Posts Tagged ‘fda’
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).
The Daily Beast published a highly relevant story a few days ago, slamming Fireball and propylene glycol. Fireball is a hugely popular “Cinnamon Whisky,” and a recent label approval is here. The story explains that Fireball contains propylene glycol, commonly known as PG, and in the most alarming way that could probably be set forth without a big lawsuit, the article heaps scorn upon PG and Fireball. As of today, Google has more than 81,000 stories about fireball propylene glycol, but the Beast story was one of the first.
The article trots out alarming buzzwords such as: recall, antifreeze, swill, Prestone, Low-Tox, disease, health risks. It says:
One key ingredient of the stuff: Propylene glycol, a synthetic liquid that absorbs water. The Centers for Disease Control note that it is used to ‘make polyester compounds, and as a base for deicing solutions.’ In food production, the CDC adds, the syrupy stuff also can be used to “maintain moisture… It is a solvent for food colors and flavors.”
I called on a few experts in writing this blog post because I think Tim Mak’s article may be unfair to Fireball, its producer (Sazerac) and the important food chemical known as propylene glycol. Kevin at Nutrevolve sums it up pithily: “Anyone who has compared propylene glycol to anti freeze to inspire fear has done nothing but demonstrate a lack of chemistry knowledge. … Notorious for regular application of the Precautionary Principle, even CSPI gives the propylene glycol derivative, propylene glycol alginate a green light – see here.”
I talked it over with Kate Ratliff. Kate is the Technical Director at Flavorman, a leading flavor and beverage company headquartered in Louisville. By the way I think Tim is a great writer, and he picks great topics, such as this gem about beer labels. But the Beast article seems like a prime example of junk science; it is sensationalist and it actually makes readers and consumers dumber. It does no favors for the Beast’s readers, or for anyone who cares about science, or high quality foods. The tenor of the article is inconsistent with the fact that propylene glycol has been widely and safely used in a large percentage of foods and beverages, over more than 50 years, around the world. Many food products would not be as good without this key building block. Even if you are looking at an ingredient list on a food label, and PG is not noted, it may well be in the package and probably is. This is because PG is used in thousands of flavors, and there is no requirement to show a flavor’s ingredients on any food label. Moreover, most alcohol beverage labels do not show any ingredient list at all, and ShipCompliant’s amazing LabelVision system shows not even one label that mentions PG (among over 1.5 million indexed labels, and hundreds of thousands of alcohol beverages that probably contain this substance).*
When I talked it over with Kate, she said “Robert, don’t be silly. Everything has established toxicity levels, even things like water and vitamins. Yet, we are encouraged to drink lots of water and supplement our diets with multivitamins. PG is fine.” I happened to be down the street from Sazerac’s plant yesterday, at Kate’s office, whereupon she offered me a shot of propylene glycol, straight up. With assurances from her colleagues (and FDA) that it’s safe for human consumption, I sipped the PG. It seemed oily and bitter, and wholly without any smell. The bitter aftertaste lingered for a few minutes and later I tasted a small amount of sweetness. I am pleased to report that I woke up just fine this morning without any apparent effects. For the record I note that the city and her plant are full to brimming over with some of the finest beverages in the world, but Kate only offered me the PG and a bottle of water.
We thought it was important to respond to Tim’s article because it seems clear that it is aimed at low-information consumers such as your typical frat boy. The article is replete with references to “Bummer, Dude” and Total Frat Moves, not exactly paragons of nuance or subtlety (and yes, the Food Babe also has it wrong). We think they are likely to take away precisely the wrong message — for example the entirely incorrect idea that PG is worse than too much alcohol, or too much sugar, or too much junk food. Or, the entirely wrong idea that Fireball is somehow worse than any of the next 10 cinnamon whiskeys, which probably contain PG as well. The Beast story also tends to suggest that US regulators such as FDA and TTB are asleep at the switch here, and once again this is highly misleading or wrong.
Flavor expert Vince Ficca explained that it is important to use PG as a solvent where alcohol is not a good choice; for example, to bring down the flashpoint, or for countries (such as Muslim countries) where alcohol is not legal. Vince also pointed out that nobody should confuse PG with its toxic cousin, ethylene glycol. Good old Wikipedia explains:
Propylene glycol … is considerably less toxic than ethylene glycol and may be labeled as “non-toxic antifreeze”. It is used as antifreeze where ethylene glycol would be inappropriate, such as in food-processing systems or in water pipes in homes where incidental ingestion may be possible. As confirmation of its relative non-toxicity, the FDA allows propylene glycol to be added to a large number of processed foods, including ice cream, frozen custard, salad dressings and baked goods.
Fireball does a nice job of injecting some reason into this discussion here:
Fireball does not contain any antifreeze at all and the suggestion is ridiculous. Sadly, this is the media’s way of crafting attention grabbing headlines, but it simply is not true. We would not dream of putting antifreeze in our product. … PG is a clear, colorless liquid with the consistency of syrup. It is practically odorless and tasteless. It is the ideal stabilizer and clarifier for a large variety of flavors that give most of today’s food and beverages their distinctive taste. … Flavor companies use it to carry flavor ingredients through to the final product, to preserve the integrity of the flavor and to ensure it is shelf stable. We understand that very few flavors can be made without it.
Food scientists tell me it would take many ounces of PG at a sitting to induce a harmful effect in an average person. A bottle of Fireball has less than an eyedropper full of PG. Please don’t take any of this as medical advice. But, now that the Ice Bucket Challenge is passe, I want to publicly call out Tim for the PG challenge. He should put up some examples of ill effects from PG, or drink a shot of PG forthwith.
* Stop the press. LabelVision did find one lonely label unabashedly declaring the presence of PG, and it’s here.