# How the FDA Is Helping Big Tobacco and Encouraging Teen Smoking



## Alex (10/5/16)

*How the FDA Is Helping Big Tobacco and Encouraging Teen Smoking*

Jonathan H. Adler 


Today, the Food and Drug Administration finalized regulations asserting regulatory authority over e-cigarettes and various tobacco products, such as cigars. According to the agency, this rule will help protect public health. Insofar as the rule subjects actual tobacco products to the same regulations as cigarettes, this might be so.

But the part of the rule that “deems” e-cigarettes to be tobacco products and subjects them to extensive regulatory requirements is more likely to harm public health than to help it. Big Tobacco, meanwhile, is likely to be pleased with the new regulations.

The new FDA regulation “deems” e-cigarettes to be tobacco products, for the purposes of federal law, but e-cigarettes do not contain tobacco and do not present anywhere near the health risks of smoking. E-cigarettes create vapor, not smoke (hence the term “vaping”), and the lack of combustion means that e-cigarettes expose users to relatively few of the harmful substances contained in tobacco smoke.

Most e-cigs do contain nicotine, however, which makes them a potential substitute for cigarettes. So, while e-cig use may not be risk-free (and what is?), e-cigs present a small fraction of the risks posed by smoking. This is but one reason the United Kingdom’s Royal College of Physicians urges the use of e-cigs as a tool to help smokers quit.

E-cigarette use has boomed in recent years, fueled largely by current and former smokers. Many cigarettes users have learned that they can satisfy their nicotine craving while doing less damage to their lungs (while also lowering their dry-cleaning bills, spending less on their habit and doing less potential harm to bystanders and family members).

Because e-cigarettes compete with traditional cigarettes — and many e-cigs and vaping products are made by small upstart companies — major tobacco companies, such as Altria (a.k.a. Philip Morris), have sought to clamp down on this market. The Big Tobacco companies have created or acquired e-cig brands while also pushing for regulation that will make it more difficult for little guys to compete. With the new FDA rule, Big Tobacco is getting just what it wanted. (For more on how and why tobacco companies support e-cig regulation, see this paper, forthcoming in the Yale Journal on Regulation.)

The most significant part of the FDA’s rule is a requirement for government approval of all deemed tobacco products placed on the market since 2007. As a practical matter, this means that just about all e-cigs must go through a new approval process if they are to continue to be sold. This is a costly process — an estimated $1 million or more per product — and must be done for each and every model, flavor, etc. For tobacco giants such as Reynolds and Altria, this is no big deal. For smaller e-cig makers, however, these rules could be the kiss of death.

Even if smaller manufacturers can satisfy the relevant regulatory deadlines, the rules will increase the cost of e-cigs, limiting their cost advantage vis-a-vis traditional cigarettes and inhibit continued product innovation (thereby inhibiting the ability of e-cig manufacturers to make their products even more attractive to current tobacco users). So, as a consequence of the FDA rule, the e-cig market will shrink, and Big Tobacco will be in a better position to dominate what’s left. A vibrant competitive market will be replaced with a cartel, much like the one we see in the cigarette market.

The Washington Post’s initial story on the rule highlights the new prohibition on e-cigarette sales to minors, echoing the emphasis of the FDA’s press release on the rule. Is this rule a good idea? Maybe, but maybe not. As I noted in a post last fall, a recent Yale study found that restrictions on e-cigarette sales to youth actually increase teen smoking rates. Since then, another study (this one from Cornell) has found similar results. So even with regard to restrictions on youth sales, the FDA’s new regulations could help cigarette manufacturers and undermine public health.

As it happens, states are already adopting various rules limiting e-cigarette sales to minors. With such rules in place, it would have made more sense to allow states to experiment with different policies to discourage teen e-cig use so that we could learn which approach is most effective. Instead the FDA has adopted a nationwide approach that, according to the best empirical work done thus far, could actually make things worse.

The FDA would have you believe today’s announcement is a major step in the war against smoking. It’s nothing of the sort. It’s a gift to Big Tobacco and could be a significant setback for public health.

_This article first appeared at the Volokh Conspiracy._





Jonathan H. Adler


Jonathan H. Adler is the inaugural Johan Verheij Memorial Professor of Law and Director of the Center for Business Law and Regulation at Case Western University School of Law. He teaches teaches constitutional, administrative, and environmental law.

Reactions: Like 4


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## Silver (10/5/16)

Thanks for sharing @Alex
This ruling by the FDA is just so sad 

Although many of us were sort of expecting it, there was always some hope it wouldnt be as stringent given the positive studies on vaping that have come out over the past year or so.

Reactions: Thanks 1


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## Lord Vetinari (10/5/16)

One thing though: Prime Nic. Where does the nicotine come from? Last I read it is extracted from tobacco...

I suggest we use other sources. Tobacco is not the only plant with nicotine and nit even the one with the highest concentration.

By far the biggest use for nicotine is as pesticide in organic growing. Can we not classify our tomatoes as tobacco products then?

Also... the East has made it clear they dont give a stuff about American regulations so I think far as our supplies go we are safe.

We get everything from new tanks to new flavors faster than them too, we are a little ahead of the curve here really.

Many great vape companies are not American. Aromamizer. JayBo.

China is known for manufacturing incredibly pure chemicals. Getting our nic from there might not be all bad. Only problem I have seen is it being mis labelled and fellas mixing with 99 percent pure nic when they thought it was waaaaaaaay weaker. Tons of warnings on that but none for dodgy quality...

Interesting times. Anything can still happen. But I think SA has bigger fish to fry right now and this will mostly pass us by.


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## Oupa (10/5/16)

All pharmaceutical grade nicotine currently available is extracted from tobacco leaf, due to the relatively low cost of growing tobacco and the high nicotine content of tobacco leaf. The eggplant contains the second highest amount of nicotine after tobacco... 10 kg of eggplant have roughly the same nicotine content of 1 cigarette. So you can see the practical and financial problem with extracting nicotine from any other source.

Once extracted, pure nicotine should not be classified as a tobacco product, neither should it be classified as a pharmaceutical product imo. Well it's clearly not tobacco anymore and in e-Liquid it is not going to be used for any type of medical treatment (not directly anyway). Why not just classify it on its own when used in e-Liquid, completely separate from tobacco or pharmaceutical products, with it's own regulations and rules. Is it really that difficult to create a new classification for such a revolutionary product? No it's not... but we all know the politics behind this whole circus unfortunately. Obviously money is wayyyy more important than the lives of billions of people 

Just my

Reactions: Informative 1


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## Lord Vetinari (10/5/16)

Oupa said:


> All pharmaceutical grade nicotine currently available is extracted from tobacco leaf, due to the relatively low cost of growing tobacco and the high nicotine content of tobacco leaf. The eggplant contains the second highest amount of nicotine after tobacco... 10 kg of eggplant have roughly the same nicotine content of 1 cigarette. So you can see the practical and financial problem with extracting nicotine from any other source.
> 
> Once extracted, pure nicotine should not be classified as a tobacco product, neither should it be classified as a pharmaceutical product imo. Well it's clearly not tobacco anymore and in e-Liquid it is not going to be used for any type of medical treatment (not directly anyway). Why not just classify it on its own when used in e-Liquid, completely separate from tobacco or pharmaceutical products, with it's own regulations and rules. Is it really that difficult to create a new classification for such a revolutionary product? No it's not... but we all know the politics behind this whole circus unfortunately. Obviously money is wayyyy more important than the lives of billions of people
> 
> Just my


Damn so no sneaking it past by using a different source and still staying economically viable  

I am still rooting for China not giving a stuff and us still getting our gear.


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## Oupa (10/5/16)

Yes, many countries that do not adopt the FDA regulations will probably look to China. The issue with China most of the time is poor quality control unfortunately and you don't want to mess around or compromise with nicotine quality. This will be a golden opportunity for a few Chinese nicotine manufacturers to get their act together and build a reputation for high quality nicotine as well as stringent quality control measures.

BUT... I think the FDA will not get away with it this easily. The industry is already huge in the states and there are many role players that will fight this and make their voices heard (CASAA being one of them). Quite a few respected doctors, professors, research bodies and other scientists also making their voices heard. There is currently a bill in the making in the US government that can override the FDA's rulings. Not sure about the name or the link to it at the moment, but people can sign it and make their voices heard as well. Maybe someone can post the link here...

It will certainly be a very interesting few months lying ahead.

Reactions: Agree 1


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## Bartart (10/5/16)

Here is a link to a petition to overturn the fda ruling
https://wh.gov/iodIQ


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## Stevape;) (10/5/16)

This is so messed up. The only thing I can see is a underground market that will start up and allot more home made mods some safe others surely not so safe.


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## Cespian (10/5/16)

My 2-cents about nicotine (and possible regulation and mis-classification):

Nicotine by definition can never be classified under tobacco, similarly to why cyanide can never be considered a nut (almonds contain minute amounts of cyanide). Once nicotine is extracted from tobacco (or egg plant, or tomatoes, or wherever else), it is a drug (and a very poisonous one). 

We should be fine sourcing the ingredients to make e-juice as the ingredients on their own cannot be pin pointed to vaping...


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