Moonshine. A word that typically conjures up thoughts of illicit high-octane liquor, clandestine stills, mason jars, potential blindness and bearded mountain men with colorful nicknames. Producing moonshine without a license is still illegal in the United States, but a large and growing number of licensed distilleries are now producing their own interpretations of moonshine. And despite moonshine’s negative associations from the past, TTB seems to have no issue allowing the word to appear on distilled spirits labels, as evidenced by the scores of moonshine labels approved so far.  There is also an upsurge in approvals for moonshine’s cousins, such as white dog, white whiskey and white lightning.

As far as we know, there are no specific TTB requirements to label a product “moonshine.” Apparently, moonshine can be a whiskey, a specialty product with flavors of apple or blackberry (for example), a high poof neutral spirit distilled from apples, peach brandy and even tequila. Although it appears that you can call just about any distilled spirits product “moonshine,” we think it is unlikely that TTB would allow the word on beer or wine labels anytime soon.

Tags:

drinkwire, history, policy

Posted in:

alcohol beverages generally

For quite some time, I have noticed that alcohol beverage packaging tends to be prettier than lots of other packaging. Now, perhaps, I am on the verge of proving this hunch, though the manner of proof, in the form of a BuzzFeed article, may be a bit light on evidence.

The article shows the “34 Coolest Food Packaging Designs Of 2012.” Of this sampling, fully 20 are beverages. Of those, no less than 13 (more than a third) are alcohol beverages. Not bad, considering all the other categories represented, such as chocolate, cheese, jam, pasta, and bread.

Within the alcohol beverage category, I think the Slamsey’s Gin (as above) and Dancing Pines Bourbon bottles look good. I did not notice US approvals for those two, or most of the others on the list, so far. So this may be a harbinger that there is plenty of interesting work to look forward to in 2013. Of the products listed, Kraken Spiced Rum is the most familiar, and the US approval is here.

Tags:

design

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alcohol beverages generally, distilled spirits specialty

Under the new and important Food Safety Modernization Act (FSMA), FDA was supposed to commence food facility re-registrations yesterday. This was mandated by section 102 of the FSMA law, enacted in 2011.

This piece of the FSMA puzzle is not off to a propitious start. It was bad enough that there was not much guidance or clarity about how this would work, before the October 1, 2012 to December 31, 2012 re-registration period began. But it’s even worse that the brief window for required and biennial re-registration began yesterday — and yet there is still no means by which to accomplish what is required. The renewal website was briefly available last week, for a few hours, then it froze, then it disappeared, to be replaced with an oh so calm assurance that:

Biennial Registration Renewal for Food Facilities will not be available on October 1, 2012.  We therefore will not be accepting food facility registration renewals at this time.

Natural Products Insider has explained:

FDA is delaying the registration renewals that are mandated under a 2011 law after the Grocery Manufacturers Association and numerous other trade associations recently sought guidance in meeting the registration requirements.

“It would be extremely inefficient and costly for companies to re-register shortly after October 1st based on the old procedures, only to find out later they have to do it all over again after FDA clarifies the new procedures in its guidance,” wrote Leon Bruner, senior vice president, science and regulatory affairs, and chief science officer of the Grocery Manufacturers Association, in a Sept. 21 letter to the Office of Management and Budget. “Thus, it will be difficult, if not impossible, for food facilities to effectively and efficiently meet FSMA’s registration renewal mandate without guidance from FDA.”

This leaves several hundred thousand food facilities around the world, plus their required agents, with a looming and ever closer deadline, but no means by which to comply with the law.

A few weeks earlier, in late summer, two groups sued FDA “for declaratory and injunctive relief regarding the failure by [FDA] to promulgate final regulations by mandatory deadlines contained in [FSMA].” The non-profit food groups said:

FDA has missed not one, not two, but seven critical deadlines, and counting, in failing to implement FSMA’s major food safety regulations. FDA has submitted several of these unlawfully delayed regulations to [OMB], where they are still awaiting approval. However, FDA has authority to promulgate the regulations without OMB approval.

Despite this bump in the road, here’s what food companies around the world can do, to avoid missing the renewal deadline. Make sure you have a reputable FDA food agent, if you are based outside the US. Make sure that agent has up-to-date information about your facility. You should be especially careful if your agent hides its true identity, or has vaguely (and confusingly, aggressively, and in many cases not so vaguely) pretended to be affiliated with FDA. Some of the agents charge as much as $900 in the first year. If your US importer, or a friend, has handled this for you in the past, it may be time to reconsider and at least make sure your agent is aware of the changed environment. The law can subject the US agent to substantial liability for the costs related to recalls and re-inspections.

For more information about agents and registration, go to www.food-agent.com. The site is affiliated with Lehrman Beverage Law, a law firm in the Washington, DC area that has been acting as US agent for hundreds of companies around the world, since the earliest days of the FDA agent requirement, almost 10 years ago. Unlike many other leading agents, food-agent works within traditional attorney ethics rules, has moderate fees, and tries to avoid confusing food companies about their identity or their relationship with FDA.

October 19, 2012, 9 pm Update:  FDA has announced that “Biennial registration renewal for food facilities will begin at 12:01 a.m. on October 22, 2012. At that time, the system will be accepting food facility registration renewals.”

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fda

Posted in:

alcohol beverages generally

In early July TTB announced a massive and important change to the COLA system. TTB greatly expanded the “Allowable Revisions to Approved Labels” (hereinafter “ARTAL,” as on page 3 of the new 4-page COLA form).

TTB began laying the groundwork for big “streamlining” changes in early 2012, as summarized here. Although some of the ideas seemed very modest as of then, the streamlining train clearly picked up momentum in the next few months. It seems entirely possible that some of the new changes could or should cut a very large percentage of the more than 10,000 labels submitted to TTB every month. Compared to a few years ago, it is quite amazing that the lighthouse label on the left (above) could change to something as different-looking as the striped label on the right — without any need for a new COLA.

The TTB ID number on this label, for example, shows that TTB received at least 671 label applications on just one day in April 2012 — to say nothing about the labels submitted via paper. That should not happen anymore. Instead, applicants should get familiar with ARTAL. It can eliminate lots of waiting, expense, frustration, inconsistent determinations, TTB work and applicant work.

In my view, the biggest changes to ARTAL are these. Now, it’s ok to:

1. move things, as at 2.
2. change typesizes and fonts, as at 3.
3. change colors and spelling, as at 3.
4. shift amongst paper v. painted v. etched, as at 3.
5. make one COLA cover all sizes, as at 10. (Previously, the table said “separate applications must be submitted for containers of 237 ml or less, containers over 237 ml to 3 liters, and containers over 3 liters.”)
6. add/delete/change awards and medals, as at 27.

ARTAL is much more powerful now. Like other powerful things, such as a chainsaw, it can do great things when used carefully — and make big problems when used improperly.

Tags:

policy, procedure

Posted in:

alcohol beverages generally

TTB announced a big policy change — about gluten free — just before the Memorial Day holiday weekend.

For many years before the announcement, plenty of companies have tried to make “gluten free” claims, but we still didn’t see any approved TTB labels referring to “gluten free.” A few weeks back, we thought we had one, when we heard a lot of buzz about Omission beer as above. But alas, even the Omission label has had a big omission when it comes to this particular claim.

All this is about to change in a big way, as result of this TTB Ruling, released late last week. As a result, we may begin to see various gluten free claims on TTB labels in the very near future.

To show the earlier TTB policy, a fairly recent TTB rejection is here, and it may help explain why Widmer did not come out and say it louder or earlier. TTB’s caution may well have been justified; Brewbound has explained:  “The release of Omission Beer comes just a few months after a study published in the Journal of Proteome Research found that eight commercial beers currently labeled as ‘gluten-free’ contained as much gluten as regular beer.”

Brewbound further explained that there are plenty of other beers that seek to minimize or eliminate gluten, but most of the others (such as this Bard’s Tale) are made with sorghum as a substitute for malted barley:

Ordinarily a new product release wouldn’t be so newsworthy but the launch of Omission marks the first time a U.S. craft brewer has been able to produce a gluten-free beer while still using malted barley in the brew process.

In the same article, the beer company’s CEO explains:

Omission beer is brewed with malted barley, but we’ve developed a proprietary process to reduce the gluten levels to well below the internationally accepted gluten-free standard of 20 parts per million of gluten. We are currently working with the TTB and the FDA to update the definition of the term ‘gluten-free.’… The inspiration behind Omission beers was personal. I am a 12-year celiac, our brewmaster’s wife is a celiac, as are several other members of our team. … We’re also going to talk about the extensive testing that Omission beers go through to ensure that every batch of Omission beer is well below the international gluten-free standard of 20 ppm. In fact, each bottle of Omission Beer caries a date stamp connecting the brew to its specific batch. Consumers can visit www.OmissionTests.com, type in the date code stamped on their bottle, and see that beers’ test results. … An estimated three million Americans have celiac disease.

Even though there is little to no gluten talk on Omission’s approved label (so far), there is plenty of gluten talk on the brand’s website. For example, the FAQ says “Is Omission beer gluten free?  According to federal guidelines, we aren’t legally allowed to claim that Omission beer is gluten-free outside of Oregon … . While the FDA proposed to define the term ‘gluten free,’” that definition has not been formally adopted … .”

As a result of TTB Ruling 2012-2, look for Widmer and many others to push much further toward gluten free claims in the near future.

Tags:

policy, rejections, therapeutic

Posted in:

alcohol beverages generally, malt beverage