New FDA Regulations: How Do They Impact the Pipe World?
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Kevin Godbee - Aug 2, 2016
- 6 min read
Tom Wolfe
There has been a lot of hype and rumor the last few months about the new FDA "Deeming" rules that go into effect on August 8, 2016. What with the Nashville Pipe Show being cancelled, and several pipe makers deciding to quit the business, there is a lot of panic in the industry.
First, a little background is in order. Congress passed the Family Smoking Prevention & Tobacco Control Act of 2009, which granted the FDA authority over cigarettes, roll-your-own and smokeless tobacco. The law also allowed the FDA to "deem" new products to be covered under the law. E-cigarettes became popular in the US after the law was passed, so the FDA "deemed" them to be covered. Unfortunately, the FDA also decided to "deem" cigars and pipes while they were at it. (Yes, you can blame the Obama administration for this.)
The FDA’s new definition of a "tobacco product" includes pipe tobacco, pipes and their parts. The rules cover manufacture, packaging, and sales. Importers of tobacco products must ensure that the tobacco products they import are in compliance with the law.
US pipe and tobacco makers (but not importers) are required to register with the FDA. They require business information, a product listing, and advertising samples for each product they manufacture.
Any new products that were not on the market on 2/15/2007 must submit a Premarket Tobacco Application that is wildly expensive. (Not even the FDA is willing to estimate the cost.) The only ways to avoid this is to prove that the new product is substantially equivalent to one on the market on 2/15/07, or to apply for an exemption for standard equivalence. Proving that your product is substantially equivalent to somebody else’s product is not acceptable.
Furthermore, only pipes and pipe tobaccos that were on the market on (not prior to) 2/15/2007 are grandfathered in. Reintroduction of an old pipe model or tobacco blend is considered by the FDA as a new product. A recent lawsuit was filed to stop the FDA from punishing the pipe & cigar industries. More on this later, first let’s see the impact of the current regulations.
Pipe Makers
The FDA deeming rules are being applied to pipes as a "tobacco product," and must be viewed in that light. Importers may just give up, not wanting to deal with the costs involved. Some of our favorite pipe brands may disappear from the US market.
The FDA is officially making no exceptions for artisan pipes. One-of-a-kind pipes may become extinct. Samples of new tobacco products must be submitted to the FDA. They recommend providing 20. How many artisan pipe makers do you think have the luxury of ‘donating’ 20 identical copies of each pipe they make?
Nonetheless, it is unclear how the FDA will enforce the rules regarding pipes, as the rules are obviously oriented towards tobacco. For example, none of their rules about product labeling apply to pipes. What is clear is that the FDA is clueless about pipes.
Pipe Tobacco
The FDA will also put many small tobacco blenders out of business. These rules will essentially close down the market for all new pipe tobacco blends. Standard Tobacco of PA has already announced that their blends (shown below) will no longer be made. They are just the first.
Older blends, which have been grandfathered in, will still need to have new warning labels taking up 30% of the tin. "WARNING: This product contains nicotine. Nicotine is an addictive chemical." These warning labels must be on all pipe tobacco manufactured after May 18th 2018. [Editor’s note: Nicotine naturally occurs in tomatoes, potatoes, eggplants, cucumbers and green peppers.]
Pipe tobacco (and pipes) will also be subject to FDA "user fees" that are in addition to the current federal tobacco taxes. Wholesale prices will go up. Nobody knows how much.
Retailers
As of 8/8/16, brick and mortar tobacco shops will no longer be able to custom blend tobacco for you. Blending tobacco is considered manufacturing by the FDA. So, custom blends are now a thing of the past. Also, no more free samples. Retailers will not be able to sell tobacco without a health warning after May 18, 2018. Fortunately, most imported and most domestic tobaccos already have California-mandated health warning labels. This will be sufficient.
The "manufacturing" handle also applies to simply packaging bulk tobacco. Many "house blends" will disappear from individual tobacco stores, as they can’t afford to meet the new FDA requirements. Jeff Packer, a Tinder Box franchise owner, stated that the Tinder Box blends will be prepackaged by their headquarters in several sizes.
Other shops’ bulk blends will have to be prepackaged and marketed using their distributor’s name. For example, one popular blend that is currently sold at retail stores under many names. In the future, it will be prepackaged as "1-Q."
The Lawsuit
The International Premium Cigar and Pipe Retailers Association (IPCPR), along with the Cigar Association of America and the Cigar Rights of America, filed suit in Federal District Court on July 15th against the FDA’s deeming rules. The lawsuit is well worth reading. It describes the issues far better than FDA’s website. It all boils down to these points.
- The FDA rules on pipe tobacco and cigars are more restrictive than Congress intended.
- The FDA’s "user fees" are essentially restrictive taxes.
- The FDA did not determine the costs vs. benefits of these rules.
- Congress could have added pipe tobacco and cigars in the original legislation and did not. Therefore, Congress clearly, did not intend for the FDA to regulate these products.
- Retailers that blend and package tobacco for customers should not be considered tobacco manufacturers.
- Pipes should not be considered "tobacco products."
The lawsuit asks the court to completely vacate these FDA rules. This is not the only lawsuit filed against the FDA Deeming rules. Just don’t count on lawsuits stopping this madness. The court may place a temporary injunction, but barring a miracle, most of the rules will remain.
The Bottom Line – Start stocking your cellars now!
A glut of new blends has shown up on the market in the last few months. Pipe tobacco makers are rushing to get on the market before the August 8th deadline. What you see now, is what you get. You won’t see many new tobaccos for quite a while, if ever.
Pipe tobaccos that came on the market between 2/15/07 and 8/8/16 have two years to submit their products for approval. This process is quite expensive, prohibitively so! I have heard estimates ranging up to $250,000 per item.
Many of these blends will disappear over the next 18-24 months, as supplies dwindle. Those that remain will be more expensive.
Artisan pipe makers may well be advised stay under their radar. The FDA is hunting for bigger fish to fry. Pipe shows may be the one saving grace for pipe makers. After all, gun shows have survived many years of scrutiny by the feds.
Don’t bother complaining to the FDA; the comment period is over. Let us all hope the lawsuit vacates the deeming rules.
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Written by Kevin Godbee
26 Responses
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That’s a dry-eyed step-by-step walk through the deeming regulations as they are written and currently expected to be enforced. If the law suits delay and waylay the process, that may be a saving grace, but clearly that’s not to be expected. The effect on pipe manufacture or hand crafting sounds especially ominous, not least for our friends and compatriots at Sparta, N.C., at the Dr. Grabow plant, and Washington, Missouri, at the Missouri Meerschaum plant. And at blending workshops throughout the U.S. and beyond (beyond as relates to importing, etc.). So maybe estate pipes (and all of the pipes on your rack) will be worth five times what you’d ask today, but that isn’t much fun, nor solace. Most of us don’t won ’em to sell ’em anyway. Thanks, Tom, good story, hard reality. Looking for a brighter day.
I’m obviously missing something here.
I’m looking at the FDA’s published document on rules governing tobacco product manufacturers and importers. on page 3 of their summary the FDA explicitly EXCLUDES “components and parts not made or derived from tobacco”. On page 5 the FDA gives EXPLICIT examples of items EXCLUDED from regulation including “Pipe, mouthpieces, pipe bowls”. So please explain to me, when the FDA EXPLICITLY EXCLUDES REGULATION of these items in its PUBLISHED GUIDELINES how any of this requires pipe carvers to provide 20 example of their work for FDA approval. Either I’m missing something, or somebody else did and error is becoming a “fact”.
There are other parts of the article that don’t exactly gibe with what I’ve read, but let’s start with that one.
I,too, agree. This is somewhat different from what I’ve been reading. I also don’t believe that all of this will stick. The silence in response to this article is palpable.
The web page defining the FDA Regulation of Pipe Tobacco specifically states “This includes components and parts such as pipes, but excludes accessories such as lighters.”
Here is the link: http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482580.htm
My honest opinion ,in french, f—- them. Don’tworry till they knock on your door. And in all likelihood, they won’t. This is tantamount to the Volstad act and it just won’t-Jeb yes, I’m not afraid to voice my opinion. There are loopholes.
Carry on your business as you have. Let them come see you,and make the first move.Dee
The FDA COULD be about to seriously impinge, and eventually to “abrogate”, the civil rights of the “original pipe makers & smokers”, Native Americans themselves.
I say this because where the FDA seems to be strongly intending to affect the availability of much more than just pipe mixtures themselves, but just about everything involved with our enjoyment – pipes, pouches for tobacco, “you name it” – just as “sablebrush52” has reminded us that the “FS & TCA” from 2009 PROHIBITS the FDA from affecting ANYTHING more than pipe mixtures, PERIOD.
With a serious number of the 600+ Federally- and state-recognized Native American tribes (the number for the entire United States), for those tribes within that number living east of the Rocky Mountain Continental Divide that still have involvement with tobacco as a traditional part of their cultures and traditions, and everything that’s connected with them, ANY move by the FDA – even the long-feared “tobacco-pocalypse” of a 16-fold increase in pipe mixture Federal excise taxes to hearly $50/pound, among many other measures the above article includes – WOULD impact such long-held civil rights of indigenous Americans, something they should NOT be expected to ignore in any manner.
A recent attempt to auction off Chief Red Cloud’s catlinite, or “pipestone” bowl/shank ceremonial pipe by the State of Texas – in VIOLATION of Federal law – is being opposed vigorously by the Oglala Lakota of today, as mentioned at http://thinkprogress.org/justice/2016/06/07/3785666/native-american-auction-cultural-items/ as evidence of HOW strongly some tribes feel about anyone messing with their civil rights…(just copy & paste if it’s not an active link to get there)…and likewise, the native peoples of the USA have their own civil-rights-related site at http://www.narf.org/ .
If the FDA manages to get so “controlling” concerning pipe tobacco AND everything that goes along with it, that involves both general American culture, AND the Native American tribal nations that have always had, and continue to have a cultural and spiritual involvement with pipes and their tobacco, it IS eventually going to impact them as well…and in a much more serious manner…as it IS, quite likely — even if it’s seem by some as a non-intentional “infringement” of such rights — the tribal cultures being affected will quite rightly see such FDA action as a central attack on Native American civil rights regarding pipe tobacco and everything else that’s directly related to such traditions and culture.
Check this – sent over from the author – I haven’t had a chence to read it yet –
http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482580.htm
The problem is that pipes are defined as “components or parts” of pipe tobacco. It doesn’t make sense, but that is why it is part of the lawsuit mentioned in the article.
“In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including pipe tobacco. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of pipe tobacco. This includes components and parts such as pipes, but excludes accessories such as lighters.”
See the following link for details: http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm482580.htm
Thanks Kevin.
I touted contacting our Congressmen/women, but now, of course, they are on Summer “recess”. But THEIR OFFICES STILL WILL TAKE OPINIONS FROM THEIR CONSTITUTENTS – PLEASE CALL THEM TOMORROW! Let them know that this overkill will eliminate multitudes of jobs, shut industry and retailers, is restraint of trade, and is an affront to ADULT CITIZENS’ freedoms. Also, Mitch Zeller, the head of the Center for Tobacco Products division of the FDA is a former lobbyist for pharmaceutical companies that produce “smoking substitution products”. Ask your Congressman to start an investigation into Zeller’s conflict of interest.
A question: cannot individuals and retailers, in some way, join these lawsuits? And/or file letters to the courts expressing our testimony and dissatisfaction with this action taken by the FDA?
To sablebrush52, I have only found the online version of the FDA deeming regulations. No page numbers given. However on one of the summary pages, tobacco components are specifically stated to include pipes. I have not found the ‘exclusions you mention. I would be very appreciative if you could give me a link to the full regulations you reference in your comment above. Thanks!
The FDA uses three different definitions of tobacco products. “Tobacco products” includes both pipe tobacco and pipes. “Covered tobacco products” includes pipe tobacco, but not pipes. “Finished tobacco products” includes both.
I had to go back and re-read everthing, keeping those definitions in mind..
Did they do their research before making these new regulations?
Did they even know artisan pipes and pipe makers existed?
Did they know about the yearly limited once off holiday pipes made?
Did they know about the yearly limited once off holiday pipe blends?
Did they know about house pipe blends?
Did they know about limited batch blends or special edition blends?
What about estate pipes and vintage tobacco sales?
How can you regulate without the research?
I think there will be much information presented at the lawsuit which of which the FDA did consider or know about.
-Tim
Clearly the FDA needs to be destroyed!
I’ve only just taken the trouble to read this. I was vaguely aware something was afoot in the States and that it was detrimental to smokers in general but never realized the severity of the situation.
Here in the UK we have crippling taxes on anything smokeable and of course have to put up with the hideous and downright disgusting stickers plastered all over our packaging but I think compared to what is happening over the pond we should count our blessings and keep quiet lest we open up the hornet’s nest.
I always thought America was the land of the free? History may well have to be rewritten.
Good luck.
Regards,
Jay.
re “did they do their research” from timpiper: no – no one in Congress did any research – can’t you understand this. Our representatives just whole-heartedly handed over a bill (probably written by the FDA Center for Tobacco Products office of the zealot Mitch Zeller) with carte’ blanche authority. Yep, let’s give them total power over this stuff and get it out of our way.
I’ve again called the offices of my Senator and Representative today, giving my opinion on this, and asking the rep to stop the FDA deeming regulation, in order to investigate the impacts, rights and legality of this. HAVE YOU?
To timpiper
Retailers do have a problem with old tobacco stock that does not carry the newly required warning labels. They must be sold before May 2018.
Pipes would also fall under the warning label requirements, but the FDA’s required labels “this product conains nicotene” and “this product is made from tobacco” obviously do not apply. This is a great example of where pipes just “fell thru the cracks”. They are really clueless when it comes to pipe making. I am still awaiting their reply to question like this.
Yes, they do know about house blends. They just do not care. Retailers that blend their own tobacco are considered pipe tobacco manufacturers under their rules. This is true if all they do is package popular blends, like 1-Q.
As to estate pipes, the FDA makes no mention of secondary markets, so that should not be a problem. (Just do not remind them about it.)
To timpiper
Retailers do have a problem with old tobacco stock that does not carry the newly required warning labels. They must be sold before May 2018.
Pipes would also fall under the warning label requirements, but the FDA’s required labels “this product conains nicotene” and “this product is made from tobacco” obviously do not apply. This is a great example of where pipes just “fell thru the cracks”. They are really clueless when it comes to pipe making. I am still awaiting their reply to question like this.
Yes, they do know about house blends. They just do not care. Retailers that blend their own tobacco are considered pipe tobacco manufacturers under their rules. This is true if all they do is package popular blends, like 1-Q.
As to estate pipes, the FDA makes no mention of secondary markets, so that should not be a problem. (Just do not remind them about it.)
Tom Wolfe
One of my least favorite things is for anyone too stick their nose in my business, yet anti-tobacco has done this worldwide, and now in my backyard. It’s hard for me to understand FDA as anything but a powerful meddler. Good thing I have plenty of pipes and a lifetime supply of tobacco, as I foresaw this day coming, you miserable bastards!
Thank God for the “dark web”. Through browsers like Tor, we can still engage in commerce without restrictions and in total privacy. I suspect we underground pipers are considered as notorious as those who want to buy LSD and nitroglycerin.
Ok guys, so we have all these rules set forth by the FDA(nsdap) . Now, I’ve seen people throw up their hands in surrender.Well, what are the ramifications ? Are they going to throw you into prison, Fine you into bankruptcy, or what. I’m tired of seeing this automatic submission to their so called authority. Push their buttons. Just my honest opinion. P.S. If your going to throw all the tobacco into the bay like tea,let me know, I’ll take it. We either hang together or surely we shall all hang saperatly. Jeb
I really hope my comments get some folks to thinking. They may run over you, but I’ll be damned if they’ll run over me or mine (of which I hope I can include all of you !) FDA take care,we’llsee ya in court.
FDA Loses lawsuit over tobacco labeling
https://www.facebook.com/groups/unitedpipeclubs/permalink/904759139650866/
“this product conains nicotene”
Tom, for one writing about tobacco and related products I would have thought you would know how to spell ‘nicotine’. As for ‘conains’ I’m sure we can put that down to a mere typo 😉
New here,.. and returning to the pipe after a 30 year break. Glad to see there is still pipe smokers out there,.. because as of now,… I have seen none and know none. I appreciate the information found here. From the article and the following comments,… I see there is some confusion as to just what is what. I have little to offer other than my support for the cause. I too have great distain for govt. telling us what is good and not good for us.
I look forward to future updates. The simpler the better,…. as all of that lawyer “gobility gook” can be quite confusing. (just as they intended it to be,.. I am sure)
It is good to be back! 🙂