New Fda Proposed Regulations, Not Good For Hookah

[Culinarytracker]

Has anyone in the forum seen the FDA proposal that just came out regarding tobacco products?

 

It classifies all hookah, e-cig, nicotine gel, and other products under the FDA regulation of tobacco products.

 

Part of these regulations would be that any product not on the market before 2007 would have to be approved by the FDA as a new tobacco product.

Every flavor, package size, label, any little difference would require a separate approval from the FDA.

 

These are just the main point. It's over 200 pages long and has lots of possible implications to hookah as well as electronic cigarettes.

 

There is a lot of information about this in the electronic cigarette community, and a few good videos on youtube.

I would really like to hear if anyone has been looking at how this will affect the hookah world.

 

 

This is a link to the whole document.

https://www.federalregister.gov/articles/2014/04/25/2014-09491/deeming-tobacco-products-to-be-subject-to-the-federal-food-drug-and-cosmetic-act-as-amended-by-the

 

 

[Stuie]

Interesting. One of the problems will be the flood of requests will overwork their tiny office and the companies will go ahead with any new product, because the FDA will be drowning in request to actually up hold their own regulations.

 

Primarily I see this as just a legal work around to classify electronic cigarettes and hookahs as tobacco products.

 

Maybe after finals I can take a look at the whole document.

[Chreees]

So does this mean if Tangiers wants to release a new line, Eric will have to submit to the FDA first?

[Hassouni]

Good thing Nakhla has been sold here for years!

[wek-sos]

I've been slightly concerned about this. I sold most of my collection while hookah prices are still high and used that money to stock up on shisha. 

 

If shisha prices are higher and less online vendors can stay in business, the used hookah market is going to see a significant price deflation. And that will be nice. 

 

Now if the brands that have been around for years like Nakhla somehow get special taxes and regulations, I will be investing in an e-hookah bowl for the daily smoking. Regular shisha will be for weekends and special occasions. 

 

 

As far as Tangiers (and other US-produced brands), are they at more of a risk for being shut down? I am not sure if this will affect shisha produced overseas more than American shisha. 

[Culinarytracker]

In order to be sold in the USA, the product will have to be EXACTLY as it was before 2007. This includes every detail about contents, package size, the packaging itself, and probably much more.

 

The hardware is likely to fall under the same requirements.

I would assume that it would be highly unlikely to see brands from outside of the US after the regulations go into effect. The cost of post 2007 "new" product applications has been estimated from t0's of thousands, up to tens of millions.of dollars per product. This would include every new flavor,etc... In fact if they get around to banning flavors other than tobacco or menthol (or whatever they do)  in e-cigs, it looks like it would apply to hookah as well.

 

These application processes were designed to make it nearly impossible for the tobacco companies to release any new cigarette products. (it was the law that changed camel lights into camel blues)

 

Right now we are about a week into a 75 day public comment period which has to be completed before anything may be revised or  made final.

 

I'm not trying to be any kind of expert here, but have been following it very closely from the e-cig side of things. I am also a big of the hookah, so I wanted to bring it to the hookah communtiy's attention.

The more people that are aware of this, and the more good quality comments made to the fda, makes for a better chance of changing the outcome, or even better getting this tabled and never made final.

 

FDA Pamphlet on making comments:

http://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM314421.pdf

 

Google it for several interpretations of the proposal, but here are some sources generally recognized as reliable in the e-cig community) are:

 

Casaa

http://casaa.org

 

GrimmGreen

http://youtu.be/MAa60mWNzXY

 

Dimitri and Dr. Gilbert Ross

http://youtu.be/InSCNdJKa0I

 

If there is interest I can dig up good more of the good ones.

Edited May 6, 2014 by Culinarytracker

[wek-sos]

^ Thanks for your input. So you think that overseas brands would completely disappear? 

[Culinarytracker]

^ Thanks for your input. So you think that overseas brands would completely disappear?

 

 

I don't know what kind of money those companies are dealing with. Some of them might be big enough to eat the costs of dealing with the FDA, but I think smaller to mid sized companies would probably just stop shipping to the US.

In any case it would only be products that could be absolutely proven to be exactly like they were before Feb. 15, 2007. 

I don't know how difficult it would be to prove this, or how they are going to register all the older products so that they know if something changes in the future. Definitely more questions than answers. The first electronic cigarette commercially available in the US was in May 2007. So there are no grandfathered products at all. So I haven't seen much info on issues with the grandfathering.

 

Anything newer than that would likely cost hundreds of thousands of dollars, if not millions to apply. And that is with no guarantee of approval.

From what I understand it's not just a paper application. The process includes scientific analysis and studies. It's even worded to require proof that the product would be in the interests of public health (definitely not exact wording).

 

I would love it if someone involved in the hookah industry could look into this. If my assumptions are correct then maybe there are some trade magazines or other ways to get the word out to more people that this will effect.

[tjmitch]

I just see companies selling tobacco and base separately in a "mix it yourself" loophole.

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[â€On]

I would really love to have a company that sells me the molasses/flavoring mix and just says "for this much, mix with 250g of tobacco". That way I could use whatever tobacco I want until I find the right blend.

That being said, that would never happen until things got extremely bad.

[wek-sos]

I would really love to have a company that sells me the molasses/flavoring mix and just says "for this much, mix with 250g of tobacco". That way I could use whatever tobacco I want until I find the right blend.

That being said, that would never happen until things got extremely bad.

never thought about that. That's what you have to do in Germany 

[Legatus]

I have a feeling that we're just a couple of years away before smoking hookah is illegal in this damn country.

[â€On]

Maybe it's time we revive the interest in Hookah Island....

[Chreees]

Maybe it's time we revive the interest in Hookah Island....

 

No kidding.

[Culinarytracker]

OK, I've done enough research to be quite certain of at least these points.

Take a second and imagine all the flavors and products that have came out since Feb 15th, 2007. Kiss them goodbye.

If you are the owner of a hookah related business please contact me directly at culinarytracker@gmail.com.

I am kind of taking it upon myself at this point to involve the hookah community across the country in this. I need help.

Here is a link to my thread in the E-Cigarette Forum where I hashed this out with others who are familiar with the proposal.

http://www.e-cigarette-forum.com/forum/fda-regulations/560182-effect-hookah-bars-lounges.html

 

The important thing right now is that we have less than 75 days to submit comments to the FDA before they make this final. (July 9th is the cutoff date I believe)

The lawyers and advisers in the e-cig community are saying the most important thing right now is to request an extension of this 75 day comment period.

(Please see the above link for PDF about submitting comments)

This information needs to spread like wildfire to every hookah user, hookah bar/lounge, supplier, vendor, or manufacturer as quickly as possible. Businesses should probably consult lawyers.

Unfortunately all the reliable information is from the perspective of e-cigarettes. However, the new definition will make no separation between e-cigs, real cigs, hookah, etc...

 

 

My best information shows the following will affect the hookah industry if this proposal goes through.

 

- [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.(and most likely pay quarterly for "FDA Users Fees" according to market share)
- [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] Hookahs, hoses, bowls, coals, etc.. will fall under the same regulations.(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.)

 

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I am also looking for information about where to go to get this information out. Are there trade publications? other popular forums? influential youtube reviewers? Are there any advocacy groups who may be able to review the proposals and make a more formal statement regarding its effects on the hookah industry? Or does no one care and my time would be better spent elsewhere?

This is getting very real, very fast.

[Legatus]

I submitted my comments to the FDA, but they will probably be ignored as the war on the rights to enjoy tobacco is near its end. It's a shame that "The Land of the Free" has come to this.

[agunn1231]

I can forsee this leading to underground speak-easy hookah lounges...

 

It seems like a lot to take in right now, and I will have to read through all of it later on this week. I hope that hookah is around for a long time though. 

[Epitocom]

I have a feeling that we're just a couple of years away before smoking hookah is illegal in this damn country.

 

I wouldn't say it would go that far. Not when certain larger companies can still make money off of it. Most likely Marijuana will be completely legal within a few years. Its all about the money my friend. If anything, I see this bill as a way to cut out the mid to low level guys, and then Marlboro or some other company in the government's pocket buying up all of the big hookah brands. Then TAXES.

[wek-sos]

Hmm never thought about a big tobacco company scooping up the shisha brands. I'm okay with taxes, as long as my favorite flavors are still available. 

 

I'm sure Starbuzz is big enough to take a hit on fees and regulations, but I would rather not smoke hookah if Starbuzz is all I can buy