Posts Tagged ‘fda’
Here is a fun little article that combines a few of my favorite things: beer, law, The Washington Post and four-leaf clovers.
The article tends to say that Flying Dog had to skirmish with FDA a wee bit, before getting the go ahead to put the clovers in the beer. From the article, I can’t tell if the issue was clovers in general, or only the lucky ones.
The article also hints at other quirks in the law. It says Flying Dog submitted the beer to FDA for approval, but this seems unlikely. I can see this Maryland brewer submitting a formula to TTB for approval, but not to FDA. Also, I would have expected to see a TTB approval for the label, but I can’t find one, and this must signal that Flying Dog only plans to sell this beer intrastate, in the near term. Mostly, this beer probably signals a good excuse for a St. Patrick’s Day-timed press release.
Even though clover seems pretty common, not so new, and generally recognized as safe (whether in 21 CFR 182.10 or via common sense), this article does serve as a good reminder that brewers can’t just use any article that is lying around the field or the grocery store. Some things need a TTB and an FDA ok first.
Update. Hark. I got lucky. A nice person alerted me that the COLA is here.
Kombucha law is on the front page of tomorrow’s Wall Street Journal. Because kombucha law is so interlinked with alcohol beverage law, this is to underscore some alcohol beverage points only touched upon lightly in the article (subscription required).
- TTB has decided that most kombucha is beer for tax and permit purposes.
- This is because it is fermented tea. It is beer rather than a “malt beverage” because it lacks hops and malted barley.
- Most kombuchas are over 0.5% alcohol by volume during production, but less than that amount after bottling and at consumption. These can be called over-under kombuchas.
- It is ok for a kombucha to be 0.5% alcohol by volume or higher, after bottling, but only if the product jumps through most of the hoops required for Budweiser. This would include permits, taxes, a Government Warning, no sales to minors, sales via the three tier system. These can be called over-over kombuchas.
- Unlike Budweiser, the legal requirements would not include TTB label approval, because, like gluten free beer, the product lacks the hops and malted barely that would otherwise confer labeling jurisdiction upon TTB.
- Most kombuchas need FDA rather than TTB labeling.
- The article mentions a few recent lawsuits on these topics. So far there are five class action lawsuits. Two of them allege that GT Dave’s Enlightened Kombucha has hundreds of percent more than the legal limit of alcohol, for a product marketed as non-alcoholic. One of them alleges similar for the Health-Ade brand.
- The biggest case is Retta v. Millennium Products, Inc. I say biggest because it is a nationwide class action suit, and it is much farther along in litigation, compared to the other cases. It was first filed in March of 2015 but it was only amended to include the alcohol claims as of October 8, 2015. Before that, the claims were based on allegedly exaggerated anti-oxidant claims. This case is filed in federal court in Los Angeles. The first three pages of the 85-page complaint are here.
- Two other class action lawsuits allege that the same brands grossly understate the amount of sugar.
Kombucha raises some great legal issues. Lately I have been saying that kombucha has a lot to do, to catch up with the law, and the law has a lot to do, to catch up with kombucha. For lots more information on this topic, see this post from just a few hours ago, covering a kombucha law webinar of last week. And for lots and lots more information on this topic, see AHPA‘s six or so recent hours of webinars on kombucha law. It was a great pleasure to be part of this webinar series.
For those without a Wall Street Journal handy, here are some juicy excerpts:
Federal regulators have fired off warning letters in recent weeks to some kombucha producers after finding alcohol levels above one-half of 1%, the U.S. dividing line between alcoholic and nonalcoholic drinks.
Two consumer complaints seeking class action status also were filed last month in California claiming deceptive practices in alcohol-content labeling by industry leader Millennium Products Inc., the maker of GT’s Enlightened and Synergy brands. One of the lawsuits allege alcohol levels of up to 3.8% compared with about 5% in beer.
Millennium and others dispute the government’s and the lawsuits’ alcohol-content allegations, and say the government’s method of testing is flawed. Millennium says its drinks’ alcohol content is below the U.S. limit for labeling alcoholic drinks.
And for those without Westlaw, here are some juicy excerpts from the Retta complaint:
Millennium Products, Inc. has passed off millions of bottles of its wildly successful kombucha beverages as non-alcoholic, when, in fact, the beverages contain two to seven times the legal limit for non-alcoholic beverages. Having been caught selling alcoholic kombucha beverages to unsuspecting customers in 2006 and 2010, Millennium decided to market and distribute an alcoholic version of its kombucha products (the “Classic” kombucha line) and a “non-alcoholic” version (the “Enlightened” line), knowing that the non-alcoholic line has a much greater market appeal and could be sold in far more retail locations. But the purported distinction between the “Classic” and “Enlightened” lines is a sham designed to confuse the public and government regulators, as both lines of products contain alcohol levels far surpassing the legal limit for non-alcoholic beverages.
Just like Ben Carson who finds himself newly in the spotlight for good (polls) and bad (almost stabbing a person with other than a scalpel), kombucha has so arrived. It faces the glare of TTB, the courts, the plaintiffs bar, AHPA, the press and Rep. Polis.
Last week I had the honor of participating in AHPA‘s webinar on kombucha law. Part of the recording is above and here. The American Herbal Products Association has been active since 1982, and now has more than 300 food, beverage and supplement members. It was an honor because of the eminence of my co-presenters:
- Justin Prochnow, FDA lawyer at Greenberg Traurig, Denver
- Will Garvin, FDA lawyer at Buchanan Ingersoll, Washington
- Peter Evich, Lobbyist, Van Scoyoc Associates, Washington
- Art Libertucci, Consultant, The Buckles Group, Washington
Justin spoke on bottle bills issues. Will covered FDA labeling. Peter covered pending legislative issues. Art helped organize the webinar. I spoke on the various TTB issues raised by kombucha.
It was also an honor because the issues are so timely and challenging. Kombucha is surging in popularity. It raises difficult issues such as:
- is it beer, wine, cereal beverage, malt beverage, food, supplement, or some combination
- what TTB permits may be needed
- does it need FDA or TTB labeling, or both
- what taxes apply
- what penalties may apply, if you blow it
The entire video is about 2 hours, but I have chopped it down to the 30 minutes or so that covers the TTB issues (1-5 as listed above). The entirety, with about 20 minutes of questions and answers, is available from AHPA as here.
Here is a good and recent Warning Letter from FDA. I say good because it certainly appears to be well written, and to explain the law in a way that is sometimes hard to glean from the boring old regulations. Also, it seems to be a good thing, that we have a government whose first response is to send a firm letter, instead of, for example, some jackbooted thugs. FDA seems to put out a handful of such Warning Letters per month, on food and food labeling.
I am looking at this today because I often wonder why TTB does not get into the Warning Letter business. I think it could be a good way to explain some of the arcane rules so the people who want to comply, have a better chance to do so. Of course, like in so many other areas where TIWWCHNT, another lawyer explained how such letters can badly backfire. He explained that such letters, especially when they are good and clear, tend to serve as a template, for rapacious plaintiff class action lawyers to feast upon.
Here are some useful lessons, from this snapshot/letter, roughly in order of appearance in the letter:
- FDA really does conduct food inspections in far away places such as Japan.
- It is weird to see a US agency going after a foreign producer, because I am so accustomed to other agencies, such as TTB, doing so almost elusively through their licensed importer.
- There is such a thing as Hello Kitty Milk Flavored Chewy Candy.
- FDA likes to bandy about the term “misbranded,” and mentions it 6 times in this 3 page letter. I am getting the impression it is not a good thing.
- Good old wheat is a “major food allergen.”
- The food is misbranded because “it contains information in a second language, Japanese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). For example, the Nutrition Facts panel and ingredient statement must be declared in both the foreign language and English.” I have explained this scores of times over the years, to skeptical clients. I have wondered myself, because I see so many labels that don’t seem to bother with this.
- Even on an ingredient as common as sweetened condensed milk, you need to list all the sub-ingredients. That is, “products are misbranded [when they] are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required. …”
- At 4., the letter says you can’t make up your own serving sizes.
- Surprise, surprise, the little kitties don’t meet any known standard to substantiate the “healthy” claim.
Now, for the denouement, what the heck is FDA going to do about it, other than use up some paper? FDA says:
- “We may take further action” if the kitty people blow off the warning, and, for example, tell Customs not to let the candy into the country.
- The company has 15 days to respond.
But compared to 1 and 2, the big hammer, at least potentially, is pushing the company, or its US Agent, to pay for the cost of FDA’s inspection. The letter wraps up by saying:
[The law] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees. … For a foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs. Please consider providing a copy of this letter to your U.S. Agent.
In a future post, I would like to see how often, and under what circumstances, FDA drops this hammer. From what I can see in the letter, and in my opinion, the tone seems about right. Not too harsh, not too lax. It would be a foolish kitty purveyor that would ignore such a warning.
It looks like moonshine.
But it’s not spirits. It’s not even beer or wine, and yet it is 28 proof.
I stumbled on Great America “Carolina Clear” at a gas station in Bardstown, Kentucky, of all places. It was just a couple miles from Jim Beam and Four Roses. I would have assumed the heart of Bourbon Country is roughly the last place for a product such as this to thrive. And yet, the guy loitering and smoking out front advised it is an excellent product and will get one messed up almost as good as the illegal stuff. The display had about 40 jars of the product, in various flavors, a couple days ago. When I went back today, only one jar was left.
The front label describes it as Carolina Clear, Malt Specialty. There is no mention of beer, and there is no TTB label approval, because the product apparently lacks the hops and malted barley required to fit within the U.S. definition of a “malt beverage.”
The back label explains, in the FDA-style ingredient list, that the product only has three ingredients. I don’t think anyone will be surprised, at least at this point, that those ingredients are not the ones elevated in the Reinheitsgebot (the German Beer Purity Law of 1487, allowing beer to be made with water, barley and hops only). The North Carolina-made “malt specialty,” selling for $5.99 a jar, is made only with high fructose corn syrup, distilled water, and sodium benzoate. It is tough to imagine an alcohol beverage that could be produced at lower cost.
The product can’t fit within TTB’s label rules for beer-type beverages due to the lack of hops and barley. It falls outside the spirits labeling rules due to the lack of distillation. It is harder to see why the product falls outside TTB’s wine labeling rules, because it is like saké, at least in the sense that is also fermented from grain, and the federal government treats saké as wine, for labeling purposes. It is clear that Great America views the product as outside the TTB labeling rules because:
- TTB would have required a label approval. I see one label approval for this company, but none that match this product.
- TTB might have eventually said it looks too much like a spirits product, and might have required a clearer and more prominent statement of identity on the front label.
- The product seems to do a decent job of complying with the FDA food labeling rules (as opposed to the somewhat different TTB labeling rules). The serving size, however, at 3 ounces, seems very small (and the 7.8 servings per container seems absurdly large). This Joose-brand flavored malt beverage has a similar net contents and alcohol content, and yet is sold in single-serve cans.
Notwithstanding these distinctions, the federal taxes and permit requirements would be the same for this product as compared to typical beer.
This product is put out by Stout Brewing Company and also comes in common moonshine flavors such as peach, apple pie, and strawberry. Stout also markets similar products in 3 ounce tubes (as in the image immediately above).