As previously stated, Whole Leaf Tobacco is not affected. Stock up now. It'll only be a matter of time before the FDA goes after it.
New FDA Regs; What Isn't Affected?
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From the legislation related summaries I have read I am inclined to agree with brian64. This latest move is regulatory capture; pure and simple.
If the motivation was what it claimed to be, i.e. public safety / think of the children etc, then the combination 2007 sunset date plus the exorbitant cost of SE evaluation of a new product line would not be necessary. Kids cannot purchase rated R movies, or hobbyist model glue; an age restriction, in this regard, would squelch the "save the children" reason; at least as effectively as other age limits have done.
If it were about public health and safety then the SE regulatory testing could be offer at a graded cost, for instance, based on the income of the applying agency. Sure, Phillip Morris can pay the $300k fee and wait the three years for a new product to be approved but a smaller operation cannot.
There could also be an approved list and some FDA preapproval (for example mixing pure blending tobaccos are OK with no additives). However, the notion that changing a 50/50 burley/virginia blend to a 20/80 blend of the same ingredients triggering a "standard equivalence review" (paperwork, scientific testing, substantial monetary cost) is (a) a pay wall to drive consolidation by weakening the viability of smaller producers and give larger companies buyout leverage to increase their market share and (b) an artificial torpor placed on the market space to keep it from 'evolving too quickly' again for the status quo to maintain control.
If the motivation was what it claimed to be, i.e. public safety / think of the children etc, then the combination 2007 sunset date plus the exorbitant cost of SE evaluation of a new product line would not be necessary. Kids cannot purchase rated R movies, or hobbyist model glue; an age restriction, in this regard, would squelch the "save the children" reason; at least as effectively as other age limits have done.
If it were about public health and safety then the SE regulatory testing could be offer at a graded cost, for instance, based on the income of the applying agency. Sure, Phillip Morris can pay the $300k fee and wait the three years for a new product to be approved but a smaller operation cannot.
There could also be an approved list and some FDA preapproval (for example mixing pure blending tobaccos are OK with no additives). However, the notion that changing a 50/50 burley/virginia blend to a 20/80 blend of the same ingredients triggering a "standard equivalence review" (paperwork, scientific testing, substantial monetary cost) is (a) a pay wall to drive consolidation by weakening the viability of smaller producers and give larger companies buyout leverage to increase their market share and (b) an artificial torpor placed on the market space to keep it from 'evolving too quickly' again for the status quo to maintain control.
It's interesting too when combined with the international trade deals that require adherence to US regulatory standards. The domestic regulations can then be exported; extending the regulatory capture overseas and the reach of select US businesses. It's not some unique American evil, either. It's standard practice and has been going on for centuries (east India trading company, standard fruit co., etc etc)
On another thread, Russ told us all to chill out. There will be lawsuits that will shape this thing, as they always do. It is way too early top know what will be left in or taken out of this deal. This is what I hear everywhere. So, we can wring our hands and stomp our feet, but worry has never accomplished anything positive.
I think it's important to note that the pre 2007 still includes wording that original packaging must be kept or the retailer is considered a manufacturer. I have lots of questions about the details- but it does seem that the repackaging of tobacco is no longer ok. For example- 1Q is sold in 5 pound bags. A retailer will now either have to hope it is sold to us in smaller (FDA approved) bags or sign up and get smaller packaing approved by the FDA in order to sell by the ounce to the end consumer. I am curious as to if we are grandfathered if we have been packaging that way since pre 2007
I second Cosmic's motion based on Russ's advice. Too much arm flapping isn't good. When someone can frame something useful we can do to correspond with FDA or legislators, petition in an organized way, or otherwise apply pressure in a directed effective way, then everyone can get aboard. In the meantime, squirrel away some leaf you like and stay cool.
I just watched a webinar with the FDA that was focused on the retail side of the issues. As expected everything was as clear as mud.
In short, here is what I gleaned. Pipes themselves are considered a component but will not require warning labels.
The era of free samples are over. I did submit a question asking for clarification of free sample versus a gift but they didn't get to my query.
Pipe tobacco will need to carry a warning label effective 5/10/2018.
If a retailor imports a blend they will be considered a manufacturer and therefore subject to the deeming regulations; though most by through distributors who will have to bear that responsibility. So buy up your European blends as fast as you can.
They are a smarmy bunch. I fully expect an injunction against these rulings but that's just one man's opinion.
In short, here is what I gleaned. Pipes themselves are considered a component but will not require warning labels.
The era of free samples are over. I did submit a question asking for clarification of free sample versus a gift but they didn't get to my query.
Pipe tobacco will need to carry a warning label effective 5/10/2018.
If a retailor imports a blend they will be considered a manufacturer and therefore subject to the deeming regulations; though most by through distributors who will have to bear that responsibility. So buy up your European blends as fast as you can.
They are a smarmy bunch. I fully expect an injunction against these rulings but that's just one man's opinion.
For those who missed my postings, this is what SmokersHaven have said...
"Hello Nate,
Sorry, I am all sold out of Our Best Blend. Just a heads up, I am also going to run out of Exotique and the other blends soon. I may or may not get a re-stock before the FDA ruling goes into effect August 8th. I am so sorry for the delay. I have been shipping non-stop and I am a one man team. Thank you so much for your support and patience. Your package is ready to go out now and I am emailing the shipping confirmation with tracking to you. Enjoy!
Best Regards,
Premal Chheda"
"Hello Nate,
Sorry, I am all sold out of Our Best Blend. Just a heads up, I am also going to run out of Exotique and the other blends soon. I may or may not get a re-stock before the FDA ruling goes into effect August 8th. I am so sorry for the delay. I have been shipping non-stop and I am a one man team. Thank you so much for your support and patience. Your package is ready to go out now and I am emailing the shipping confirmation with tracking to you. Enjoy!
Best Regards,
Premal Chheda"
This has got my head spinning. I just recently gotten into pipe smoking (now on to month 6) and am about to have the joys that I find so appealing taken away from me...
Is there an organized petition going on? Possibly just for the pipe and cigar?
Is there an organized petition going on? Possibly just for the pipe and cigar?
I read above someone talking about the "substantial equivalency" application costing $330k. The summary I read from the National Association of Tobacco Outlets on deeming regulations says something completely different. There are two categories of application, the substantial equivalency (SE) or the premarket tobacco application (PMTA). SE is an application for products that are substantially similar to other products that were on the market before Feb 2007, while the PMTA is for products that have no equivalent product pre-2007. The PMTA estimated cost is approximately $330k, while the time and cost for the SE is substantially less (but in the summary at least, unnamed).
Unless I'm way misunderstanding this, all non-aromatic pipe tobacco blends (and most aromatics that don't have off the wall casings) would fall under the category that requires only the SE, being made of just tobacco. Even if they break down into specific cultivars of tobacco, most blends and combinations have some equivalent from pre-2007. Am I wrong here?
The industry that does not have equivalents pre-2007 is solely the vaping/e-cig industry.
Unless I'm way misunderstanding this, all non-aromatic pipe tobacco blends (and most aromatics that don't have off the wall casings) would fall under the category that requires only the SE, being made of just tobacco. Even if they break down into specific cultivars of tobacco, most blends and combinations have some equivalent from pre-2007. Am I wrong here?
The industry that does not have equivalents pre-2007 is solely the vaping/e-cig industry.
It's up to the manufacturer to make that decision. Either way it falls the FDA hasn't approved any cigarette SE or PMTA's since regulation went into affect on them. I'm not confident they'll be timely in approving pipe blends whichever regulatory route the manufacturer decides to go - if they decide to put the time and cost into preparing the applications at all, considering the non-existant prior approval rate. Both applications still have language in them that puts a burden on the manufacturer to prove that the SE product or new product is less harmful (or isn't more harmful - I forget exactly how it was written) than what was on the market in 2007.
Halfwheel.com recently announced that the CRA, IPCPR, and CAA plan to file a joint lawsuit on July 4th, which will most certainly request an injunction, as well as changes to the 2007 predicate date. Other lawsuits have been filed by the vape and cigar industry, and there is a bill in congress through appropriations that seeks to change the predicate date from 2007 to 2016. These are all small glimmers of hope, but at least the fight is on. The thing that sucks about this is that this is only round 1 of regulatory rules, with more to come. The end-goal of the FDA is to create a tobacco-free generation and collect as much Franklin as they can in the process.
One interpretation of these regulations would honor Russ O. and other blenders who meticulously recreate discontinued blends from days of yore with truly forensic accuracy, taking samples of the old blend and analyzing the constituent particles. If old is what they want, this could be provided. We might all smoke like our forefathers and mothers. Seems silly, but it might be one workaround. Another is to litigate into the foreseeable future to delay things. Or get dispensation for medicinal use of pipe tobacco for stress reduction and enhancing the sociability of old guys. Think about that one....
Meanwhile, check out the new 7 ounce can of Iwan Ries Three Star Blue, a blend that goes back to the beginning of time, and although aromatic is quite tobacco forward. And Edward G. Robinson, another oldie. And so on.
Meanwhile, check out the new 7 ounce can of Iwan Ries Three Star Blue, a blend that goes back to the beginning of time, and although aromatic is quite tobacco forward. And Edward G. Robinson, another oldie. And so on.
Even without litigation delaying full enforcement of the deeming process even further, tobacco manufacturers have until FEB 2018 to submit paperwork, and in the meantime can continue business as usual. If they do submit paperwork they have an extra 12 months to continue as normal while the paperwork is reviewed. That's a good amount of time for most of us to stock up, and hopefully our favorite blenders will give us a heads up whether they intend to submit paperwork for the SE or PMTA, or let the brand/blend die.
That might work for discontinued blends that were in production in 2007, though I really think not. But something like Balkan Sobranie, which was not in production in 2007, will be subject to the deeming process, or go out of production. Hmmmmmmmmmmm...maybe not such a bad thing in the case of this version.
The SToP versions of old blends will be toast.
Apparently the National Association of Tobacco Something or Other (NATO) doesn't list aros as being toast. At least for now.
Regardless, the handwriting is on the wall.
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