Deeming Regulations have been released!!!!

VNeil

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The thing to remember is that if the FDA's new definition of intended use passes muster in the courts it will not just pertain to e-cigarettes. The precedent will be used not only in what the FDA regulates but, will spread through out all the other agencies in the government and,eventually to the state level to allow government to intrude on any and all aspects of human activity.

Intended use will be the means for government agencies to write their own ticket in their quest to expand and to obtain more power and control over us.
:2c:
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Mike
Exactly my point.... and why it is such a dangerous precedent

ETS: think Orwellian Thought Control...
 
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Verb

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Intended use has been around for a while. It was just used against behaviors that were already well demonized. Most folks just accepted it because the stretch was needed to control the devil.

possesion above an arbitrary amount => intended sale
3 or more cohabitating non-related females=> brothel
Commit a crime=> all your cash was intended to fund future criminal activity
I can think of intended use laws regarding explosives & inhalant intoxicants where possesion of different legal items seperately is legal but collectively is a crime because it is assumed you intend to use the legal items together.
 

skoony

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Intended use has been around for a while. It was just used against behaviors that were already well demonized. Most folks just accepted it because the stretch was needed to control the devil.

possesion above an arbitrary amount => intended sale
3 or more cohabitating non-related females=> brothel
Commit a crime=> all your cash was intended to fund future criminal activity
I can think of intended use laws regarding explosives & inhalant intoxicants where possesion of different legal items seperately is legal but collectively is a crime because it is assumed you intend to use the legal items together.
The difference is with the new interpretation it elevates the doctrine from things that are provable ie,(you did in fact possess more than this) to, scant evidence or trivial evidence implies that it is reasonable to presume you were,are or were going to to possess or do something in violation of the regulations or law.

This will have the affect of lowering any and all criminal determinations to be a case of the evidence showing a likelihood of intent rather than the preponderance of evidence proving your intent.
:2c:
Regards
Mike
 

VNeil

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The difference is with the new interpretation it elevates the doctrine from things that are provable ie,(you did in fact possess more than this) to, scant evidence or trivial evidence implies that it is reasonable to presume you were,are or were going to to possess or do something in violation of the regulations or law.

This will have the affect of lowering any and all criminal determinations to be a case of the evidence showing a likelihood of intent rather than the preponderance of evidence proving your intent.
:2c:
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Mike
Not even a likelihood. Intended use is totally in the mind of the beholder, be he a regulator or a prosecutor. It is truly a thought crime. It is the stuff of dystopian novels and movies.
 

skoony

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Not even a likelihood. Intended use is totally in the mind of the beholder, be he a regulator or a prosecutor. It is truly a thought crime. It is the stuff of dystopian novels and movies.
I think we are agreeing on the same thing.

Prior to the new interpretation certain facts or conditions had to be met. The new interpretation is based on pure assumption and,not in need of obbjective fact.
:2c:
Regards
Mike
 
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VNeil

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I think we are agreeing on the same thing.

Prior to the new interpretation certain facts or conditions had to be met. The new interpretation is based on pure assumption and,not in need of subjective fact.
:2c:
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Mike
Yes we are in agreement. I just wanted to expand on the implication for the benefit of others.
 

Lessifer

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The thing to remember is that if the FDA's new definition of intended use passes muster in the courts it will not just pertain to e-cigarettes. The precedent will be used not only in what the FDA regulates but, will spread through out all the other agencies in the government and,eventually to the state level to allow government to intrude on any and all aspects of human activity.

Intended use will be the means for government agencies to write their own ticket in their quest to expand and to obtain more power and control over us.
:2c:
Regards
Mike
Was a challenge to the FDA's intended use in any of the lawsuits filed? I haven't read through them.
 

Kent C

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Was a challenge to the FDA's intended use in any of the lawsuits filed? I haven't read through them.

Yes.

http://www.clivebates.com/documents/NicopureMSJ.pdf

Many mention of it - search "intended". But it gets complicated:

The Rule tries to evade the plain meaning definition of “tobacco product” by “defining ‘component or part’ to mean any software or assembly of materials intended or reasonably expected: (1) To alter of 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.”

That approach might have been appropriate if, in the TCA, Congress had adopted the definition framework of the drug or device provisions of the FDCA. But as FDA itself has previously recognized and told Congress: “Drugs and devices are defined by their intended use, while tobacco products are not.”

FDA cannot, via interpretation, amend the TCA to adopt an “intended use” approach for “tobacco products” that Congress itself did not adopt.

FDA Deeming Rule Complaint.pdf

Count 6 on definitions pages 32-33 (unable to copy/paste for some reason :- )
 

Hdivr

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Just stopped at our local BM store and saw the new "sign" explaining that come Aug. 8th "our clerks can no longer help build coils and in no way can explain that vaping could be a way to combat smoke cessation".

No more selling individual coils for tanks, etc. If it has a manufacturer's seal, then it can't be broken. Coils can only be bought in original manufacturer sealed packs. No more "vape bars". You can sample an individual juice, but they will have to charge a $1.00 fee for it. He said 90% of his eliquid manufacturers will be gone from the shelves as they haven't met the application process.

Top name juice which was selling last week for $17 or $18 for a 30ml was on clearance for $5.00 a pop.
 

zoiDman

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Just stopped at our local BM store and saw the new "sign" explaining that come Aug. 8th "our clerks can no longer help build coils and in no way can explain that vaping could be a way to combat smoke cessation".

No more selling individual coils for tanks, etc. If it has a manufacturer's seal, then it can't be broken. Coils can only be bought in original manufacturer sealed packs. No more "vape bars". You can sample an individual juice, but they will have to charge a $1.00 fee for it. He said 90% of his eliquid manufacturers will be gone from the shelves as they haven't met the application process.

Top name juice which was selling last week for $17 or $18 for a 30ml was on clearance for $5.00 a pop.

Just curious if they had any Information about Cole-Bishop or HR2058 or CASAA or SFATA or stuff like that?
 

Bronze

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Actually, no. There is no freedom of free speech for commercial transactions. Businesses are frequently limited by regulation and law as to the claims that can be made and their advertising concerning their products.
Fine line between commercial transactions and casual talk. Not to mention the falsities surrounding the marketing of products are very widespread and you get to unfairly targeting only some.
 

Eskie

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Fine line between commercial transactions and casual talk. Not to mention the falsities surrounding the marketing of products are very widespread and you get to unfairly targeting only some.

This happens to be a pharmaceutical story, but I'm not suggesting the FDA will follow this course again. There was a drug on the market called Neurontin, originally approved as an antiseizure medication. It was found to be useful in other conditions, and was prescribed for what are known as "off label" uses. Warner Lambert was the original developer of the drug, but Pfizer eventually bought them.

Drug salesmen were frequently describing to doctors the success of the drug in other, unapproved disorders. While it was perfectly legal for physicians to prescribe a drug for any disorder they feel it is effective for, the pharmaceutical company was not allowed to promote such use without FDA approval for use in those disorders.

Long story short, Pfizer ended up paying $430 million dollars in both civil and criminal penalties for those "off label" marketing "suggestions" sponsored by the company. You could claim it was just a casual talk between the salesmen and the doctors, but I wouldn't rely on that to avoid penalty. This issue in not unique to only this onesituation, as other companies have paid large fines for such claims. Pfizer adds another $325M to Neurontin settlement tally. Total? $945M | FiercePharma
 
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bigdancehawk

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Actually, no. There is no freedom of free speech for commercial transactions. Businesses are frequently limited by regulation and law as to the claims that can be made and their advertising concerning their products.
Although some governmental limitations on commercial speech are permitted, the First Amendment applies to commercial speech. This has been the subject of a number of U.S. Supreme Court decisions, e.g.:
"The commercial market place, like other spheres of our social and cultural life, provides a forum where ideas and information flourish. Some of the ideas and information are vital, some of slight worth. But the general rule is that the speaker and the audience, not the government, assess the value of the information presented. Thus, even a communication that does no more than propose a commercial transaction is entitled to the coverage of the First Amendment." Edenfield v. Fane, 123 L. Ed. 2d 543, 113 S. Ct. 1792, 1798 (1993).
"[First] . . . [the commercial speech] at least must concern lawful activity and not be misleading. Next, we ask whether the asserted governmental interest is substantial. If both inquiries yield positive answers, we must determine whether the regulation directly advances the governmental interest asserted, and whether it is not more extensive than is necessary to serve that interest." Central Hudson Gas & Electric Corp. v. Public Service Com., 447 U.S. 557, 563, 65 L. Ed. 2d 341, 100 S. Ct. 2343 (1980).

In this instance, the FDA has gone too far. Prohibiting statements like, "Our products do not produce smoke or carbon monoxide" is unreasonable, excessive and promotes no substantial governmental interest.
 
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