the pharmaceuticals. Imagine the financial impact if every smoker now turned vaper gets one less cold every year and if millions of people don't have to be treated for all sorts of smoking related disease and cancers

Reactions: Agree 1


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## Byakko (19/5/16)

That's a good point.The public in general would be healthier aswell,due to less second hand smoke inhalation.Less people using nicotine gum and patches too (and those aren't cheap)

Sent from my LG-D855 using Tapatalk

Reactions: Agree 1


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## Casper (19/5/16)

I agree. It is all about the money.

The thing is, I believe in the US this is just going to cause the Vapers to go underground. They are going to be forced to do things illegally, in the name of better health.

What really pisses me off is that the entire industry is now going to be effected because of this, only cos some arrogant Americans made their voice heard. Why, WHY must the entire world listen to the USofA??

FDA approval my ass!!!


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## Casper (19/5/16)

Byakko said:


> That's a good point.The public in general would be healthier aswell,due to less second hand smoke inhalation.Less people using nicotine gum and patches too (and those aren't cheap)
> 
> Sent from my LG-D855 using Tapatalk



No, not cheap, and do yourself a favor, read the fine-print on those patches, they are whole-heatedly BLOODY BAD for you!! The side effects, OMW!


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## RichJB (19/5/16)

Capitalism is all about the money, though. So the vaping status quo was never going to sustain. It is estimated that the global vaping industry will be worth $50bn annually by 2025 - with headroom for further growth. That sort of incentive is going to attract the attention of the heavy corporate hitters. The "mom and pop" type companies will always succumb or be bought out. They can't match the economies of scale or market reach of the big corporations.

This applies to all industries, not just vaping. For eg, how many "mom and pop" stores in the US have been shut down by WalMart? How many corner cafes in SA have been shut down by neighbourhood chain stores? How many individual burger or fish 'n chips take-away stores have been shut down by the fast food chains? How many internet start-up businesses and apps have been consumed by google, Sony, Apple, Microsoft? Capitalism leads inevitably to the large multinationals devouring the little guys. There is no reason why vaping would be an exception.

FDA regulatory approval was also an entirely predictable development. In the 21st century, allowing manufacturers to sell products which consumers inhale into their lungs, with no regulatory oversight of those products, was never going to fly. If your pharmacy sold medicines which hadn't been tested, but the pharmacy still offered them on the basis of "we trust our suppliers, they have honest faces", would you buy and use those medicines?

Even with regulatory oversight, people are still able to get around the regulations at the expense of their customers. VW used technological deception to cheat diesel emissions testing in the US and EU. The regulatory regime isn't watertight but at least it offers some sort of deterrent. How much worse will it be in a totally unregulated industry?

I don't like the way the industry is going. But it would have been foolishly optimistic/idealistic to expect anything different. Unfortunately it's just how the world works these days.


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## Jan (19/5/16)

What is in our favour though is that the British government backs vaping (for know anyway)

Reactions: Like 1


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## Jan (19/5/16)

Maybe someone should let Donald Trump know that if he backs vaping he will get a lot of votes from people who otherwise might vote democrat


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