FDA TVECA post table of contents for Deeming Final Rule

[FlamingoTutu]

This is the reply I got from my congressman:

Dear Ms. Reeves,

Thank you for writing in and sharing your concerns about the Food and Drug Administration's (FDA) proposed rule for new tobacco products and H.R. 2058, the FDA Deeming Authority Clarification Act of 2015. I appreciate the opportunity to hear from you.

In April 2014, the FDA released a draft rule that proposes stricter regulations on pipe tobacco, cigars, nicotine gels, water pipe tobacco, hookah, and e-cigarettes. The proposed rules would require manufacturers to register products and ingredients with the FDA, garner FDA approval before marketing new products, and utilize science-based evidence before making direct or implied claims of product benefits.

In the proposed rule, the FDA laid out two different paths for the consideration of new tobacco products. If a new tobacco product has the same characteristics as a tobacco product that was commercially marketed before February 7, 2007, it would not be subject to a new approval process. If the product does not have the same characteristics as a tobacco product sold by that date, the producer would have to apply with the FDA for a premarket product review of new tobacco products. This could only be avoided if the FDA finds that the products do not raise different questions of public health.

If the FDA finalizes this rule, it is anticipated that new vapor product manufacturers, including those of electronic cigarettes, would have to attempt to have their products qualified as having the same characteristics as other products (also known as "substantial equivalence"). I've heard from some folks who are concerned this would increase the regulatory burden for manufacturers of new tobacco products and limit the ability of consumers to purchase them.

In response to concerns about the impact of this proposed rule on small businesses, Rep. Tom Cole (Okla.) introduced the FDA Deeming Authority Clarification Act of 2015. This legislation would move the deeming regulation date (i.e., the date from which products would have to demonstrate substantial equivalence) from 2007 to 2015. This legislation has been referred to the House Committee on Energy and Commerce, where it is pending a hearing. Though I do not sit on this committee, if this issue does come before the full House for a vote, I will take your thoughts into account.

"I will take your thoughts into account." If I see one more form letter with that line in it, I'm going to scream. Or start playing the drinking game.

I can't imagine them being able to regulate everything they want to. Wouldn't it then be on the states individually to enforce the law? I just think the whole thing is ridiculous, and I really hope the powers that be are listening closely to us right now. This is in now way fair or just, either to us or to the businesses we rely on for our products!

Have you read what the states have/are doing? It's worse, plus taxes from around 60-90%+. Wait until the federal taxes hit.

Per my calculations, 1 liter of 100 mg/ml nicotine base should last me about 5.5 years (at 4-5 ml per day, 10-12 mg/ml, roughly).

Better buy more. Looks like it keeps at least 10 years in the freezer.

I'm not sure How to Interoperate 0mg right now.

The OCR Software did such a So-So job of converting the PDF, I'm having a hard time Searching.

I did see this on Page #6


212 ... For the purposes of this guidance document, liquid nicotine and nicofille-
213 containing e-liquids (i.e .. liquid nicotine combined with colorings, flavorings, and/or potentially
214 other ingredients) are generally referred to as e-liquids. Liquids that do not contain nicotine or
215 other material made or derived from tobacco but that are intended or reasonably expected to be
216 used with or for the human consumption of a tobacco product also are referred to as e-liquids for
217 the purposes of this guidance document. For example, where a "zero nicotine" or "nicotine free"
218 e-liquid is imended or reasonably expected to be mixed with liquid nicotine. that e-liqu.id may be
219 a component or pan of a tobacco product and subject to FDA' s tobacco control authorities. FDA
220 considers such e-Liquids to be a tobacco product even if sold separately from an aerosolizing
221 apparatus.

I can see people in a back alley standing in huddles adding nic to their nic-free liquid. Are they going to hold a seance to determine if nic is going to be added? Then what, toss them in prison?

 

[inspects]

I feel sorry for the millions of people who could have had the opportunity to quit smoking.

I feel exceptionally sorry for the idiots who claim vaping is a tobacco product. I assume they probably consider processed food as being safe, no need to restrict folks from buying that class-1 carcinogen.

 

[MattVid]

Of course it will be easy as pie. If I make an EGO type battery I would have scientifically
prove using every clearo that would fit in all resistance settings using every combination
of PG/VG/nicotine and flavoring combinations using a sliding scale as the voltage on
the battery drops the precise amount of every chemical being delivered per puff in
parts per million or better.
Piece of cake.
Regards
Mike

I can guarantee that that won't happen. They can say what they want to say, but vaporizers in general are far to easy to make. Samsung and LG batteries are used in vaporizers, sure, but that isn't what the batteries were made for.

I could see manufacturer's needing to develop a special battery type and format for vaping. There is no possible way they could ban and regulate every piece of wire, cotton and battery ever made.

The government is too dumb and slow to react the the hive mind of people in the world. I just don't think that "looking into it more" is such a bad idea. Though the regulations definitely seem over bearing in many spots, and are simply unrealistic in a society where wire, cotton and batteries are within arms reach at basically all times.

I wish focus would be made more on the juices/chemicals/nicotine than the electronic parts. The electronics are very, very simple, and can't see how they could be regulated.

I am going to write a couple letters to government officials, and do my part. Some kind of middle ground will be found, I am sure. I think the idea/heart may be in the right place, but the verbiage definitely isn't. As it stands, this would be completely unenforceable, as basically everything on the planet has cotton, wire and/or batteries in it, haha.

 

[Katya]

I can guarantee that that won't happen.

With all due respect, you really can do no such thing.

 

[Katya]

I feel sorry for the millions of people who could have had the opportunity to quit smoking.

This! ^

Most of us, old timers, are prepared and we'll be able to survive. But all those other smokers out there who want to quit but haven't tried/discovered vaping yet--I feel for them.

Shame.

 

[Vapez]

How can I support the vaping community in this critical time as a Norwegian?

 

[skoony]

I can guarantee that that won't happen. They can say what they want to say, but vaporizers in general are far to easy to make. Samsung and LG batteries are used in vaporizers, sure, but that isn't what the batteries were made for.

I could see manufacturer's needing to develop a special battery type and format for vaping. There is no possible way they could ban and regulate every piece of wire, cotton and battery ever made.

The government is too dumb and slow to react the the hive mind of people in the world. I just don't think that "looking into it more" is such a bad idea. Though the regulations definitely seem over bearing in many spots, and are simply unrealistic in a society where wire, cotton and batteries are within arms reach at basically all times.

I wish focus would be made more on the juices/chemicals/nicotine than the electronic parts. The electronics are very, very simple, and can't see how they could be regulated.

I am going to write a couple letters to government officials, and do my part. Some kind of middle ground will be found, I am sure. I think the idea/heart may be in the right place, but the verbiage definitely isn't. As it stands, this would be completely unenforceable, as basically everything on the planet has cotton, wire and/or batteries in it, haha.

If it were not for the fact that 90% of the population would obey the law you would
have a point. If DIY´ERS gain any significant market share there will be fines and
suspensions.
Mike

 

[Katya]

How can I support the vaping community in this critical time as a Norwegian?

No idea ATM, Vapez, but thanks for asking. Just keep your fingers crossed--for the time being... Or pray for us.

 

[MattVid]

With all due respect, you really can do no such thing.

It just doesn't make sense. They are going to start monitoring cotton balls, wire of any sort and batteries like cough medicine? Good luck with that.

With all the time restrictions, it really just looks like some BS the Big Tabacco companies are pushing for. I hope they have fun climbing into the ring with every electronics manufacturer on the planet.

 

[MattVid]

If it were not for the fact that 90% of the population would obey the law you would
have a point. If DIY´ERS gain any significant market share there will be fines and
suspensions.
Mike

Well, the 5th of November is coming up ...

 

[Vapez]

No idea ATM, Vapez, but thanks for asking. Just keep your fingers crossed--for the time being... Or pray for us.

I'll do what I can.

What happens in US will affect the rest of the world.

 

[RipCigs]

Croatia here, Europe. Anything I can do to help?
[HASHTAG]#rant[/HASHTAG]
I believe reasoning is futile here. The decisions that are being made are not, in my opinion, mainly influenced by the concern of the public well being, but by politics and profit. I've watched some of the US anti vape congress (at least i think it was congress) speeches, and they have no idea what they are talking about. I keep hearing the buzzwords "but the children", "nicotine = poison" and such, which give people with less understanding a topic to feel smart about (from personal experience, people love hearing a buzzword such as the previous on the news and spreading it "knowingly"). This of course makes it hard to near impossible for us to reason with the general non PV educated public (again, personal experience).
There is a plethora of research and evidence proving them wrong, but all of that does not matter because someone a couple years ago pushed 4 volts for half an hour through a dry coil and conducted it was terribly harmful. Damn shame.

So once again, i would like to help if i can, because if this happens to you guys, it is only a matter of time it happens to the rest of the world. And i really don't feel like getting fined or arrested for creating watermelon vapor that is safer than smog filled city air.

 

[Bootiewootsy]

Thanks for the information.. Very disturbing...

 

[Katya]

It just doesn't make sense. They are going to start monitoring cotton balls, wire of any sort and batteries like cough medicine? Good luck with that.

With all the time restrictions, it really just looks like some BS the Big Tabacco companies are pushing for. I hope they have fun climbing into the ring with every electronics manufacturer on the planet.

It really isn't about cotton balls and wire. It's about harm reduction and helping people quit. If prices skyrocket, eliquid manufacturers are forced out of business and imports from China are halted, the golden age of vaping will be over. Period.

 

[cooladdict]

"if this issue does come before the full House for a vote, I will take your thoughts into account."

Not good. If it doesn't, we're screwed. If it doesn't pass, we're screwed. We're screwed.

I wish he was on the committee for tomorrow. It sounds like he really is interested in hearing exactly how vaping is different from smoking. I heard back from another one of my state reps a few months ago when I first signed the Change.org petition and he is totally on our side. I lost the folder that had his reply in it, though, and I can't remember who it was!!

 

[Shelbey Champagne]

Do we know what the new additions about flavorings is? Certainly not banning flavored e liquids right? Probably just about each flavor needs it's own pre market application right?

 

[LimJaheyyy]

What exactly are they trying to do? Im having trouble weeding through all of this.

 

[zoiDman]

What exactly are they trying to do? Im having trouble weeding through all of this.

In a Nutshell.

Restrict the sale of e-Cigarettes and e-Liquids to ONLY FDA Approved Products.

 

[DC2]

Well, if anything can spoil my vacation, this would be it.
I almost wish I had waited until I got back from vacation to open this thread.

It just doesn't make sense. They are going to start monitoring cotton balls, wire of any sort and batteries like cough medicine? Good luck with that.

I think the thing to understand is that they seem to have given themselves carte blanche.
Carte blanche to go after whatever they want as it relates to vaping.

They don't have to go after everything they say they can go after unless they want to.
And what they'll want to go can after change whenever they decide to change it.

In the new wording, they have made it crystal clear that vaping equipment is a valid target.
And they have made it pretty darn clear that nicotine liquid is a target.

Even flavorings designed for vaping.
Like diketone-free ones perhaps.

This whole thing appears to have been tailored to our worst fears.
But yeah, everything will be just fine.

 

[SeniorBoy]

Page 7, Lines 253 ~ 281


2. ENDS Retailers Who Mix or Prepare Their Own E-Liqlljd.~ or Create or
Modify Acrosoiidng Apparatus ji-om VariOliS Componerus


An ENDS retail establishment that mixes and/or prepares combinations of liquid nicotine,
flavors, and/or other liquids for direct sale to consumers for use in ENDS or creates or modifies
aerosolizing apparatus for direct sale to consumers for use in ENDS (sometimes known as a vape
shop) meets the defmition of .. tobacco product manufacturer" in section 900(20)6 of the FD&C
Act (21 U.S.c. 387(20» and the combinations il mixes and/or prepares are "new tobacco
products" within the meaning of section 91 O(a)( 1). Section 91 O(a)(1 ) defi.nes a '"' new tobacco
product" as "any tobacco product (including those products in test markets) that was not
commercially marketed in the United States as of February 1 S, 2007," or '"any modification
(including a change in design, any component. any pan. or any conslituent. including a smoke
constituent. or in the conlent. delivery or fonn of nicotine, or any other additive or ingredient) of
a tobacco product where the modified product was commercially marketed in the Uni ted States
after February 15, 2007." Therefore. those establishments engaged in mixing and/or preparing
combinations of liquid nicotine, flavors, and/or other liquids or creating or modifying
aerosolizing apparatus for direcl saJe to consumers for use in ENDS are tobacco product
manufacture rs and, consequentl y, are subject to all of the requirements applicable to
manufacturers.

C. How Will FDA Review an ENDS PMTA '!

FDA will review an ENDS PMTA consistent with the requirements of section 910(c) of the
FD&C Act. Under section 91O(c)( J )(A), FDA must act on a PMTA "as promptly as possible, bUI
in no event later than 180 days after the receipt of an application." A PMTA must include all
information specified in 910(b)(1) upon submission and FDA may refuse to file incomplete
applications. However, FDA may request additional information about your PMTA as necessary.
FDA may also want to inspect your manufacturing, clinical research, or nonclinical research sites
to support its review of your PMTA.
Note: Sorry if some words are Wacked. The OCR Software I used on the Original PDF isn't the Greatest.

Thanks.

"lines 253 ~271? "ENDS Retailers Who Mix or Prepare Their Own E-Liquids"

Assuming the "leaked" is the final rule sometime in 2016 (my guess), Vape Shops are in serious trouble. Speaking from my own visits in Vegas to perhaps 20 or more of them in my activist efforts this section will:

- A huge hit to their bottom line with "house" mixes which are extremely popular and provide very high margins. If you DIY (like I do) you understand the margins and return visits it creates

- Many shops do "builds" on attys. Very popular and generates sales of toppers. That's the revenue source per sey, the sale of the topper. Buy it and we will build it for you. Also brings the customer back to the shop for more sales.

- Most Vape Shops will vanish. Hundreds of people will be unemployed.

- People who currently smoke face huge obstacles in switching to ecigs. That's criminal. A death sentence if you will. A tragedy.

- Vegas has big shops and little shops. I don't know any who have the large amount of money, time, and papper work to obtain official FDA approval.

AND, I'm only focusing on a single section that you were kind enough to post. Not the rest of the documents and other "leaks" which will see daylight in the next few days.

/sigh/