FDA Crackdown....

Status
Not open for further replies.

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,232
SE PA
Ah ok, here every part of an e cigarette or part that can be used to make an e cigarette is an e cigarette for TPD purposes (which leads to hilarious rejections of small bags of "atomizer screws" by customs), the US seems to have a different definition then.
I think they could do that here too, but here's some actual text from the FDA that accompanied the Deeming Regulation:

The definition of a tobacco product includes components and parts, and these products are subject to the automatic provisions of the FD&C Act, including premarket authorization requirements. However, at this time, FDA intends to limit enforcement of the premarket authorization provisions to finished tobacco products. In this context, a finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the market without authorization. In contrast, an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend to enforce the premarket authorization requirements against such e-liquids or other components and parts of newly deemed products that are sold or distributed solely for further manufacturing without a marketing order.
Source here.

I think they would have to publish a revision to this statement before they could go after the type of products that Evolv sells, and even then, they could only do so for the domestic market, since they have no authority at all over products that will be exported.
 

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,232
SE PA
They're saying "at this time" so they're already aware of it and thinking about it. Afaik they paid Evolv $277.7k to build an ecig test rig so maybe they got a special relationship ;)
Yeah. I have a lot of respect for Evolv because they have been the on the leading edge of innovation in this industry since they introduced the Darwin in 2010. But I see this as dancing with the devil.
 

Eskie

ECF Guru
ECF Veteran
Verified Member
May 6, 2016
16,087
77,744
NY
Washington was built on a swamp for a reason…so that those who would endeavor there would not presume to set up shop there.

Good luck. :)

Yeah, if they had known air conditioning would be invented one day they would have chosen something way more inhospitable.
 

OldBatty

Super Member
ECF Veteran
Verified Member
Nov 28, 2014
561
1,400
North Georgia USA
(snips)
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.

Interesting, why has no one used that to try and stop it? Wife and I quit on 4/14/2009 and it was some months before the 'carpet glue' started in Georgia. Remember coworkers and relatives who still smoked complaining for weeks until they got used to the taste.
 

ScottP

Vaping Master
ECF Veteran
Verified Member
Apr 9, 2013
6,393
18,809
Houston, TX
The definition of a tobacco product includes components and parts, and these products are subject to the automatic provisions of the FD&C Act, including premarket authorization requirements. However, at this time, FDA intends to limit enforcement of the premarket authorization provisions to finished tobacco products. In this context, a finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits). For example, an e-liquid sealed in final packaging that is to be sold or distributed to a consumer for use in a finished tobacco product will be subject to enforcement if it is on the market without authorization. In contrast, an e-liquid that is sold or distributed for further manufacturing into a finished ENDS product is not itself a finished tobacco product. At this time, FDA does not intend to enforce the premarket authorization requirements against such e-liquids or other components and parts of newly deemed products that are sold or distributed solely for further manufacturing without a marketing order.
Source here.

Take a look at the part in red, that means that at least currently the raw nic base is not on the chopping block. Now with what they have announced as possible further actions it could be in the future, but not for now.
 

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,232
SE PA
Take a look at the part in red, that means that at least currently the raw nic base is not on the chopping block. Now with what they have announced as possible further actions it could be in the future, but not for now.
Yeah, that's been kicked around plenty. One problem is that at this time, all "manufacturers" are supposed to be registered with the FDA, and the FDA could easily and quickly require suppliers of unfinished "components and parts" to limit sales to registered manufacturers only.
 

zoiDman

My -0^10 = Nothing at All*
Supporting Member
ECF Veteran
Apr 16, 2010
41,619
1
84,742
So-Cal
Yeah, that's been kicked around plenty. One problem is that at this time, all "manufacturers" are supposed to be registered with the FDA, and the FDA could easily and quickly require suppliers of unfinished "components and parts" to limit sales to registered manufacturers only.

Another problem is that the Referenced Document was published on 5-10-2016.

So what was "not at this time" on 5-10-2016 might Not be the same as what is happening on 3-22-2018.
 

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,232
SE PA
Another problem is that the Referenced Document was published on 5-10-2016.

So what was "not at this time" on 5-10-2016 might Not be the same as what is happening on 3-22-2018.
I think they would have to give public notice that their policy has changed. But as I said, I think that could happen rather quickly.
 

zoiDman

My -0^10 = Nothing at All*
Supporting Member
ECF Veteran
Apr 16, 2010
41,619
1
84,742
So-Cal
I think they would have to give public notice that their policy has changed. But as I said, I think that could happen rather quickly.

I really don't Know what type of Advanced Warnings they may choose to give?

I know that much of the "not at this time" wordage was in lieu of the Guaranteed Lawsuits which would come. But the FDA came out of that round pretty much Unscathed.
 
  • Useful
Reactions: stols001

ScottP

Vaping Master
ECF Veteran
Verified Member
Apr 9, 2013
6,393
18,809
Houston, TX
I really don't Know what type of Advanced Warnings they may choose to give?

I know that much of the "not at this time" wordage was in lieu of the Guaranteed Lawsuits which would come. But the FDA came out of that round pretty much Unscathed.

I don't know if there is a required minimum time, but I doubt they are going to change the rules and start immediate enforcement of the new rules without giving manufacturers and retailers some time to make necessary adjustments.
 

Rossum

Eleutheromaniac
Supporting Member
ECF Veteran
Verified Member
Dec 14, 2013
16,081
105,232
SE PA
I really don't Know what type of Advanced Warnings they may choose to give?
I don't know either, but I think without some public notice of a change in policy, sanctions against a supplier would not hold up in court. I.e. they couldn't just come along and fine Evolv for selling boards to hobbyist end-users, or fine a nic-base vendor for supplying DIYers, without first publishing something in the Federal Register that says, "Unfinished products may only be sold to registered manufacturers".
 

zoiDman

My -0^10 = Nothing at All*
Supporting Member
ECF Veteran
Apr 16, 2010
41,619
1
84,742
So-Cal
I don't know if there is a required minimum time, but I doubt they are going to change the rules and start immediate enforcement of the new rules without giving manufacturers and retailers some time to make necessary adjustments.

The thing is the FDA isn't Changing any Rules. They have just chosen to Not enforce existing Rules that are already in place.

So I have No Clue what Advanced Notice the FDA may or may not extend to Manufactures or Retailers?
 

zoiDman

My -0^10 = Nothing at All*
Supporting Member
ECF Veteran
Apr 16, 2010
41,619
1
84,742
So-Cal
I don't know either, but I think without some public notice of a change in policy, sanctions against a supplier would not hold up in court. I.e. they couldn't just come along and fine Evolv for selling boards to hobbyist end-users, or fine a nic-base vendor for supplying DIYers, without first publishing something in the Federal Register that says, "Unfinished products may only be sold to registered manufacturers".

Like I said, I just Don't Know.

This is part of the Problem when someone like the FDA publishes a Rule Set. But doesn't choose to Enforce some Parts or Individual Rules.

The Deeming Rule Set was Convoluted enough. This Selective enforcement only adds to the Confusion.

But like I said, I understand why they Needed to do it. Because many things might have Changed if things had gone Differently with the Nicopure et al Lawsuit.
 

stols001

Moved On
ECF Veteran
May 30, 2017
29,338
108,119
Yes, this is one of the unfortunate parts of changing administrations. So many things remain unfinished, yet not "turned off" as it were. It kind of allows the "new" set of administrators to exploit what they find "useful" from the old regulations, while giving them time to find their feet, say they want vaping to continue (I remain firmly sure that first announcement was made by Gottleib so he could sell of his share in a vape shop without losing money but I'm jaded) and then enforce, whatever and whenever they want, while getting rid of what they don't want and stating, "That was not in OUR agenda."

The way things are now things could happen quite fast, or at a reasonable pace, but I have no idea which.

I highly doubt the FDA is going to care whether vape shop owners have to take a HUGE loss on their inventory, because they can't sell it. I really really highly doubt that a great deal. Compared to tax revenues and sin taxes, do you really think the government cares ONE WHIT about private businesses? It has been my opinion that they really do not, and have not, in quite some time. Etc.

Anna
 
Status
Not open for further replies.

Users who are viewing this thread