Deeming Regulations have been released!!!!

[bigdancehawk]

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?

Nicopure's lawyers would make that distinction and I think it's valid in context.

The problem you and I and everyone posting here is having is contextual: We're Alice trying to make sense out of Wonderland rules. This stems, in turn, from the FDA's determination to regulate e-cigarettes and everything related to them under the FSPTCA, a statute which was not drawn up with e-cigarettes in mind. It's like trying to force an elephant into a closet. So it's almost inevitable that the results don't make sense in the real world--only to a select few in Wonderland, the capital of which is Silver Springs, Maryland.

 

[zoiDman]

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.



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.

If a Stakeholder contacts the FDA and can not receive a Clear Written Answer to a Straightforward Question, then I question the FDA's ability to hold the Stakeholder Responsible for Regulatory Violations if the Stake Holder is acting in "Good Faith" with respect to something like Assisting Customers in the Proper and Safe Use of the Products that they sell.

---

If an Owner does not have Legal Expertise in running their Business, isn't the Cost of Hiring a Lawyer or Consultant part of the Cost of Doing Business?

 

[zoiDman]

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

 

[zoiDman]

Nicopure's lawyers would make that distinction and I think it's valid in context.

The problem you and I and everyone posting here is having is contextual: We're Alice trying to make sense out of Wonderland rules. This stems, in turn, from the FDA's determination to regulate e-cigarettes and everything related to them under the FSPTCA, a statute which was not drawn up with e-cigarettes in mind. It's like trying to force an elephant into a closet. So it's almost inevitable that the results don't make sense in the real world--only to a select few in Wonderland, the capital of which is Silver Springs, Maryland.

I just think there is Too Much Guessing and Reading In as to what the FDA says a Retailer Can and Can Not do.

I can Only Speak for Myself. But if I was the Owner of a B&M, I would contact the FDA thru my Attorney as to Exactly what I Can and Can Not do with regards to things like Showing a Customer how to Fill a Tank or How to Change a Coil.

And if the FDA Fails to reply, in writing, with a Clear Answer, so be it. It will be part of the Public Record. And I will Present it if I receive some Notification that I am Not In Compliance with something either Real or Imaginary.

 

[Robino1]

I just think there is Too Much Guessing and Reading In as to what the FDA says a Retailer Can and Can Not do.

I can Only Speak for Myself. But if I was the Owner of a B&M, I would contact the FDA thru my Attorney as to Exactly what I Can and Can Not do with regards to things like Showing a Customer how to Fill a Tank or How to Change a Coil.

And if the FDA Fails to reply, in writing, with a Clear Answer, so be it. It will be part of the Public Record. And I will Present it if I receive some Notification that I am Not In Compliance with something either Real or Imaginary.

Precisely. Make sure to have a paper trail.

 

[zoiDman]

Precisely. Make sure to have a paper trail.

Yep.

I have found when Dealing with Monolithic Agencies (such as the FDA) that you can receive very Conflicting Verbal Information.

But when some Smuck has to Sign their Name at the bottom of a piece of Letter Head Paper and then send it to an Attorney that you tend to get a more Consistent Answer to a Question.

BTW - Don't you think the FDA is Laughing in their Sleeves when they Read Forum Threads like this knowing that their Vagueness has caused some B&M's to Possibly Over-Regulate their Businesses.

 

[bigdancehawk]

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

We were talking about warnings and you've now moved on to inquiries. Which is fine. I'm going to make Alexander Mundy happy and not reply further.

 

[Lessifer]

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!

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?

I agree that it's improbable but not impossible. To me, the closest analogy would be to RYO tobacco. A store can sell the tubes and the tobacco, and even provide a self serve packing stuffing machine. However, if they take the tobacco you purchased and stuff it into tubes for you, they become a manufacturer and are now in violation. So, in our case, they can sell you the tank and the liquid, but if THEY put the liquid into the tank for you, they've "manufactured" a complete product. Just speculation on my part, but that's how it plays out in my head. If it were just a case of "ok, now you need to register as a manufacturer" that would be one thing, but if it means you have to register the filling of various tanks as individual tobacco products, and submit PMTAs for those products, that's something else entirely.

 

[zoiDman]

I agree that it's improbable but not impossible. To me, the closest analogy would be to RYO tobacco. A store can sell the tubes and the tobacco, and even provide a self serve packing stuffing machine. However, if they take the tobacco you purchased and stuff it into tubes for you, they become a manufacturer and are now in violation. So, in our case, they can sell you the tank and the liquid, but if THEY put the liquid into the tank for you, they've "manufactured" a complete product. Just speculation on my part, but that's how it plays out in my head. If it were just a case of "ok, now you need to register as a manufacturer" that would be one thing, but if it means you have to register the filling of various tanks as individual tobacco products, and submit PMTAs for those products, that's something else entirely.

JMO again.

I can Clearly see why the FDA made a Distinction between a Retailer and a Manufacture with regards to e-Liquids that contain Nicotine which was derived from Tobacco. Don't see that as a Big Breakdown in Common Sense.

And I don't see Issues where an e-Liquid that contains Nicotine that was Derived from Tobacco is Placed in an Atomizer for the purpose of Selling the Assembly to an End User.

But I Think (once again - JMO) that the Issue of a Retailer automatically becoming a Manufacture just because they show a Customer how to Fill a Tank or Change a Coil after a sale is more a Result of Internet Speculation and Advocacy "Experts" Conjecture.

I think the FDA is Smiling right Now. Because they know that this Automatic becoming a Manufacture will not Stand Up to Judicial Review. But if the Public wants to believe it, and if Retailers are Afraid to show their Customers how to Properly use the Products that they sell, that this is Fine by the FDA.

 

[Bea-FL]

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.… 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.

Eskie that is exactly what I was thinking and was getting ready to post when I saw yours. They are scrared of loosing their business so they go the most extreme route, at lease until they know they dont have to. Better safe than sorry.

If an Owner does not have Legal Expertise in running their Business, isn't the Cost of Hiring a Lawyer or Consultant part of the Cost of Doing Business?

Every business should have a lawyer but every business doesnt because of the exhorbitant cost. Especially in the small, ma-an-pa type businesses where every penny goes back into it.

You can pay a lawyer for a quick consultation and it costs a few hundred dollars, versus a longer one which could cost thousands.

 

[bigdancehawk]

I agree that it's improbable but not impossible. To me, the closest analogy would be to RYO tobacco. A store can sell the tubes and the tobacco, and even provide a self serve packing stuffing machine. However, if they take the tobacco you purchased and stuff it into tubes for you, they become a manufacturer and are now in violation. So, in our case, they can sell you the tank and the liquid, but if THEY put the liquid into the tank for you, they've "manufactured" a complete product. Just speculation on my part, but that's how it plays out in my head. If it were just a case of "ok, now you need to register as a manufacturer" that would be one thing, but if it means you have to register the filling of various tanks as individual tobacco products, and submit PMTAs for those products, that's something else entirely.

Which would be yet another absurd result. But that's how this thing is written. If a vape shop offers 100 liquids and wants to sell samples, then every time they put liquid in an EGO vape pen so it can be sampled they will have manufactured a new tobacco product.

 

[Bea-FL]

But I Think (once again - JMO) that the Issue of a Retailer automatically becoming a Manufacture just because they show a Customer how to Fill a Tank or Change a Coil after a sale is more a Result of Internet Speculation and Advocacy "Experts" Conjecture.

You know that wouldnt surprise me at all. It seems so many people take the Internet as gospel because the FDA is not providing them with any type of information or with information that is difficult to read and make sense off.

 

[bigdancehawk]

Eskie that is exactly what I was thinking and was getting ready to post when I saw yours. They are scrared of loosing their business so they go the most extreme route, at lease until they know they dont have to. Better safe than sorry.


Every business should have a lawyer but every business doesnt because of the exhorbitant cost. Especially in the small, ma-an-pa type businesses where every penny goes back into it.

You can pay a lawyer for a quick consultation and it costs a few hundred dollars, versus a longer one which could cost thousands.

Any ol' lawyer won't do. Most lawyers are specialists. The vast majority have very little, if any, knowledge of federal regulatory law or the Administrative Review Act, much less the TCA and the deeming regulations. So if you were to go to the lawyer who wrote your articles of incorporation, wrote your will, handled your divorce or fixed your traffic ticket, he/she is going to (a) face climbing a very steep learning curve and (b) be very cautious about given advice and will probably err on the safe side--way over on the safe side.

 

[seminolewind]

So, if you smoke and roll your own cigarettes, it makes you a manufacturer? Is removing cigarettes from their packing and putting them in a fancy metal box called repackaging? This whole thing makes the FDA look like it's trying to put a square peg in a round hole to make their case without using bona fide facts. I do wish we people had better access to people in the government who are non biased, and research a product thoroughly and weigh both sides , and can categorize vaping products properly. If the FDA would have made their grandfathered-in clause to give us some leeway at more fair date, it would have helped us along with our vaping guidelines. Their regulations are biased towards Big Tobacco. Can we sue on bias or favoritism?

In the government making a decision, it should have been more like a "jury of our peers" which could be 6 educated laypeople , and 6 representatives chosen by us.

I could scream over the unfairness. It's INcorrect that we are a tobacco related product with no tobacco. We are a group of ANTI tobacco people. Their regulations should reflect that. We have a nicotine delivery device alternative that can replace smoking tobacco with a healthier cleaner device that is 99% better and safer than smoking tobacco. We are ANTI-tobacco. I resent being lumped in with tobacco smokers because most of us wanted desperately to quit and found a method that works for us. It's really stupid that people and government can't see this for what it is.

So see you later, I have to go pull some more hair out and scream.

 

[zoiDman]

Any ol' lawyer won't do. Most lawyers are specialists. The vast majority have very little, if any, knowledge of federal regulatory law or the Administrative Review Act, much less the TCA and the deeming regulations. So if you were to go to the lawyer who wrote your articles of incorporation, wrote your will, handled your divorce or fixed your traffic ticket, he/she is going to (a) face climbing a very steep learning curve and (b) be very cautious about given advice and will probably err on the safe side--way over on the safe side.

This is a Very Good Point.

 

[bigdancehawk]

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?

LOL. You are hereby and henceforth deemed a tobacco product and YOU WILL BE REGULATED. Resistance is futile.

 

[Alexander Mundy]

Indefinitely, until there's unconditional surrender.

We were talking about warnings and you've now moved on to inquiries. Which is fine. I'm going to make Alexander Mundy happy and not reply further.

I believe you misunderstood me when I said:

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

I was inquiring about the Nicopure suit and how many times the lawers for both sides would go back and forth with documents about what the other said not about anything said here in this forum thread.

 

[Rossum]

So, if you smoke and roll your own cigarettes, it makes you a manufacturer? Is removing cigarettes from their packing and putting them in a fancy metal box called repackaging? This whole thing makes the FDA look like it's trying to put a square peg in a round hole to make their case without using bona fide facts.

My understanding is that you can "manufacture" or "repackage" all you want, provide it's for your personal use and not offered for sale (technically in interstate commerce, but unfortunately since Wickard v. Filburn pretty much all commerce is considered "interstate").

 

[Lessifer]

Which would be yet another absurd result. But that's how this thing is written. If a vape shop offers 100 liquids and wants to sell samples, then every time they put liquid in an EGO vape pen so it can be sampled they will have manufactured a new tobacco product.

Right, it's absurd, but that's how it's written. Which is why I, personally, am not sure how "okay" the whole "charge a dollar for sampling" is, and I can understand why a shop is reluctant to do anything to the product for the fear that it would make them a manufacturer. It appears, at least for now, that the FDA is quite happy to not clarify any of this.

 

[bigdancehawk]

I believe you misunderstood me when I said:



I was inquiring about the Nicopure suit and how many times the lawers for both sides would go back and forth with documents about what the other said not about anything said here in this forum thread.

Ha! Well, I guess having read all these briefs I'm in an excessively adversarial mode.
Now that I understand your question:
The briefing is almost over. There will probably be only one more brief.
The way motion practice works in federal court is this:
1. Somebody files a motion along with with a brief to support it.
2. The other side files its brief opposing the motion.
3. The party who filed the motion gets to reply to the points made in opposition to its motion.
In this case, both sides have filed motions: first, the plaintiffs (Nicopure, etc.) asked for summary judgment and filed their supporting brief. Then the FDA filed its own motion for summary judgment and a combination brief which both supports its motion and opposes the plaintiffs' motion. The plaintiffs have now filed a combination brief which opposes the FDA's motion and replies to the FDA's attack on the plaintiffs' motion. The only thing left is for the FDA to file a reply brief responding to the plaintiffs' attack on its (the FDA's) motion. The FDA has been ordered to do that by September 9, 2016.
In rare instances the court may allow for "sur-replies." A party may not file a sur-reply without the court's permission.
The case is scheduled for oral argument on October 19th. Sometimes following oral argument the judge will ask for further briefing to focus on what she thinks is a decisive issue or possibly something needing more clarification.