FDA FDA response to lawsuits.

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Semiretired

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They had better read the whole freaking thing or I don't know what we are paying them for!

Most higher ups don't read for themselves, but I don't know in this case - that is kind of why I asked - I would bet they have high confidence in their abilities and feel skimming is enough...
 

Ed_C

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Most higher ups don't read for themselves, but I don't know in this case - that is kind of why I asked - I would bet they have high confidence in their abilities and feel skimming is enough...
If you're right, it's really sad that they can't be bothered to read a document that will effect thousands of people and could cost countless dollars.
 
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WillyZee

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Personally - I am hoping that that is their downfall. They just took it to an extreme and any judge should be able to see that.

My one question - does the judge read the entire deeming reg or do they get foot notes???

The judge will read whatever is in the envelopes :blink:

157929769_e7b7346816.jpg
 

Lessifer

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If you're right, it's really sad that they can't be bothered to read a document that will effect thousands of people and could cost countless dollars.
You mean how our Congressmen read all the bills that come before them?

In this case, I don't know that the judge HAS to read all 499 pages, though she might. What she will definitely read is whatever sections the plaintiffs and defendants specifically reference. The plaintiff's have brought forth issues with specific portions of the regulations, it's not her job to go searching for more. At least I don't think that's the way it works.
 

Semiretired

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What she will definitely read is whatever sections the plaintiffs and defendants specifically reference.

It just seems she needs to capture the entire thought process to make a proper ruling. Hopefully everything referenced, if that is what she will read, does that...
 
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Lessifer

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It just seems she needs to capture the entire thought process to make a proper ruling. Hopefully everything referenced, if that is what she will read, does that...
We just have to keep in mind that she is not deciding whether or not the regulations are fair, or even if they make "sense." What she is deciding is whether or not the FDA violated the law in the way the plaintiffs say they did.
 

Semiretired

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We just have to keep in mind that she is not deciding whether or not the regulations are fair, or even if they make "sense." What she is deciding is whether or not the FDA violated the law in the way the plaintiffs say they did.

I know, I know - it is just the wait and seeing on our end that is hard...
 
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bigdancehawk

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bigdancehawk, let's say for the moment that the FDA prevails against these lawsuits.

Does such a victory then set them up legally to start fining vapers and/or confiscating their vaping gear and supplies? Or would such a move be beyond their reach?

Can they actually criminalize vaping, all by their lonesome, via regulations?
Their powers under the Tobacco Control Act don't extend to criminalizing non-commercial individual behavior.
 

bigdancehawk

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Personally - I am hoping that that is their downfall. They just took it to an extreme and any judge should be able to see that.

My one question - does the judge read the entire deeming reg or do they get foot notes???
You mean Cliff's Notes? Just guessing, but I bet she reads all of it. Unlike a certain former Speaker of the House.
 

rico942

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I was just wondering, has the FDA actually done anything yet towards vape stores or manufactures or even contacted anyone, or is everyone operating under the fear that they can do something?

Its time again to look at the FDA OCI, and their personnel sources and objectives ...

Who are the OCI Special Agents

What OCI Investigates

An excerpt from the second link ...

The FDA regulates approximately 25 cents of every dollar spent annually by American consumers.
 

bigdancehawk

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I was just wondering, has the FDA actually done anything yet towards vape stores or manufactures or even contacted anyone, or is everyone operating under the fear that they can do something?
Unless they catch somebody selling to minors, they say their usual practice will be to first just issue a warning letter. So it will be a while before much happens.
 

Lessifer

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I was just wondering, has the FDA actually done anything yet towards vape stores or manufactures or even contacted anyone, or is everyone operating under the fear that they can do something?
Remember that so far, only a few provisions have actually gone into effect, and really only the age restriction and health claims are readily enforceable. Well, depending on how they plan to enforce the "no new products" bit. I think that takes awhile though.
 

Verb

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At the state level, I think motorcycle helmets were earlier. I'm not sure what the first federal "you will do [or not do] such-and-such even though it has no effect on the health or safety of others" was.

I would guess the Harrison Act of 1914.
 

Verb

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We are well overdue for a revolution in this country. The federal government is (and has been) out of control, "we the people" have no say in anything anymore. All our politicians are bought and paid for before they even take office. I truly don't know what it will take for the average citizen to wake up and smell the tyranny.

It has to be bad enough that many folks are willing to die for the change.
 

Lessifer

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I kind of wonder about that myself - there are so many new products released every year from all kinds of venues - are all policed?
Vaping is a very different animal than anything they've regulated before. They're used to dealing with big tobacco manufacturers who for the most part play ball according to their rules, it's easy to see if Reynolds releases a new product. If "AJ's customs" releases a new mod, in a limited run, that's only available one place, they MAY not even notice. Even for shops mixing their own liquid, technically right now they shouldn't be making new products, but they haven't had to submit their product lists yet, they aren't even required to be registered as manufacturers yet. So, who knows?
 

zero7starz

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    I can't for the life of me find the publication where congress defined a tobacco product.

    The FDA response to the lawsuit was just a rewrite of why they think they're right.

    I still feel like we could argue the point of our products not being created from tobacco. During this venture I've learned more about government and legal system than I ever did in school trying to understand all of this.

    Really I'm commenting to subscribe to the thread.
     

    Kent C

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    I can't for the life of me find the publication where congress defined a tobacco product.

    The one from Congress - the Family Smoking Prevention and Tobacco Control Act (FSPTCA or TCA) is here:

    Frequently Asked Questions on the Passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) Updated October, 2010

    What products are considered to be tobacco products as defined by the Tobacco Control Act?
    The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product. This includes, among other products, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco.

    What products are not considered to be tobacco products as defined by the Tobacco Control Act?
    The term “tobacco product” does not apply to raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product. Nor does it mean something that is defined as a drug, device, or combination product under the Federal Food, Drug, and Cosmetic Act.

    However, the FDA deeming has 'deemed' it differently than Congress where 'made or derived from tobacco' is no longer applicable (except in the sections on labeling where some 'range' is allowed). Instead anything that is 'intended for human consumption' - the use of component parts, are now 'tobacco products'.

    Some lawsuits are addressing this disparity from what Congress wrote and intended, vs. how the FDA wants to redefine in order to affect electronic cigarettes.

    https://brvliquids.com/wp-content/uploads/2016/06/R2B-Complaint.pdf

    Count Six pg. 32

    112. Under the TCA, the term “tobacco product” is defined to mean, in part, “any
    product made or derived from tobacco that is intended for human consumption, including any
    component, part, or accessory of a tobacco product.” 21 U.S.C. § 321(rr).

    113. In the Deeming Rule, FDA defines “component or part” as “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.” 21 U.S.C. § 1100.3. Components and parts
    are subject to regulation under the Deeming Rule. 81 Fed. Reg. at 28,975.
     
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