How Government Kills: Vaping and Hoxsey - Parallels in Persecution.

I think that the FDA (and general "medical science") war on Hoxsey is very, very much a parallel to the FDA war on vaping.  (I touched on it in this 2011 is this article written before vaping had been around my house a year.)

Hoxsey was hounded by the FDA, state and local governments until he moved his practice to Mexico.  Much like vaping the "establishment" did not like people succeeding where they had failed.

How Healing Becomes a Crime (if it doesn't appear then watch at this URL) is a documentary on this topic:

Note to vapers: Hoxsey was in court a lot - arrested up to once every three days or so on average at the peak of the attacks.  He won many court victories demonstrating he had cured cancer yet none of these victories stopped the attacks.

For posterity (ingredients and descriptions from http://www.docevaonline.com/articles/hoxsey.html originally by Eva Urbaniak, N.D.):

Barberry root bark (10 mg.)
Buckthorn Bark (20 mg.)
Burdock root (10 mg.)
Cascara sagrada (5 mg.)
Red clover blossoms (20 mg.)
Licorice root (20 mg.)
Poke root (10 mg.)
Prickly ash bark (5 mg.)
Queen's delight root (10 mg.)
Bloodroot (added for external use only)

(This is list also described somewhat but this.)

Note to vapers: This is all stuff you can buy anywhere or find in your fields.  Free, easy to access, etc. just like what makes a vape.  This is, I believe, among the reasons why the FDA so strongly attacks.  They must balance a justifiable need to eliminate quacks against true advancements in science and technology.  Unfortunately, I think this has turned into a simple monetary power struggle to maintain the status quo.

It should be noted that these herbs are added to a potassium iodide solution in varying amounts, depending on what type of cancer a patient may have, so at the Hoxsey clinic today, each formula is custom made. One teaspoon of the tonic is taken four times a day, after meals and at bedtime. External applications of the salve are also used as indicated.

Let's first look at each herb in the formula individually and explore its main attributes:

Barberry root bark (Berberis vulgaris): A gallbladder and liver stimulant, laxative and bitter tonic. Excellent for weak or debilitated people to cleanse and strengthen the system. Has the ability to reduce an enlarged spleen. Effective treatment for malaria and protozoal infections such as Leshmaniasis.

Buckthorn bark (Rhamnus cathartica): A laxative, alterative (like St. John's Wort), and diuretic. As its botanical name suggests, this is a cathartic and can cause diarrhea if too much is used.

Burdock root (Arctium lappa): A bitter, alterative and diuretic. As you may recall, this is one of the main ingredients in the Essiac formula. Traditionally used for psoriasis, joint problems, anorexia, dandruff, and as a poultice for speeding wound and ulcer healing.

Cascara sagrada (Rhamnus purshiana): This is the main ingredient in Ex-lax. It is a mild purgative, excellent in cases of chronic constipation. It encourages peristalsis and tonifies a weak colon.

Red clover blossoms (Trifolium praetense): An alterative, expectorant, anti-spasmodic, and phytoestrogen. This herb is also one of the Essiac herbs, and has been the focus of renewed attention recently with the promotion of the plant's constituents which are plant based estrogens. Plant estrogens do not have any of the side effects of animal derived or synthetic estrogens, and the beauty of phytoestrogens is that they can also inhibit abnormal estrogenic activity, as in the case of suppressing tumor growth. Genistein, (also found in soy extract and used to treat cancer), Daidzein, Biochanin, and Formononetin are the four main recently isolated coumarins in red clover blossoms, that are being promoted as a natural alternative for menopausal symptoms. They are also potent antioxidants. Traditionally, red clover was considered a tonic, a "blood purifier" and a dermatologic agent used externally as a nourishing hair rinse, and in steam baths to soften and heal the skin. The blossoms are still a source of all of the above and make a delicious and nourishing tea.

Licorice root (Glycyrrhiza glabra): An expectorant, demulcent (softens skin and mucous membranes), anti-inflammatory, anti-spasmodic (relaxes muscles), a mild laxative and an adrenal supportive agent. The glycosides in licorice act like steroids in the body, revitalizing the adrenal glands. Since the impact of stress on the development of disease is now well documented, balancing the glands that regulate the release of the stress hormones is an excellent approach for restoring health. Licorice can also be used successfully to help restore the adrenals after steroid therapy (i.e., prednisone, cortisone, etc.).

Poke root (Phytolacca americana): A lymphatic cleanser, stimulant, anti-catarrhal (breaks up stubborn mucus), anti-rheumatic, purgative (strong laxative), and emetic (can induce vomiting in higher dosages). This herb can be helpful in shrinking enlarged lymph glands, mumps, and is excellent for infections of all kinds, but especially those of the respiratory tract.

Prickly ash bark (Zanthoxylum americanum): A stimulant, especially of the circulatory and lymphatic systems, a carminative (soothes the digestive system), tonic, alterative, and a diaphoretic (induces sweating). It is helpful for varicose veins, leg cramps, rheumatism and skin diseases.

Queen's delight root (Stillingia sylvatica): An astringent, alterative, anti-spasmodic, expectorant, diaphoretic, and sialagogue (promotes saliva). This aromatic herb has historically been used to treat skin disorders, but is also a very powerful lymphatic stimulant. Its astringent properties also make it an effective treatment for hemorrhoids.

Bloodroot (Sanguinaria canadensis): Although this herb can be taken internally, Hoxsey preferred to only use it topically. It is a very potent medicine. It is an antiseptic, cathartic, anti-spasmodic, emetic, cardioactive (stimulates the heart and circulation), expectorant, and topical irritant/escharotic, and anti-fungal. It is very effective in treating bronchitis, laryngitis, sore throat, asthma, and is used in naturopathic treatment of HPV (human papilloma virus), the cause of cervical warts in women.

Hoosier Vapers, Common Sense and Simple Science

I have to say that I like the Hoosier challenge to the Indiana anti-vaping law.  This is not just a "you didn't do your homework lawsuit."  It seems to reach further into the more substantive issues.

(The link above is to a drop box containing both the suit as well as the arguments of the defendants - in this case the State of Indiana.  So far I don't see the state refuting the basic science put forth.  There is, of course, argument about the application of the law which is harder to discern at this point.)

This suit contemplates a difference between tobacco and nicotine, a difference between e-liquid containing nicotine and one that does not, a difference between a "tobacco product" and things not made of tobacco.  Seems like common sense.

It also addresses an important notion of basic science: nicotine is not tobacco.  One which various advocacy people think cannot be won.

In Count III we here customer's won't be able to discern between "tobacco nicotine" and synthetic nicotine (98).  Similar to this post I wrote two years ago.  Of course, if it fails I accept my failure as well.  None-the-less its good to see there is a place for common sense and science.

Next we see this:

Here they argue that the new law creates standards that are stricter for e-liquid than for food or tobacco.  I think this applies in the case of the FDA "deeming regulations" as well.

Finally:

Here the argument is simple: nicotine is a "naturally occurring substance" to which the state magically applies special properties if its used in e-liquid and magically makes e-liquid without nicotine an item to be regulated.

Of course there are substantive legal elements here if you read the various back and forth between the parties in the drop box.

But these types of arguments are what's required to keep vaping free.

Arguments to delay the FDA, for example, don't really make vaping free.  These arguments do.

Maybe the Enemy isn't the FDA...

"We have met the enemy and it is us." - Pogo

I have been involved in vaping advocacy for some time.  Not as a "Greg Conley" or other famous vaping personage but as a grunt using what I know to try and advance an agenda of "less risk" (to quote the FDA) with regard to vaping and combustion smoking (mostly technology stuff).

In 2011 most of my family were smokers...  today there are none.

I am writing this column today because there is no leadership of the "pro vaping" forces.  No discernible over-arching strategy (financial, technological, political, etc.).

Yes, there are a number of individual people who are at the "top of the food chain" in the sense are very involved and active within their personal sphere.  But the real question that needs to be asked is "involved in what?" exactly.  

Everyone throwing rocks and sticks at the dragon while our homes are incinerated.

Vapers want vaping to be "left alone;" the vile FDA has created deeming regulations so that all of vaping can now look like this according to vice.motherboard:

A canonical "big tobacco" package.  Vetted, taxed, approved and FDA cleared (just like Vioxx).  Properly labeled (er, maybe or maybe not), and ready for Joe Six Pack to consume during the game.

The regs from the FDA have been a long time in coming and I have posted about them for several years.  They are no surprise.

What has been surprising to me, though, is the level of "resistance" to addressing the regulations as they were pending.

I recall fondly posts being thrown out of the CASAA Facebook page and the e-cigarette forum for trying to spur financial advocacy, e.g., a variety of contests (the first non-tobacco nicotine for which I offered a $10,000.00 USD cash price - since withdrawn).  The reason for this?  Its a "contest."  No, it was supposed to be like the fucking "X Prize" for space exploration!  Was that a "contest?"

I could go on but the bottom line is there seems to be very little interest in leading consumers to actually do things about the regulations other than complain and "call your congressman."

How's that working out?

I've been calling mine for two years - he doesn't care, as far as I can see, to touch this political "third rail." 

There is no leadership.

There is no plan other than to let others, e.g., Nicopure or Lost Arts, sue.  As to what this will bring I am not sure but at best it will take years - years of additional uncertainty about a lifesaving product.  What if they sue and win a bad victory for the rest of us - line their pockets and we get shit? 

When I started writing about this there wasn't nearly the positive vaping medical science there is now.  (I went on the words of my daughter and wife who had researched the various chemicals and technologies on the internet around 2011 when it first started in my house: a housewife and fantasy author spent a month digging and ended up five years ahead of the Royal College of Physicians.)

Today we know its safer (or in terms of the FDA deeming regs page #30 - "less risk") - than combustion tobacco.

But as vapers (I vape but never smoked, I've also vaped nicotine for a year but was unable to create a heroin-like addiction promised by the ANTZ) we are utter failures in terms of advancing our cause.  (Truth: I have the mutant gene that makes me not need nicotine; is it an addiction if its genetic?)

I think there are a several reasons for our leadership fail:

First, smokers (and vapers) are by and large cheap - hence all the "givaways" at trade shows, contests online, and so on.  So donating a $1.00 a month to save vaping is far too much to consider or ask. 

Consider there are now about 10,000 vape shops.  Imagine if each shop simply donated $10/week to a legal fund.

$10.00 a week per shop.

10,000 x $10 = $100,000 x 52 = $5,200,000 US dollars for lawyers, suing the FDA, and media time.

All shops spend more than that on soft drinks, energy drinks and junk food.

Only one problem - no one in charge - no place for the money to go.

(Hell, even the pot guy's have NORML...)

Sure we have CASAA - but they are only a "consumer advocacy" organization - they tell you to "call your legislator "(with some success) and what petitions to sign.

We have SFATA, VTA and a few others, but they are for "commercial" businesses - they pay lobbyists (I don't think these organizations will sue).

So here we sit - with nothing clutching holding our underwear at the side of the road.  

Next problem with defending ourselves is this.  Say you create a legal entity to collect this money and hire lawyers.  Now, let's go tell people about it in a CASAA or (an/the) e-cigarette forum...

[ Nasty buzzer sound ] - STOP!!!

You're advertising, i.e., looking for money.

You're promoting... You're EVIL...

We can't have this!  Go a way - your post is deleted!

So what do you do?  You're out the legal fees to set it up and no one can find out about it.

Yep - can't compete with the ads running or the vested interests of God knows who...

BTW - I tried this two years ago - long before http://www.seviausa.org/.  

I took my own money, time, etc. and went around trying to garner interest in getting out front of the deeming regs.  I didn't have enough dollars to close the full deal on my own.  I spent a whole trade show going around to drum up support.  

The result?

Zero interest... (as recently as February of this year there was still a lack of interest in SEVIA USA).

NOTE: Apparently since May 5th (Cinco de Mayo no less) there's been might be a change of attitude.

Another reason we fail to defend ourselves is that there is a great effort afoot to deprive vapers of their Constitutional rights conducted by non-other than vapers.  

Yes, we are our own worst enemy.

"Oh no - you'd don't have the right to vape anywhere its not wanted..."

I have to smell perfume, deodorant, cleaning spray, diacytel-filled cooking odors I don't want to smell but God-forbid not vape!

And such.  Trumpeted by those in charge of CASAA from my perspective at least.

So, er, why not just roll over for the FDA then?  How's the FDA different, say, than a business like Chili's (one of my favorite examples).

We fail because we have no media presence.  

On guy gets on some sub-optimal CNN report for the deeming regs.

Yet there are millions of vapers spending billions of dollars - hey, but we're less than a junkie in societies eyes...

I was thinking: Let's kick that $10/week up to $30/week (oops, maybe no free pizza one week) and get out on the internet and air waves and make some noise...  but there's no where to send the $30 each week.

There's no where to send the check.

And finally we fail on the technology aspect.  

Oh no - vapes banned from planes!

Er, there are standards for battery powered devices and aircraft THAT VIRTUALLY NO ONE IN VAPING PAYS ATTENTION TOO.

In point of fact battery explosions on aircraft are a very bad thing.

Doesn't anyone think we need to pay some bit of attention to this?  If we think things are bad now image if someone with a vape turns out to be the cause of a crash (or even in a car, bus or boat...)?

We need to attend to the actual OBJECTIVE dangers involved and not pretend we don't all know somebody who built a zero-ohm coil, left their mechanical on the car seat with the button pressed, or whatever...

Again - no leadership.

If we want recognition in the world of technical things we need some responsibility for ourselves.  I don't want some unregulated (no pun intended) sex toy in the baggage to take down a plane any more than a vape.

If you haven't guess by now I am somewhat bitter and sad.  It doesn't have to be this way.  I'm a tech guy and I live in the land of self driving cars, cars that will kill people, but we're going to get those whether they do or not, and we don't even need them...  But don't vape sonny... its dangerous!

I don't know how to change things but, as things are, I don't really see much real hope.

(Now the dragon has taken to the air, he's pissed, so he's circling around for a hot fly-over.  We're still standing in the field clutching our wooden spears and staring into the sky...)

How about this:  

It's time for well funded organization.  I don't care who runs it.  I don't care who owns it.  But it must be run for vapers by vapers and must act like we are in this to save our own collective asses lives.

I like many others have (and are) spending a lot of personal resources on this.  Eventually it will run out.

"We have met the enemy and it is us." - Pogo

Family Smoking Prevention and Tobacco Control Act: FDA "Misbranding" Vaping

To quote the Family Smoking Prevention and Tobacco Control Act (2009):

"Section (903): 
    "(a) In General.--A tobacco product shall be deemed to be misbranded--

   "(1) if its labeling is false or misleading in any particular;

   "(2) if in package form unless it bears a label containing--

     "(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;

     "(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;

     "(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and

     "(D) the statement required under section 920(a),"

The deeming regs say "programmable software" must be labeled as a "tobacco product."

It's also interesting me that the we must put the percentage (underlined by me in the above quote) of US and foreign tobacco used in "programmable software" (or eliquid for that matter - which is the chemical compound nicotine, not tobacco).

Somehow the FDA escapes the need to follow Section 903 in the deeming regs - software isn't a "tobacco product" nor does it contain physical tobacco.

Software is actually made up of electrons.

It would surely seem that this labeling of software would be "false."

New FDA "Tobacco Products" - USB Cables, cotton, ohm meters...

As the lawyers descend on the FDA and its "deeming" regulation we see the new suit by Lost Art Liquid including this list of potential "regulated" tobacco products (in addition to software and digital displays):

Unfortunately this is not in text form but we now see "USB cables," "cotton," and "Ohm meters." 

On the topic of FDA: "Programmable Software" is a "tobacco product..."

So let's look at what the FDA says about software for medical devices.

This says in part:

"2.1

This guidance applies to:

• Software used as a component, part, or accessory of a medical device;
• Software that is itself a medical device (e.g., blood establishment software);
• Software used in the production of a device (e.g., programmable logic controllers in manufacturing equipment); and
• Software used in implementation of the device manufacturer's quality system (e.g., software that records and maintains the device history record).

This document is based on generally recognized software validation principles and, therefore, can be applied to any software. For FDA purposes, this guidance applies to any software related to a regulated medical device, as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) and by current FDA software and regulatory policy. This document does not specifically identify which software is or is not regulated."

Which from my perspective as someone with 40+ years of software experience seems reasonable.  You also find this in FAA regulations for things like airplanes (and probably drones real soon).

I have numerous family members involved with and investments in things which this potentially applies to and, if you read the rest of the linked section above, seems reasonably well thought out.  Software development is a complex process and they try to rationalize how someone who makes, say a defibrillator, would go about the process to ensure that it works reliably and doesn't harm people.

On the other hand in the deeming regs we see this (page #8):

"FDA may clarify the distinctions between ‘component’ and ‘part’ in the future. Specifically, "Component or Part" means "any software or assembly of materials intended or reasonably expected: 1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or 2) to be used with or for the human consumption of a tobacco product. The term excludes anything that is an accessory of a tobacco product." Components and parts of the newly deemed tobacco products, but not their related accessories, are included in the scope of this final rule. The following is a nonexhaustive list of examples of components and parts used with electronic nicotine delivery systems (ENDS) (including ecigarettes): e-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software."

Now reading a bit before this we see that the FDA is deeming anything it decides is a "tobacco product" into a "component" or "part" of a "tobacco product" - including batteries, software and digital displays.

This is quite a distinction from the medical software described above.

After some thought it seems to me that this is because of the Soterra decision (also this) that prevented the FDA from treating vaping and e-cigs as medical devices (which they lost in 2010).  So they can't really apply the "software for medical devices" stuff for vaping because they can't call them "medical devices."

So I guess rather than coming up with something reasonable (or because they are unhappy about Soterra) the choice was to make software (or anything else listed in the regs) a "component" of a "tobacco product."

Now a "medical device" is a sensible term when discussing software.  Most modern "devices" these days have some sort of computer in them, even if its just to "debounce" a power switch.  "Software" in this context means the code running some bit of electronic computer hardware inside the "medical device."  The discussion also makes perfect sense in their section "2.1" above when discussing how to develop said software.

On the other hand the new "deeming" regulations seem to lump e-liquid, bottles, flavors and software into the same "component" part model and lash them to the Electronic Nicotine Delivery System (ENDS) device such that these things are all in fact "tobacco products."

This seems a significant stretch because clearly software cannot be "derived from tobacco" primarily because its composed of electrons and does not have a physical embodiment.

Rationally it would seem that over the long haul you would want software regulations, such as the medical ones listed above, to apply to ENDS to ensure that the ENDS don't catch fire, burn someone, cause the batteries to explode, etc. to the extent reasonably possible.

Most devices today use standard chips of various sorts to perform these functions so I don't see a huge need - but I readily admit that there need to be some standards in place.  After all, these devices do output heat at a significant wattage level. Unfortunately for vaping there seems to be zero interest in this type of regulation - save for the Chinese who build most devices.  From disassembling Chinese devices it would seem that they are all using a relatively small subset of technologies which by this point should be properly vetted for safety.

So my thought is that we are being punished, as vapers, for the Soterra decision.

No one could reasonably argue if the FDA suggested the medical device process be applied to ENDS design and manufacture.  (Though with the number of devices already in the field and the extremely small number of recorded "incidents" its seems the industry is doing a very good job policing itself in this area.  Additionally, to acquire insurance when building and selling these devices there is significant impetus to "do the right thing" relative to testing and development.)

But that doesn't appear to be what's been done for ENDS.

Instead they've created a new notion: software as a tobacco product under a different set of rules.

Best Vaping Battery Discussion I Have Seen...

https://www.e-cigarette-forum.com/forum/blog-entry/9-battery-basics-for-mods-the-ultimate-battery-guide.4848/

Message to Developers (FDA Deeming...)

NOTE: This cannot be posted directly on Apple's site because it contained the word "tobacco" in the heading.

We license a software-based, multi-platform controller software and hardware that is used, among other things, to control electronic cigarettes we manufacture.  It involves a variety of both proprietary and GPL-based components (used only on the e-cigarette as open source).  Specifically the software I am writing about here uses an iPhone (GRX Controller 1.0), Android, Windows or OS X via Bluetooth or Wifi web page to control the e-cigarettes.  This includes both a display (power levels, etc.) and a controleller (setting power levels).  (Other versions of this run on Windows, Mac, and Android to do the same.)

The FDA recently released these "deeming" regulations that govern this:

http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm

and

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

These regulations, which did not previously as far as I know include these items, now include "Programmable software" and "Digital display or lights to adjust settings."

They make the software (and perhaps hardware) components involved with "Programmable software" and "Digital display or lights to adjust settings" such as our products and potentially iOS, OS X, Windows, Android, etc. "tobacco products."

It would seem that since the phone or computer are the "digital display" there would be a requirement to follow the above regulations.

It would also seem that some portion of my code and perhaps some or all of iOS, Linux, Windows or Mac OS would now qualify as "programmable software" under these regulations.

We will have to comply ourselves but its unclear to me what the FDA will say about other things it now "deems" to be components of tobacco products.

This potentially means that Linux, iOS, Mac OSX, Windows, and who knows what else will be impacted in unimaginable ways.  "Tobacco products" cannot, as examples, be given away or sold to children.

The deadline for this to begin is August 8th, 2016.

This would be funny if it weren't so serious.

FDA - All Software On Earth is a "Tobacco Product"

The "Bluetooth" Laisimo Mod

The latest FDA deeming regulations (see pages 7-8 at https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf) include the following language: 

FDA may put in place "restrictions on the sale and distribution of a tobacco product," 

and

This final rule has two purposes: (1) To deem all products that meet the definition of "tobacco product" under the law, except accessories of a newly deemed tobacco product, and subject them to the tobacco control authorities in chapter IX of the FD&C Act and FDA's implementing regulations; and (2) to establish specific restrictions that are appropriate for the protection of the public health for the newly deemed tobacco products. In accordance with section 5 of the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.

and

The final rule defines "component or part" and "accessory" to provide additional clarity as to which products are subject to FDA’s tobacco product authority.

and finally

Specifically, "Component or Part" means "any software or assembly of materials intended or reasonably expected: 1) to alter or affect the tobacco product’s performance, composition, constituents or characteristics; or 2) to be used with or for the human consumption of a tobacco product. The term excludes anything that is an accessory of a tobacco product."  Components and parts of the newly deemed tobacco products, but not their related accessories, are included in the scope of this final rule. The following is a nonexhaustive list of examples of components and parts used with electronic nicotine delivery systems (ENDS) (including ecigarettes): e-liquids; atomizers; batteries (with or without variable voltage); cartomizers (atomizer plus replaceable fluid-filled cartridge); digital display/lights to adjust settings; clearomisers, tank systems, flavors, vials that contain e-liquids, and programmable software. Similarly, the following is a nonexhaustive list of examples of components and parts used with waterpipe tobacco: flavor enhancers and the vials in which they are contained; hose cooling attachments; water filtration base additives (including those which are flavored); flavored waterpipe tobacco charcoals and the wrappers or boxes that contain the charcoals; and bowls, valves, hoses, and heads.

Note the underline above includes “digital displays” and “programmable software.”

How interesting - software as a “tobacco product.”

Now the PrimusZ Bluetooth controllable mod (discussed on this blog, sold during 2014 and 2015, and actually still available in limited quantities, supporting iPhone, Windows, Apple and Android) would clearly fall under this designation.  The mod is controlled via the phone or computer display (“digital display”) and uses “programmable software.”

Now the software included here would have to include iOS, Android, Windows and Linux (and I suppose BSD) as the PrimusZ requires these to operate (as in "runs on them in the canonical way as appropriate per platform").

But, as they say “Wait! There’s More…”

Additionally these are available as “free apps” in various app stores - so while not "sold" they could not be given away in an app store.  Are they "free samples" as restricted by FDA tobacco regulations?

There’s also GNU-GPL code used (which is freely available) - is this now a “tobacco product” too (and hence no longer "freely available," at least to "the children?"

These control programs are Bluetooth and/or Wifi applications (using third party software technology) not specifically designed to control a mod but instead to control general classes of electronic hardware controllers wirelessly.

Of course, there’s a web site (now dormant), which uses .NET.  This was called "www.vaporscloud.com" at the time - but now its owned by another unrelated party.  It logged data such that you could see how you were using your "tobacco product."

I wonder if any "data" is also included in this...

Now of course, these commercial packages are a “requirement” to operate the "tobacco product" and enable its operation.  So, at least to me, it would seem to qualify under the above FDA language.

The PrimusZ is, of course, not the only mod like this.  There is the Laisimo (shown above) as well as others made by companies such as SMOK.

So, at least from a regulatory perspective, these FDA regulations would be trumping all software licensing on earth.

UPDATE: First lawsuit: https://lookaside.fbsbx.com/file/Halo%20E-liquids%20challenge%20to%20CTP%20Deeming.pdf?token=AWxI38E5I4UFILDdkQsCXaNDYmjMqwwSYv7RCpV4_XF84-894rrxQ12wt-3ASCIzZXk1TejppPcbZr-JV118QdnGVavK7YC74sSZUKjYminZwn56RyzDlXUJa6Wjtobin1wxFbBFYrhlila4FYNq3Tpg

(Software explicitly called out..._

FDA: Genocide by Regulation

New FDA regulations for vaping:

https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf

This fight will not be won in a court room but instead in the court of public opinion.

The regs say on page #30: “FDA believes that the inhalation of nicotine (i.e., nicotine without the products of combustion) is of less risk to the user than the inhalation of nicotine delivered by smoke from combusted tobacco products.” (Of course there's some expected maybe's and "limited data" caveat's...) Then: "... nicotine exposure by inhalation without combustion are likely NOT responsible for the high prevalence of tobacco-related death and disease in this country" (my emphasis).

Vaping as it stands today, without FDA regulations, involves "less risk" than smoking.

Some 440,000 people die each year from smoking-related illnesses.

Will these new regulations make today's vaping experience safer?

The FDA is proposing to interfere with a successful "less risk" option.

Can Mr. Zeller guarantee his regulations will not make "more risk?"

He and the FDA must be questioned about this publicly.

Making vaping a "more risk" scenario is genocide (genocide: the deliberate killing of a large group of people).

Unless we stand up and hold the FDA accountable for these facts we are done for.

Chili's Part III

I have now spoken to your local “AD” and with Mr. Bill Himey (sp?) (214) 755-6835 regarding my recent experience with Chili’s.

Most recently Mr. Himey indicated to me the as far as Chili’s concerned vaping and smoking were “the same.”  I find this position troubling from several perspectives.

Most importantly vaping and smoking are not “the same” - not in terms of definition or physics, not in terms of treatment under the law, and not in terms of health.

To “smoke” obviously you must A) involve combustion and, if you extend “smoke” to mean “smoke cigarettes,” B) use tobacco in some form.

The device which I use, which is not an “electronic cigarette,” does not involve either, nor does it involve nicotine.  It “vaporizes” by heating, not burning, and uses the same ingredients that you find in the cake frosting served in Chili’s (see http://lwgat.blogspot.com/2015/01/ejuice-in-indiana-criminalized-frosting.html).

If I wish to use my device under your current policy I am relegated to the area where people are using combustion cigarettes so I can inhale their second hand smoke.  If I am there with my young grand children they would have to accompany me.  This is both unfair and counterproductive to everyones health.

My device is no different than an inhaler in terms of function and uses the same ingredients, save for any prescription medicines which I am forced to inhale from the inhalers of others, as inhalers which are not banned within your establishments.

Next is the issue of the law.

Smoking cigarettes where I live is in fact banned in establishments such as the Chili’s near me.  As this is the law its perfectly acceptable.

On the other hand, there is no law of any kind related specifically to vaping where I live.  So vaping is in fact a perfectly legal activity.

The problem I see here is this: anyone smoking where it is legally prohibited can reasonably be asked to leave. In the case of vaping, however, there is no legality involved so the question becomes very simply: by what authority am I being asked not to engage in a legal activity?

Equating smoking and vaping outside a legal context is merely a fiction or excuse, and also, I believe, a mistake.

It seems obvious that here the “Pennsylvania Human Relations Act” (see http://www.phrc.pa.gov/Resources/Law-and-Legal/Documents/PA%20Human%20Relations%20Act%20(1).pdf) would address this, but it doesn’t.

What is more appropriate to consider is that smoking cigarettes is a disease.  There is a long and detailed Constitutional history of persons having the right to “treat their own disease” (see http://www.rbs2.com/rrmt.pdf).

Tobacco use is a disease - clearly the DSM (http://www.theravive.com/therapedia/Tobacco-Use-Disorder-DSM--5-305.1-(Z72.0)-(F17.200)) indicates it as such and it kills people, some 440,000 a year.  

Vaping, according to many reputable sources, is an effective treatment (see https://www.rcplondon.ac.uk/projects/outputs/nicotine-without-smoke-tobacco-harm-reduction-0).

Federal Courts have, over many decades, repeatedly indicated that you do have a right to "treat your own disease" in numerous of decisions.

So while its possible to pretend “smoking is vaping” and “vaping is smoking” the legal fiction created simply prevents me from addressing my personal health issues in public accomadations.

Finally, a legal fiction is problematic from the perspective of the “Pennsylvania Human Relations Act.”  

While anyone in authority in a given establishment can ask me to leave if I use my vaping device the question is whether that is an actual policy reason or simply a “catch all” reason to discriminate against me based on some other attribute(s).

Here there should be a requirement of rationality.  If, for example, “gang colors” are banned then it seems obvious that the decision to ask someone to leave is based on the science of color, that is, the actual color the person is wearing falls within the definition of a particular gang color.

If “red” is banned then it is questionable that someone would ask an individual to leave who is wearing “green.”

Yet here, by defining “vaping as smoking,” the requirement of rationality is cast aside; am I being asked to leave because I am black, or too old, or is it really because I am simply vaping?

I think you should also consider there is clear evidence (see this: http://www.seattlepi.com/national/article/Flavoring-additive-puts-professional-cooks-at-risk-1259353.php) that merely operating a commercial kitchen may be as or more “dangerous” than vaping.

So what does all this mean?

I think very simply that if I am in your establishment discretely vaping I am causing no harm to anyone else.  I am doing what Chili’s kitchen and other patrons are already doing, basically generating harmless aerosols.

Does Chili’s have the right to ask me to leave if I am a nuisance?  Of course.  Just like asking anyone who is too loud, or too scantily dressed, etc. to leave.

While your organization is certainly free to do whatever it likes I feel obligated to bring these facts to your attention and to no longer patronize your restaurants so long as you continue policies which I consider counter to common sense and my personal well-being.

Thank You

Todd Kueny