FDA Regulations: Touching Vapes AFTER the Sale...

Here's a technical question: In your shop you sell a customer a setup with, say, a separate coil, tank, etc.

Under the FDA regulations even though they are a beginner you cannot "manufacture" for them by helping them to set it up (touching or installing batteries, messing with coils, etc.).

However, once purchased aren't the items no longer yours and now owned by your customer?

So the customer gives the items back to you, the shop owner, after purchase...

Can you help someone in your shop to set up their equipment in this way?

It's no longer yours, after all, you the shop owner no longer posses the item.

In our case we have videos to prove this as well as detailed times and dates in the cash register and on the receipts.

I speculate that once the change is returned to the customer you, the shop owner, is no longer covered by FDA regulations because the items in question are no longer in your inventory and you are no longer selling them.

If this were not true then hanging out behind the convenience store for a smoke could cause problems: the clerk gives you a light and suddenly the convenience store owner becomes a "manufacturer."

If you don't own an ENDS system, is there a problem with you touching it?  Changing it?

How is this different than the convenience store clerk taking the wrapper off your smokes and throwing it away: the clerk and convenience store owner would, under this logic, also be "tobacco manufacturers."

Perhaps the new owner could "hire" you personally to fix their vape?

Give you personally a fiver to set things up.

On the other hand the FDA could claim the "vape shop" is somehow magic and these thoughts and ideas don't apply.

Again, though, it would also apply to throwing away the wrapper from a pack of cigarettes.

What if I go to your shop?  Can I help someone in your store?

What if I have contract employees, i.e., people in my store who are employed say, by a temp agency, and not me, the shop owner?  Could they help a customer?

DNC Emails: Russian "Hackers" or Simply "Foreign Journalists"?

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FDA Espouses False Labeling...

[The] FDA says this: "Regarding your fourth question, if the product does not contain nicotine and you have submitted a statement to FDA certifying so, according to the regulatory requirement, then you would not have to include the mandatory warning regarding the contents of nicotine in the product."  (from http://tobaccoanalysis.blogspot.co.il/2016/07/fdas-convoluted-response-to-simple.html)...

(This post is interesting in and of itself...)

But on to the business at hand...

SO if I have e-liquid that contains no nicotine AND I register it with them then I don't have to label it as a nicotine product if I register it?

Now if you look at page #8 of the deeming regs (https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-10685.pdf) it clearly says that e-liquids ARE tobacco products through the "components and parts" logical nonsense espoused on that page.

This is the nonsense: "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."

And here we find "e-liquid..." - really anything else that does not contain nicotine: mods, ENDS, software, whatever.

So it would seem that, according to this FDA correspondence, if your e-liquid (or software) does "not contain nicotine" AND you have "submitted a statement to the FDA certifying so" you would not have to include a mandatory warning label that it contained nicotine.

Hmmm.....  this is new - recall my blog posts about the FDA making software a "tobacco product."

Now it would seem that, if we register it with the FDA, at least it won't be labeled as such...

So if its not LABELED as nicotine (because it isn't) and it does not contain nicotine (because it doesn't) it's apparently still regulated as if it were nicotine because...?

Could it be an "accessory:"

(page #8 and #9 of the deeming regs): "FDA is defining "accessory" to mean "any product that is intended or reasonably expected to be used with or for the human consumption of a tobacco product; does not contain tobacco and is not made or derived from tobacco; and meets either of the following: (1) Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product or (2) is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but (i) solely controls moisture and/or temperature of a stored product or (ii) solely provides an external heat source to initiate but not maintain combustion of a tobacco product."

 No, probably not...

 So I guess e-liquid that contains no nicotine and is properly registered with the FDA as having none is an unlabeled tobacco product.

 But we have this: "... this rule authorizes FDA to take enforcement action against manufacturers who sell ... or false or misleading claims on their labeling or advertising, ..."

 The result of all this is that we have an unlabeled tobacco product which is a clear violation of  the FDA regs - this being exactly what the FDA tells us to do.

So to be unclear it would seem that if we certify something with no tobacco content has no tobacco content with the FDA and our product contains no nicotine then what, its a regulated tobacco product?

At least from my point of view there is certainly nothing lost in registering anything without nicotine with the FDA...!?!??

Vaping Tax: Harbinger of Holocaust

(Note: I know many of those reading this blog were educated in the United States after the teaching of history was corrupted (perhaps since about forty years ago); thus much of what you are about to read will be both politically incorrect and, quite honestly, frightening.

If you are wearing your tin foil hat (or if you have newly joined the tin foil hat ranks after last week's budget vote) you'd better tie it on securely.

Sources are provided for your convenience.)

Let's start out with a quotation from the Huffington Post (see if you can guess if these quotes are about the 40% Pennsylvania "vaping tax..."):

"... the story of going from freedom and entrepreneurship to living under the oppression ... , lost her business almost overnight. But, how did the [they] target entrepreneurs for their theft? Why did they block entrepreneurship and free ideas? And, perhaps most importantly, how did their efforts to tax and seize ... wealth so quickly ..."

"... would be required to declare their wealth. If they hid any assets, they would receive an automatic ten-year prison term and have their wealth confiscated."

"... used this data to institute a 20% tax on ... wealth, raising millions for the government."

Sure sounds to me like the same thing.

Tax those bastard vapers.  Ignore the Royal College of Physician's report.  Fill those government coffers...

But it's not.

No, this is none other than the story of the rise of Nazi power in post World War I Germany.

According to the linked article perhaps one third of Germany's war effort was financed through the confiscation of Jewish wealth.  Accomplished just as Pennsylvania's Governor Tom Wolfe (it was he who proposed it last year) has done with Article XII-A of House Bill 1198 (see page #50).

Seizing wealth for "government purposes."

Ignoring the welfare of those whose assets are being seized.

Oh no! You cry... That's not what our good Democratic governor and Republican representatives are doing!

I believe it did not pass last year because the FDA had yet to weigh in on whether or not vaping was a "tobacco product."

I was sadden to see many I know revile at the action of our state's government.

I saw betrayal, treachery, and worse.  Representative were called vile names on open Facebook posts by those who felt the betrayal the strongest.

Yet for those who read this blog there should be little surprise what a government is capable of doing for "your own best interest."

For me, to express my feelings, I created the shirt linked at the top of this post.

Its a picture of the Nuremberg trails.  According to Wikipedia (linked previously): "... the prosecution of prominent members of the political, military, judicial and economic leadership of Nazi Germany who planned, carried out, or otherwise participated in The Holocaust and other war crimes. The trials were held in the city of Nuremberg, Germany."

What is different here?

Not much really...  In jolly old England, for example, the medical establishment is not so far gone toward evil that they cannot see true benefit of vaping.

Here the state uses its power to tax as the first step in eliminating that which is unacceptable to it.

In your case vaping.

Imagine, what you do to help your own health - despite decades of FDA failure - is taxed.  Taxed to finance, er, well, something other than your health.

How does that make you feel?

The slight of hand in the government of Pennsylvania is our officials are hoping that all that "core curriculum" which expunges the deeds of the Nazi's and Japanese in World War II is forgotten.

If you don't know this has happened before why you won't realize the extent of the problem.

Instead of marching along with the police we vapers now huddle outside  the back of most buildings or restaurants - if we are even allowed to vape on the property, e.g., UPMC is a good example because you can be fired if you test positive for "nicotine."

Sadly these sorts of activities are concentrated in the "blue" portions of the state with the pending Allegheny county "anti-vaping" laws.

(And yes, Virginia, there are consequences to political choices - and they have now arrived at your door.  Its good to see many in the vaping illuminati have now discovered that their political favorites are really not much concerned with their constituents well being...)

I have created the shirt linked at the top of the article from this image:

Feel free to download it and spread it around with this article.  (If the blog makes this image too low-res message me for the high-res...)

Better yet, make a shirt for your representative who voted for this tax (they are all listed in the image).  Send it to them in a gift wrapped box along with a copy of the Royal College of Physician's report.  (Don't forget to include a "Thank You!" card.)

The point of this post is that, after the war, those fighting Nazi Germany conducted the Nuremberg Trials.  These trials convicted many of the Nazi's who perpetrated the heinous against the Jews.

Like smokers the Jews had little choice but to ultimately be rounded up for what they were and shipped off to re-education concentration camps.   They complied because, like a frog in a pot of cold water on a lit stove, they didn't see the threat until it was too late.

Which is sort of the point.  These words aren't a threat to anyone.  But actions have consequences and hopefully we will all be around for that part: whether conducted in the voting booth or a trial.  Imagine betrayal having to explain to elder mom that the vape that makes her blood oxygen "normal" has to go away because it now costs too much...

Smokers are docile and trained by decades of anti-smoking rhetoric to believe they smoke because they are bad people: just like the Jews.

So you also need to ask yourself: "If I proudly vote for the libertarian guy" what is really going to happen to my vape shop and the vape shops of those who are still around after the election?  (Hint: Senator Richard Burr is one of the very few who I have seen personally stand up for vaping...  Please make a wise choice.)

Seems this Post was Lost... 1963 Communist Goals for the US

From here.

Congressional Record--Appendix, pp. A34-A35
January 10, 1963

Current Communist Goals

EXTENSION OF REMARKS OF HON. A. S. HERLONG, JR. OF FLORIDA

IN THE HOUSE OF REPRESENTATIVES

Thursday, January 10, 1963

Mr. HERLONG. Mr. Speaker, Mrs. Patricia Nordman of De Land, Fla., is an ardent and articulate opponent of communism, and until recently published the De Land Courier, which she dedicated to the purpose of alerting the public to the dangers of communism in America.

At Mrs. Nordman's request, I include in the RECORD, under unanimous consent, the following "Current Communist Goals," which she identifies as an excerpt from "The Naked Communist," by Cleon Skousen:

[From "The Naked Communist," by Cleon Skousen]

CURRENT COMMUNIST GOALS

1. U.S. acceptance of coexistence as the only alternative to atomic war.

2. U.S. willingness to capitulate in preference to engaging in atomic war.

3. Develop the illusion that total disarmament [by] the United States would be a demonstration of moral strength.

4. Permit free trade between all nations regardless of Communist affiliation and regardless of whether or not items could be used for war.

5. Extension of long-term loans to Russia and Soviet satellites.

6. Provide American aid to all nations regardless of Communist domination.

7. Grant recognition of Red China. Admission of Red China to the U.N.

8. Set up East and West Germany as separate states in spite of Khrushchev's promise in 1955 to settle the German question by free elections under supervision of the U.N.

9. Prolong the conferences to ban atomic tests because the United States has agreed to suspend tests as long as negotiations are in progress.

10. Allow all Soviet satellites individual representation in the U.N.

11. Promote the U.N. as the only hope for mankind. If its charter is rewritten, demand that it be set up as a one-world government with its own independent armed forces. (Some Communist leaders believe the world can be taken over as easily by the U.N. as by Moscow. Sometimes these two centers compete with each other as they are now doing in the Congo.)

12. Resist any attempt to outlaw the Communist Party.

13. Do away with all loyalty oaths.

14. Continue giving Russia access to the U.S. Patent Office.

15. Capture one or both of the political parties in the United States.

16. Use technical decisions of the courts to weaken basic American institutions by claiming their activities violate civil rights.

17. Get control of the schools. Use them as transmission belts for socialism and current Communist propaganda. Soften the curriculum. Get control of teachers' associations. Put the party line in textbooks.

18. Gain control of all student newspapers.

19. Use student riots to foment public protests against programs or organizations which are under Communist attack.

20. Infiltrate the press. Get control of book-review assignments, editorial writing, policymaking positions.

21. Gain control of key positions in radio, TV, and motion pictures.

22. Continue discrediting American culture by degrading all forms of artistic expression. An American Communist cell was told to "eliminate all good sculpture from parks and buildings, substitute shapeless, awkward and meaningless forms."

23. Control art critics and directors of art museums. "Our plan is to promote ugliness, repulsive, meaningless art."

24. Eliminate all laws governing obscenity by calling them "censorship" and a violation of free speech and free press.

25. Break down cultural standards of morality by promoting pornography and obscenity in books, magazines, motion pictures, radio, and TV.

26. Present homosexuality, degeneracy and promiscuity as "normal, natural, healthy."

27. Infiltrate the churches and replace revealed religion with "social" religion. Discredit the Bible and emphasize the need for intellectual maturity which does not need a "religious crutch."

28. Eliminate prayer or any phase of religious expression in the schools on the ground that it violates the principle of "separation of church and state."

29. Discredit the American Constitution by calling it inadequate, old-fashioned, out of step with modern needs, a hindrance to cooperation between nations on a worldwide basis.

30. Discredit the American Founding Fathers. Present them as selfish aristocrats who had no concern for the "common man."

31. Belittle all forms of American culture and discourage the teaching of American history on the ground that it was only a minor part of the "big picture." Give more emphasis to Russian history since the Communists took over.

32. Support any socialist movement to give centralized control over any part of the culture--education, social agencies, welfare programs, mental health clinics, etc.

33. Eliminate all laws or procedures which interfere with the operation of the Communist apparatus.

34. Eliminate the House Committee on Un-American Activities.

35. Discredit and eventually dismantle the FBI.

36. Infiltrate and gain control of more unions.

37. Infiltrate and gain control of big business.

38. Transfer some of the powers of arrest from the police to social agencies. Treat all behavioral problems as psychiatric disorders which no one but psychiatrists can understand [or treat].

39. Dominate the psychiatric profession and use mental health laws as a means of gaining coercive control over those who oppose Communist goals.

40. Discredit the family as an institution. Encourage promiscuity and easy divorce.

41. Emphasize the need to raise children away from the negative influence of parents. Attribute prejudices, mental blocks and retarding of children to suppressive influence of parents.

42. Create the impression that violence and insurrection are legitimate aspects of the American tradition; that students and special-interest groups should rise up and use ["]united force["] to solve economic, political or social problems.

43. Overthrow all colonial governments before native populations are ready for self-government.

44. Internationalize the Panama Canal.

45. Repeal the Connally reservation so the United States cannot prevent the World Court from seizing jurisdiction [over domestic problems. Give the World Court jurisdiction] over nations and individuals alike.

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.