Deeming Regulations have been released!!!!

[Eskie]

So, a follow up. I read it, and think they hit on all the issues raised without using lots of big words. It was in understandable English, which I think always looks better, as it doesn't feel as much as a snow job. They clearly demonstrated the inconsistencies in both the regulations, as well as the legal motions in defense offered by the FDA in support of them.

The only part that left me underwhelmed was the First Amendment argument applied to samples. The "contains no peanuts" argument was strong, as classifying such statements as a modified risk tobacco claim is just plain stupid. I really don't view sampling one way or another as important to fight for, but what do I know?

 

[bigdancehawk]

I thought the concern was that filling a tank = modifying the product = (under the regs) manufacturing. Unless you sold filled tanks prior to 8/8, you've now manufactured a new product.

I get what you're saying and I'm not ruling it out. I'm saying it's unlikely the FDA would try to enforce that interpretation.

Incidentally, if you read Nicopure's reply brief, they make a pretty good argument that a tank isn't a tobacco product under the FSPTCA because it doesn't contain tobacco and isn't derived from tobacco. Therefore, they argue, it isn't subject to FDA regulation. By that logic, the second a store puts juice in it, presto, it's transformed into a tobacco product!

 

[Robino1]

By that logic, the second a store puts juice in it, presto, it's transformed into a tobacco product!

In a sense, that would be more accurate. A tube of paper does not become a cigarette UNTIL the tobacco is put inside the tube.

Does that mean that I agree with the statement, no but I can see the similarities.

 

[Alexander Mundy]

I would say that as long as they don't sell it with nicotine inside it that it isn't a tobacco product, but rather a tank with a tobacco product put inside it post sale. Otherwise any manner of objects such as myself become tobacco products. Alas, common sense isn't a strong point nowadays.

I was very pleased that the document was in english and not legalize.

@bigdancehawk how many times does this he said she said go back and forth?

 

[zoiDman]

... By that logic, the second a store puts juice in it, presto, it's transformed into a tobacco product!

But Isn't there some Legal Distinction between showing a person How to Put e-Liquid into a Tank after the sale of a Empty Tank? Verses putting e-Liquid into a Tank and then selling the Tank/e-Liquid as a combined Item?

 

[Eskie]

But Isn't there some Legal Distinction between showing a person How to Put e-Liquid into a Tank after the sale of a Empty Tank? Verses putting e-Liquid into a Tank and then selling the Tank/e-Liquid as a combined Item?

There should be, but as in all legal distinctions, that remains to be determined. Common sense can be incompatible with legal interpretations.

 

[bigdancehawk]

Nope. You just can't say sorry we will not do this again nor will my employee's.
Think ISO 9000 requirements.
If your response is less than 50-100 pages with documentation backing that up
they wont even look at it. This will not be a parking ticket. The beauty of this is
even you successfully completed a PTMA your obligated yearly to go through the
process more or less to prove nothings changed. Maybe not expensive as the
original PTMA but,an ongoing cost that will dwarf the original cost over time.

There are no back doors unless or, until the courts or congress changes it.

Regards
Mike

Well, yes you can. That's exactly what happened in THIS CASE involving sales to minors. The first time he got caught the owner simply apologized and said he'd instructed his employees. Nothing further was required until the store did it two more times and the FDA hit him with a $500 civil penalty.

Violations occur all the time. In each instance the FDA issues an initial warning letter. It's well documented and a matter of public record on the FDA's website where you can read the warning letters, read their enforcement guidelines, etc.

 

[zoiDman]

There should be, but as in all legal distinctions, that remains to be determined. Common sense can be incompatible with legal interpretations.

I just think that a Reasonable Person would recognize the Difference of a Seller Combining a "Tobacco Product" with a Non-Tobacco Product for the Purpose/Intent of a Sale. Verses a Seller showing How a Non-Tobacco Product is to be Used with a Tobacco Product.

 

[bigdancehawk]

I would think that after a sale is completed and if that transaction was completely legal, that the FDA should cease to have any interest or legal standing in the product. Ownership is passed on and any laws that the FDA deemed are/should finished. So why at that point couldn't the owner/employee help the customer with questions, changing or inserting batteries, etc? More importantly, how could the FDA enforce anything at that point? I understand the owner/employees of the vape shop would still be scared [Moderated] to do anything, but what really could the FDA do?

This is so stupid........grrrrr.

Yes, and irrational. It would be irrational to say that if a perfectly legal product breaks the shop can't repair it because the FDA has arbitrarily decided that's a "modification." It's equally irrational and arbitrary to prohibit a demonstration of how to properly use a legally sold product. If the FDA were to adopt such a position, I don't think it could withstand judicial scrutiny.

 

[zoiDman]

In a sense, that would be more accurate. A tube of paper does not become a cigarette UNTIL the tobacco is put inside the tube.

...

These 2 Sentences are Fundamental as to How Much Regulatory Authority the FDA was granted under the TCA.

It is Also at the Heart of the Mythology that the FDA Created when it defined "Intended Use" and "Reasonable Expectations" as a vehicle for Regulations.

 

[bigdancehawk]

Joint Petitioners Opposition and Reply Brief - AS FILED.pdf

Page 8 refers to AA batteries that may be used in powering ecig devices? Where did they get this wrong information? Or are they testing the knowledge of the FDA or courts?

Or have I totally missed something?

You missed the footnote.

 

[Sugar_and_Spice]

Yes, and irrational. It would be irrational to say that if a perfectly legal product breaks the shop can't repair it because the FDA has arbitrarily decided that's a "modification." It's equally irrational and arbitrary to prohibit a demonstration of how to properly use a legally sold product. If the FDA were to adopt such a position, I don't think it could withstand judicial scrutiny.

Ok, I agree. Then why are these shop owners saying they cannot do these things for the customers? Where do they get that idea? From not being able to claim 'these products cannot be advertised that they will help you stop smoking'? That is a really big leap if that is true.

eta.....I am addressing this as an 'after legal sale of product has been completed'.

 

[zoiDman]

Ok, I agree. Then why are these shop owners saying they cannot do these things for the customers? Where do they get that idea? ...

JMO. But it is because too many Owners rely on FB and Internet Forums for Legal Advice.

Instead of Contacting the FDA and asking for a Legal Clarification in Writing.

 

[bigdancehawk]

Wow! This is beautiful. The plaintiff's team was obviously ready for this.

Very nice piece of work, in stark contrast to most of the amicus briefs.

 

[bigdancehawk]

Or more like the more words, the more that will get lost in the skimming of those words.

Double speak is always a lengthy confusing read.

The FDA may have taken its opportunity to "weigh in" too literally.

 

[bigdancehawk]

So, a follow up. I read it, and think they hit on all the issues raised without using lots of big words. It was in understandable English, which I think always looks better, as it doesn't feel as much as a snow job. They clearly demonstrated the inconsistencies in both the regulations, as well as the legal motions in defense offered by the FDA in support of them.

The only part that left me underwhelmed was the First Amendment argument applied to samples. The "contains no peanuts" argument was strong, as classifying such statements as a modified risk tobacco claim is just plain stupid. I really don't view sampling one way or another as important to fight for, but what do I know?

It's probably a "throwaway" argument. That can be good strategy. And sometimes you have to take a position your client thinks is important, even though you think it's a loser.

 

[Eskie]

Ok, I agree. Then why are these shop owners saying they cannot do these things for the customers? Where do they get that idea? From not being able to claim 'these products cannot be advertised that they will help you stop smoking'? That is a really big leap if that is true.

eta.....I am addressing this as an 'after legal sale of product has been completed'.

Because they're scared and no one is giving them accurate information. the reason for that is the FDA hasn't issued anything that makes sense to base those decisions off of.

JMO. But it is because too many Owners rely on FB and Internet Forums for Legal Advice.

Instead of Contacting the FDA and asking for a Legal Clarification in Writing.

Contacting the FDA won't help, as attempts for simple answers have been met with pages of irrelevant information in reply. Remember the response Michael Siegel of Boston University School of Public Health got when asking a simple question from the FDA on the regs? Here's a partial quote from a Forbes article on it:

".....But judging from correspondence that Boston University public health professor Michael Siegel posted today, the FDA is incapable of giving a succinct—or even comprehensible—answer to this basic question.

Siegel, who supports the use of e-cigarettes as a harm-reducing alternative to the conventional kind, says “someone” (presumably a business owner) shared with him the FDA’s response to this question: “Are e-cigs that do not contain nicotine (or any other tobacco extracts) also covered by the FDA deeming regulations? If so, will they also require pre-market approval like products that do contain nicotine?” The agency’s reply, which you can read in its entirety (if you dare) on Siegel’s tobacco policy blog, is more than 1,300 words long and consists mostly of irrelevant boilerplate. When the FDA finally attempts to answer the question, in the 10th paragraph of its missive, the answer makes no sense:....."

Forbes The FDA's Incomprehensible Answer To A Crucial Question About Its E-Cigarette Regulations

And let's face it, the average vape shop owner does not have the capital to hire an attorney to advise them on interpreting the regulations either, so there is no reliable source for them to turn to.

 

[bigdancehawk]

@bigdancehawk how many times does this he said she said go back and forth?

Indefinitely, until there's unconditional surrender.

 

[Rickb119]

JMO. But it is because too many Owners rely on FB and Internet Forums for Legal Advice.

Instead of Contacting the FDA and asking for a Legal Clarification in Writing.

Correct me if I'm wrong but, isn't the use of FDA and clarification in the same sentence considered an oxymoron?

 

[skoony]

Well, yes you can. That's exactly what happened in THIS CASE involving sales to minors. The first time he got caught the owner simply apologized and said he'd instructed his employees. Nothing further was required until the store did it two more times and the FDA hit him with a $500 civil penalty.

Cigarette sellers are not considered manufacturers and thus not under the same regulatory
stipulations.

In the deeming regs if you are a B&M and mix your own juice or assemble components or
do any of the things that would make you a manufacturer according to the regulations the
standards for compliance are more involved. Responses to any inquiry whether informational
or a C&D will be by their very nature a little more involved than a one paragraph reply.

Come to think of it this makes sense in a weird sort of way. The FDA is treating vaping
as it would cigarettes. Any B&M's still left will essentially be just like any other vendor
selling cigarettes. Here's your pack of smokes and book of matches or,Bic lighter if
you prefer. Thank you for your purchase. In our case it would be,here's your battery
and pre-filled tank (maybe refillable if allowed),your bottle of juice,thank you for your
purchase. I personally have never seen a vendor having to demonstrate the use of
a pack of cigarettes and a bic lighter to any customer,chillin' included.

As long as I am at it I might as well give my thoughts concerning free samples.
The best the court can do is to make it resemble what the Federal regulations
say concerning cigarette samples and promotions.


Regards
Mike