FDA Economic Impact Analysis

[Bobbilly]

Even if they changed the grandfather date. How many vapourizers are approved by the FDA as of the date of the culling. I mean deeming?

 

[Kent C]

Even if they changed the grandfather date. How many vapourizers are approved by the FDA as of the date of the culling. I mean deeming?

Per the doc:

4.Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation [Regulatory Alternative 3]

"This alternative would change the grandfather date for determining which products are new from February 15, 2007, to the date this rule is finalized. Therefore, new product submissions would not be required for products introduced between February 15, 2007, and the date of a final rule."

 

[Jman8]

Even if they changed the grandfather date. How many vapourizers are approved by the FDA as of the date of the culling. I mean deeming?

As post #263 notes, but doesn't say, all of them would be 'approved.'

 

[Kent C]

As post #263 notes, but doesn't say, all of them would be 'approved.'

lol. Thanks. And any products developed until the final rule.

 

[2coils]

As post #263 notes, but doesn't say, all of them would be 'approved.'

If the FDA wanted to be "reasonable", this is the very least that could be done.

 

[Bobbilly]

Sorry but from what I have seen. Unless something is explicitly stated inference is a bad thing. I read that as products between 07 and the final rule wouldn't have to have premarket authority as other new products. The ones on the market could apply as a SE with any approved ones prior to the final rule

Not to mention I believe Zeller didnt think they even had the authority for that option as 2007 is in the act. I think it's a faint hope clause. The whole deeming was to have less opposition to it

 

[Jman8]

Sorry but from what I have seen.

Apology accepted.

Unless something is explicitly stated inference is a bad thing.

Thus, all those ECFers who infer that eCigs would be regulated out of existence are engaged in a bad thing, yes?

I read that as products between 07 and the final rule wouldn't have to have premarket authority as other new products. The ones on the market could apply as a SE with any approved ones prior to the final rule

The ones on the market after the final rule would have to seek SE, under the alternative. With grandfathering, the alternative automatically includes them as 'on the market' already, and approved. Otherwise, by what you are saying, traditional tobacco would need to seek approval by way of this updated proposal.

Not to mention I believe Zeller didnt think they even had the authority for that option as 2007 is in the act. I think it's a faint hope clause. The whole deeming was to have less opposition to it

FDA doesn't have this authority to change the statute.

But Congress does.

 

[Bobbilly]

Apology accepted.



Thus, all those ECFers who infer that eCigs would be regulated out of existence are engaged in a bad thing, yes?



The ones on the market after the final rule would have to seek SE, under the alternative. With grandfathering, the alternative automatically includes them as 'on the market' already, and approved. Otherwise, by what you are saying, traditional tobacco would need to seek approval by way of this updated proposal.



FDA doesn't have this authority to change the statute.

But Congress does.

I agree that e cigs won't be removed under this proposal. If you want tobacco/ menthol flavored cig a likes controlled by the tobacco industry. You'll be able to pick up a pack of smokes while you are getting your e cig likely at the same price.

If congress can change the 2007 date then they could also exempt nicotine vaporizers from the mislabeling of being an extract of tobacco mislabeling

 

[Jman8]

If congress can change the 2007 date then they could also exempt nicotine vaporizers from the mislabeling of being an extract of tobacco mislabeling

Congress can change the 2007 date, and would have incentive to do so, per the EIA.

The other part is the type of thing that litigation may be best to deal with as it remains to be seen if all products not containing nicotine will be regulated under this rule. That would be one of those inference thingies that many wish to speculate on as 'stated in the proposal' even while it is not explicitly stated.

 

[Kent C]

Sorry but from what I have seen. Unless something is explicitly stated inference is a bad thing. I read that as products between 07 and the final rule wouldn't have to have premarket authority as other new products. The ones on the market could apply as a SE with any approved ones prior to the final rule

Not to mention I believe Zeller didnt think they even had the authority for that option as 2007 is in the act. I think it's a faint hope clause. The whole deeming was to have less opposition to it

But that was my point, it is explicitly stated that the options are still open. Zeller: "And we are in a rule making period now and we need to wait for all the comments to come in and we will then consider our regulatory options in large part informed by the information..."

 

[Bobbilly]

I deal with a lot of option analysis and know quite well that the best option is easily trumpeted by the one the bosses want. Never propose an alternative one that everyone will focus on. Zeller even said they had to put out a initial deeming that would protect them from the BT money

 

[Fitzie]

After relistening to the other part, I also got this. It reopens the question of the grandfather date... still don't have the transcripts.


This is the point when first listening to the hearing, where I thought the 'regulatory options' were still open where those alternative grandfather dates were still in play. I had mentioned in a post to DC (see post 190) .... that I thought some wording by Zeller seemed to suggest this, and this is that passage around 1:53 on the video. Although they are talking about premium cigars, the options listed in the impact doc, are the same for cigars and ecigs, because in the evaluation, they say how this would affect cigars and how this will affect ecigs on each option.

Zelller:
"We've proposed regulatory options on cigars, and one of the options is to exempt premium cigars. Another one is to include them. And we are in a rule making period now and we need to wait for all the comments to come in and we will then consider our regulatory options in large part informed by the information (he gets interrupted) that comes in (assuming 'from those comments').

The underlines show that the alternative deemings are still in play. If it were only the current deeming, then there wouldn't be two alternatives given as a choice.

And the operative alternative is this one - Regulatory Alternative 3:

"This alternative would change the grandfather date for determining which products are new from February 15, 2007, to the date this rule is finalized. Therefore, new product submissions would not be required for products introduced between February 15, 2007, and the date of a final rule."

Now, I think my original ideas on this were correct according to what he says here. I'd like Bill G, CASAA, lawyers to take a look at the wording and explain whether he is talking about the options stated in the impact doc.

Again (cut and paste from post #170)

This is from:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

'C. Additional Flexibility' section starts on pg 67.

'4.Change New Product “Grandfather Date” to the Date of Issuance of a Final Deeming Regulation [Regulatory Alternative 3]' is pg 69

"The table shows the reduced burden for cigar manufacturers but this alternative would provide even greater relief for small businesses producing electronic cigarettes.

This is all under Section III. The introduction:

III. Small Entity Effects

FDA has examined the economic implications of this proposed rule for small entities as required by the Regulatory Flexibility Act. If a proposed rule would have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities.

------

I have to assume that most think (as I have a few times) that this ship has sailed once the deeming doc was published, but as you all know, since this hearing was after the deeming and by Zeller's own words, that ship is still at the dock. I think it's crucial, because if that's the case, almost all comments should be directed at accepting the "Regulatory Alternative 3" for deeming.

I think I tried to "argue" earlier that the ship was still in the dock, but eventually conceded. Frankly, I don't know how the Regulatory Flexibility Act impacts on proposed federal regs. I would hope that FDA listed the alternatives because they truly have to be considered (during the commenting phase) and addressed before the regs are finalized. I believe "the alternative" is one of the key areas to highlight when we submit our comments, but I'm also sure CASAA will address this when they provide further direction to us.

In that vein, I think it's helpful to understand the Regulatory Flexibility Act better, rather than trying to understand it's impact in a vacuum:

Office of Advocacy - Regulatory Flexibility Act - RFA in a Nutshell: A Condensed Guide to the Regulatory Flexibility Act | SBA.gov

Regarding the alternatives, it also seems there is more than one ship sailing. Though it looks like premium cigars may be sailing on a luxury liner compared to e-cigarettes' dinghy.

What proposed FDA regulations mean for e-cigarettes and cigars

Press Release: Cigar Rights of America Issues Response to FDA's Deeming Regulations | halfwheel

 

[Roger_Lafayette]

But that was my point, it is explicitly stated that the options are still open. Zeller: "And we are in a rule making period now and we need to wait for all the comments to come in and we will then consider our regulatory options in large part informed by the information..."

I think Bobbilly is correct when he says that the FDA doesn't believe that they have the authority to change the '07 date. I doubt they do as well.

However, I agree w/ you Kent, on the comments idea.

Since they say that they're willing to consider the option, it certainly can't hurt to have some comments that address this possibility, and explain why the FDA should do so in a particular way.

The most obvious way that I can think of is simply to point out that the FDA is not forced to exercise its enforcement authority.

Therefore the FDA can simply decline to act against any product that lacks premarket approval, provided it was introduced prior to the date of the rule finalization, and write this policy into the proposed final rule. Furthermore the FDA can and should consider subsequent SE applications for products introduced after the date of the final rule based on a reference to any such product (i.e. a product introduced before the rule became final) as a predicate.

(The second part of this is much trickier, because it involves more than a mere adjustment to the scope of their enforcement behavior. But it could also be massaged a bit, and ask the FDA to treat premaket applications for products introduced after the date of the final rule which reference products introduced before the final rule's date as if they were applications under the SE rubric.)

Unfortunately I do not think that there's much of a basis for building a case in the media, in congress, or in the courts if the FDA simply says "Sorry, we don't have the authority." Because what we're really asking them to do is to basically manipulate their enforcement and review authority in a way that effectively completely rewrites the statute.

I just think it's an extremely long shot which might as well be pursued, given that the FDA is proffering something like it (think: Lucy, Charlie Brown, and the football ;-)

Whether a large number of comments might be dedicated to this is a different matter. I don't think the number of comments that say the same thing is necessarily relevant in most cases, although it might be to an extension request.

 

[Kent C]

I deal with a lot of option analysis and know quite well that the best option is easily trumpeted by the one the bosses want. Never propose an alternative one that everyone will focus on so there

Again, just going by what Zeller is saying. There are options available, he's waiting on comments and that they'll consider the options in large part by that information.

I'm not inferring that he's already chosen an option. Like you said, "inference is a bad thing". I'm only going by what he explicitly said.

 

[Kent C]

I think Bobbilly is correct when he says that the FDA doesn't believe that they have the authority to change the '07 date. I doubt they do as well.

.

It's not a matter of changing a date. That date is only one option that is given in the Alternatives in the impact doc, where it says it could be that date or it could be the final date and there are a few other options as well. We thought the deeming doc rendered those options moot, but from what Zeller says after the deeming doc was released, that is not the case, as I've just stated in 259.

 

[Fitzie]

In my hazy recollection, prior to issuing a final reg, the federal agency addresses the comments and their impact on the final reg (any changes made based on the comments) in the federal register (when they publish the final reg). As I recall, that includes the number received on a given topic. I don't know the relevance of these numbers in their final analysis. What I do know, is the more relevant comments received, the more they have to address before issuing a final reg. Do more comments equal more time before a final reg is issued? It would seem so as they only have a finite number of staff to read them. Even tossing aside useless comments like "I hate the FDA, ecigs are great, etc" should take some time. I think Bill G. alluded to that somewhere regarding proposed OSHA regs that never came to fruition (seemingly due to the overwhelming number of comments received).

 

[Bobbilly]

I must have misread something about the date then apparently they can offer an option that under the act they don't have the authority to offer ? But another option outside the act can't be offered?

 

[Kent C]

Regarding the alternatives, it also seems there is more than one ship sailing. Though it looks like premium cigars may be sailing on a luxury liner compared to e-cigarettes' dinghy.

What proposed FDA regulations mean for e-cigarettes and cigars

Press Release: Cigar Rights of America Issues Response to FDA's Deeming Regulations | halfwheel

I would have, and did, agree with that ....until the hearing. The links take the deeming doc as we did, but Zeller's comments leave the other alternatives not only still open, but also, 'in large part' able to be influenced by comments.

 

[Fitzie]

I would have, and did, agree with that ....until the hearing. The links take the deeming doc as we did, but Zeller's comments leave the other alternatives not only still open, but also, 'in large part' able to be influenced by comments.

I think you misunderstood the point I was trying to make. I think the options are open for both industries. It just looks like premium cigars have more money and resources to get their alternative approved.

From one of my links relating to the premium cigar faction:

"There was, though, a telling commentary with the FDA narrative – that the message got through that premium cigars are different from other product categories. It proved the virtue of the federal legislative effort, through H.R. 792 and S. 772 pending in the 113th Congress, that now carries 154 bi-partisan members of the U.S. House of Representatives and 15 bi-partisan members of the U.S. Senate as co-sponsors. Various passages of the Deeming Regulation, validate the influence this advocacy effort had on this phase of the regulatory process.

CRA and other industry allies will not halt the legislative effort to seek a mandated exemption from the proposed regulations, and will continue efforts to work with the FDA and Administration for acceptable outcomes for America’s cigar enthusiasts.

Also, CRA is leading an international coalition to communicate the trade implications of regulation, which the Administration has acknowledged as a factor. Working with the embassies of the Latin American cigar producing nations, CRA will be communicating to stress the political and economic consequences of federal regulation on that region, as well as on those nations providing premium cigar tobacco."

 

[Kent C]

For clarification:

Impact doc:
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

deeming doc:
http://www.ofr.gov/OFRUpload/OFRData/2014-09491_PI.pdf