FDA Economic Impact Analysis

[Kent C]

Let's go back to this point by Azim:



I can find precious few clues about what standards - if any - the FDA uses to evaluate SE, besides that list which is already in the statute. Pages like this: Substantial Equivalence and this:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm271242.htm provide essentially no information.

However SE is a widely-used term in the food and therapeutic arenas: substantial equivalence site:wikipedia.org - Google Search

So this suggestion (and whatever comments you might suggest that we make, Kent) raises some interesting Qs:

1) Does the FDA have the authority to do something like this? We all know that it's an easy out for them to claim that they don't. It would be very helpful to discover how this process works in the context of both food and medical products, as well as in the tobacco area.

2) If the FDA were to do such a thing, could anyone complain about it? For ex., could a manufacturer of (say) combustible or even non-combustible OTPs argue that the FDA was either exceeding their authority, or perhaps sue them on other grounds based on different treatment of variegated classes of tobacco products? After all, they're all regulated under the same statutes.

3) On the other side, could the FDA be forced to promulgate such rules? (The chances of this may be remote. It's hard to force an agency to engage in rulemaking, methinks.) And if so, who would have legal standing?

BTW #2 and #3 are related to #1. For ex., if the FDA could argue that other tobacco products might be inappropriately treated by providing a "special status" to vaping that congress may not have intended, then presumably they lack the authority to do so (so some answers to #2 lead to #1). And if in fact no one can force them to engage in thsi kind of rulemaking, this may also mean that they shouldn't do so under some aspect of the APA (administrative proc. act).

These are deep and complex questions, as far as I can tell right now.

Good questions and yes, complex as well.

My view:

1. I don't know if the FDA would be able to change that on their own. The fact that our earlier view of using a different standard date from the impact doc (OP linked), upon further reflection, that had already been concluded and ended in the Feb '07 date, makes me think that they either couldn't or simply wouldn't entertain such a "threshold specs" predicate.

So... what does the FDA want to avoid. It seems, and they have said in the deeming doc, that they expect a mass exit from the industry by small vendors and you have to think that they would know that would also be a loss of jobs - d'uh. And that doesn't seem to matter.

What they might not want, are lawsuits. Zeller obviously didn't like the Sottera decision, even though he had a good understanding according to law, why the court had to come to that decision. Harkin on the other hand didn't seem to have a good grasp of that.

What I intend is to point to the fact that given the current grandfather date - the fallout of public opinion and from vendors, some of which may more likely put their money together to sue the FDA rather than spend it on attempts to file applications that from the history of the FDA on accepting isn't in their favor.

So.... .... to avoid certain challenges in court or in Congress, that they, if they have the power or could request from congress, look at, and use the alternative as Azim has suggested.

2. Again, don't know, and I would guess there might be some complaints along those lines but they have similar 'exceptions', esp. the premium cigars and others, that I seem to have quickly bypassed by in looking for ecig data. It is almost a cliché that certain products, under the authority of some regulations skate by without much fuss. Usually a tacit agreement of congress people to scratch backs on various legislation and I'm certain they keep books on who did what.

3.Again, as far as the FDA goes, force can either come from the courts or congress. Enough pressure put on congress could have an effect, but they deal with so many more 'important' issues, it is unlikely they could see an electoral defeat from their views on ecigs - although IF it could be on the scale of say the NRA or NEA - even a 25% of constituents would definitely have an effect - but part of that is letting them know that it isn't just the user that's affected. The family, extended family (thanksgiving, easter, xmas) is also affected as well as friends and the workplace.

But... this courts are the ones that can provide the most incentive, imo.

 

[Fitzie]

Something I hadn't considered re: economic impact/grandfather date, is that under the proposed regs the same requirements will also apply to cigars and pipe tobacco (this is discussed in an April 2012 article in Smoke Shop, Official Publication of the International Premium Cigar & Pipe Retailers Association (IPCPR)). It looks like BT has been worried about the grandfather date issue for at least 2 years.

Troutman Sanders Tobacco Practice Publishes Article in Smokeshop Magazine — Troutman Sanders Tobacco Team

Clearly, even though the cigar and pipe tobacco industries had plenty of products available pre-2007, they'll still face problems under substantial equivalency.

Has the FDA ever modified a grandfather date? Apparently, yes. I found a reference to this in a powerpoint presentation "FDA e-cigarette regulation: an opportunity to encourage harm reduction, by Dr. Neil L. Wilcox, Senior VP and Chief Compliance Officer, Lorillard Tobacco Company, present at the FDLAI Conference, Washington DC, October 28, 2012):

"Modifying grandfather date is supported by numerous FDA precedents:
-CTP amended grandfather date for use of non-tobacco brand name required by 1996 rule
-CTP exercised enforcement discretion: e.g. deadline for submitting HPHC testing and warning rotation plans for smokeless tobacco products
-Numerous examples for drugs and devices"

http://www.fdli.org/docs/default-document-library/wilcox.pdf?sfvrsn=0

 

[Kent C]

Hey Fitzie, how did you find those remarks by Sen. Burr in committee? I (well, Roger too) was wondering if Rand Paul had made any and thought I'd check your source. You're good!

 

[Roger_Lafayette]

Hey Fitzie, how did you find those remarks by Sen. Burr in committee? I (well, Roger too) was wondering if Rand Paul had made any and thought I'd check your source. You're good!

Can a sen. add comments to the record of a hearing even if they didn't attend? I have no clue. I know they can do all sorts of things with the congressional record in general.

Fitze ... thanks for the Lorillard slides. I think those grandparenting date ex.s are off the mark, though. (Not yours, theirs.) By that I mean that they're not statutory, looks like the FDA just tweaked its own rules?

The point about enforcement is certainly correct. They can refrain from enforcing anything they'd like, whenever they'd like. That's the perogative of the executive branch. Subject - probably - to certain constitutional objections about differential enforcement policies, congressional oversight and the like.

 

[Fitzie]

Hey Fitzie, how did you find those remarks by Sen. Burr in committee? I (well, Roger too) was wondering if Rand Paul had made any and thought I'd check your source. You're good! [/QUO

Which remarks? From the Congressional Record for the FSPTCA?

 

[Kent C]

Hey Fitzie, how did you find those remarks by Sen. Burr in committee? I (well, Roger too) was wondering if Rand Paul had made any and thought I'd check your source. You're good!

Which remarks? From the Congressional Record for the FSPTCA?

Congressional Record

 

[aikanae1]

I'm luving the direction this is going in. I think altering the grandfather date for ecigs would be managable and fair.

I spent time revisiting some old blogs for some opinions too.

In order to introduce a new electronic cigarette product to the market, the manufacturer will have to demonstrate that the product is beneficial to the public's health. This does not simply mean that one must demonstrate that the product is safer than cigarettes. The applicant also needs to show that the introduction of the product into the market will not deter smokers from quitting or encourage youth to start using the product.

http://tobaccoanalysis.blogspot.com/2014/04/fda-gives-huge-gift-to-combustible.html

Which is hard to do without having a product on the market.

If a product submits an application for a new product approval or substantial equivalence determination within the allotted 24-month period, it will not be taken off the market while the review of the application is pending.

http://tobaccoanalysis.blogspot.com/2014/04/fdas-proposed-electronic-cigarette.html

During the hearing I heard a question asking about the backlog and Zeller replied that applications were going to be reviewed as they came in - I understood "immediately". Essentially an application could be denied and the product could be removed before the 2 year window lapsed. Procedural details always makes me nervous and there's some big ones left vacant.

IMO we are dealing with 2 different products. One is mass-produced, sold anywhere with no additional instructions required. They come with pre-filled cartridges that are not adjustable by the user.

The devices we are used to use a lot of handicrafted portions (eliquids) and often require detailed instruction and support (coil building, dripping, etc). With the exception of maybe the ego and ce4 kit (and even those require eliquids) most of the ones we are concerned with are rarely sold as a kit or in a blister pack from any retailer. They are specialized with thousands of choices ... very much like premium cigars. I could adjust to over 18 yr old only vape shops. These are the ones with artisian handcrafted wood box mods and pipes, custom drip tips, ornate tanks which might be hand blown, unique finishes, etc. Even a Siegeli mechanical is not produced on the same level or volume that a Blu is. Customers could still walk in and get theri favorite dragon's blood eliquid or custom 1 flavor shot of banana and 1 flavor shot coconut eliquid.

I think there has been a number of companies that show adults prefer more complex flavors than kids or teens. Gummi Bear is a complex flavor, so is carmel, coffee and coconut per Jelly Belly.

What I think might be the issue is that we are dealing with a couple of agencies under extreme pressure from 1) competing business interests and 2) a narrow philosphy that there is only ONE "right way" to quit smoking and 3) Nicotine is a DRUG. They are in conflict with tobacco deeming independent of ecigs.

No one displayed any understanding why ecigs were not considered a medical device. I have an easier time with Harkin, but I find it inexcusable for Zeller and Mcaffee who's primary job is to understand.

I strongly object to seeing an entire industry that was developed by small and medium private business be regulated out of existance and the industry turned over to large corporations that did very, very little to help develop it. Buying a couple of "placeholder token" businesses do not count and that was at the last minute, probably during the time the FDA was writting these regulations. I don't think that would be difficult to prove at all.

I've heard estimates of up to 4,000 vape shops and most of them hire an average of 10 employees. They can also offer up to 100 juices and the economic anaylsis claims apx 1,500 products. Those figures start adding up rather quickly. The FDA and CDC can not just pretend it doesn't exist.

 

[aikanae1]

What they might not want, are lawsuits. Zeller obviously didn't like the Sottera decision, even though he had a good understanding according to law, why the court had to come to that decision. Harkin on the other hand didn't seem to have a good grasp of that.

I didn't get that Zeller understood at all. I got the impression he was just following whatever the limits that judge imposed (those he understood) and he still disagrees. Nicotine is a drug and any device delivering nicotine is medical = NRT and in treatment of an illness. I don't think he can (philosphically) believe tobacco (which it falls under) could be approved as "good for public health". Even harm reduction would fall under medical to him. That could be why they claim the individual benefit has dimished value if even a single smoker delays abstenance. (I'm guessing. Know they enemy).

 

[Fitzie]

You can find the Congressional Record here:

Legislative Search Results | Congress.gov | Library of Congress

or

http://thomas.loc.gov/cgi-bin/thomas2

Yay, I figured out how to do links I haven't read most of it, but what I read pertaining to Senator Burr was very interesting.

On the second link, you'll have to type it in yourself. Thomas times out so the link doesn't work (but I think it's easier to read).

 

[Bobbilly]

I think the two types we are dealing with are one that doesn't work and promotes dual use. Net benefit to a company that produces that is smokers/ dual users / cig a like users. And two a product not tied to a big corporation that works and hasn't reached its full potential. It's net benefit is to consumers of nicotine

 

[Kent C]

I didn't get that Zeller understood at all. I got the impression he was just following whatever the limits that judge imposed (those he understood) and he still disagrees. Nicotine is a drug and any device delivering nicotine is medical = NRT and in treatment of an illness. I don't think he can (philosphically) believe tobacco (which it falls under) could be approved as "good for public health". Even harm reduction would fall under medical to him. That could be why they claim the individual benefit has dimished value if even a single smoker delays abstenance. (I'm guessing. Know they enemy).

When I have time I'll give you the time slot on what part to which I'm referring. I thought he explained it rather well but I'll recheck.

 

[Kent C]

You can find the Congressional Record here:

Legislative Search Results | Congress.gov | Library of Congress

or

http://thomas.loc.gov/cgi-bin/thomas2

Yay, I figured out how to do links I haven't read most of it, but what I read pertaining to Senator Burr was very interesting.

On the second link, you'll have to type it in yourself. Thomas times out so the link doesn't work (but I think it's easier to read).

Thanks Fitzie!

 

[Kent C]

I think the two types we are dealing with are one that doesn't work and promotes dual use. Net benefit to a company that produces that is smokers/ dual users / cig a like users. And two a product not tied to a big corporation that works and hasn't reached its full potential. It's net benefit is to consumers of nicotine

This is an excellent point in regards to Zeller's comments and with Dr.F's? study on nicotine blood levels - the second (and third) generation ecigs are the ones that would tend to reduce 'dual use' since they get all that is needed with those ecigs.

That said, it doesn't address (and frankly, I don't think there is any good answer to) the case where an individual - if ecigs didn't work for them, would use other NRT's to end their smoking. And it is very likely in that case, that a second/third gen. ecig would likely continue their usage.

Now, we (most of us) are convinced that, that isn't such a big problem and that it would never 'lead' a person back to cigarettes and has the best chance of eliminating dual use. But it would be hard to convince them(fda) of that fact. The only thing where that would 'sit well' with them, is if there were overwhelming evidence that ecigs pose no health risks, and even then, for some in the ANTZ groups, just the sight of someone vaping tends to 'renormalize' the idea of smoking.

 

[Bobbilly]

Not sure if I read it correctly but if someone was to continue vaping but not using a combustible then I would argue there is still a net benefit.( of course short of some new evidence of vapourizers emitting 4000 chemicals along with 40 or so cancer causing agents). At this point nicotine could be treated like caffeine or alcohol.

As for normalization of smoking. If it can be believed that studies in France and the UK that the "gateway to combustibles" is a fallacy then it could be argued that seeing vapourizers could be helpful in more smokers switching. For those who just can't live with vapers on the street, they'd have to learn to live with it. I have to live with lots of things I don't like

Even so if 1000 people took up vaping instead of smoking and 1000 switched from smoking to vaping. That's still 2000 not smoking.

 

[Kent C]

Not sure if I read it correctly but if someone was to continue vaping but not using a combustible then I would argue there is still a net benefit.( of course short of some new evidence of vapourizers emitting 4000 chemicals along with 40 or so cancer causing agents). At this point nicotine could be treated like caffeine or alcohol.

As for normalization of smoking. If it can be believed that studies in France and the UK that the "gateway to combustibles" is a fallacy then it could be argued that seeing vapourizers could be helpful in more smokers switching. For those who just can't live with vapers on the street, they'd have to learn to live with it. I have to live with lots of things I don't like

Even so if 1000 people took up vaping instead of smoking and 1000 switched from smoking to vaping. That's still 2000 not smoking.

Yeah... they don't look at it that way And the US don't have the same culture as UK or EU. These guys still think they know what's best for us and renormalizing smoking - after all the time, effort and money they've spent to denormalize it, they don't look kindly even IF it reduces harm.

 

[Bobbilly]

I guess what's one more war on...

 

[Kent C]

When I have time I'll give you the time slot on what part to which I'm referring. I thought he explained it rather well but I'll recheck.

To aikanae... the passage is when Harkin asks "Does the FDA have authority to regulate drug delivery devices?" 2:09 And he explains that 'in the absence of a cessation claim'. Then Harkin says "I don't understand..." which is why I said Zeller understood better than Harking. And perhaps this was your problem - I said he 'understood it', not that he agreed with it, but according to law and the Sottera citation, he understood it.

What I found a bit comical, is that later, Harkin actually reads the 'non-cessation claim' on one of the labels IOW, the ecig company knew the law better than Harkin, who was likely (he's been around long enough) was responsible for it. lol

 

[Kent C]

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 DC2 (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.

 

[Jman8]

Currently, I plan to explore the alternative for all its worth, through Congress, bypassing FDA, hopefully influencing final rule. I would like to think I won't be the only one. Also, will be surprised if CASAA doesn't include this as a CTA at some point.

 

[Kent C]

Currently, I plan to explore the alternative for all its worth, through Congress, bypassing FDA, hopefully influencing final rule. I would like to think I won't be the only one. Also, will be surprised if CASAA doesn't include this as a CTA at some point.

I was hoping you'd see this CTA? plural of CYA?