FDA Economic Impact Analysis

[rico942]

Of course, any employer can issue an office regulation that says you can't eat or drink at your desk. If they can do that, then they can ban ecig use inside even if it's zero nic.

I work for a reasonably benign company, but with a layer of middle management that apprently has nothing better to do than to troll for "violations" of company policy. If they see a behavior that personally offends them, they cry until a new restrictive policy is adopted ...

Yesterday I got a two page email memo listing all of the electronic appliances that are now forbidden in offices and cubicles. Apparently some guy had a nearly complete kitchen in his office, with refrigerator, microwave, convection oven, and espresso machine, all running from one wall outlet, and he was popping the breakers several times a day ...

The memo says that any violators will have their appliances "confiscated", a lawsuit waiting to happen ...

Guess I'll start using my solar charger at work ...

 

[patkin]

And how Exactly does Anyone know if you are using a 0mg Nicotine e-liquid when you Blow your Clouds inside a Restaurant or an Elevator?

I'm not going to argue with you that a 0mg is a tobacco Product. Because Clearly it is Not. But how are you going to Adequately Convince a Policy Maker to make an Exclusion to a e-Cigarette Use Policy for 0mg?

This is why they're going after our setups and everything that goes into them (components) as "intended" for use with nic. It won't matter what you put in those that are left in the end. If you're seen blowing a cloud, you're using an FDA-regulated device. They're, effectively, capturing many other industries with one fell swoop... IE: dieting, herbals, etc. The companies that sell them for those purposes are not going to go through the FDA process. They'll just drop out.

 

[StormFinch]

Please excuse me as I'm trying to wrap my head around the economic impact. Please don't hesitate to correct my understanding:

A vendors single ejuice is NOT affected by the above costs IF it was created and released to the marketplace in 2007 or earlier? Call it grandfathered? ALL other ejuice released after 2007 IS subject to these HUGE fees? Coorect?

I realize I'm simplifying this subwhat but I would appreciate some guidance. Thanks

IF a liquid is substantially equivalent, which in FDA speak is pretty much identical in every way, to liquid that existed in the U.S. marketplace before Feb. 2007, then yes. The problem is that 99.9% of the juices, if not more, in the U.S. at the time were Chinese made. The base was 100% PG and only the Chinese know where the flavorings came from; think Dekang. And I'm not even sure they were selling bottles here in the U.S. at the time, or if it was only prefilled cartos. Someone that predates me can correct me if I'm wrong, but I also believe VG didn't start making an appearance in e-liquid until late 2010.

 

[SeniorBoy]

IF a liquid is substantially equivalent, which in FDA speak is pretty much identical in every way, to liquid that existed in the U.S. marketplace before Feb. 2007, then yes. The problem is that 99.9% of the juices, if not more, in the U.S. at the time were Chinese made. The base was 100% PG and only the Chinese know where the flavorings came from; think Dekang. And I'm not even sure they were selling bottles here in the U.S. at the time, or if it was only prefilled cartos. Someone that predates me can correct me if I'm wrong, but I also believe VG didn't start making an appearance in e-liquid until late 2010.

Thank you! I've had an upset stomach all day learning about this issue. Actually, in the pdf are the fda's own words on this "equivalence" issue:

page 34
For newer categories of products that were not well established before 2007, such as electronic cigarettes or other novel tobacco products, we assume that all products currently on the market would be considered new.

page 35
3 All electronic cigarettes currently marketed are expected to be considered new products. The number remaining on the market under the proposed rule is uncertain, as discussed below.

EDIT: new juice products costs from page 36 : 335k plus extras and time per a given juice formula. (I simplified this somewhat in the interest of clarity so please forgive me) Who among us can offered 335k for a given juice approval?

 

[aikanae1]

Asked elsewhere.

 

[Kent C]

IF a liquid is substantially equivalent, which in FDA speak is pretty much identical in every way, to liquid that existed in the U.S. marketplace before Feb. 2007, then yes.

I don't think so. See:

http://www.e-cigarette-forum.com/fo...economic-impact-analysis-14.html#post13031037


For something to be 'substantially equivalent', it has to be equivalent to something - a 'predicate tobacco product' that was already registered with the FDA prior to Feb 11, 2007. No eliquid has ever been registered, to my knowledge.


edit: perhaps not....see post 159

 

[aikanae1]

Already registered?

There has to be a beginning at some point. How many cigars, pipes, RYO products were already registered because those are new under deeming as well. There are figures listed for SE products in those categories.

I must not be understanding something.

One of the things I'm noting is that these regulations are disproportional when applied to electronic cigarettes in many, many ways. I wonder if the FDA is allowed to make regulations so discriminatory against a single sector of the market.

 

[Katya]

I don't think so. See:

http://www.e-cigarette-forum.com/fo...economic-impact-analysis-14.html#post13031037


For something to be 'substantially equivalent', it has to be equivalent to something - a 'predicate tobacco product' that was already registered with the FDA prior to Feb 11, 2007. No eliquid has ever been registered, to my knowledge.

Catch 22 anyone?

 

[Kent C]

Already registered? There has to be a beginning at some point. How many cigars, pipes, RYO products were already registered because those are new under deeming as well. There are figures listed for SE products in those categories.

One of the things I'm noting is that these regulations are disproportional when applied to electronic cigarettes in many, many ways. I wonder if the FDA is allowed to make regulations so discriminatory against a single sector of the market.

I've quoted the part on SE and "valid predicate products" - one has a 'cigar and pipe tobacco' part to it before it gets into electronic cigarettes and actually uses that as a comparison, where some cigars will have predicates whereas "by contrast" ecigs will likely not.......

Here:

"ii. Premarket Tobacco Applications
Among traditional product categories such as cigars and pipe tobacco, the proportion of proposed deemed products that would not be found substantially equivalent to a valid predicate product is uncertain. Therefore, the number of new products requiring premarket tobacco applications within those categories would also be uncertain, though our best forecast is that it would be small. (As of November 2012, no premarket tobacco applications had been submitted to FDA for currently-regulated products.) By contrast, it is uncertain whether there exists a valid predicate for the electronic cigarette products currently on the market. Because all electronic cigarettes are expected to qualify as new products, if no such predicates exist or if they are hard to identify, then all or most electronic cigarettes would require premarket applications in order to remain on the market."

 

[Katya]

I give up...

 

[Kent C]

Catch 22 anyone?

That's exactly, precisely, literally right, Katya. The FDA, by making the deeming rule, is actually saying that ecigs are substantially equivalent to cigarettes. Otherwise, why make the rule? But one couldn't use cigarettes as a 'valid predicate product' to prove substantial equivalency of ecigarettes!

Catcha 22

 

[Kent C]

I give up...

And that .....is the desired, intended result

see below

 

[aikanae1]

But can they make a sector of the market illegal?

Under the Tobacco Control Act, FDA can not issue a regulation “banning all cigarettes, all smokeless tobacco products, all little cigars, all cigars other than little cigars, all pipe tobacco, or all roll-your-own tobacco products.”

This is a ban based on what you're saying.

BT cigalikes are prepared to get approval for market, how do you suppose they will do it?

 

[Kent C]

But can they make a sector of the market illegal?


This is a ban based on what you're saying.

Another weasel wording - not banning!! Just not accepted as a substantially equivalent product.

 

[pamdis]

But can they make a sector of the market illegal?


This is a ban based on what you're saying.

BT cigalikes are prepared to get approval for market, how do you suppose they will do it?

There are two ways : Substantial Equivalence and New Product. E-cigs will all have to go the New Product route.

 

[Katya]

And that .....is the desired, intended result

No, no... I give up on trying to understand. I'm going to wait for the lawyers to figure it all out--because they speak the language.

I'm going to wait for CASAA and Bill G and SJ and others to issue a call to action.

 

[Kent C]

No, no... I give up on trying to understand. I'm going to wait for the lawyers to figure it all out--because they speak the language.

I'm going to wait for CASAA and Bill G and SJ and others to issue a call to action.

stooped limit

 

[StormFinch]

I don't think so. See:

http://www.e-cigarette-forum.com/fo...economic-impact-analysis-14.html#post13031037


For something to be 'substantially equivalent', it has to be equivalent to something - a 'predicate tobacco product' that was already registered with the FDA prior to Feb 11, 2007. No eliquid has ever been registered, to my knowledge.

The problem is though Kent, no tobacco product was registered with the FDA prior to Feb. 15 2007. Congress didn't even officially pass the FSPTC Act until 2009, which is what legally gave the FDA control over tobacco products. Here's the pertinent FDA word on the matter:

A tobacco product manufacturer must show that a new tobacco product is “substantially
equivalent, within the meaning of section 910, to a tobacco product commercially
marketed (other than for test marketing) in the United States as of February 15, 2007, or
to a tobacco product that the Secretary has previously determined, pursuant to subsection
(a)(3) of section 910, is substantially equivalent and that is in compliance with the
requirements of this Act.” (Section 905(j)(1)(A)(i) of the Act.) The comparison product
chosen by the tobacco product manufacturer is referred to by FDA as the predicate
tobacco product.

For the purposes of this guidance document, FDA refers to predicate tobacco products
that were commercially marketed (other than for test marketing) in the United States as of
February 15, 2007 as “grandfathered tobacco products.”

- http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

So technically, a DSE-801/901 (pen style) or RN-4072/4081 battery would be considered a grandfathered, or predicate, product and if the technology hasn't changed too much between those and the current cigalikes (what we used to know as minis) then substantial equivalence could be claimed... if the FDA ever bothers to review the application of course.

 

[Kent C]

The problem is though Kent, no tobacco product was registered with the FDA prior to Feb. 15 2007. Congress didn't even officially pass the FSPTC Act until 2009, which is what legally gave the FDA control over tobacco products. Here's the pertinent FDA word on the matter:

- http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM239021.pdf

So technically, a DSE-801/901 (pen style) or RN-4072/4081 battery would be considered a grandfathered, or predicate, product and if the technology hasn't changed too much between those and the current cigalikes (what we used to know as minis) then substantial equivalence could be claimed... if the FDA ever bothers to review the application of course.

Ok thanks....I originally thought that was the case but I saw something that changed my mind. Plus I thought the FDA has had control of cigarettes way before 2007?? Perhaps not in this capacity though....

 

[StormFinch]

Ok thanks....I originally thought that was the case but I saw something that changed my mind. Plus I thought the FDA has had control of cigarettes way before 2007?? Perhaps not in this capacity though....

Actually, they tried to claim authority over cigarettes in 1996 but the tobacco companies sued. Sounding familiar? In 2000 the Supreme Court ruled in FDA v. Brown & Williamson Tobacco Corp. that Congress had not given the FDA explicit authority over tobacco or tobacco advertising, and it took the Hill until 2009 to change that.