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Thursday, August 7, 2014

Letter to the FDA

Submitted as comment: 1jy-8dns-o8i6 here.

So it's time to write comments for the US FDA regarding e-cigarettes.

Here's the high-level view:

First, on the economic side and from what I see there are probably 14,000 US vape shops.  I estimate (based on various sources) that each shop (very conservatively) stops 100 people a year to permanently stop smoking "combustion tobacco."

So this will probably account for between 1 and 1.4 million new non-smokers in 2015 - and that's just shops and does not count those that vape without the benefit of a shop.

I think this will double each year for the next couple of years until a substantial percentage of new non-smokers exist.

Many people have already become permanent non-smokers because of vaping - my wife among them who went from 40 years of a pack a day of "combustion tobacco" to zero.

Nicotine not withstanding, as I will discuss below, this is possibly the biggest single positive change to public health in decades.

Second, there is the issue of flavors and current technology.  My wife owns a vape shop and many days I spend time in the shop helping her.

I observe most people who come in want to stop smoking and fall roughly into two categories: young adults (18 and over to thirty or forty) who think smoking is something they should not be doing and are eager for a variety of reasons to try vaping and older smokers (forty and over) who have unsuccessfully tried most or all of the traditional FDA-approved methods.

In the first group many are able to simply select a vaping technology (developed after 2007 - often new technology less than a year old) and a flavored non-tobacco-tasting juice and just stop smoking.  Very few are interested the dual use model of "smoking and vaping" or "chewing and vaping."  Females often urge male husbands and boyfriends to vape.  Of course a certain number are unsuccessful or use both but in virtually all cases where there is even modest motivation vaping stops young people from smoking "combustion tobacco."

The second group tend to be between thirty five to forty and over.  I think more women than men - often health conscious and very concerned about the consequences of smoking on their health and the health of their families - some or all of whom smoke.  This second group tends to like to start vaping with tobacco-tasting flavors mostly for what I will call "security" reasons.

They have smoked twenty years or more and feel literally "frightened" about depending on something new as compared to "combustion tobacco" - there is concern about "running out of vaping supplies, "what do I do if you are closed," and so on.  However, once they start vaping they quickly covert (I think in the majority if they are ready) to non-combustion tobacco smokers.

The second group tends to want to "convert" other family members - children, spouses, friends.  We hear stories of how whole families, groups of friends or neighborhood blocks stop smoking combustion products.

Third is the concept that nicotine is "derived from tobacco" is required by law.  This is nonsense as I will point out below.  The same argument applies to many, many natural compounds used daily by billions of people, e.g., vitamin B12.   Science defines compounds based on molecular structure and not on what a thing is "derived from."  The molecular structured is what uniquely defines a chemical and not its source.

Thus B12 "derived from tobacco" is the same compound as B12 derived from any other source.  The notion of a designation such as "USP" identifies how pure such derivations are.  "USP" is a government designation indicating a compound is safe for use in food and drugs.  So "USP"-grade vitamin B12 is B12 independent of whether it was "derived from tobacco" or acquired from any other source.  This is how modern science works.

Designating nicotine as "derived from tobacco" is simply dishonest as it implies that dietary nicotine (from many plants) is somehow "different" than the tobacco found in tobacco plants.  Nicotine is nicotine regardless of its source.

Fourth is the concept that nicotine is both addictive and dangerous.  There are studies referenced below that show that nicotine alone and outside the context of "combustion tobacco" is not addictive and most likely a "necessary nutrient" from some perhaps genetically identifiable class of people.  I imagine designating nicotine as "addictive" to many people as equivalent to saying vitamin B12 or C are "addictive" because people naturally gravitate toward consuming them.

Little study has been done about nicotine alone and outside of the mechanism of "delivery by tobacco combustion" and, what has been done, seems to indicate that nicotine is something many people need to "feel normal."  There seems little evidence that any true science is dedicated to nicotine study and, objectively, nicotine as delivered by vaping has only positive scientific and health results.

In a rational world nicotine alone or as part of vaping would be classified like any other natural substance such as a vitamin and would be used, outside of smoking, as such where those consuming it regulate how much they need.

Fifth, to my knowledge no one has been harmed by vaping, i.e., there is no objective evidence that to any degree people have been A) harmed by or B) killed by vaping.  Hence more people die from choking on food or riding in a car than vaping.  There are no known vaping deaths.  There are no known negative side effects of any significant public health consequence.  People can die from too much vitamin D or A so, in the same context, vaping might kill people via "misuse" but that would be only from willful ignorance or outright stupidity - just like everything else in the world.

Sixth, modern science is studying vaping as are vapers themselves.  No one wants, in general, to harm themselves.  So far vaping appears to be a dramatic improvement over smoking cigarettes.  Vapers would stop if there were some objective scientific reason to do so.  However, none exists today.  And, unfortunately, there are many macro-economic reasons for industries (such as tobacco, government including smoking-funded science and tobacco bonds) to need smokers in order to function.

Public health requires that conflicts of interest - such as the FDA's Center for Tobacco Products - that rely on smoking revenues (directly or indirectly) not be put in a position of "the fox monitoring the hen house" - be addressed and eliminated from both the science and public policy.

Vaping is the consequence of fifty years of anti-smoking policy and now that a dramatic change has appeared its appears that its not the smokers who are resisting but instead those that are supposedly fighting smoking.

Seventh, the "danger" of nicotine supposedly requires "childproof caps" for vaping supplies.  I wrote on my blog about how the number one cause of poison center calls in Washington, D.C. was for makeup.   Yet there is no interest in creating "childproof" makeup.  Nicotine e-juice is perhaps one of the most disgusting tastes available so mostly the "childproofing" is about political control and not based on science or evidence of any real, objective danger.

Eighth is the fact that doctors and other health professionals send patients to vape shops.

Ninth is the moral dilemma you encounter when an under age tobacco smoker wants to switch to vaping.  Is it morally acceptable to tell a young person who sees vaping as a means to stop their smoking - say the child of a parent who now no longer smokes combustion tobacco and vapes - to instead continue because, by some confused logic, they are "not old enough" to use a so far safer alternative?

And finally impeding vaping regulations will cause vapers to return to smoking.  What kind of twisted thinking is this?  My wife no longer smokes after 40 years of a pack a day.  Not one cigarette in nearly four years.  By what "public health logic" would the FDA do anything to change this?  Turning back vaping to 2007 will kill people - this we know because they will return to smoking.  Will vaping kill people?  So far it has not and until there is some significant evidence pointing to true objective danger that vaping is at least as harmful as combustion tobacco why would you or anyone stop vaping?

Below are the low-level details:

I. Economics.

My wife and a partner owns one of the 14,000 vape shops I mention (this number is based on estimates available on the Electronic Cigarette Forum  But there is more than just her and her partner employed or partially employed because of this one shop.  There are all the people who work at her suppliers: bottlers, label printing, shipping such as UPS, USPS, DHL, Fedex.  There are those that sell fixture (display cases, shleves, etc.) and equipment (lab equipment, paper towels, etc.).  There are utilities such power and internet.  There is the landlord.

I would estimate that for each active vape shop (and three have sprung up withing a 10 mile radius of my wife's shop within the last six months) there are at least as many people as work at the shop who are employed in supporting industries.

This, of course, does not count actual employees.

Then there all the people involved in the importation of vaping equipment and supplies: pilots, truck drivers, customs inspectors, and so on.  A typical active shop probably spends eight to ten thousand dollars on inventory each month and does business across the face of the planet.

Then there are US vaping equipment manufacturers.

There are also those that call on vape shops to sell traditional products such as insurance and advertising.

There is, of course, the "negative" economic impact to those that make a "living" from the deaths of smokers who will now lose revenue: gas stations and convenience stores selling cigarettes, government tax collectors, and so on.

Arguing that this negative impact is important would be, however, like arguing we should still use horse-drawn carriages because automobiles kill people.  This is a flawed argument because many more people are helped by the existence of automobiles and many of those employed by, for example, the buggy whip industry, simply move on and find new jobs in new industries.  Bringing up the "negative impact" is simply an argument against progress and for "status quo" and hence a continuation of 430,000 smoking related deaths a year.

The number of shops will, in my estimation, double next year.  The vaping industry in the US alone will employ probably a hundred thousand people.

II. Flavorings and post-2007 Vaping Technology

On flavoring: the notion that smokers want to vape "tobacco flavors" is nonsense.  "Tobacco flavors" in vaping is actually a "gateway" to becoming a non-smoker.  Smokers are fearful of vaping because they derive comfort from smoking.   They don't want to smoke but are fearful that relying on a strawberry vape flavor instead of cigarettes - there are fewer vape stores than convenience markets - vape stores are not open at 3:00 AM, etc.

So they start with tobacco-like flavors.  This makes the transition to the process of vaping easier and more comfortable.

In many cases, particularly with older smokers, the habitual aspects of smoking require months or years to over come once vaping starts.  After they become familiar with vaping they tend to switch to non-tobacco flavors.

Flavors are also attractive to children who smoke combustion tobacco.   Most children smoke because of being raised in a smoking environment and many do not like it.  They do not like the taste of cigarettes.  They do not like the taste of tobacco.

But if you consider that smoking is perhaps the only way to consume nicotine as a nutritional need then they feel compelled as there is no alternative.  (Imagine if the only way to get enough vitamin C was to "smoke" it...)

Young smokers typically don't want to smoke and are not yet "addicted" to cigarettes.  They are also not stupid and know smoking is bad.

Flavors do attract them - to stop smoking combustion products.

Once on flavors we see smokers able to reduce nicotine levels very effectively on their own.  I personally believe that smoking forces users into fixed nicotine consumption patterns set by tobacco companies.

Established vapers rely on non-tobacco flavors to keep from using combustion tobacco and elimination of flavors will literally send them back to tobacco.

There are many sources for this information and the study of "gateway" vaping is very active and, at least at the time of me writing this, points to the fact vaping is a "gateway" for children to smoke is nonsense.

As with flavors the vaping technology of 2014 is vastly superior to helping people stop combustion tobacco as compared with what was available in 2007.

The technology available in 2014 allows smokers to immediately stop combustion tobacco if that's their desire (from my wife's shop many people - typically younger people - walk out the door and stop smoking permanently).  The new technology supplies an adequate "throat hit" and sufficient vapor to completely simulate smoking a cigarette.  In 2007 the technology was barely usable and those vaping the longest appear to have started in 2009.

Technology continues to advance, particularly on the battery front.  New mods and eGo devices support bluetooth and will allow direct data collection on usage.

These devices, like most modern technology, will advance rapidly both in terms of power and capability.

These advances will allow even more smokers to adopt them and abandon "combustion technology."

And realistically as long as the total number of youths taking up smoking and vaping remains stable public health is advanced by reductions in "combustion tobacco" usage.

III. Nicotine "derived from tobacco"

I have been studying this for some time.  The gist of why nicotine is handled specially in the 2009 Family Tobacco act is that the FDA says it should be, or rather, wants it to be.

The reading is somehow that "nicotine" falls under some or all of what is a "drug" and is therefore the target of regulation.

However, a careful reading shows, I believe, that the FDA has created a new category of substance called "nicotine" which is magically different from anything else on the planet and defies the scientific process.

The issue arises when you consider how the FDCA defines a drug:

(1) The term “drug” means

(A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and

(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and

(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and

(D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343 (r)(1)(B) and 343 (r)(3) of this title or sections 343 (r)(1)(B) and 343 (r)(5)(D) of this title, is made in accordance with the requirements of section 343 (r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343 (r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.

And then there is the DSHEA which says:

DSHEA for the first time defines dietary supplements by law. According to Section 3 of the Act, the term "dietary supplement":

(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary supplement used by man to supplement the diet by increasing the total dietary intake; or
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).

Note the DSHEA defines "tobacco" as an exclusion but not "nicotine."  Water, starch, various sugars, vitamins, amino acids, minerals, etc. all occur in tobacco as well nicotine - yet they are not subject to special regulations by the FDA.

Note that nicotine occurs in many other foods, e.g., tomatoes, egg plant, etc. and several CDC studies indicate that "dietary nicotine" is present in virtually all humans.

Now if one considers, say, vitamin B12, which occurs in both tobacco and other plants and compares this to nicotine you get a conflict between the FDCA and the DSHEA.

I can derive B12 from tobacco or tomatoes.

Since B12 is chemical compound its source is irrelevant.

The FDCA implication via the 2009 Family Smoking Prevention and Tobacco Control Act and the deeming regulations is that nicotine is a compound that is somehow different than B12, i.e., special to tobacco.

Even though from a scientific position their properties with respect to tobacco (and the DSHEA) are the same (I believe nicotine actually falls under DSHEA (F)).

This is a hand wave by the FDA to gain control of e-cigarettes.

Clearly B12 is important in health and affects the treatment of vitamin deficiencies (anemia) and also affects the structure of the human body (promotes healthy growth of nerve and brain tissue).

Under the FDCA and FSPTCA it is clearly a "drug" in (g) above.

But its not a drug -- its a necessary nutrient.

I suspect that once the science becomes settled nicotine will be considered a necessary nutrient as well.  In terms of its properties its really no different than B12 other than it turns up in tobacco sold in cigarettes (and for all I know its in snuff) - which does not change it scientifically

Further, when you consider that USP "nicotine" is basically pure nicotine devoid (by government definition) of adulterating tobacco components in terms of purity you are left with the conclusion that the FDA wants nicotine regulated as tobacco for purposes other than science and health.

The FDA will argue that nicotine is addictive - and it may be in conjunction with other tobacco alkaloids when smoked or chewed.  But other science shows that nicotine alone is not.

Today no one knows if a vaper who starts with nicotine vaping, i.e., never smoked, will actually even become addicted.  Yet the FDA wants us all to pretend it is in order for them to control it.

IV. Nicotine is Dangerous and Addictive.

This is another falsehood promoted by many who wish to see vaping stopped.

Too much vitamin D is also dangerous - but no one is concerned about vitamin D.

Children can eat vitamin D 50,000 unit capsules and become ill.

Ditto for nicotine.

Ditto for bleach.

Its danger is simply a red herring to scare people.

Its addictiveness (which I myself am apparently immune from) is probably a side effect of the fact that it provides necessary nutrition.

Clearly once might consider English sailors "addicted" to citrus fruit - but are they "addicted" or are their bodies simply "craving" necessary nutrition.

No scientific study I have seen can tell you the role of nicotine in nutrition (yet dietary nicotine is present everywhere).

There are many studies which show nicotine alone is not addictive.

Yet most substitute tobacco studies and pretend nicotine is what is being studied.

Far more real research is required before anyone can say for sure what is going on.

In addition, I have witnessed vapers involuntarily reduce their nicotine consumption over time - if it were so addictive this would not be possible (witness opiate users).

V. Death by Vaping.

Save for the lone suicide by injection of e-liquid I believe there have been zero deaths attributed to vaping.

So the objective danger of vaping makes it far safer than eating (many people die choking each year in the US)  or driving (which kills around 40,000).

Zero objective danger.

VI. Vaping Studies

Nothing more needs to be said.  True science will determine the safety of vaping.

Science is interested and should be allowed to take its course.

Today there are no alarm bells except by those with a vested interest in controlling vaping.

Let science decide - not money or politics.

VII.  Childproof Caps

No one will drink e-juice.  It tastes horrible.

Its no worse than bleach or other household chemicals that DO NOT have safety caps.

Safety caps may deter older vapers from stopping smoking.

VIII.  Doctors and Vaping

Doctors send people to my wife's vape shop.


Apparently the FDA knows this is a bad idea without actual knowledge of the persons medical condition.

How do they know this?

IX. The Morality of Promoting Smoking over Vaping

Imagine the following scenario: A 17 year old walks into a vape shop smelling of cigarettes and asks to purchase vaping supplies.  Carding the youth results in him/her being told they may not purchase said products.

Isn't this promoting smoking?

Obviously the youth already has access to cigarettes and is using them despite all laws and government program to the contrary.

The youth most likely wants to stop smoking because since birth they have been told its bad.

But apparently this doesn't apply if you're a kid.

So your age causes you to be discriminated against and forced to continue smoking.

Is this wise public health policy?


Vaping is a disruptive technology (like the automobile, the cell phone, the telegraph and telephone, etc.) that is changing smokers into non-smokers at a rate which the established status quo cannot accept (too quickly).

It negatively impacts tobacco bonds, promotes people to live healthier (so far), and terminates smoking of combustion tobacco products.

It involves simple technology which people can set up and use from home.

It does not require government intervention to use or do effectively to quit smoking.

Yet for some reason the FDA considers it a regulation target - like laser pointers that idiots point at aircraft.

Don't send vapers back to smoking by altering what the market has created.

Allow vaping to flourish unless there is some real objective (scientific) danger.

Accept that combustion tobacco and the government agencies, regulations, and money spring from will go away - and that if they do you at the FDA CTP have been successful.

Allow those who vape to live free.

Don't condem them to combustion tobacco with controlling regulations related to money and politics.

No one wants to vape unsafe products so promote industry-based self regulation, science and knowledge sharing.

Become a partner with vaping and help steer it in the healthiest directions possible.