Please Break Down FDA Ruling

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cigrmaster

Preferred Member
May 26, 2012
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For us older folks who have serious reading comprehension, could you please break it down so we can understand it. From what I can dicern, blends after 2007 are on the chopping block is this true? What about blends pre 2007, are these affected in any way? I really appreciate the time you take to edify people of my persuasion who are comprehension problems. Thanks

 

iamn8

Preferred Member
Sep 8, 2014
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Moody, AL
From my own dealings on this forum with Harris, I'd like to assist by suggesting any response utilize a large font and small words. You're welcome.

 

pipesmokingtom

Preferred Member
May 4, 2015
3,213
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As it stands:
Within a year of August, all products will need a warning covering 30% of the packaging.
Starting August, no new blends without approval.
All products on the market pre-Feb 2007 are exempt from the FDA approval process (warning labels still apply)
All post-Feb 2007 SKUs need to submit for approval with an application and a shit-load of money. They'll have two years from August to do so. If they've submitted by then and haven't gotten a response, they can continue for at least another year.
Each and every SKU needs its own application. I.E, a 50 gram tin and a 100 gram tin, even of the same blend need their own approval.
That's the hit points. Who knows which parts of what will stand. The biggest piece if legislation on the table right now is attempting to move the "grandfather" date to now so all the stuff on the market now can stay with no issue. That's the most important one.

 

cigrmaster

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May 26, 2012
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pipe, is there a good chance many of these blends could go the way of the dodod? Even if the mfgs do everything the FDA wants, do they have outs in the contracts that could bury these blends?

 

pipesmokingtom

Preferred Member
May 4, 2015
3,213
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Right, so the biggest concern is that it's going to be so expensive to get approval for each blend, manufacturers are going to have to choose which ones they want to submit.
A logical person might say, "but just get all the components approved and then any blend made from them should be fine." The FDA built in language specifically nixing that, which is why each and every SKU needs its own approval. They argue a component change could materially change the safety, so each blend itself needs its own application and approval.

 

pipesmokingtom

Preferred Member
May 4, 2015
3,213
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It is possible that blenders can argue precedent and put forth comparable blends safety documentation as prior proof, but they will still have to apply for each blend. No word on the costs for all of this yet.

 

pipesmokingtom

Preferred Member
May 4, 2015
3,213
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An interesting side effect I forsee coming from this, which I haven't seen addressed, is trade secret information.
For example, with all of this mandated transparency, we may come to find out some things behind the curtain we didn't really want to know... IE, Escudo really is the same as DNR, or Golden Sliced really doesn't have perique. Not stating those things as fact, but just as an example.

 

jacks6

Preferred Member
May 9, 2016
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Trade Secret information won't be exposed - only the FDA will be privy to the % of components and flavoring. The closest consumers will get is an "ingredient listing" like on food packaging but the cigarette industry has successfully pushed that one back

 

pipesmokingtom

Preferred Member
May 4, 2015
3,213
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Right, right, but...
If they are using prior applications studies as precedent to reduce the cost of the application process, they'll have to reveal that Escudo is the same as DNR. Otherwise, the studies will have to be done for each blend, and I doubt blenders want to duplicate costs and effort that way. See what I mean?

 

jacks6

Preferred Member
May 9, 2016
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Right, right, but...
If they are using prior applications studies as precedent to reduce the cost of the application process, they'll have to reveal that Escudo is the same as DNR. Otherwise, the studies will have to be done for each blend, and I doubt blenders want to duplicate costs and effort that way. See what I mean?
I get what you're saying - They'll have to reveal that to the FDA - it just doesn't mean that this information would be available to consumers.

 

warren

Preferred Member
Sep 13, 2013
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They are regulations and so will morph, especially when the courts begin their input and the politicians enter the discussion.

 

perdurabo

Preferred Member
Jun 3, 2015
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Exactly Warren.
This is turning out hilariously idiotic. Big Government crowd, is looking at one another"Did we just fuck ourselves, I just want to smoke a pipe! Go take some old redneck's gun and leave me alone." Don't work like that now, does it?

 

bigpond

Preferred Member
Oct 14, 2014
2,023
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pipe, is there a good chance many of these blends could go the way of the dodod?
It's hard to say without knowing the application fee, which as far as I'm aware, has not yet been made public. Depending on the fee and the length of the application process we may see blenders reduce or eliminate seasonal and limited release blends, (tobacco of the month, c&d's small lots, new recipes for christmas blends).
I believe Harris asked about Capstan, St Bruno and DSK specifically in another thread. All three are produced outside the US and only domestic sale will be impacted. Even if they are pulled from the US market they will be available abroad.

 

tobaccojoe

Member
May 30, 2016
224
0
USA
A few newspapers and journals have talked about application fees and they are astonomically imposing and restrictive in nature:
But e-cig companies will also incur great costs in both time and expense in complying, if they're even able to do so. The FDA itself admits it could take as many as 5,000 hours to complete the necessary paperwork and cost "only" several hundred thousand dollars per product. Industry estimates, however, run orders of magnitude higher, between $3 million and $20 million per product. Plus applications have to be submitted for everything a manufacturer wants to do. New product design? Submit an application. Make a health claim? Submit an application. Register with the agency? Application. Introduce ingredients? Application.
It's obvious the only e-cig companies that will be able to afford such time-consuming and costly processes, even at the decidedly lowball figures offered by the FDA, are the established players in the industry: the tobacco giants that have their own e-cig and vapor products on the market. The many thousands of smaller players that currently populate the market will find those costs impossible to pay. Instead they'll be driven from the market by the ruinous costs. If they're lucky they may be bought up by Altria or Reynolds, which will further solidify Big Tobacco's dominance.
Source: http://www.fool.com/investing/general/2016/05/20/the-fdas-electronic-cigarette-rules-are-here-and-t.aspx

 

iamn8

Preferred Member
Sep 8, 2014
4,253
1
Moody, AL
With this VAST new revenue stream, just think of all the wonderful work the FDA will be able to do! They'll be able to branch out further and make our lives far better and healthier than we can possibly imagine!

 

tobaccojoe

Member
May 30, 2016
224
0
USA
Here is the most simple page ("simple") from the FDA regarding Pipes and Pipe Tobacco specifically:
http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482580.htm#references
Honestly, I am bummed that 1/3rd of the tins will need those ridiculous health warning stickers. Talk about ruining art! I'm not thrilled about losing some of my favorite smokes from post-2007, as will surely happen (if everything goes through), but I'll be even more upset if prices double. This would effectively price me out of the pipe tobacco hobby I love so much.

 
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