FDA rules announced
- Thread starter prairiedruid
- Start date
- Status
It will be interesting how this plays out.
I have only perused the 499 pages, but what I have gleened so far is as follows:
1. A blend that was marketed in the US on February 15, 2007 (an "Old Blend") will be exempt from requiring FDA approval.
2. If a blend was not marketed in the US on February 15, 2007 (a "New Blend"), the approval of the FDA will be required.
3. There are fundamentally two ways a New Blend can obtain approval. First, New Blends will be able to be marketed if they persuade the FDA that they are "substantially equivalent" to an Old Blend. This seems to require an application to be submitted to the FDA demonstrating, inter alia, that the blend contains the same sort of ingredients and is processed in the same way as one or more Old Blends and that fundamentally the New Blend does not pose any greater level of health risk as compared to an Old Blend. Alternatively, a far more onerous mechanism to obtain market clearance is available for New Blends, which is a pre-market tobacco application process that will require significant clinical data to be submitted for review by the FDA.
4. Given the size of the pipe tobacco market, I would assume very few blenders would want to go the latter route. Presumably, pipe tobacco manufacturers will try the substantial equivalence route, which the FDA itself suggests is the expected route for most conventional pipe tobacco.
Take STP's recently introduced War Horse blend for example. Even though the name of the blend is old, it would seem that it would likely be classified as a New Blend because War Horse was not marketed in the US on February 15, 2007. Based on what I have read, this would seem to mean that they would have to apply to the FDA to demonstrate substantial equivalence between War Horse and an Old Blend. Objectively, one would hope that this would be easy to do - there are numerous Old Blends that I am sure are comprised of similar, if not identical, tobacco and undergo fundamentally the same type of processing, and I expect that the same could be said for many other New Blends.
What concerns me, however, is how tough the whole substantial equivalence process is going to be. My worry is that there will be so many applications submitted that these New Blends will be stuck in an interminable bureaucratic limbo while the FDA sits on its hands or applies an unrealistically impossible standrard for measuring substantial equivalence.
I have only perused the 499 pages, but what I have gleened so far is as follows:
1. A blend that was marketed in the US on February 15, 2007 (an "Old Blend") will be exempt from requiring FDA approval.
2. If a blend was not marketed in the US on February 15, 2007 (a "New Blend"), the approval of the FDA will be required.
3. There are fundamentally two ways a New Blend can obtain approval. First, New Blends will be able to be marketed if they persuade the FDA that they are "substantially equivalent" to an Old Blend. This seems to require an application to be submitted to the FDA demonstrating, inter alia, that the blend contains the same sort of ingredients and is processed in the same way as one or more Old Blends and that fundamentally the New Blend does not pose any greater level of health risk as compared to an Old Blend. Alternatively, a far more onerous mechanism to obtain market clearance is available for New Blends, which is a pre-market tobacco application process that will require significant clinical data to be submitted for review by the FDA.
4. Given the size of the pipe tobacco market, I would assume very few blenders would want to go the latter route. Presumably, pipe tobacco manufacturers will try the substantial equivalence route, which the FDA itself suggests is the expected route for most conventional pipe tobacco.
Take STP's recently introduced War Horse blend for example. Even though the name of the blend is old, it would seem that it would likely be classified as a New Blend because War Horse was not marketed in the US on February 15, 2007. Based on what I have read, this would seem to mean that they would have to apply to the FDA to demonstrate substantial equivalence between War Horse and an Old Blend. Objectively, one would hope that this would be easy to do - there are numerous Old Blends that I am sure are comprised of similar, if not identical, tobacco and undergo fundamentally the same type of processing, and I expect that the same could be said for many other New Blends.
What concerns me, however, is how tough the whole substantial equivalence process is going to be. My worry is that there will be so many applications submitted that these New Blends will be stuck in an interminable bureaucratic limbo while the FDA sits on its hands or applies an unrealistically impossible standrard for measuring substantial equivalence.
Peck - FDA has 180 days to act on an application or it is approved. I think blends without toppings should be easy to get approval. It's all the ingredients used as toppings, from full-on aromatics to blends with a slight hint of something or other. I think those will be tough. And "match" blends including things like the new WarHorse seem to have an uphill battle because presumably they don't have access to the exact original recipe.
jmatt, I saw the 180 day reference for the full pre-market application process, but not for the substantial equivalence process. But if the 180 days applies to both, then that would at least put a timeline on it.
And this is partly what I meant by referring to how the FDA would determine substantial equivalence. As long as warhorse contains the same types of tobacco (albeit perhaps in different quantities) than other Old Blends, then I hope that would be sufficient. I mean should it really matter if a blend has 40% burley and 60% Va while another blend is 50/50?
I agree with your observation on aromatic blends and blends with toppings that are not used in any old blends.
Would love it if Russ or GL Pease or Dan/Simon could chime in with their thoughts on how this will play out and what it all really means. I am sure those guys will have read this thing cover to cover.
I find it interesting that there is a very apparent effort to remove any flavorings from tobacco. In other words, they don't want tobacco to appeal to those who like, generally, sweeter products. I doubt that sweeter tasting products are any worse, or better, for us than unflavored blends. If tobacco is so bad that "they" want to restrict its use, why not ban it altogether? Because they have no definitive proof of direct causation, only opinions.
I also find it interesting that "they" want to ban sweet tobacco products but allow sweetened alcohol.
It all boils down to forcing one group's opinions and morals on others.
I also find it interesting that "they" want to ban sweet tobacco products but allow sweetened alcohol.
It all boils down to forcing one group's opinions and morals on others.
The other impact I fear is blends being made in Europe no longer being imported to the U.S. Not to start an even worse stampede, but think Germain (although those might all pre-date 2007), Semois, Strang?
And if you're GL Pease, does SixPence go away? If you're C&D is the "small batch" idea already dead, as I imagine it would be too expensive and time consuming to get approval for a 500 tin run of anything?
And if you're GL Pease, does SixPence go away? If you're C&D is the "small batch" idea already dead, as I imagine it would be too expensive and time consuming to get approval for a 500 tin run of anything?
We could mail a copy of John Stuart Mill's "On Liberty" to each of our congress members since liberty has definitely been chained. The FDA is just continuing the movement away from individual choice and responsibility.
Cost for getting a "new" blend approved will be at the least several hundred thousand to close to a million dollars per the FDA. That should pay for more FDA personnel; must feed the monster.
Let's just assume $200,000. If C&D did a Small Batch of 800 tins, it would cost $250 per tin just to get the blend approved. How about anniversary blends like Peterson's or W.O. Larsen (different every year)? I'd hope McClelland's Christmas Cheer wouldn't need new approval each year for another crop of straight Virginia though.
Yes, we've read this thing cover to cover. Out crack
Let's take pipe club meetings: If someone shows up with their latest favorite (a blend of Dunhill Elizabethan Mixture and Mark Ryan's Picayune), and they proceed to pass the tin around, is that person now a manufacturer handing out free samples? According to the FDA regulations, they are.
Do we now have to carefully screen new club members in an attempt to keep out FDA informants?
Did you know that the FDA has it's own well-armed response team?
This is just the beginning of a beautiful relationship...between the pipe smoker and the government.
I seriously doubt that any legal team could interpret this new FDA regulation at this juncture. Then again, I seriously doubt that even the FDA itself has any idea how to interpret their new regulation. But, that's never stopped the bureaucratic divisions of the government before as they'll just make up and fudge around with the rules as they go along to whatever suits them at any given time. The IRS is a prime example of that, and just another completely dysfunctional branch of the government that wields way too much power.
As for lawyers, most could not interpret a 'Men' or 'Woman' washroom sign. Then again, that's becoming much more difficult these days so perhaps a bad analogy.
Here are few of my preliminary thoughts on the thing. Without getting in the least bit political it should be remembered certain types of administrations like monopolies as they are easy to deal with and control especially when planning a client state. Much of this was apparent from the pre-1980 model of American capitalism were companies were controlled by professional managers for the benefit of employees and the unions and the stockholders amounted to an annoying irrelevance. Managers were often looked up to by the community but more often then not owned very little of the company. This status quo was born out of Democrat administrations total fear of the stock market and the distant echoes of the 1929 crash. All that changed in the 1980s with the likes of Sir James Goldsmith who figured out that these top heavy organizations that were nothing more than employment grounds for the offspring of the liberal elite and that the assets of the companies were many times the value of the underlying share price. Ergo you had the take over boom of the 1980s and everything zipped along for a while.
Meanwhile like every government it exists to expand the power and reach of each individual department. New issues such as gender diversity or some under represented minority require more bodies, committees, budgets and expansion. Couple that with a prohibitionist mindset and you create the perfect storm in the form of the Deeming regulations published by the FDA. In many regards its serves the interests of 'Big Tobacco' as this piece of legal flatulence puts every small player out of the game so now you will be confronted by tobacco A, B and C as offered by Big Tobacco, no choice as no competition exists. Furthermore as a sweetener they are handed the whole e-cigarette market as a monopoly as only they can afford the expensive testing which is in reality a hidden pay off to the government for delivering said monopoly.
Lets now look at the potential for a huge expansion of Federal employees in tobacco monitoring of trade shows, pipe clubs and all manner of other aspects of daily discourse. I can see the vetting of outsiders at pipe club meetings becoming the norm, of rewards being offered to snitches and a whole plethora of very nasty derivative developments all courtesy of your local DNC. We are looking very hard at all this at SToP but at this stage as no one else is willing to mount a legal challenge we are really not in the mood to carry the water for the whole industry. When manufacturers started branding RYO as pipe tobacco they gave the government the excuse and like most things repressive they are often the result of greed. Big Tobacco will be next and there will be no one there to lift a finger for them when the tobacco zealots answer to Carrie Nation shows up for a hatchet-than.
Meanwhile like every government it exists to expand the power and reach of each individual department. New issues such as gender diversity or some under represented minority require more bodies, committees, budgets and expansion. Couple that with a prohibitionist mindset and you create the perfect storm in the form of the Deeming regulations published by the FDA. In many regards its serves the interests of 'Big Tobacco' as this piece of legal flatulence puts every small player out of the game so now you will be confronted by tobacco A, B and C as offered by Big Tobacco, no choice as no competition exists. Furthermore as a sweetener they are handed the whole e-cigarette market as a monopoly as only they can afford the expensive testing which is in reality a hidden pay off to the government for delivering said monopoly.
Lets now look at the potential for a huge expansion of Federal employees in tobacco monitoring of trade shows, pipe clubs and all manner of other aspects of daily discourse. I can see the vetting of outsiders at pipe club meetings becoming the norm, of rewards being offered to snitches and a whole plethora of very nasty derivative developments all courtesy of your local DNC. We are looking very hard at all this at SToP but at this stage as no one else is willing to mount a legal challenge we are really not in the mood to carry the water for the whole industry. When manufacturers started branding RYO as pipe tobacco they gave the government the excuse and like most things repressive they are often the result of greed. Big Tobacco will be next and there will be no one there to lift a finger for them when the tobacco zealots answer to Carrie Nation shows up for a hatchet-than.
You nailed it. Here's the main factors that led to this:
1) Cigarillos, mostly considered to be large cigarettes, repackaged themselves as Cigars, avoiding regulation.
2) RYO (Roll Your Own) Tobacco for making your own cigarettes, rebranded themselves as "pipe tobacco," avoiding regulation.
3) e-Cigs, which had never existed, and the health risks of which are relatively unknown, escaped regulation.
So yes, "real" cigars and "real" pipe tobacco just got caught up in the mess.
Another big driver is flavored cigarettes are no longer legal, as the perception is adding sweet flavors to tobacco (Swisher Sweets) is/was intended by big tobacco companies as a method to get youth introduced to smoking. So if flavor additives are in the crosshairs, I fear for aromatic tobaccos, especially anything with a flavor in the name like "cherry" or "vanilla." I also wonder about the cartoon packaging of many C&D blends, as the regulators will claim the cartoons appeal to youth (think, Joe Camel) and that artwork will soon be gone as well. Especially if the artwork is newer than 2007.
P.S. I'm an avid racer (hence my avatar is me in my blown alcohol dragster), but my day job I'm a corporate attorney practicing administrative regulatory law at the federal level. I'm an energy attorney though (FERC - Federal Energy Regulatory Commission), not an FDA attorney.
http://www.dailywire.com/news/5190/5-times-transgender-men-abused-women-and-children-amanda-prestigiacomo
It's pretty simple, if you have a dick, use the men's room, if you have a vag and sit and pee in a stall, use the woman's. The problem with this is there's no rational thought involved, they've thrown the door open to any perv walking into a woman's bathroom and claming his civil rights are being violated because he can't go in a woman's bathroom. I can't wait to see the backlash against target and their reversal of this, kind of like A&E with duck dynasty. If anything "redneck" conservatives in the US have taught me, is respect their buying power.
- Status