FDA Crackdown....

Status
Not open for further replies.

t8kiteasy

Ultra Member
ECF Veteran
Verified Member
Sep 22, 2012
2,690
1,980
60
virginia beach
You would think the FDA could spend 23 million (our tax dollars) on better things, like real research.
That would be to easy to do. I feel for anyone who has an order outside of this country with any vape related items.
I always wondered if all the stuff confiscated at customs is now free gear/items for the person that confiscated it???
 

Sugar_and_Spice

ECF Guru
ECF Veteran
Verified Member
Sep 11, 2010
13,663
35,225
between here and there
Yes this sucks for vapers. I have/had a package with three mods from FT hit customs on the 11th and has now dropped out of site???
Over $300.00 worth of gear and mds and now I am ......!
It will show up. Nothing is being search/seized yet. I had one since the 9th and it just showed up in NY, so yours is next. Fingers crossed.

:)
 

MacTechVpr

Vaping Master
ECF Veteran
Verified Member
Aug 24, 2013
5,725
14,411
Hollywood (Beach), FL
You would think the FDA could spend 23 million (our tax dollars) on better things, like real research.

We don't need more gov research. We've needed for gov to listen to the research. They haven't, and won't. Their goal is the appropriation of the vaping industry such as to perpetuate tobacco tax revenues. The President and Congress should not dare fund such a lethal farce, an insult to the intellect only validating the lawless criminality of Agency by all who participate in it.

Good luck. :(
 
Last edited:

t8kiteasy

Ultra Member
ECF Veteran
Verified Member
Sep 22, 2012
2,690
1,980
60
virginia beach
It will show up. Nothing is being search/seized yet. I had one since the 9th and it just showed up in NY, so yours is next. Fingers crossed.

:)
I sure hope your right about that. I have never had one drop out of site for this length of time before. My wife is telling me not to worry about it but,it's easier said then done .
 

ENAUD

Resting In Peace
ECF Veteran
Verified Member
Jul 23, 2013
9,810
64,089
Bordertown of ProVariland and REOville
I'm surprised that they dragged their feet this long on this. Zeller had said they would have " boots on the ground" as soon as the deeming took effect. Now they are just getting around to sourcing for a manpower provider to go out into the market and spy on shops and MFG.s and report their findings back to the FDA??? What a joke! I hope they go broke trying to enforce this deeming regulations, and I hope a healthy black market develops to fill in whatever damage they do to the industry. Resistance on a grass roots level can never be defeated. I hope this country becomes a battlefield resisting the FDA's ridiculous "Deeming" nonesence.
 

MacTechVpr

Vaping Master
ECF Veteran
Verified Member
Aug 24, 2013
5,725
14,411
Hollywood (Beach), FL
I'm surprised that they dragged their feet this long on this. Zeller had said they would have " boots on the ground" as soon as the deeming took effect. Now they are just getting around to sourcing for a manpower provider to go out into the market and spy on shops and MFG.s and report their findings back to the FDA??? What a joke! I hope they go broke trying to enforce this deeming regulations, and I hope a healthy black market develops to fill in whatever damage they do to the industry. Resistance on a grass roots level can never be defeated. I hope this country becomes a battlefield resisting the FDA's ridiculous "Deeming" nonesence.

I'd wager it's money. They've gotten some funding to play with. If there's no pushback, they'll have more. That's why we shouldn't assume interventions will be minimal or demonstrative.

I've always believed it will take millions of us deciding that we are the adults in the room and putting an end to the juvenile hysterics of gov. A community engendered to be participatory by a dedication to open systems and its variety would have gone a long way. But to my dismay over these past five years since I quit the delusion that this can be a business like any other has prevailed.

It's a marvel to me given our optimism that we've been allowed the latitude we've enjoyed. We are after all still the pariah's gov has consistently counted on…as long as vaping is tobacco.

Good luck. :(
 

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,232
SE PA
Question for the experts: when I receive concentrated nicotine and savours, can I freeze them in the original packages or will I need to manipulate them (ie: store them in larger bottle because the liquides will expand)?
Water is one of the very few substances that expands below a certain temperature.

The liquids we use do not expand when they get colder; in fact they shrink.
 

Dubminer

Ultra Member
ECF Veteran
Apr 10, 2016
1,431
4,905
I sure hope your right about that. I have never had one drop out of site for this length of time before. My wife is telling me not to worry about it but,it's easier said then done .
I once had one in customs for seven weeks from FT,it arrived eventually. I also found out " processed through facility" just means it is in customs and not actually processed through, strange wording if you ask me.
 

WillyZee

Vaping Master
ECF Veteran
Verified Member
Sep 23, 2013
9,930
36,929
Toronto
I'm surprised that they dragged their feet this long on this. Zeller had said they would have " boots on the ground" as soon as the deeming took effect. Now they are just getting around to sourcing for a manpower provider to go out into the market and spy on shops and MFG.s and report their findings back to the FDA??? What a joke! I hope they go broke trying to enforce this deeming regulations, and I hope a healthy black market develops to fill in whatever damage they do to the industry. Resistance on a grass roots level can never be defeated. I hope this country becomes a battlefield resisting the FDA's ridiculous "Deeming" nonesence.

Mitch_Zeller.jpg
 

mikepetro

Vape Geek
ECF Veteran
Verified Member
Feb 22, 2013
10,224
81,686
67
Newport News, Virginia, United States
SMOK is going to be the most impacted manufacturer. They aren't going to be able to put out a new product (at least to US customers) every couple of weeks. This COULD actually be a good thing. They have the market share and money to comply with the rules, but they will have to slow down and make better products to do it. The result could actually be better products from them.

I just hope Evolv has all their ducks in a row for this.

Remember, at this date, only "new" products AFTER 8/8/16 are at issue.

There are a variety of ways manufacturers can prove a product was “commercially marketed” before the Aug. 8 2016 grandfather date. According to an FDA guidance document, these are some examples:

  • Dated copies of advertisements
  • Dated catalog pages
  • Dated promotional material
  • Dated trade publications
  • Dated bills of lading
  • Dated freight bills
  • Dated waybills
  • Dated invoices
  • Dated purchase orders
  • Dated customer receipts
  • Dated manufacturing documents
  • Dated distributor or retailer inventory lists

Evolv is very conscious of this. Even the just released DNA250C is compliant. In order for the 250C to have features that werent available on 8/8/16, like Replay or 400w, an end user would have to load an "International" version of the firmware. As shipped, with "USA" firmware, it is compliant. If a USA end user chooses to alter the product after they buy it, ie load different firmware to upgrade it to 400w, that is not currently illegal.

Also, in the last months leading to 8/8 Evolv was literally working around the clock, sleeping in their office, etc.. Many items were commercially "sold" by Evolv, to customers like HCIGAR, and a full documentation trail was created. Many of these items have not been produced on a mass scale yet, but small batches were produced and sold/invoiced/shipped (Bills of Lading)/etc in order to get fully documented as being legally "under the wire".

Evolv has also heavily invested in the PMTA route, and is probably one of the best prepared to succeed via that route. PMTAs will be all about having the appropriate data, and Evolv has been collecting a lot of data ever since the DNA75.
"data automatically recorded by your Evolv Products such as the statistical data associated with each puff of an e-vapor device made with an Evolv Product such as date, time, duration, temperature, energy, ambient temperature, resistance, draw volume, orientation, and other sensor and device parameter information,"
And Evolv has literally millions of hard data points.

Evolv also built the analytical Vaping Device for the Department of Health and Human Services so they know what data is being collected that will likely be used as benchmarks in the PMTA process. See this post (and the one directly above it) for a little background, Evolv did win this contract. Keep in mind that part of the deal is this:
"All intellectual property including patents and FDA filings will follow the standard data rights clauses. Please see page(s) 20, 23-24 of the RFP. The small business awardee owns, and has full right and title to, the data it develops under an SBIR award. Additional details can be found in Section 5.5 of the solicitation and here:"
So Evolv has an inside track to the data the Department of Health and Human Services is collecting.

Anyway, Evolv has done their due diligence, but it is all subject to a changing political environment.

While I have no inside info to this effect, I anticipate a Pod Mod type system to be submitted via the PMTA route. One with multiple coil cartridges to choose from, and a chip in the cartridge that identifies the coil material, resistance, safe temp range, etc that will tell the Mod how to perform and meet the stated PMTA criteria.
 

VHRB2014

Ultra Member
ECF Veteran
Verified Member
Sep 16, 2014
2,593
4,587
Nic`d Up in Oklahoma!
We don't need more gov research. We've needed for gov to listen to the research. They haven't, and won't. Their goal is the appropriation of the vaping industry such as to perpetuate tobacco tax revenues. The President and Congress should not dare fund such a lethal farce, an insult to the intellect only validating the lawless criminality of Agency by all who participate in it.
Good luck. :(

Amen Mac. Perfectly said. If some num nut will walk a mile for a camel, I am disposed to shoot someone for my right to vape. I don't think it will come to that, and I have a lot of faith in our new administration. But, that's where I will stand.
 

MacTechVpr

Vaping Master
ECF Veteran
Verified Member
Aug 24, 2013
5,725
14,411
Hollywood (Beach), FL
Amen Mac. Perfectly said. If some num nut will walk a mile for a camel, I am disposed to shoot someone for my right to vape. I don't think it will come to that, and I have a lot of faith in our new administration. But, that's where I will stand.

Believe me it saddened me to write those words and not without some pause.

Good luck. :)
 

ScottP

Vaping Master
ECF Veteran
Verified Member
Apr 9, 2013
6,392
18,809
Houston, TX
Remember, at this date, only "new" products AFTER 8/8/16 are at issue.

There are a variety of ways manufacturers can prove a product was “commercially marketed” before the Aug. 8 2016 grandfather date. According to an FDA guidance document, these are some examples:

  • Dated copies of advertisements
  • Dated catalog pages
  • Dated promotional material
  • Dated trade publications
  • Dated bills of lading
  • Dated freight bills
  • Dated waybills
  • Dated invoices
  • Dated purchase orders
  • Dated customer receipts
  • Dated manufacturing documents
  • Dated distributor or retailer inventory lists

Evolv is very conscious of this. Even the just released DNA250C is compliant. In order for the 250C to have features that werent available on 8/8/16, like Replay or 400w, an end user would have to load an "International" version of the firmware. As shipped, with "USA" firmware, it is compliant. If a USA end user chooses to alter the product after they buy it, ie load different firmware to upgrade it to 400w, that is not currently illegal.

Also, in the last months leading to 8/8 Evolv was literally working around the clock, sleeping in their office, etc.. Many items were commercially "sold" by Evolv, to customers like HCIGAR, and a full documentation trail was created. Many of these items have not been produced on a mass scale yet, but small batches were produced and sold/invoiced/shipped (Bills of Lading)/etc in order to get fully documented as being legally "under the wire".

Evolv has also heavily invested in the PMTA route, and is probably one of the best prepared to succeed via that route. PMTAs will be all about having the appropriate data, and Evolv has been collecting a lot of data ever since the DNA75.
"data automatically recorded by your Evolv Products such as the statistical data associated with each puff of an e-vapor device made with an Evolv Product such as date, time, duration, temperature, energy, ambient temperature, resistance, draw volume, orientation, and other sensor and device parameter information,"
And Evolv has literally millions of hard data points.

Evolv also built the analytical Vaping Device for the Department of Health and Human Services so they know what data is being collected that will likely be used as benchmarks in the PMTA process. See this post (and the one directly above it) for a little background, Evolv did win this contract. Keep in mind that part of the deal is this:
"All intellectual property including patents and FDA filings will follow the standard data rights clauses. Please see page(s) 20, 23-24 of the RFP. The small business awardee owns, and has full right and title to, the data it develops under an SBIR award. Additional details can be found in Section 5.5 of the solicitation and here:"
So Evolv has an inside track to the data the Department of Health and Human Services is collecting.

Anyway, Evolv has done their due diligence, but it is all subject to a changing political environment.

While I have no inside info to this effect, I anticipate a Pod Mod type system to be submitted via the PMTA route. One with multiple coil cartridges to choose from, and a chip in the cartridge that identifies the coil material, resistance, safe temp range, etc that will tell the Mod how to perform and meet the stated PMTA criteria.

That is excellent news for Evolv and the boards themselves. With those any DIY mod maker or anyone with a 3D printer can make their own as needed.

I guess the real question is the commercial mods made with these boards. From what I have read even changing the color of the paint on a mod qualifies it as a "new product" So I am wondering of the mods made using these boards are going to have problems. Just as an example the HCigar VT 75D (DNA 75C board) or any mods that will use the new 250C board.
 
  • Like
Reactions: stols001

mikepetro

Vape Geek
ECF Veteran
Verified Member
Feb 22, 2013
10,224
81,686
67
Newport News, Virginia, United States
That is excellent news for Evolv and the boards themselves. With those any DIY mod maker or anyone with a 3D printer can make their own as needed.

I guess the real question is the commercial mods made with these boards. From what I have read even changing the color of the paint on a mod qualifies it as a "new product" So I am wondering of the mods made using these boards are going to have problems. Just as an example the HCigar VT 75D (DNA 75C board) or any mods that will use the new 250C board.

Thats a very good question. I dont think we will know the answer until they actually start enforcement, and then await the subsequent litigation. The language pertaining to “new tobacco product” was basically boiler plate language copied from the original Tobacco Act. Can they really apply that, in its entirety, to vaping? If the VT 75D is now sold in gold metal-flake, will this language be applied? If the 510 connector now has a stronger spring, will this language be applied?

(B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

So much of the deeming regs were just copied straight over from cigarette legislation. I think it going to take a few inspections to see just exactly how they will try to shove this square peg into the original round hole.

Heck, this language has even been "violated" by State governments when it forced "Fire Safe" cigarettes legislation that required adding ethylene/vinyl acetate copolymer, which in many States occurred after the 2/15/07 date.
 

untar

Vaping Master
Feb 7, 2018
3,406
17,583
Germany
I think I have a misunderstanding regarding the regulations. In the EU we assumed all US regulations were delayed until 2022, obviously this doesn't seem to be true. I tried to find the right documents that tell me what regulations are and are not in place right now but they seem to be hard to find in the paper maelstrom.

Could somebody please summarize in a few short sentences to clear up my confusion?
Links would be very much appreciated.
 
  • Like
Reactions: stols001

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,232
SE PA
I think I have a misunderstanding regarding the regulations. In the EU we assumed all US regulations were delayed until 2022, obviously this doesn't seem to be true. I tried to find the right documents that tell me what regulations are and are not in place right now but they seem to be hard to find in the paper maelstrom.

Could somebody please summarize in a few short sentences to clear up my confusion?
Links would be very much appreciated.
The biggie is that nothing that wasn't on the market before 2016-08-08 is supposed to be on the market now, and I think everything is supposed to be "registered" with the FDA, although that deadline got pushed back once or twice too, and I haven't kept track of whether it's actually in effect.
 
Status
Not open for further replies.

Users who are viewing this thread