FDA Effect on Hookah Bars/Lounges

[Culinarytracker]

I haven't came across any references to this, but I will have to do some more searching...

These regulations include the hookah products also. I assume this would put it into the "tobacco Product" category as well.
This could also effectively eliminate the hookah bars and lounges that are popping up all over the place. Sure the products were all available before 2007, but if it falls under the new regulations wouldn't that mean they can't be used indoors in any way?

Just a thought. With the popularity of hookah on the rise, especially around college campuses, this might get a lot more people interested.

 

[Roger_Lafayette]

The proposed rule extends the FDA's authority to every tobacco product for consumer use (ingestion), including "components or parts." You're right that hookah tobacco and equipment which was in use prior to 2/15/07 would be exempted. Anything that the FDA approves as "substantially equivalent" to such products would also be exempted (an application would still be required).

FDA can't regulate indoor use. But OSHA could. They proposed a rule back in (?) '94 concerning workplace use, but got over a million comments, and it never became final. State and local gov'ts primarily ban tobacco smoking in indoor locations that are accessible to the public. Existing exceptions for certain locations ("cigar lounges") are not under the FDA's control and would not be affected by their proposed rule.

 

[TheProphet]

Most Hookah bars in Houston allow their use inside. The only thing I can see affecting the hoookah bar industry woud be if the FDA decides to start regulating allowed flavors, which I think we all hope doesn't happen.

 

[Culinarytracker]

What about new products, or the need to file SE applications?

 

[Kent C]

What about new products, or the need to file SE applications?

The current thoughts with a few exceptions, are that only large ecig companies would be able to pay the expense. Small to medium vendors not as likely.

see:

http://www.e-cigarette-forum.com/fo...-economic-impact-analysis-9.html#post13010038
post 81

Some could benefit from whatever the large ecig companies do, but probably just in selling their products or some that are almost duplicates of the ones that are passed.

 

[Culinarytracker]

Thanks for the information in the previous posts... I understand the e-cig side of all of this. I'm just trying to apply this issue to the other products mentioned in the proposed regs. I can only assume that given it's recent surge in popularity, there must be many products in the hookah world that will be similarly affected. And even products that have been on the market for quite some time could come under the same challenges regarding proof of substantial equivalence and post 2007 products.

From what I understand, there is a very good chance that even very minor details related to ingredients as well as packaging etc... could become difficult to pass through the system.

I'm just brainstorming ways to get more people interested in what is going on, and figured if there was any possible reason for concern that there might be some friends there.

 

[Roger_Lafayette]

Thanks for the information in the previous posts... I understand the e-cig side of all of this. I'm just trying to apply this issue to the other products mentioned in the proposed regs. I can only assume that given it's recent surge in popularity, there must be many products in the hookah world that will be similarly affected. And even products that have been on the market for quite some time could come under the same challenges regarding proof of substantial equivalence and post 2007 products.

From what I understand, there is a very good chance that even very minor details related to ingredients as well as packaging etc... could become difficult to pass through the system.

I'm just brainstorming ways to get more people interested in what is going on, and figured if there was any possible reason for concern that there might be some friends there. [bold added]

This is what my favorite vaping reporter Melissa Vonder Haar of CSPNet has to say. This woman really knows her stuff:

http://www.cspnet.com/category-mana...les/editorial-deeming-regs-look-promising-now

This could prove disastrous for vaping and e-liquid companies, who will have to file a separate new-product application for each flavor, nicotine amount, bottle size and propylene glycol/vegetable glycol ratio. It's an expensive and time-consuming process that, unfortunately, many of the smaller-to-midsized players may not be able to afford.

Bear in mind that the above quote applies to e-liquid, which has to be approved (probably) under the new product rubric. But SE is a very tough row to hoe as well.

That said, the hookah industry had many products on the market prior to the grandparenting cutoff date of 2/16/07. As long as these are identical products (almost certainly down to the packaging), the FDA will not be able to touch them. The same goes for your equpment.

I assume you've also read the other thread in this area called "Common Misperceptions ...". I'm kinda on the borderline here rules-wise in terms of pimping my own thread. But hopefully I'll be forgiven ;-)

 

[Culinarytracker]

Hookah flavor lines, and products are coming out all the time. They have even started with products such as hookah stones, which are porous stones that get soaked and re-dipped in what is basically e-juice, Electronic coals, and a constant flow of artisticly designed hookahs. Much like the products in the vaping community, they have been constantly evolving at a faster and faster rate. Especially if packaging sizes and details would be required to be identical to the pre-2007 products.

Also I find it unlikely that companies outside of the US will jump through the hoops necessary to remain on the market here.

I am convinced that the hookah industry would be seriously affected and there just might be a large community there to request comment period extensions and make comments. I have posted a simple thread on a couple hookah forums to see what kind of response it gets. I already received a couple quick questions from some people that seemed to be invested in the industry. They were basically "Really? We'd have to apply to the FDA every time we release a new flavor line?" So I provided links to the deeming regs, FDA pamphlet on making quality public comments, as well as Casaa and some of Dimitri's stuff.

If I'm going to continue this line of communication I would like someone who knows more than I do to confirm that their products would be subject to the same hurdles as we would be.

Like I said, I'm just trying to gather more voices.

 

[Roger_Lafayette]

You say: "If I'm going to continue this line of communication I would like someone who knows more than I do to confirm that their products would be subject to the same hurdles as we would be." ... but I'm not sure what you mean exactly.

Well, I already cited Melissa Vonder Haar, who is a very respected source. As far as your equipment goes, would CASAA do?

Try this link: CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA ... they say this:

Although the regulations do not openly ban the refillable devices that are preferred by experienced users, they impose a costly registration and approval process that would effectively eliminate them. Such registrations offer minimal benefits, but ensure that only a few large companies who mass-produce small and disposable products would be able to afford the necessary filings. Additionally, while the regulations do not immediately ban the variety of popular flavors for e-cigarette liquid, they signal an intention to do so in the future.

"Our research and others’ shows that higher-quality hardware and appealing flavors are important for smoking cessation,” says Phillips. “Many former smokers report that they were always tempted to go back to smoking while using the smaller devices with imitation tobacco flavoring, but they quit smoking for good when they found better hardware and flavors that no longer reminded them of smoking.”

Now if you want me to cite a source that specifically identifies products used in hookahs, I'm afraid I can't help you.

All I can say is that anything derived from tobacco for consumer recreational ingestion (including dermally) is a "regulated tobacco product" (no one disputes that). So anything that you're using that falls into that category is going to be treated just like e-liquid for vaping - except for the nicotine-free e-liquid, which isn't regulated. Furthermore, all of your equipment which is a "component or part" of a "regulated tobacco product" is going to come under the statute as well (see p.7 of the FDA PDF). Also listen to the discussion at approx 14:05 right here: FDA Deeming Teleconference 4 24 2014 YouTube - YouTube

But as I said, if you need an "expert" to point to a specific name brand of hookah product or a particular type and say "Yep, the FDA is going to regulate that as a [component or part] of a tobacco product" ... yeah, sorry. No expert opinion that I'm aware of on hookah stuff.

However let's keep in mind that the statute doesn't distinguish between hookahs and vaping. Or cigarettes or smokeless tobacco either. They're all "tobacco products." And the FDA's "deeming" to extend its authority as far as the statute goes, with just one acception: accessories of things that aren't tobacco cigarettes. So if one of your equipment manufacturers has a tee shirt, you can still buy and wear one (unlike tobacco cigarettes - no more Marlboro gear).

I do have additional authoritative cites regarding vaping if you'd like.

Hookah flavor lines, and products are coming out all the time. They have even started with products such as hookah stones, which are porous stones that get soaked and re-dipped in what is basically e-juice, Electronic coals, and a constant flow of artisticly designed hookahs. Much like the products in the vaping community, they have been constantly evolving at a faster and faster rate. Especially if packaging sizes and details would be required to be identical to the pre-2007 products.

Also I find it unlikely that companies outside of the US will jump through the hoops necessary to remain on the market here.

I am convinced that the hookah industry would be seriously affected and there just might be a large community there to request comment period extensions and make comments. I have posted a simple thread on a couple hookah forums to see what kind of response it gets. I already received a couple quick questions from some people that seemed to be invested in the industry. They were basically "Really? We'd have to apply to the FDA every time we release a new flavor line?" So I provided links to the deeming regs, FDA pamphlet on making quality public comments, as well as Casaa and some of Dimitri's stuff.

If I'm going to continue this line of communication I would like someone who knows more than I do to confirm that their products would be subject to the same hurdles as we would be.

Like I said, I'm just trying to gather more voices.

 

[Culinarytracker]

You say: "If I'm going to continue this line of communication I would like someone who knows more than I do to confirm that their products would be subject to the same hurdles as we would be." ... but I'm not sure what you mean exactly.

First, thanks for the informative and understandable replies.

I simply mean that I have brought it up on hookah forums, but I've spent the last week or so researching this from a vaper's viewpoint. So everything I can share with the hookah users and business owners is from that perspective. I can say "This is how it's being interpreted in the vaping community, and as far as I can tell, hookah products would be subject to the exact same regulations."
If I'm going to tell them much more than that, I would like a second opinion that I am correct in my assumption.

It seems like you might be interpreting my posts as coming from a concerned hookah smoker. I'm a vaper that is aware of some of what has gone on in the hookah world in the past several years. I just want to reach out to them if I'm correct in thinking that this could all have serious implications for hookah users and businesses. So far I've only said it doesn't look good for them, and they should look into it.

But as I said, if you need an "expert" to point to a specific name brand of hookah product or a particular type and say "Yep, the FDA is going to regulate that as a [component or part] of a tobacco product" ... yeah, sorry. No expert opinion that I'm aware of on hookah stuff.

However let's keep in mind that the statute doesn't distinguish between hookahs and vaping. Or cigarettes or smokeless tobacco either.

I'm not looking for specifics.
The proposal itself states some hookah products that would be considered regulated tobacco products. And some that would be exempt as an "accessory". However there are so many parts of the document that are posed as questions or FDA beliefs and so on. Even though I've read it and am somewhat used to reading legal speak, I know I could be missing some detail.

As I read it so far, these are the issues the hookah world could face:
-They would now be regulated as a "Tobacco Product"
-All "Tobacco Products" (even those on the market before 2007) will be required to register with the FDA.
-The "grandfatherability" of products may be hard to prove because of the amount of details required.
-Anything brought to market after 2007 (of which there are many, and new flavors come out monthly it seems) will have to deal with all the issues of a new tobacco product application process.
-Flavors may be eliminated if the FDA (or the legislature, or whoever) removes flavors for vaping, and the hookah company is unable to prove that every flavor is "grandfatherable".
-Companies outside of the US may not have the resources or the necessary drive to comply.
-The definition of "Components" is up in the air, as the FDA states what they feel it should be, but is not officially defined at this time.

If this is correct then there are plenty of reasons for Hookah users and companies to join us vapers in the effort to extend the comment period, get the "component" issue removed, and generally fight these regulations. There may even be trade publications or other media resources that could help make more people aware of what is happening.

I just don't want to be the idiot that went on the hookah forums crying wolf.

 

[Roger_Lafayette]

It seems like you might be interpreting my posts as coming from a concerned hookah smoker. I'm a vaper that is aware of some of what has gone on in the hookah world in the past several years. I just want to reach out to them if I'm correct in thinking that this could all have serious implications for hookah users and businesses. So far I've only said it doesn't look good for them, and they should look into it.

If this is correct then there are plenty of reasons for Hookah users and companies to join us vapers in the effort to extend the comment period, get the "component" issue removed, and generally fight these regulations. There may even be trade publications or other media resources that could help make more people aware of what is happening.

I just don't want to be the idiot that went on the hookah forums crying wolf.

OIC. Yes, I was confused because of your post count and also because you seemed to know a whole lot more about hookahs than most vapers. (Not that it matters, but reading your description made me think: "Hmm, I should try this before it goes away or gets severely hobbled." and then I realized that I don't do combustible tobacco anymore. Which seems to be a common stance around here.) So I deserve ten lashes with a wet noodle for my preconceived notions.

But to the extent that hookah afficiandos (is that the right term?) mind being bombed back to the pre-07 age, then yeah - it's gonna be rough, methinks. Some of us around here refer to what we anticipate for vaping as "vapapocalypse." Maybe "hookapocalpse" works too - at least as a description. But I don't want to "put words" in the hookah community's collective mouth, as it were

Bear in mind, however that the rules may never become final. You might have a look at this thread, in which Bill Godshall talks about that - see post #28: http://www.e-cigarette-forum.com/fo...se-would-give-e-cig-industry-big-tobacco.html In particular, Bill thinks that a GOP victory in the Sen this fall would greatly reduce the likelihoood of the FDA making their reg.s final. Note also that proposed reg.s rarely survive a Presidency even if the same party remains in power. I don't have a cite for that, but can find it (it seems to be common knowledge).

I presume you are also aware of the 2-year "window" right? I.e. the time period that they say that they will wait before enforcing the reg.s, after they become final. Registration still applies (see below), and the dates are in the PDF - no more than 6 mo.s I think after the rule becomes final.

Oh, and you know the steps right? Comments, then proposed final rule to OMB, and finally presented to Congress. Cong. doesn't have to vote "for" the final rule, but they can zap it (subject to a potential veto) under the Congressional Review Act, I believe. There's a pretty PDF with the steps: http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

***

I simply mean that I have brought it up on hookah forums, but I've spent the last week or so researching this from a vaper's viewpoint. So everything I can share with the hookah users and business owners is from that perspective. I can say "This is how it's being interpreted in the vaping community, and as far as I can tell, hookah products would be subject to the exact same regulations."
If I'm going to tell them much more than that, I would like a second opinion that I am correct in my assumption.

Well, I'm no expert. My thread in this forum which you've doubtless seen about "common misconceptions" merely collects others' wisdom. But there's another link that might be helpful and more credible, it's a panel discussion with the genuine experts (you may have already heard it), and for some reason I can't seem to locate it. I know a few people who might be able to (I'm pretty sure it ended up on soundcloud), so let me know if you want me to shout out. (Someone reply, please - VPLive Panel Discussion link?

***

YMMV, but here are my not-an-expert opinions on your Qs:

1) Yes, all hookah products containing tobacco or nicotine derived from tobacco would be considered "tobacco products" as well as any "component or part" of a "finished tobacco product." In the vaping world, we interpret that as referring to essential equipment and even supplies, except that there seems to be general agreement that items with many other applications (186xx batteries, O-rings etc.) will not be considered "components or parts" because that's just impractical.

2) I don't know for sure whether "grandparented" products would have to be registered. You might check the PDF. This is something that the manufacturer should be handling. I don't believe there's a registration fee, it appears fairly simple from what I can tell.

3) There are some standards for proving that a product was on the market prior to 2/15/07, I believe they are in the PDF itself. Bear in mind that the FDA is only interpreting this, see #44 here (actually you started this thread, so you must be aware of it?): http://www.e-cigarette-forum.com/forum/fda-regulations/558435-nic-base-available-pre-2007-a-2.html

4) Things brought to market after 2/15/07 may be able to fly a little bit under the radar by filing a "substantial equivalence" (SE) application. It's not even clear to me that this is a whole lot easier than a new product appl. And of course you have to show that the old ("predicate") product was also available. You may have seen the thread on this.

5) Flavors are murky. On p.7 of the PDF, the FDA refers to flavorings as "components or parts" - I think this had to do with additives to something that is itself a "tobacco product." As far as a flavored tobacco product, i.e. tobacco products with "characterizing flavorings" (see p.10 of their PDF), things are once again tricky because they only have the authority to regulate "characterizing flavorings" in a "cigarettes." Could they do that w/ e-liquid? Vapers are wondering and p.10 implies that they aren't ready to do that yet. Could they declare flavored hookah tobacco to be a "cigarette?" Your guess is as good as mine. Might require some interesting semantic gymnastics.

6) I'm clueless about this one.

7) Again, most of us vapers think that a "compoenent or part" is anything which is essential to vaping (or hookahing if that's a word), and which is not very common to other applications such as a generic type of battery (as opposed to, say, an EGO). However the materials used to make them are not - for example, VG is not a "compoenent or part" of e-liquid. How does that apply in the hookah context? Your guess will be much better than mind, but I'd say that all the "pieces" of a hookah set up which are essential are probably covered. For vaping, I'd say: drip tip, tank[O], cart[O], atty (RDA or even a coil), RTA, clearos, APVs, mech mods, all EGO batteries and other special-purpose (stnadalone) batteries. Again on p.7 there are some interesting hookah examples. The "charcoal burner" one threw us vapers for a loop, but you probably already know that it's an "accessory" because it's not absolutely required for hookahing (if that's the word).

***

Anyway that's my ... but I am not an expert, so again YMMV. Let me know if you wnat that roundtable discussion link from VPLive, and hope that helped!

P.S.: Feel free to follow up and I'll do my best to clarify ambiguities or sloppy explanations. Kudos to you for trying to get the hookah community involved. We need all the help we can get!

I'm not looking for specifics.
The proposal itself states some hookah products that would be considered regulated tobacco products. And some that would be exempt as an "accessory". However there are so many parts of the document that are posed as questions or FDA beliefs and so on. Even though I've read it and am somewhat used to reading legal speak, I know I could be missing some detail.

As I read it so far, these are the issues the hookah world could face [numbers added]:
- [1] They would now be regulated as a "Tobacco Product"
- [2] All "Tobacco Products" (even those on the market before 2007) will be required to register with the FDA.
- [3] The "grandfatherability" of products may be hard to prove because of the amount of details required.
- [4] Anything brought to market after 2007 (of which there are many, and new flavors come out monthly it seems) will have to deal with all the issues of a new tobacco product application process.
- [5] Flavors may be eliminated if the FDA (or the legislature, or whoever) removes flavors for vaping, and the hookah company is unable to prove that every flavor is "grandfatherable".
- [6] Companies outside of the US may not have the resources or the necessary drive to comply.
- [7] The definition of "Components" is up in the air, as the FDA states what they feel it should be, but is not officially defined at this time.

 

[Culinarytracker]

OIC. Yes, I was confused because of your post count and also because you seemed to know a whole lot more about hookahs than most vapers. (Not that it matters, but reading your description made me think: "Hmm, I should try this before it goes away or gets severely hobbled." and then I realized that I don't do combustible tobacco anymore. Which seems to be a common stance around here.) So I deserve ten lashes with a wet noodle for my preconceived notions.

No problem. I smoked a lot of hookah with a Lebanese friend in college. Got my own and shared it with people on and off for several years. I quit smoking and started vaping around Christmas 2013. So the last 6 months have been filled with a sort of immersion into all things vaping.

But to the extent that hookah afficiandos (is that the right term?) mind being bombed back to the pre-07 age, then yeah - it's gonna be rough, methinks.
...
4) Things brought to market after 2/15/07 may be able to fly a little bit under the radar by filing a "substantial equivalence" (SE) application. It's not even clear to me that this is a whole lot easier than a new product appl. And of course you have to show that the old ("predicate") product was also available.

I suppose since they have predicate products, minor variations in packaging and such might just get SE. Since the FDA apparently doesn't have to worry about e-cigs having a predicate to begin with. My gut tells me that they won't be so lenient though and wouldn't think twice of squashing hookah as much as they can.

I presume you are also aware of the 2-year "window" right? I.e. the time period that they say that they will wait before enforcing the reg.s, after they become final. Registration still applies (see below), and the dates are in the PDF - no more than 6 mo.s I think after the rule becomes final.

Oh, and you know the steps right? Comments, then proposed final rule to OMB, and finally presented to Congress. Cong. doesn't have to vote "for" the final rule, but they can zap it (subject to a potential veto) under the Congressional Review Act, I believe. There's a pretty PDF with the steps: http://www.reginfo.gov/public/reginfo/Regmap/regmap.pdf

Yes I am quite aware of the 2 year window. What type of registration are you referring to when you say registration still applies? Facilities?
And thanks for that PDF. I have heard of the steps, but this is nice info.

But there's another link that might be helpful and more credible, it's a panel discussion with the genuine experts (you may have already heard it), and for some reason I can't seem to locate it. I know a few people who might be able to (I'm pretty sure it ended up on soundcloud), so let me know if you want me to shout out. (Someone reply, please - VPLive Panel Discussion link?

Yep, I've heard it. Grimmgreen posted it on his page.
https://soundcloud.com/vp-live/deeming-regulations-simplified

2) I don't know for sure whether "grandparented" products would have to be registered. You might check the PDF. This is something that the manufacturer should be handling. I don't believe there's a registration fee, it appears fairly simple from what I can tell.

This is the wording I was going by for that one.

"Once finalized, products deemed under this rule will be subject to the same FD&C Act provisions that cigarettes, roll-your-own tobacco, and smokeless tobacco are subject to, with respect to the following: (1) Enforcement action against products determined to be adulterated and misbranded; (2) required submission of ingredient listing and reporting of harmful and potentially harmful constituents (HPHCs) for all tobacco products; (3) required registration and product listing for all tobacco products; (4) prohibition against use of modified risk descriptors (e.g., “light,” “low,” and “mild” descriptors) and claims unless FDA issues an order permitting their use; (5) prohibition on the distribution of free samples (same as for cigarettes); and (6) premarket review requirements."

5) Flavors are murky. On p.7 of the PDF, the FDA refers to flavorings as "components or parts" - I think this had to do with additives to something that is itself a "tobacco product." As far as a flavored tobacco product, i.e. tobacco products with "characterizing flavorings" (see p.10 of their PDF), things are once again tricky because they only have the authority to regulate "characterizing flavorings" in a "cigarettes." Could they do that w/ e-liquid? Vapers are wondering and p.10 implies that they aren't ready to do that yet. Could they declare flavored hookah tobacco to be a "cigarette?" Your guess is as good as mine. Might require some interesting semantic gymnastics.

Call me a pessimist but I am expecting congress to eventually help out with this one if needed.

7) Again, most of us vapers think that a "compoenent or part" is anything which is essential to vaping (or hookahing if that's a word), and which is not very common to other applications such as a generic type of battery (as opposed to, say, an EGO). However the materials used to make them are not - for example, VG is not a "component or part" of e-liquid. How does that apply in the hookah context? Your guess will be much better than mine
...
Again on p.7 there are some interesting hookah examples. The "charcoal burner" one threw us vapers for a loop, but you probably already know that it's an "accessory" because it's not absolutely required for hookahing (if that's the word).

Take a quick look at a couple of these sites. A glance should show you why I think hookah is in the same boat as vapers in all of this.

Hookah | Hookahs | Shisha

The Official Starbuzz Store

https://www.hookahcompany.com/hookahblog/hookah-blog/best-new-hookah-products-of-2013

We need all the help we can get!

Yep.

 

[pamdis]

No doubt about it - they are in the same boat. No question.

 

[Roger_Lafayette]

I suppose since they have predicate products, minor variations in packaging and such might just get SE. Since the FDA apparently doesn't have to worry about e-cigs having a predicate to begin with. My gut tells me that they won't be so lenient though and wouldn't think twice of squashing hookah as much as they can.

The SE pathway is not an easy one, see #13 here for some links if you haven't already checked out what they have to say on it: http://www.e-cigarette-forum.com/fo...8-early-innovator-marketer-e-ciig-vaping.html

Hoewver the grandparent pathway is much easier. It just has to be exactly the same product, probably right down to the packaging. There's the niggling issue of what to do in order to prevent the FDA from mistakenly siezing and destroying such products. Any "modified risk descriptors" would have to be removed, and labelling would have to be added to "tobacco products" but not "components or parts" (which might change the packaging, but the FDA probably can't complain about that.) And of course no more free samples such as in-store tasting. You've already quoted all of that above in #12.

***

This is the wording I was going by for that one [...]

You're right, and I'm wrong. Registration is not "simple" as I incorrectly claimed - especially to the extent that the ingredients have to be submitted. I have no clue what the FDA is going to demand for that, but it's possible that existing filings from BT co.s regarding tobacco cigarettes might be a matter of public record (or available via FOIA). However registration and ingredient listings etc. only applies to "tobacco products" - not "components or parts" of grandparented products, as I read that sentence you quoted from p.8.

Also see the part about user fees on p.24, I'm not sure what the deal is there. More on registration on p.27 and pp.s 116, 127 et seq. (you can use the find option on Adobe as well as I can

Any tax consequences? I haven't really thought about that, but these might apply at all three levels of gov't. It may be that some taxation is automatic, viz. some state and/or local taxes may come with FDA jurisdiction based on how the statutes are written. Also interesting to watch - for a long time, RYO "pipe" tobacco has slid under the FDA's radar as those of us who used injector machines know. Some states have put the kibosh on that and decided to tax it the same way (TX, I believe). To the extent that hookah tobacco works to make cigarettes (?) then it may also be vulnerable. I haven't really looked into this since I quit smoking tobacco cigarettes, but this is a potential area of concern for hookah tobacco users.

Internet sales? Hmm, FDA has no current authority over those. Ditto advertising at the moment. But state and local jurisdictions can regulate internet sales and almost certainly marketing. However I don't believe a local jurisdiction could regulate internet marketing, only B&Ms or online retailers located within their boundaries.

The one good thing I can say about all of these topics is that none of them probably apply to anything unless it's a "tobacco product." "Components or parts" are likely not affected by FDA registration/ingredient listings, FDA user fees, excise taxes at all levels, and internet sales/marketing rules that might be imposed by local juridictions on actual or potential transactions involving adults. (Caveat: I believe excise taxes have been applied to vaping equipment MN [?]. These are also currently proposed in [?] RI and VT.)

That said, this ancilliary stuff is a lot to think about

***

Call me a pessimist but I am expecting congress to eventually help out with this one [flavorings in things besides "cigarettes"] if needed.

My biggest fear is that Congress will go all the way and regulate everything that's "misted," "smoked," or "vaporized." At some point they're going to ban aromatherapy.

It's almost as if we've stepped into a technology-fueled time machine, and gone back to the late 19th and early 20th centuries, during which myriad now-illegal substances were commonly used and available. Except, of course, that this time we're talking about nothing more than flavored tobacco (or less - those steam stones don't even have nic., right?).

The word "absurd" doesn't even begin to cut it.

***

Take a quick look at a couple of these sites. A glance should show you why I think hookah is in the same boat as vapers in all of this.

Hookah | Hookahs | Shisha

The Official Starbuzz Store

Best New Hookah Products of 2013 - Hookah Company

Wow.

All I can say is that you really opened my mind. I went on YT initially to figure out what those flavored rocks were ("steam stones" I think they're called). I was absolutely mesmerized by the complexity of the technology, and watched at least 20 videos. "This ain't your parents' water pipe anymore"

I have to confess that my level of igorance was comparable to that of the media on vaping, i.e. the reporters (and politicians) who think that vaping is all about Jenny McCarthy puffing away on a Blu.

The first time I saw a video of someone doing a quad coil build on an IGO-W3, I wasn't all that blown away. It just didn't appear to be such a great leap over a cigAlike to me in terms of the basic technology. (Hopefully no one will be offended by that - I do not mean to suggest that a good quad build is "easy," nor that it should be confused w/ any BT product.)

But if the moralizers and prohibitionists freak out when they see some younger vapers blow a cloud or hotbox, I can only imagine what they'd think about some of this hookah stuff. And to make matters worse, the cessation argument is much weaker (not all of it contains nic, right? The steam stones don't, for ex.). I suspect the average age is also younger. Older vapers who have quit smoking have much in the way of moral leverage and real-world experience that perhaps the average younger hookah user doesn't.

There's also plenty of fodder for junk science. If Pru Talbot or the FDA can "shake and bake" a cheap 2008 Chinese cigAlike, and pretend that the results have any relevance ... imagine what they can do w/ hookah gear. The mind boggles. I can see an avalanche of junk science papers, conferences, and research institute funding coming down the pike. Our tax dollars at work.

The only way in which the hookah community might be better off than vapers is that there are plenty of potentially-grandparented products. At the end of the day, the water pipes used back in the 70s and 80s are still valid "grandparentable" products, and they can always be stuffed with pipe tobacco.

 

[pamdis]

Regarding the user fees: The FSPTCA section 919 spells out total amount, mfgs and importers have to report their sales, and then the total fee is split proportionally between them:

Section 919 of the Federal Food, Drug, and Cosmetic Act - User Fees

Probably the main reason they want you to register and list your products. So they have a record of you, can compel you to report your sales, then assess you your part of the fee, which is paid quarterly.