FDA's case for regulating pipe tobacco - trouble coming

[Rusty]

If my cellar of pipe tobacco suddenly increases in value by a factor of 10.... I'll quit smoking and turn to peddling.

Ugh! You are bereft of principles. This is the saddest post in the thread so far and it's hardly a happy thread. Profiteering in a crisis. This is a new low.

I'll tell you what, Mr. Winston Circle, you do that and WI shows up looking for unpaid tobacco taxes, ok?
Get off your butt and help.

[Rusty]

It's just foulin' ridiculous, just an excuse to jack up taxes and put thumbs in the eyes of people who aren't doing anyone any harm.

Ok but it's far worse than that. It's not just increased cost though that is almost certain to happen. It's independent of taxation; they don't control taxation. The market may start shrinking again. They may also go after online buying though that hasn't been a topic in the FDA doc. They are looking at sales access anyway. The worst case is we may lose a lot of existing tobacco products introduced after feb. 15, 2007 and/or it increases the cost of doing biz for some treasured very small American pipe tobacco manufacturers. We could lose some of them.This is far more dangerous than just taxes. It's a small industry and, despite appearances, a small market. There are no legislative hurdles to slow or divert them either. They really are like a steamroller.

We have to find out what the manufacturers and importers plan to do about this and where pipe smokers fit into this if at all. They should respond to the document and educate the FDA about the pipe tobacco market and their customers. The FDA's picture of the market, usage levels etc, is flawed & likely biased. It's very confused because the RYO makers did label their products as pipe tobacco. It's a reasonable play to use pipe smokers as protesters but I have no idea how successful that might be. At least the story has broken and now it starts.

[Spyderweb]

Well, I did sign the "protest". Hopefully this will get noticed by more pipe and cigars smokers, and blossom into something that makes this legislation harder to get passed.

On a personal note, I think I probably have enough pipe tobacco to keep me going for the rest of my life. Concerning cigars, well I'm not that lucky. Many of the cigars I like are under the $10 amount. And I don't have that many of them. I prefer pipe smoking, so there is that.

This just sucks.


Sent from my iPad using Tapatalk

[Rusty]

Well, I did sign the "protest". Hopefully this will get noticed by more pipe and cigars smokers, and blossom into something that makes this legislation harder to get passed.

On a personal note, I think I probably have enough pipe tobacco to keep me going for the rest of my life. Concerning cigars, well I'm not that lucky. Many of the cigars I like are under the $10 amount. And I don't have that many of them. I prefer pipe smoking, so there is that.

This just sucks.


Sent from my iPad using Tapatalk

There is no new legislation required here. So there is nothing to pass or make harder to pass. It passed! That's past tense.
"The Family Smoking Prevention and Tobacco Control Act, [signed into law June 22, 2009] commonly referred to as the Tobacco Control Act gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health."

Period. That's from the FDA's website.
They were given tobacco to regulate. The legislation explicitly directs the FDA to regulate cigs, and smokeless but it also places all the other products in reach. All they have to do is make a good case to 'deem' (that's their technical word) that public health requires that OTP falls under their regulation as well. And the document is the draft of that case provided for comment.

For the protest to succeed your federal legislators would have to draw up new legislation to limit the big bad wolf after our goodies.

It's always good to recognize reality at the outset. We are underdogs. Get used to it. The best that can happen is that the FDA be educated that pipe tob. is not a threat and their understanding is flawed.

Maybe I should have summarized the current state of things and regurgitated old posts. I've been watching the FDA for quite a while now since they started making noise about their intent to regulate OTP. You can see this in the tobacco in the news thread, a thread to which you posted.

[UncleBob]

Doctors to vote on cigarette sale ban for those born after 2000

[coco]

Rusty has some excellent advice for long-term cellaring in this thread.

[Rusty]

Doctors to vote on cigarette sale ban for those born after 2000

We get to see reuse in tobacco control. They're watching other countries and their experiences. And there is something like a bank of tried and untried control ideas and experiences that are shared among nations. And this is vivid evidence of that. We also know that the ongoing WHO FCTC efforts brings together national teams annually and then they must share some of this. So we see repetition. The first mention of this idea was with Tasmania and it's a topic in the tobacco in the news thread. And the experiment seems to be running since the legislation to do this was enacted in Tasmania Australia.

[gravel]

Bumping this thread. Take action.

http://www.pipesandcigars.com/page/fda- ... n-comments

[OldWorldSwine]

Bumping this thread. Take action.

http://www.pipesandcigars.com/page/fda- ... n-comments

Done.

[SmokinGordon]

Bumping this thread. Take action.

http://www.pipesandcigars.com/page/fda- ... n-comments

Done

[SmokinGordon]

Bumping this thread. Take action.

http://www.pipesandcigars.com/page/fda- ... n-comments

Done

[Del]

http://www.pipesandcigars.com/page/fda- ... n-comments

I got this email from Pipes & Cigars. I suppose we all did.

Commit yourselves right now to send some sort of response. Don't agonize over what you write; they won't read it anyway. Just be sure to be counted.

[Hovannes]

Done

[adauria]

Done

-Andrew

[CW Spook]

Done.

[coco]

...All the FDA has done is provide a draft of their case for FDA regulation of the poor dears and published it for comment. That's it. They are not regulating it yet. Nothing has changed nor will anything change this year... unless somebody wants to write a case that demonstrates that the FDA misunderstands. That would be a good idea and timely. Unlike the situation in '95 the FDA is now saying there is a case for regulating pipe tobacco. The difference? The market for pipe tobacco stopped shrinking & grew.

It may also be a good time to start threatening your politicians ie you will not only not vote for them but will hold them responsible & campaign for some other nutcase. It's happening on their watch. There is plenty of time for them to act too. We need more noise and angst. Also you might consider threatening the IPCPR. They evidently have a pretty good plan for cigars but, apparently, have abandoned pipe tobacco. At least that is the picture the FDA paints. Does the IPCPR and perhaps its associated cigar manufacturers think there are rewards for sacrificing pipe tobacco? That ought to wake them up. Their plan is a good one for pipe tobacco too and for all the same hobbyist reasons they already have for cigar smokers. Traitors.

To paraphrase Churchill.... Now this is not the end. It is not even the beginning of the end. It has yet to proceed far enough to even be called the end of the beginning. But it is a good time for some saber rattling. The population of pipe smokers isn't tiny and declining anymore. That has pro's and cons. It has attracted FDA attention but it also has much more political clout.

Prudence says you should begin stocking up. The aromatics and sweet stuff takes precedence now because if those blends are threatened then those will likely be threatened earlier than blends like the Revival Ashtons. But you should be looking at the case for stocking up at least.

More of you should also at least make one pass reading of the FDA case. It'll help encourage outrage.

For most of the Ashton Revival blends the critical date is about 3 years in the future. That's twenty-four months beyond the date where they establish regulating procedure (expected next year earliest) and begin using it. The applicable deadline is for gaining FDA approval of new blends intro'd after Feb 15, 2007, for which these Ashtons probably qualify. The FDA will publish a non-operative draft of the regulations for comment sometime within a year and then they publish the regulations. So you should be stocking up (present tense) or at least have a plan. Ok? Until then it's Christmas in KC and time to rattle sabers. Yup.

But don't go crazy. We're anticipating the worst case. But it hasn't happened yet. It's like a disaster in slow motion. If you're a procrastinator and like last-minute pressure then you have a lot longer to wait.

The FDA is a very slow moving, procedure bound, steamroller. Deadly but very slow. Just avoid sleeping in front of it.

[Rusty]

I've been thinking about this and responding to the FDA's proposed case. There is still time to reply. If it is not a response to the document then what would be useful and is missing so far? I'm skeptical about simply objecting, as the P&C page indicates. Why would that matter when they've been given the right and the duty to regulate tobacco by law? The FDA is presuming a threat in the growth that may not be a threat at all. And I think the growth, or recovery in the market, is the only difference from 1995-96 when they last looked at this. It's the connection with youth smoking.

Tell them what your pipe smoking is for you. Is it important? Where does it fit in your life? Tell them your age. This is important because you may not be 18 -24 yo. Tell them when you started and tell them how often you smoke. Why did you take up pipe smoking? Were you a cigarette smoker or are you new to smoking? Do you see your pipe smoking as harmful to you or anybody else? Where do you smoke? What stops or impedes you from smoking more? Some of Dan's comments capture this really well. Pipe smoking is an awkward fit for this world. This is important stuff that only you know. And this information, in the aggregate, is really behind some of the FDA's suspicions about pipe smoking. They may be misunderstanding. Their idea about who you are and why you smoke pipes may be completely mistaken. And only you know your facts and reasons. This isn't just objecting; this is telling them why you object.

.... I get sick of this. The more I learn about tobacco and disease, the more I'm convinced that while smoking those FOULIN' cigarettes can't POSSIBLY be good for you, at least if inhaled, moderate cigar and/or pipe smoking has a chance of hurting you so low that in most people, it simply isn't worth worrying about.

And who has the opportunity to smoke immoderately these days? How? in my case, I cannot smoke in the house (asthmatic wife); I cannot smoke at work; I cannot smoke in my work vehicle; God knows I cannot smoke whilst shopping at Wal-Mart.

I mean, really: where the shale am I supposed to find the time to smoke enough to do myself some harm? I have a hard time getting through more than a bowl and a half (if that) every day. ...

We have young members here but it's certainly not solely young people that have taken up the pipe. There are folks of all ages that have started pipe smoking. The growth doesn't appear to be solely driven by youth smoking. It appears to be a hobby interest for those we see online.

It appears that many new pipe smokers are not responding to cigarette tobacco controls in taking up the pipe. This needs to be said.

And many are hobbyists, just like the premium cigar hobby smokers, who find it hard to integrate pipe smoking into their life and therefore smoke very little.

This 482% growth number over 2000-2011, making pipe smoking the fastest growing smoking alternative to cigs, bothers me. How are they measuring that? They cite CDC statistics. It's likely tobacco sold. And they are associating the growth with new young smokers. I think they're missing context at least.
Pipe smoking was still declining through the middle of that period at least. And it looks like the incidence bottomed out to something on order of 0.5% of the adult population. That accounted quite well for the amount of tobacco sold up to 2007. It did the same thing in other countries too. If the incidence of pipe smokers indeed grew by 482% then it's gone from 0.5% of the adult pop. to approx. 2.91%. I'm skeptical. But is it really a public threat at 2.91% ? Incidentally, that might put the market demand back to where it was in the early to mid 1990's when they last gave it a pass.

I don't know if the CDC's numbers actually represent pipe tobacco volumes sold and are not contaminated with the relabeling of RYO as pipe tobacco. There are lots of reasons to be suspicious about their alarm concerning the growth rate.

[les]

I too sent in a simplistic objection. But in reading over this thread, I find some trenchant and meaningful thoughts worthy of further action.

This part really struck me:
"Pipe smoking was still declining through the middle of that period at least. And it looks like the incidence bottomed out to something on order of 0.5% of the adult population. That accounted quite well for the amount of tobacco sold up to 2007. It did the same thing in other countries too. If the incidence of pipe smokers indeed grew by 482% then it's gone from 0.5% of the adult pop. to approx. 2.91%. I'm skeptical. But is it really a public threat at 2.91% ? Incidentally, that might put the market demand back to where it was in the early to mid 1990's when they last gave it a pass."

This may not pertain much to the vast majority (such as it is) of non-fora-connected pipesters, but it sure looks like the Internet media have a strong impact on the supply and demand of infamously hard to get blends. I assume the market share enjoyed by the big web stores has grown greatly, coincident to and maybe because of the growth of the fora. Certainly the amount of premium tinned tobacco at B&M's has declined during this period, partly due to their going out of the business and partly due to buyer migration to the Internet.

Rusty - may I use your quote directly? I think using numbers like those will engage the attention of the bureaucratic reader, especially if they recognize them as from their own sources. Maybe I will physically write them a letter in that vein.

I think my next response to the FDA will strike an analogy to another market artifice: the surge and hoarding of ammunition with the election of the current US government. Or would this be just preaching to the choir and not really reaching the bureaucrats doing the deeming? I am trying to 'think like a deemer' much as I try to think like a trout when I am out ffishing......

hp
les

[Rusty]

I too sent in a simplistic objection. But in reading over this thread, I find some trenchant and meaningful thoughts worthy of further action.

This part really struck me:
"Pipe smoking was still declining through the middle of that period at least. And it looks like the incidence bottomed out to something on order of 0.5% of the adult population. That accounted quite well for the amount of tobacco sold up to 2007. It did the same thing in other countries too. If the incidence of pipe smokers indeed grew by 482% then it's gone from 0.5% of the adult pop. to approx. 2.91%. I'm skeptical. But is it really a public threat at 2.91% ? Incidentally, that might put the market demand back to where it was in the early to mid 1990's when they last gave it a pass."

This may not pertain much to the vast majority (such as it is) of non-fora-connected pipesters, but it sure looks like the Internet media have a strong impact on the supply and demand of infamously hard to get blends. I assume the market share enjoyed by the big web stores has grown greatly, coincident to and maybe because of the growth of the fora. Certainly the amount of premium tinned tobacco at B&M's has declined during this period, partly due to their going out of the business and partly due to buyer migration to the Internet.

Rusty - may I use your quote directly? I think using numbers like those will engage the attention of the bureaucratic reader, especially if they recognize them as from their own sources. Maybe I will physically write them a letter in that vein.

I think my next response to the FDA will strike an analogy to another market artifice: the surge and hoarding of ammunition with the election of the current US government. Or would this be just preaching to the choir and not really reaching the bureaucrats doing the deeming? I am trying to 'think like a deemer' much as I try to think like a trout when I am out ffishing......

hp
les

Sure you can use it. But understand that it is my estimate of where we bottomed out in the mid-2000's. It's very hard short of polling to determine the incidence of pipe smokers. It has to have large error bars on estimates that are as small as those. Canada (Health Canada in their annual CTUMS survey) has estimated the incidence of pipe smokers and they still find 0.5% of the adult pop. in Canada. I also estimated exactly the same before they included pipe smoking in their survey. But these estimates do make sense given the incidence of pipe smokers in the past vs. tobacco volumes consumed etc. Plus you can see manufacturers (eg Swedish Match) acknowledging the market trend commenting about their performance in a market that is shrinking every year and is in long term decline in the early 2000's (annual reports). Then there is BAT commenting about why they closed Murray's, expected decline in market demand continuing, and outsourced manufacturing in 2005 and finally actually used the word 'disposal' in selling the bulk of the BAT/Rothman's accumulated pipe tobacco TMs to STG in early 2007. There is a fair amount of consistency with a very low incidence of pipe smokers from many sources. It's so low that it's certainly not a threat to public health. We celebrate even seeing another pipe smoker.

I suspect that the CDC was using TTB volumes from Federal excise. If true then the numbers are contaminated following 2009 with manufacturers relabeling RYO as pipe tobacco. So I'm very suspicious about approx. 3% incidence as well. The 482% growth is likely still fiction. That the FDA did not address the issues that occurred that contaminate the date and why their figure might be questionable makes it opportunistic dishonesty. The individual States registered RYO products for each manufacturer and they may have the data in their volumes taxation in the aggregate. AFAIK nobody has actually tried to separate the RYO from pipe tobacco. So I think the FDA is being opportunistic and isn't presenting a fair case. But it's very hard to know without understanding the source of their data.

We were aware of the turnaround in demand for pipe tobacco reported in 2009 for the year 2008. That's in the following thread:

viewtopic.php?f=19&t=9173

But before that it was very hard to find any evidence of any moderating of market decline. Every report that I found going back in history showed a decrease in demand every single year. After 2008 it's very obvious from the reintroductions, acquisitions, etc that the market demand was increasing. So why would the FDA hide a real profile of the market?

Certainly if you are long term pipe smoker you're aware of ongoing manufacturing consolidations, outsourcing for big tobacco, distributors dropping pipe tobacco products and product losses throughout the 80's and right into 2008. Yet the FDA has taken 2000-2011 as their period and did not comment at all about the first eight years of that period. That's just wild. It seems credible when they use numbers like three bowls per day that they have no idea of the incidence of pipes smokers. That number suggests that they view that as the average consumption. I'd like to challenge them to show us their model that makes any of that credible.

I would love to know what our favourite manufacturers and importers submitted in reply to the FDA case. Surely they can't have remained silent.

What is FORA?

[Rusty]

Industry reaction from the Pipe Tobacco Council acting on behalf of its members who are the manufacturers & importers of PT in the US. The Pipe Tobacco Council Inc operates as a professional trade association. The Association represents the pipe tobacco industry. Pipe Tobacco Council Inc acts as a communications network and lobbying group. Pipe Tobacco Council Inc offers educational resources, publications, research, political representation, conferences, and seminars.

Early reaction to the FDA back in April - http://www.reuters.com/article/2014/04/ ... RN20140424

Aug. 7, 2014 PTC submission to the FDA in response to their case - https://research.tdwaterhouse.ca/resear ... 219p8982-1
All the news outlets have exactly the same text that was provided by the PTC as follows. I doubt that the PTC would object to us copying it in and that way it stays.

Arguing for a "meaningful and feasible framework" that accommodates the unique characteristics of the pipe tobacco market, the Pipe Tobacco Council, the national trade association representing the pipe tobacco industry, today submitted comments on Food and Drug Administration efforts to regulate pipe tobacco.

The FDA has proposed to regulate pipe tobacco under the Family Smoking Prevention and Tobacco Control Act. The move would create new legal and regulatory frameworks that would impact every element of the pipe tobacco supply chain, from manufacturers to end users.

"Genuine pipe tobacco represents about 0.1% of all tobacco sales in America, and we believe it is not practical to regulate pipe tobacco like other tobacco products," said PTC President Craig Williamson. "We're calling on the FDA to approach regulation with fairness and feasibility that safeguards America's proud pipe tobacco tradition."

Specifically, PTC comments on proposed FDA regulations addressed:

I. Defining Pipe Tobacco: The proposed deeming regulation does not define "pipe tobacco," but PTC believes it is important to clearly separate pipe tobacco from tobacco that, although labeled for pipes, is intended for roll-your-own use. PTC offered a number of criteria to help the FDA draw this distinction.

II. Regulating Pipe Tobacco: PTC proposed that pipe tobacco should adhere to requirements for registration and listing; user fees; Good Manufacturing Practice ("GMP"); minimum age and identification restrictions; health warnings; and the prohibition against vending machine sales, unless in a facility that excludes youth. Pipe tobacco should also be subject to some of the prohibitions against adulteration or misbranding.

However, PTC argued that premarket review requirements should not apply to pipe tobacco because most of the changes to pipe tobacco are undertaken to maintain a consistent taste that satisfies consumer expectations. Pipe tobacco manufacturers change tobacco blends, casings and flavorings to maintain a consistent taste, and these changes are not designed to create "new" products to attract new users.

III. Retailer ObligationsPTC asked the FDA to clarify that regulations apply only to manufacturers, and not to pipe tobacco retailers who mix their own blends from bulk pipe tobacco. PTC does not believe this activity amounts to manufacturing, fabricating, assembling, or processing of a tobacco product, and the tobacco products being mixed were already manufactured by companies subject to FDA's laws and regulations. Subjecting retailers to FDA regulations would be financially burdensome.

IV. Path to Market

-- Grandfather Date: FDA states that the grandfather date for purposes of substantial equivalence comparisons is February 15, 2007. PTC believes that date will unfairly disadvantage the pipe tobacco industry relative to the cigarette, smokeless, and roll-your-own industries. PTC proposed that FDA use the date of the proposed deeming regulation, April 25, 2014, as the grandfather date. Doing so would place pipe tobacco on the same footing as currently regulated tobacco products that have a grandfather date of February 15, 2007, reflecting when manufacturers first became aware of the Congressional intent to regulate cigarettes, smokeless tobacco and roll-your-own tobacco.

-- Natural Variation: PTC argued that blending changes necessary to maintain a consistent taste should not be considered new products and should be considered substantially equivalent.

-- HPHC Testing: Currently, neither a HPHC list for pipe tobacco nor a testing methodology exists; therefore, pipe tobacco manufacturers cannot evaluate the HPHC level in their products. PTC asserted that FDA should not require a comparison of HPHCs in new and predicate products.

-- Brand Names: Retailers may mix bulk products together to create their own blends. As a result, the same pipe tobacco product is often sold under a bulk manufacturer label and a private label. PTC disagreed with FDA's current position that a new brand name for an otherwise unchanged tobacco product renders the tobacco product a "new tobacco product."

V. SamplingPTC opposed FDA's proposed prohibition against free sampling. Given the small size of the market, pipe tobacco advertising is limited. Sampling is a very important part of the sale of pipe tobacco, and PTC argued that sampling should be allowed to continue at age restricted venues.

VI. Mail Order SalesPTC supported FDA's position of permitting mail order sales for pipe tobacco, as mail order sales constitute a very large portion of pipe tobacco sales.

VII. Prohibition against Adulterated or Misbranded ProductsPTC supported the prohibition against adulterated or misbranded products, but asked the FDA to consider important aspects of the pipe tobacco manufacturing process, such as the importance of maintaining moisture content.

VII. Registration and ListingRegistration and listing requirements will be costly for the pipe tobacco industry, and PTC requested an 18-month delay for suppliers to meet the requirements.

IX. Ingredient Lists and HPHCs.PTC did not oppose a requirement to provide ingredient listings and reports of HPHCs, but requested that HPHC data should only be required of "new" tobacco products. Further, because pipe tobacco products are often blended and mixed, ingredient listings and HPHC reports should only be required for "base" blends.

X. Modified Risk Tobacco ProductsPTC did not oppose the requirement for FDA's premarket review of modified risk descriptors (e.g., "light", "low" or "mild") or direct or implied claims of reduced/modified risk.

XI. Vending Machine SalesPTC did not oppose a prohibition against vending machine sales in facilities where persons under the age of 18 may be present.

XII. AccessoriesPTC asked for clarification on whether pipes would be subject to regulation. The proposed rule excludes "accessories," and PTC argued that pipes fit this description.

The Pipe Tobacco Council, Inc. is the national trade association of manufacturers and importers of pipe tobacco.

Media Contact:Craig WilliamsonPresident, Pipe Tobacco Council(202) 223-8204cwilliamson@cigarassociation.org

SOURCE Pipe Tobacco Council, Inc.

We should exercise some caution & discretion concerning any open commentary here in response to PTC submissions etc..