America – Absinthe Legalization

~ US Legalization in 2007 ~

In 2007, after 95 years of prohibition, absinthe with less than 10ppm of thujone was finally authorised for sale in the United States. This remarkable development was largely thanks to the efforts of two companies, working independently of each other: the small family owned Kübler distillery in Switzerland (the same distillery, that two years earlier, had been instrumental in the re-legalization of absinthe in Switzerland itself) and Viridian Spirits, a new startup headed by Jared Gurfein, a New York attorney. There is some dispute as to which of the two companies deserves the lion’s share of the credit. Kübler undeniably were involved in the legalization process far early than Viridian were, equally undeniably though it was Viridian’s Lucid absinthe which was first to market in the US, a few months ahead of Kübler.

It appears that the Alcohol and Tobacco Tax and Trade Bureau (usually abbreviated to just TTB ) pursued entirely independent negotiations with both companies simultaneously, with hard-won concessions to the one company not necessarily immediately resulting in similar concessions to the other. Ultimately of course this is academic – the important thing is that thanks to their joint efforts, the door to legal absinthe sales in the US has at last been re-opened.

The informal account below of the entire 4 year process from Kübler’s perspective, is based on an online interview with Mr. Robert C. Lehrman of Lehrman Beverage Law, PLLC, the law firm who assisted Kübler in their protracted negotiations with the TTB and the FDA, and published with his permission. Included, by kind permission of Mr. Lehrman are several documents illustrating different stages of the process. This is followed by a parallel first-hand account from Mr. Gurfein of the legalization process as seen through Viridian’s eyes.
For further clarity we’ve also added a transcript of the most recent TTB circular which outlines the current requirements for legal absinthe in the US, as well as the TTB standards for thujone testing.

When did the whole process begin?
Kübler of Switzerland set out to legalize quality absinthe in the US in 2003, a short time after working to change the Constitution in Switzerland to once again permit the legal manufacture and sale of absinthe there.

How did you as a lawyer get involved?
I began specialising in US alcohol beverage law in 1988. In the late 1990s I worked on Absente Liqueur; this is the closest to traditional absinthe that US law would allow at the time. In 2003 a Texas-based alcohol beverage importer asked me to seek approval for Kübler Absinthe. It was obvious that it would be a giant struggle, and I tried to convey this to the Texas importer (Dan Dotson) and Kübler. To Dan’s credit, he was undaunted. As a good Texan, he didn’t want to hear about all the impediments. A month later I sent a bill for the first few hours of work. Dan expressed dismay. In turn, I was surprised that Dan thought a few hours was too much, and so obviously we had some talking to do. We talked it through and came to an understanding that held up well over time; it gave me an incentive to spend as many hundreds or thousands of hours as may be necessary, so long as there was a good chance we would prevail eventually.

What were the initial steps taken? And how was the product formulated?
During 2004 we made good progress toward obtaining TTB approval for the traditional Kübler Absinthe formulation. A few weeks after submitting samples and documentation for analysis at TTB’s laboratory, and after just a few discussions, we were delighted to learn that TTB had confirmed that the product was safe, and that TTB would not require any changes to the formula. This was especially critical because Kübler was not willing to change the traditional formulation. Kübler Absinthe dates back to 1863 and has been made according to the same recipe by four generations of the Kübler family, in the Val-de-Travers. Based on my available information, this is more than two and a half years before TTB agreed to allow any other absinthe (with Artemisia absinthium, fennel, anise and thujone).
But there was one serious problem. TTB would not allow it to be labelled as “absinthe.” TTB said it was an illegal drug term. On the other hand, Kübler was, as I think you can imagine, not interested in removing this term or calling it something like herbal liqueur.

So the actual use of the word “Absinthe” was a bigger problem than the thujone content?
Yes. We spent the next two years evaluating whether to use a term slightly different from absinthe, or take out the thujone, or to get litigators involved. The first two ideas would have been temporary measures only. But Kübler was not interested in selling a compromise product. Peter Karl (Kübler’s export manager) said “we will never call a horse a pig”.

You’d reached a kind of impasse. How did you move forward?

By 2007 the project had chewed up thousands of hours of my small law firm’s time. I decided that we had to find a way to win or lose and be done with it, or risk running my practice into the ground. I consulted with several big-time FDA experts and litigators. We had assembled a considerable budget, but many of the other lawyers advised that the odds were not good.

Instead, we turned to the Swiss Embassy. We thought this might help because, based on the prevailing demonization, it seemed natural that TTB would have a fairly strong and negative view of those trying to “cash in” on this “dubious” stuff. The debonair Embassy person was very skilled at removing this impression. He was able to explain that absinthe is newly legal in Switzerland, Kübler is an old-line, respected, family business, and the Embassy would like to see this fine Swiss culinary product approved unless there is a good reason otherwise.

Over several weeks, we pressed for a meeting in Washington. In February 2007 TTB agreed to meet with us. TTB had about 10 officials at the meeting, including a TTB attorney and Gracie Joy (in charge of spirits labels and formulas). On our side we had Peter Karl, Urs Broennimann from the Embassy, Dan Dotson, myself and my law clerk. We made our points for about two hours. TTB listened politely and said little, even when we raised questions. TTB did not agree or disagree when we explained that it was safe, and that it complied with all duly promulgated rules from TTB, FDA and Customs. Then, without fanfare, the TTB person in charge said “we will not allow absinthe to be larger than the brand name.” Wow. With that we had almost everything we needed. We spent the next 45 minutes trying to ensure that we heard correctly, and confirming the details. Peter and I rushed back to my office and got on the phone with the graphic designer. We implemented several TTB recommendations (they were mostly peripheral) and re-submitted the label the same day. TTB moved slowly and cautiously. They didn’t like the bold print on the back label (absinthe in bold). They said 33.8 fluid ounces should be 33.82. Each little back and forth took a few weeks. Near the end, TTB raised concerns about the thujone. I suggested that TTB should qualify the label approval by requiring that the “finished beverage must be ‘thujone free’ as per 21 CFR 172.510.” We got label approval a few days later. It took extra time because Kübler refused to compromise anything beyond font sizes. Various press accounts and other evidence suggest that other brands may have made critical changes, such as lowering their thujone level or in the case of Absinto, actually avoiding the term “absinthe”. Peter Karl’s instructions to me were that “we will not compromise the integrity of authentic Swiss absinthe.”
From the point of our meeting and after, TTB was incredibly open-minded about this topic, and gave us lots of time and attention. TTB gave us all the assurances we needed, in the meeting, so that Kübler could go forward confidently and ramp up production, for the US market. TTB approved another brand within a few days after Kübler’s meeting at TTB. As soon as the policy shift became public, in this manner, we accelerated our efforts to get formal, public, label approval. Three years after the initial submission, TTB approved the Kübler label.

What do you think were the principle factors that persuaded the TTB to change its view on legalization?
In addition to showing it’s safe and compliant, one of our main arguments was that TTB’s continued refusal to allow Kübler in no way means absinthe will not come in. It only ensures lawlessness (untaxed, unregulated absinthe with no formula approval, no label approval and no government warning). Google made this very easy to prove, showing thousands of illicit sources. TTB seemed concerned (a bit surprised) and certainly did not minimize this issue. We asked what they have been doing to stop the flow of illicit absinthe. They had very little to say. We suggested that there may be no better way to foster compliance than to cooperate with the people like Kübler who are trying to play by the rules.

A few days later, TTB said they had checked with FDA and it may be better for us to wait, until FDA decides how to handle this. Fully aware of the FDA situation, we explained that we don’t want to wait any more and we are confident Kübler complies with all the relevant laws and regulations. A few days after that, we cleared the way with US Customs. At no point did TTB suggest (or demonstrate) that Kübler conflicted with the rules or regulations. That is, it was not necessary to change any laws or regulations or even interpretations. It was only necessary to change TTB’s mindset. For decades “everybody knew” (wrongly) it was bad, illegal stuff – without looking at it in a fair, clear-headed manner. It strikes me as a cautionary note about governmental and human institutions in general (capable of massive self-deception and illogic). At one point TTB summarily urged us to “delete all references to absinthe because it’s a drug term (no matter how spelled).”
There were very few Eureka moments. Instead it was hundreds of emails, dozens of phone calls, a few meetings – over the span of four years and thousands of hours. Also, it was knowing deep down that it’s all a huge misunderstanding, a historical accident not supported by facts or logic or law.

I feel strongly that Kübler did most of the heavy lifting – in the US and in Switzerland – to put an end to the nonsense. I think they deserve credit for doing something important, and for paving the way for all the other brands sure to follow.

It’s possible that several other companies helped. Some are saying they spent a lot of money lobbying FDA in late 2006, but the currently available information shows that FDA had no real qualms about this after 2004. Also, I do not understand why there should be fanfare about the realization that pre-ban absinthe had only a low level of thujone. Kübler knew this and took it as a given since minute one of our project; it was never an issue. FDA and TTB never said otherwise. It may be important as a matter of history but has no bearing on the legal situation in the US. A discovery that pre-ban absinthe had very little thujone would have almost nothing to do with TTB/FDA relaxing the ban.

So thujone itself was a surprisingly minor issue in the whole process?
There was almost no discussion about thujone (among TTB and Kübler). The FDA rule says thujone can’t be over 10 ppm. This was obvious since the initial inquiries, going back at least 10 years. Back in 2003, Kübler said fine, it’s not a problem because it’s well within the normal range (as subsequently shown by Lachenmeier, Nathan-Maister and others).

At many stages, TTB was seemingly more concerned about the “wicked” term “absinthe” as compared to concerns about thujone. As far back as 2004 we pressed TTB to test the thujone and all other aspects of Kübler and confirm that all is within federal specifications; there was very little discussion about it thereafter.

Also, there was no real need to have a discussion about the thujone because TTB has its own laboratory, about 15 miles outside Washington, with about a dozen beverage and flavour chemists. They were quite capable of figuring out, for themselves, that the product at issue was within all pertinent limits.

Throughout the four years, we knew we could probably bring absinthe to the US at almost any point, if we made enough compromises. But Kübler preferred to be patient for just a few more years, after already waiting more than 90 years, and it was a thrill see Kübler Swiss Absinthe come back to life in the US, without compromise. The new importer (Altamar Brands, LLC, with a lot of industry heavyweights) is on course to roll it out nationwide.

Viridian Spirits

The other pioneering company involved in the US legalization effort was Viridian Spirits, who although starting the process several years after Kübler, actually brought their product, Lucid Absinthe, to market a few weeks earlier. Mr. Jared Gurfein, the founder of Viridian, has kindly given Oxygéneé the following account of the legalization process:

History of Viridian Spirits

In early 2006, while working as a corporate lawyer in New York, I formed Viridian Spirits with a close friend (Jonathan Bonchick) who is the third generation in his family in the U.S. spirits industry. I had lived in Europe and during that time had become entranced by Absinthe. So when we formed our company, our goal was simple: revive Absinthe in the U.S.A. We formed a partnership with a couple of close friends, funded the company sufficiently for a long legal fight, and retained one of the most respected lawyers in the U.S. spirits industry – Vince O’Brien (former general counsel of Seagrams) – to help us in our task. And of course we partnered with Ted Breaux and the Combier distillery to produce our product.

The Legal Process

In early 2006, our attorney made some informal inquiries with the U.S. Alcohol and Tobacco Tax & Trade Bureau (TTB) about the possibility of bringing absinthe into the U.S. TTB quickly informed our lawyer’s staff that absinthe was ‘prohibited’ from being imported. Indeed, an official at TTB told our attorney that “Absinthe is not allowed, and whenever it comes up, it usually just goes away”. Early in 2006, before finalizing things with Ted, I had also approached Yves Kübler and Peter Karl of the Blackmint distillery (Kübler Absinthe) people for whom I have great respect. I emailed Peter Karl asking whether his distillery would be interested in working with us. In his response, he said that he had been approached by importers for a few years and had fought with the government but, that as of early 2006, he still did not have any permission to import Kübler. He even went on to ask me to keep him advised if I had any better luck with the government. Between the government’s dismissive response, and Peter Karl’s email, we could only conclude that we were at square one with the government. Certainly others had made the effort, but there was very little we could see of any progress in early 2006. However, we were determined to open that still sealed door. We engaged in a very expensive, persistent legal campaign with TTB. Lucid’s formula itself was not problematic. Indeed, Wormwood has long been a permitted flavouring ingredient in alcoholic beverages (since the 1970’s), and, like many pre-ban absinthes, Lucid’s thujone level was below 10 ppm. But the TTB had a problem with the very concept, and hence, labelling of a product as an “Absinthe”. They believed the term “Absinthe” was code for ‘drugs’ regardless of what actually was inside the bottle.

To combat that rigid thinking, despite being repeatedly turned away, we overwhelmed TTB with information in a campaign that we stepped up in the summer of 2006 that included nearly daily contact with them. First, we presented historical information about the real nature of true, Belle Époque Absinthe and the wine industry’s campaign to discredit it in the early 1900’s. We sent videos prepared by and featuring Ted Breaux, statements filled with information, and even a legal brief I authored showing TTB that there did not exist a single rule, regulation or law in the U.S. that actually banned the labelling or use of the term “Absinthe” in any way. We went so far as to prove that the 1912 Food Inspection Decision that originally banned absinthe was repealed in 1938 by the creation of the FDA, and had not been enforceable even prior to 1938. After countless hours of real negotiation and discussion, we began to see the light of day. First, in October 2006, our formula for Lucid was approved without much incident. By then we had already been discussing the label for months. Once we submitted it formally, we were told that because of the research and materials we presented, TTB had decided to do a full internal assessment of the concept of absinthe, and would get back to us soon. Finally, after continued, near daily contact with TTB through the remainder of the winter, we had a final meeting in February 2007 in which we, at long last were able to settle the open label issues, including the manner in which we could actually use the term ‘absinthe’. Nearly every element of the label was discussed, and most of our original label submission was approved. The key was they required that we add a word next to “absinthe” to distinguish it from any negative imagery. At the meeting, we proposed ‘Traditionelle’ but they said they needed time to consider it and then rejected it shortly after.

Next, at the suggestion of Combier and Ted Breaux, we proposed ‘Supérieure’ – this actually took place in a multi-email exchange among TTB officials, our attorneys and me. Upon receiving an email approving the term, we immediately filed a trademark application for the phrase, which is still pending at the US PTO. About a week later, after that final issue was resolved, on March 5, 2007 TTB granted our formal approval, and Lucid officially became the first genuine absinthe legally allowed to be imported into the U.S. since 1912. We unveiled Lucid in April at the WSWA wholesaler show in Orlando, and sales began in May in New York City. The real credit for all of this goes to Ted Breaux for the role he played with our company, both in creating Lucid, as well as in the support he gave us in our negotiations with TTB – TTB acknowledged that they were very impressed with Ted and several officials knew of him and had researched him. I also want to acknowledge the early perseverance of Yves Kübler and Peter Karl which surely helped our quest, having put the TTB on notice that this was not going to just ‘go away’, and they deserve credit for making that first, early push. I am glad that their product was the next to come to market, again representing genuine absinthe, and not a cheap imitation. And finally, a great deal of credit should go to our attorney, Vince O’Brien, and one of his former staff members, Deborah Ringo, who did most of the daily groundwork spending countless hours wrestling with folks at TTB. Deb is the unsung hero in all this, who deserves a great deal of credit for all the work she did.

DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade Bureau Industry Circular
Number: 2007-5
Date: October 16, 2007
Use of the Term Absinthe for Distilled Spirits
To: Beverage Distilled Spirits Plants, Importers, and Others Concerned.

PURPOSE
This circular explains the Alcohol and Tobacco Tax and Trade Bureau’s (TTB) policy regarding the use of the term “absinthe” on labels of distilled spirits products and in related advertising material.

BACKGROUND
Generally, absinthe, or absinth, is a high alcohol content, anise-flavoured distilled spirits product derived from certain herbs, including Artemisia absinthium, or wormwood. Wormwood usually contains the substance thujone, which is purported to have hallucinogenic or psychotropic effects. Absinthe was popular in the late 19th century and early 20th century, particularly in France, and was often portrayed as an addictive and psychotropic beverage due to the presence of the substance thujone. TTB and its predecessor agencies have rejected applications for certificates of label approval (COLAs) or proposals for labels with reference to absinthe because the agency frequently found that the proposed label was misleading or referenced drug use, or that the product was a health hazard.

Recently, TTB received inquiries about obtaining label approval for absinthe-related products and for the use of the term “absinthe” on COLAs. As a result of these inquiries, we are restating our position with regard to how the term “absinthe” may be used on labels and in advertisements.

TTB’S POLICY REGARDING THE USE OF THE TERM “ABSINTHE”
Thujone-Free.

We approve the use of the term “absinthe” on the label of a distilled spirits product and in related advertisements only if the product is “thujone-free”; pursuant to the Food and Drug Administration’s (FDA) regulation at 21 CFR 172.510. Based upon the level of detection of FDA’s prescribed method for testing for the presence of thujone, TTB considers a product to be “thujone-free” if it contains less than 10 parts per million of thujone. However, should the FDA set a new standard for “thujone-free”, in accordance with 27 CFR 13.51, COLAs that are not in compliance with that revised standard will be revoked by operation of regulation.

Labelling and Advertising.
In addition to the requirement that a product be “thujone-free”, TTB applies the following guidelines in approving labels and reviewing advertisements:
Since there is no class and type understanding, the term “absinthe” may not be used as the brand name or fanciful name, or as part of the brand name or fanciful name, because otherwise it would appear as a class and type designation. 27 CFR 5.42(a)(1). The term “absinthe” may not stand alone on the label; it must be accompanied by additional or dispelling information so as not to appear as the class and type designation. 27 CFR 5.42(a)(1). Any artwork or graphics on the label, advertising, and point of sale materials using the term “absinthe” may not project images of hallucinogenic, psychotropic, or mind-altering effects. 27 CFR 5.42(a) and 5.65(a). TTB will include the following qualification statement on all approved COLAs showing the term “absinthe” on a label: “The finished product must be “thujone-free” pursuant to 21 CFR 172.510”.

Submission of Samples.
Domestic producers and importers of products using Artemisia absinthium, or other ingredients containing thujone subject to 21 CFR 172.510, must submit a sample to the Beverage Alcohol Laboratory for thujone testing prior to seeking label approval. You must submit a 750 millilitre sample of the finished product, along with a copy of your permit and the formula for the product. For screening purposes, the method we use to determine whether the product contains less than 10 parts per million of thujone, is a liquid-liquid extraction – GC/MS method. We have posted more information on this method at http://www.ttb.gov/ssd/screening.shtml.

Imported Products.
Although TTB may approve the use of the term “absinthe” on the label under the standards outlined above, U.S. Customs and Border Protection (CBP) is responsible for administering the laws and regulations regarding the admissibility of merchandise into the United States. COLA approval by TTB does not constitute approval for admission into the United States. We have advised CBP of our position.

TTB Standard for Screening of Distilled Spirits for Thujone by Gas Chromatography-Mass Spectrometry.

Scope:
TTB has developed a gas chromatography/mass spectrometry (GCMS) screening method that may be used to quantitate total thujone (alpha + beta) in distilled spirits. The method has not been validated for wines, malt beverages, or non beverage products. Since menthol is added as an internal standard, all test samples should be verified for the absence of menthol. The following is a synopsis of TTB’s thujone screening method. The full screening method will be posted on TTB’s website in December 2007.

Method:
Stock Solutions and Calibration Standards 500 ppm (-)- α-Thujone (≥96% pure) and 1000 ppm Menthol (≥99% pure) stock solutions are prepared in ethanol. Five calibrations standards are prepared in 40% ethanol to contain: 1 ppm a-Thujone and 10 ppm Menthol; 2 ppm a- Thujone, 10 ppm Menthol; 5 ppm a- Thujone, 10 ppm Menthol; 20 ppm a- Thujone, 10 ppm Menthol; 50 ppm a- Thujone, 10 ppm Menthol.

Sample Preparation and GCMS analysis
5 ml of each calibration standard and 5 ml of testing sample(s) are transferred to separate glass test tubes. The testing samples are spiked additionally with menthol to 10 ppm. Upon the addition of 5 ml of saturated sodium chloride solution and 5 ml of methylene chloride, the solutions are extracted and the organic layer (bottom) is removed and placed into a GC vial for analysis.
N.B. If the alcohol content of the testing sample exceeds 45% ABV, the testing sample is diluted with DI water to 40% ABV and 5 ml of the resulting solution is extracted as described. GCMS parameters: Scan acquisition mode; splitless injection; constant flow; DB-Wax or a similar 30m capillary column.

Calculations and Reporting Data
Using the alpha-Thujone/Menthol ratio calibration curve, determine the total amount of thujone in the sample as the sum of alpha- and beta-thujone in ppm. The beta-thujone value is based on the alpha-thujone calibration curve. If the testing sample was diluted prior to extraction, the dilution must be factored. The GCMS screening method has a limit of quantitation of approximately 1 ppm.