FDA Common misconceptions about FDA regulations ( I hope CASAA will address at some point in the next few weeks)

[Roger_Lafayette]

The hurdle you must leap over to convince a federal judge to void federal regulations makes Mt. Everest look like Mt. Oread, home of my beloved Kansas Jayhawks. (I'd post pictures of both for visual interest, but I can't quite manage to get the hang of it yet).

Welcome to ECF! We need people with legal backgrounds.

No one is seeking to "void" fregs, the issue here is how we participate in the rulemaking process, which as you know is the predicate to fregs under the APA.

I need to be careful here, because I don't want to step on CASAA's toes, but broadly speaking there are several objectives:

1) Understanding the general scope of what the FDA's proposed rule allows them to do. For ex., they have made it clear that they are not extending the "accessories" language in the FSPTCA to vaping products. So if they decided to regulate Provari tee shirts without going through another rulemaking cycle, this would be one of those rare cases in which something might theoretically be done by an entity with standing (fair enough?). And as I like to remind people, the "accessories" issue is not a joke - try buying a Marlboro gym bag.

2) Understanding what specific classes of products would be covered under the proposed rule. For example, most of us believe that any "component or part" (from the statute) which is "marketed or intended for use" (not from the statute) for use with a covered "tobacco product" (from the statute) would require a separate approval process. If you're a vaper, you know what a drip tip is, and also that they're sold separately. Does that mean that the same public health studies that might normally be required for a new tobacco cigarette are going to have to be done by the company that makes Trippy Tips - these are ornate, hand made glass drip tips that retail for $20 or more?

3) Understanding what the doctrine of Substantial Equivalence actually means in this context (this is a huge can of worms, that I won't get further into, otherwise this post would get ridiculously long).

4) Understanding what legal remedies might be available at which stages of the regulatory process, and which entities (parties) might be able to invoke them (standing, and other justiciability issues).

5) Building a record that might be of use during the post-comment stages of the process - everything from OMB review to congressional review (it's not really "review" - more like a kind of "final look" under the APA), to a potential future court challenge based on either a rejected premarket application and/or a C&D letter or product siezure.

***

There are probably other goals as well, as I said - I don't want to step on CASAA's toes.

My personal objective in starting this thread was just to clear up some of the rumors and misunderstandings about the FDA's proposed rule. As I said in the OP intriduction - everyone has a natural desire to believe that everything's okay, and this will be some kind of minor dislocation at worst. Some of us a bit more willing to override this desire. Others persist in living in some kind of fantasy world.

My own unscientific guess right now is that the vast majority of the 3M US vapers have no idea what's coming, and are assuming that their access to both e-liquid and vaping equpiment will remain essentially unfettered for many years to come as a result of the kindly and beneficent FDA intervention into the market. After all, the FDA can only make vaping better, right?

Barring the intervention of a fairy godmother or some other similar mythical chimera, these happy predictions for the future seem remote.

The only thing I can say for certain is blind optimism borne of abysmal ignorance appears to be both unstoppable and inevitable.

 

[bigdancehawk]

^^^Excellent points expressed with clarity and insight. I've had very little experience dealing with the federal rule making process. But I did once spend a night at a D.C. Holiday Inn Express.

1. Nobody is going to buy any Provari T-shirts if the products themselves are regulated into oblivion.
2. Common sense would dictate that the drip tip approval process, if any, should be perfunctory. But I have no cause for optimism on that score.
3. I don't know what current products the FDA might view as a "substantially equivalent" products. I understand that this is part of the enabling statute, but this may be the most absurd aspect of the whole scheme: to facilitate obsolete technology gaining approval over current and vastly better technology. But it seems the FDA's agenda involves freezing everything in time until they can figure out what the hell is going on. It's fairly obvious they're clueless, perhaps by design or from a lazy lack of intellectual curiosity about the very thing they propose to regulate.
4. On the matter of standing, I'm having a hard time envisioning a consumer class action that could qualify under the multi-pronged FRCP test. And I can't imagine any individual or group of named plaintiffs, standing or no standing, willing to spend that kind of money to litigate an issue with no prospect of monetary gain. So, I think it will have to be done by players in the e-cigarette industry. On timing, a temporary injunction might be feasible before the regs. are actually implemented, but I see no realistic chance for a viable action until sometime after the comment period has expired and congress has had its say.
5. A legal challenge would be made on both procedural and substantive grounds. I don't think the odds of succeeding would be good. They have a lot of practice doing the procedures correctly. Substantively, the question would probably boil down to whether the regulations are arbitrary and capricious or can't serve the intended purposes of the enabling statute. If a particular application is turned down, however arbitrarily, most purveyors won't be able to afford a court challenge. But perhaps some industry-wide coalition could help defray the cost. As it currently stands, most of the small players won't be able to afford the application process, much less mount a legal challenge.

It seems it would be a very simple matter for the FDA to say, "You can't use anything but USP grade PG, USP grade VG, USP grade nicotine with no greater concentration than X%, and FDA approved flavorings." If you put anything else in the juice, you must go through the approval process. I suppose they could also reasonably place some restrictions on the materials used to make the coils so they didn't emit dangerous levels of harmful substances when activated. But it would be absurd and pointless for them to get into the business of approving every tank, battery and mod, which are not made from substances that can enter users' lungs or escape into the surrounding air. But the regs. aren't written that way. Rather, to me they seem to reflect a much broader agenda: to gain a stranglehold on every segment of the industry and crush it like a dove whenever the mood may strike or the political winds blow in the right direction.

 

[Kent C]

3. I don't know what current products the FDA might view as a "substantially equivalent" products. I understand that this is part of the enabling statute, but this may be the most absurd aspect of the whole scheme: to facilitate obsolete technology gaining approval over current and vastly better technology. But it seems the FDA's agenda involves freezing everything in time until they can figure out what the hell is going on. It's fairly obvious they're clueless, perhaps by design or from a lazy lack of intellectual curiosity about the very thing they propose to regulate.

Imo, comments made by Zeller in the recent Senate hearing raises some questions about what regulatory alternatives could be applied. Some would only allow the obsolete technology and some would allow any products existing at the time of the final rule. See:

http://www.e-cigarette-forum.com/fo...economic-impact-analysis-26.html#post13181909

post#259.

Thoughts??

 

[bigdancehawk]

I haven't read the statute and obviously I should. If I understand you correctly, you're saying Zeller believes the FDA has the option of grandfathering in all products on the market prior to the effective date of the regulations, as well as any substantially equivalent products marketed after that date. And they can do that without an amendment to the enabling statute?

If that's the case, then my only thought is that would be a good thing. Of course, it will inhibit future advances, but at least we wouldn't be rolling the clock back to the stone age.

 

[Kent C]

I haven't read the statute and obviously I should. If I understand you correctly, you're saying Zeller believes the FDA has the option of grandfathering in all products on the market prior to the effective date of the regulations, as well as any substantially equivalent products marketed after that date. And they can do that without an amendment to the enabling statute?

If that's the case, then my only thought is that would be a good thing. Of course, it will inhibit future advances, but at least we wouldn't be rolling the clock back to the stone age.

There are two fda docs to which this refers:

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

In the deeming doc, the 'grandfather date' at Feb 15, 2007 - where any products that were marketed prior to the date, would be grandfathered (and become the 'predicate products') and any products after that date would have to show substantial equivalence to the 'predicate products'.

In the impact doc, there are a number of regulatory alternatives shown, one of which, for example, is using the final rule (after all comments, etc.) as the grandfather date, so that all products existing would be grandfathered and would be the predicate products for all new products after that date.

It was assumed that the deeming doc established only the Feb 15, 2007 date, but in the hearing when Sen. Alexander was trying to pin Zeller down wrt what cigars would make it, (even thought the same rule would affect ecigs), Zeller said he couldn't say because one option would allow them and another wouldn't, depending on what regulatory option was chosen, as if nothing is in stone at this point. And further, he wouldn't know which alternative would be, until after the comment period and the information assessed, etc. But it clearly shows that the regulatory rule has not been established.

One rule 'Regulatory Alternative 3' in the impact doc pg 69, would allow all existing products to be grandfathered in and serve as predicate products for all new products after the final rule.

You can view Zeller's comments here at @1:53 into the video:

http://www.help.senate.gov/hearings/hearing/?id=a0a14829-5056-a032-526d-3bc1bfd96586

 

[beebopnjazz]

It seems it would be a very simple matter for the FDA to say, "You can't use anything but USP grade PG, USP grade VG, USP grade nicotine with no greater concentration than X%, and FDA approved flavorings." If you put anything else in the juice, you must go through the approval process. I suppose they could also reasonably place some restrictions on the materials used to make the coils so they didn't emit dangerous levels of harmful substances when activated. But it would be absurd and pointless for them to get into the business of approving every tank, battery.

This would be the simplest. I posted something similar the other day - not that I can recall which thread that was...there are so many Require vendor registration (with a reasonable registration fee) and the above simple rules. Would cover most vendors. Organic extracts, WTA's and NET's would require something in addition, if they are permitted at all. (lab certification perhaps as to composition - the WTA's have this already)

I fear that the NET's and WTA's will blow their collective heads up though.....but if they want to consider nicotine liquids as a "tobacco" product - well then.....

 

[Roger_Lafayette]

^^^Excellent points expressed with clarity and insight. I've had very little experience dealing with the federal rule making process. But I did once spend a night at a D.C. Holiday Inn Express.

I'm just going down your numbered list w/o quoting them. I'm in blue.

1. Nobody is going to buy any Provari T-shirts if the products themselves are regulated into oblivion.

Speak for yourself. I can't afford a provari. But at least I'd buy the tee shirts ;-)

***

2. Common sense would dictate that the drip tip approval process, if any, should be perfunctory. But I have no cause for optimism on that score.

Well, think of cigarette papers. Also see the FDA's comments on pp.6-7. There is nothing in the FSPTCA that I can find which suggests to me that any particular "component or part" should be treated differently (or even that the FDA has the authority to do so). It's either a tobacco product, a constructive tobacco product (i.e. regulated like one), or it's not covered. There's no other option that I can find.

***

3. I don't know what current products the FDA might view as a "substantially equivalent" products. I understand that this is part of the enabling statute, but this may be the most absurd aspect of the whole scheme: to facilitate obsolete technology gaining approval over current and vastly better technology. But it seems the FDA's agenda involves freezing everything in time until they can figure out what the hell is going on. It's fairly obvious they're clueless, perhaps by design or from a lazy lack of intellectual curiosity about the very thing they propose to regulate.

They're not as clueless as Congress was, when it drafted the FSPTCA, and its legislative history suggests that it was passed precisely to keep the "technology" of tobacco cigarettes "obsolete." You'll find that SE is a term of art used in a lot of legislation and FDA regulation in the therapeutic (medical) area. My own somewhat uninformed opinion is that the FDA has been much more exacting in its interpretation of the phrase in the tobacco cigarettes context. Basically a SE tobacco cigarette has to be all-but-identical to a predicate.

***

4. On the matter of standing, I'm having a hard time envisioning a consumer class action that could qualify under the multi-pronged FRCP test. And I can't imagine any individual or group of named plaintiffs, standing or no standing, willing to spend that kind of money to litigate an issue with no prospect of monetary gain. So, I think it will have to be done by players in the e-cigarette industry. On timing, a temporary injunction might be feasible before the regs. are actually implemented, but I see no realistic chance for a viable action until sometime after the comment period has expired and congress has had its say.
5. A legal challenge would be made on both procedural and substantive grounds. I don't think the odds of succeeding would be good. They have a lot of practice doing the procedures correctly. Substantively, the question would probably boil down to whether the regulations are arbitrary and capricious or can't serve the intended purposes of the enabling statute. If a particular application is turned down, however arbitrarily, most purveyors won't be able to afford a court challenge. But perhaps some industry-wide coalition could help defray the cost. As it currently stands, most of the small players won't be able to afford the application process, much less mount a legal challenge.

This is basically what most informed, professionally-qualified observers are saying. And a few folks from the peanut gallery like Yours Truly as well.

***

4 (cont'd?). It seems it would be a very simple matter for the FDA to say, "You can't use anything but USP grade PG, USP grade VG, USP grade nicotine with no greater concentration than X%, and FDA approved flavorings." If you put anything else in the juice, you must go through the approval process. I suppose they could also reasonably place some restrictions on the materials used to make the coils so they didn't emit dangerous levels of harmful substances when activated. But it would be absurd and pointless for them to get into the business of approving every tank, battery and mod, which are not made from substances that can enter users' lungs or escape into the surrounding air. But the regs. aren't written that way. Rather, to me they seem to reflect a much broader agenda: to gain a stranglehold on every segment of the industry and crush it like a dove whenever the mood may strike or the political winds blow in the right direction.

Again, Congress is responsible for much of this, not the FDA. (Far be it from me to refrain from beating up on the FDA, mind you. But not everything is their fault

It's the health effects balancing test that's also concerning to many of us. This was of course designed for new tobacco cigarettes. One has to wonder how one studies the health effects of a drip tip. The fact that the FDA has provided little guidance in their PDF suggests to me that they either do not feel that they have authority to set up separate standards, and/or that they don't care to.

It's worth nothing that the FDA has always steadfastly insisted that smokeless tobacco products be treated identicially to tobacco cigarettes. Many of us believe this provides us with great insight into the future of vaping. In short, the FDA does not recognize smokeless tobacco as a MRTP (modified risk tobacco product) under the FSPTCA, and has steadfastly ignored the health evidence which would support such a conclusion.

 

[Traver]

Roger_Lafayette, I know that you and some of the other vapors have helped me understand a bit about these regulations and wish to thank you for it. I have tried reading some of these documents but haven't been able to get though a single one from beginning to end.

I'm still not saying I understand but they would have been almost complete gibberish without your help and others like you.

My personal objective in starting this thread was just to clear up some of the rumors and misunderstandings about the FDA's proposed rule. As I said in the OP intriduction - everyone has a natural desire to believe that everything's okay, and this will be some kind of minor dislocation at worst. Some of us a bit more willing to override this desire. Others persist in living in some kind of fantasy world.

 

[SeniorBoy]

Thanks for the great posts. I have a question which I hope is appropriate for this thread.

For sake of discussion, lets assume that the FDA Regs become the law of the land after Congressional approval. Just please humor me.

QUESTION: Does this permit the FDA to unilaterally either revise their authority/law to institute new and more draconian laws and or revise/amend the law with favorable changes for vapers?

 

[wv2win]

Thanks for the great posts. I have a question which I hope is appropriate for this thread.

For sake of discussion, lets assume that the FDA Regs become the law of the land after Congressional approval. Just please humor me.

QUESTION: Does this permit the FDA to unilaterally either revise their authority/law to institute new and more draconian laws and or revise/amend the law with favorable changes for vapers?

FYI: thank you for the VapeFight.com banner. I found their site very informative and valuable. If you could add below your banner a request to join and support CASAA, that would be a double plus!

 

[Stosh]

Thanks for the great posts. I have a question which I hope is appropriate for this thread.

For sake of discussion, lets assume that the FDA Regs become the law of the land after Congressional approval. Just please humor me.

QUESTION: Does this permit the FDA to unilaterally either revise their authority/law to institute new and more draconian laws and or revise/amend the law with favorable changes for vapers?

The FDA cannot rewrite laws or amend laws, that the good news. They simply write the regulations to enforce the laws on the books. the bad news. How they write the regulations could cripple the vaping industry, or they could write the regulations to promote the vaping industry.

Seeing as the FDA has in the past tried to completely ban e-cigarettes and it took a long court case and appeal to slap them down, the odds that they view vaping as the future aren't very good.

 

[Roger_Lafayette]

Thanks for the great posts. I have a question which I hope is appropriate for this thread.

For sake of discussion, lets assume that the FDA Regs become the law of the land after Congressional approval. Just please humor me.

QUESTION: Does this permit the FDA to unilaterally either revise their authority/law to institute new and more draconian laws and or revise/amend the law with favorable changes for vapers?

The FDA cannot rewrite laws or amend laws, that the good news. They simply write the regulations to enforce the laws on the books. the bad news. How they write the regulations could cripple the vaping industry, or they could write the regulations to promote the vaping industry.

Seeing as the FDA has in the past tried to completely ban e-cigarettes and it took a long court case and appeal to slap them down, the odds that they view vaping as the future aren't very good.

Right ... you raise an interesting point, both of you (Stosh & SeniorBoy) ... the distinction between agency "rules," and agency "regulations" (as in the federal register), statutues ("laws"), and agency enforcement authority can get a little murky at times. I don't claim to have the expertise to always be able to tell one from another.

Maybe someone who identifies themselves as an attorney can help me out here, or to put it another way YMMV ...

1) Broadly speaking, agencies do have to go through "rule making" under the APA (admin. proc. act) to make what I am going to loosely describe as "major" changes to the existing framework. That's why the FDA had to do what it just did. "Rule making" is governed by that 9-step process under the APA: http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

2) Once the agency has authority under the rule-making process, it can then go into the Federal Register (FReg) and publish regulations. There are ways that those can be challenged under the APA, and of course any agency action against a party can always be challenged (when I say "against," I refer to the doctrine of "standing." For example, customers probably couldn't complain if the FDA shuts down a B&M for illegally selling tobacco cigarettes to minors). The APA is not the only possiible source of challenges to regulations, of course. Conflict with other laws or the constitution is always available. For example, if the FDA published regulations in the FReg indicating that it would only approve vaping products made by Anarchist or Scientologist manufacturers, I'm sure that would be a big problem under more than the APA (probably the constitution!).

3) What's the difference between something that requires rulemaking, versus something that the agency can just do by puttting a regulation in the FReg? Ach, this is again a subtle point. But generally the regulation has to be compatible and covered broadly by the rule making. So for example, the FDA couldn't spontaneously decide to publish a rule that requires pruchasers of vaping products to be at least 21 years old, if the current proposed rule becomes final.

4) The FDA also has inherent enforcement authority under the law ("enabling statutes"). The siezure leading to Soterra was probably justified in part by the declaration that nicotine is a drug (and I'm not sure whether the FDA did that or someone else), and the FDA's inherent power under an enabling statute to declare that unathorized use of certain drugs is by definition a therapeutic product. And since therapies have to be approved, you get the result (they can sieze and destroy the stuff without any rulemaking or publication of FRegs etc.). BTW I say "probably" in reference to Soterra because I haven't read the district court opinion and haven't looked at the DC circuit opinion in a while. So I stand corrected-in-advance if there's some bug there in my description. It may also be that the FDA had to allege that Smoking Everywhere was selling vaping products as cessation. Althuogh I don't believe that the FDA did make that claim.

5) Finally - and this is critical in the vaping context - you'll notice this whole business about the 2-year window. That means they sit there and collect applications, while the products are on the market. Now their standards for reviewing these applications in the case of tobacco cigarettes are mostly in the FRegs (if at all). The tobacco acts basicaly have some general blather in it about the public health balancing act. This is where the rubber is going to meet the road, because a successful vaping manufacturer applicatn is going to have to show - at a bare minimum - that their product doesn't worsen the overall state of public health. And of course the FDA hsa to make that decision based on standards that may or may not be in the FRegs. The key point to observe here is the timing of the process. The FDA can review the application whenever it likes, and pull the product from the market if the application is rejected. That might make it look as if the FDA is acting in an erratic or unpredictable way. But it's a necessary consequence of the fact that premarket approval isn't required. Rembmer those Indian mini-cigars that got "pulled" (after they were already off the market? That's what happened there - the application was submitted a long time ago, and the FDA decided to bounce it. Meantime, the manufacturer had already decided not to sell them anymore. "Your tax dollars at work"

Anyway I don't know if any of that yammering on helped. But you did ask a rather general question, SeniorBoy. Very appropriate, but quite broad in scope

Like I say, someone who IDs themselves as an attorney could chime in here (hint, hint) and I might have missed the boat in terms of trying to get at what you were asking. YMMV in all those regards.

 

[DC2]

QUESTION: Does this permit the FDA to unilaterally either revise their authority/law to institute new and more draconian laws and or revise/amend the law with favorable changes for vapers?

Mitch Zeller said that if they did not ban flavors in the final draft of the deeming regulations, which currently proposed regulations do not do...
Then they would need to issue a separate rule-making in order to ban flavors in the future.

On the other hand, as Roger says in his post above, they can just not approve any flavors.
That would be the same as banning them without having to actually ban them.

It may also be that the FDA had to allege that Smoking Everywhere was selling vaping products as cessation. Althuogh I don't believe that the FDA did make that claim.

I am pretty sure that the FDA was trying to make the case that customer testimonials on the vendors website constituted cessation claims.
Judge Leon did not agree with that view.

 

[bigdancehawk]

Again, Congress is responsible for much of this, not the FDA. (Far be it from me to refrain from beating up on the FDA, mind you. But not everything is their fault

It's the health effects balancing test that's also concerning to many of us. This was of course designed for new tobacco cigarettes. One has to wonder how one studies the health effects of a drip tip. The fact that the FDA has provided little guidance in their PDF suggests to me that they either do not feel that they have authority to set up separate standards, and/or that they don't care to.

It's worth nothing that the FDA has always steadfastly insisted that smokeless tobacco products be treated identicially to tobacco cigarettes. Many of us believe this provides us with great insight into the future of vaping. In short, the FDA does not recognize smokeless tobacco as a MRTP (modified risk tobacco product) under the FSPTCA, and has steadfastly ignored the health evidence which would support such a conclusion.[/QUOTE]

Ha, it's worth nothing alright! It's insanity to treat e-cigarettes the same as analog cigs. How can wildly different products be treated the same, particularly when one is used primarily as a harm reduction device and the other is not? It would seem to me that the FDA should be able to exercise some discretion in this regard. Haven't they solicited suggestions for regulatory standards?

Even if they did have the authority to set objective standards, they can't even begin to do so because there's no general consensus on what actual threats to health e-cigarettes pose (if any), how any such threats should be weighed against the benefits, much less what measures can be taken to mitigate any such threats without having a big negative impact on the benefits. Without clear standards, the approval process will become arbitrary and unpredictable.

Not to fixate on drip tips, but how is the little company that makes fancy drip tips going to navigate through this regulatory morass? If I were hired to advise them I'd have to refer them to a wildly expensive D.C. firm that's been through the FDA approval process many times before. Most of those firms derive their revenues from BP and the rest would like to. The legal and other compliance costs would exceed their profits. I think most juice makers would face the same obstacles.

 

[Fitzie]

Right ... you raise an interesting point, both of you (Stosh & SeniorBoy) ... the distinction between agency "rules," and agency "regulations" (as in the federal register), statutues ("laws"), and agency enforcement authority can get a little murky at times. I don't claim to have the expertise to always be able to tell one from another.

Maybe someone who identifies themselves as an attorney can help me out here, or to put it another way YMMV ...

Like I say, someone who IDs themselves as an attorney could chime in here (hint, hint) and I might have missed the boat in terms of trying to get at what you were asking. YMMV in all those regards.

As the other identified attorney here, I did a bit of googling and found this regarding "laws vs. regulations." I think it's a pretty good explanation and doesn't require anyone to read a legal thesis:

Laws vs

By happenstance, they use the FDA is an example. It appears to have been written by someone at the University of Tennessee, Knoxville.

 

[bigdancehawk]

Maybe someone who identifies themselves as an attorney can help me out here, or to put it another way YMMV ...

Roger, you have a better handle on this stuff than most attorneys. I've practice law for a long time and in a many more different fields of law than most, but this isn't something in which the vast majority of lawyers have useful experience. It's highly specialized. All the average lawyer can do is apply his education and experience in reading and interpreting all kinds of statutes and regulations. This could be of some use in understanding what we're dealing with here, but the actual process of getting products approved by the FDA for marketing and sale, and the regulatory environment in which that process occurs, is pretty much a mystery. I don't know who we have helping the industry and/or CASAA with that level of expertise. Anybody? This is not something taught in law school.

If I were approached by an e-cigarette juice maker for advice, I would be totally clueless. I could help him with his LLC, I could defend him if somebody sued him in contract, tort or IP, I could help him deal with insurance problems, with his disgruntled business partner, I could help him set up an estate plan, but I sure as heck could not help him if the FDA came knocking on his door.

 

[bigdancehawk]

As the other identified attorney here, I did a bit of googling and found this regarding "laws vs. regulations." I think it's a pretty good explanation and doesn't require anyone to read a legal thesis:

Laws vs

By happenstance, they use the FDA is an example. It appears to have been written by someone at the University of Tennessee, Knoxville.

Regulations have the "force and effect of law." For purposes of our discussion here, there is no practical difference. Only the U.S. Congress or the federal courts can trump FDA regulations.

 

[Fitzie]

Maybe someone who identifies themselves as an attorney can help me out here, or to put it another way YMMV ...

Roger, you have a better handle on this stuff than most attorneys. I've practice law for a long time and in a many more different fields of law than most, but this isn't something in which the vast majority of lawyers have useful experience. It's highly specialized. All the average lawyer can do is apply his education and experience in reading and interpreting all kinds of statutes and regulations. This could be of some use in understanding what we're dealing with here, but the actual process of getting products approved by the FDA for marketing and sale, and the regulatory environment in which that process occurs, is pretty much a mystery. I don't know who we have helping the industry and/or CASAA with that level of expertise. Anybody? This is not something taught in law school.

If I were approached by an e-cigarette juice maker for advice, I would be totally clueless. I could help him with his LLC, I could defend him if somebody sued him in contract, tort or IP, I could help him deal with insurance problems, with his disgruntled business partner, I could help him set up an estate plan, but I sure as heck could not help him if the FDA came knocking on his door.

Agreed. I'm an expert on federal personnel law. Unless you're a federal agency, employee or union, I wouldn't feel comfortable giving "authoritative" legal advice.

 

[Fitzie]

Or Congress can amend the law itself. A prime example happening right now concerns premium cigars. See the following bills: H.R. 792 and S.772 which are now pending in Congress.

Per Cigar Rights of America: "This bi-partisan legislation would decree that premium/traditional cigars should be off limits to FDA regulation and, 'to clarify the Food & Drug Administration's jurisdiction' in the 'sale, manufacturing and distribution of traditional and premium cigars."

 

[DC2]

I don't know who we have helping the industry and/or CASAA with that level of expertise. Anybody? This is not something taught in law school.

Primarily this guy...
Keller Heckman | Professionals | Azim Chowdhury

And this guy is advising SFATA...
Venable LLP | Professionals | Ralph S. Tyler


Although CASAA has a few lawyers on their board of directors.
And another lawyer named Gregory Conley who was with CASAA but is now with the American Vaping Association.

I don't think any of them have any experience with the FDA though.
But I imagine they have consulted some such lawyers, and Azim Chowhurry would be my guess.