Posts Tagged ‘fda’
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.
I would like to know if the above beer qualifies as Non GMO. I would also like to know, without a big hassle. I am sitting here with blazing fast internet and a big screen, and yet I remain in the dark as to whether this beer can be considered Non GMO. It would only be more confusing at the point of purchase, with less time and a smaller screen.
On the one hand, a recent press release claims Peak beers are the first to qualify to use the logo depicted at upper right on the image above. On the other hand, I can’t find any approved labels with the same seal (and the above is of course not the actual label). The actual label, as approved, is here. As of 2011, TTB said:
TTB has received several Certificates of Label Approval (COLA) applications proposing to display bioengineered-related information on alcohol beverage labels. Terms frequently mentioned in discussions about labeling alcohol beverages with respect to bioengineering include “GMO free” and “GM free.” “GMO” is an acronym for “genetically modified organism” and “GM” means “genetically modified.” The terms “genetically modified organism” and “genetically modified” are not synonymous with the term “bioengineered foods.” Plants can be genetically modified using any number of techniques, new or traditional.
TTB believes it is not necessary to mandate any bioengineered food labeling requirements at this time. We also find that it is misleading to refer voluntarily to those bioengineered food labeling terms or any similar references on alcohol beverage labels. This is consistent with the U.S. Food and Drug Administration’s position.
And yet FDA does seem to allow the Non GMO seal. Here is but one example (Silk almond milk). A Kashi cereal example is here. The seal and certifications are sponsored by the Non-GMO Project, “a non-profit organization committed to preserving and building sources of non-GMO products, educating consumers, and providing verified non-GMO choices.”
As of a few weeks ago, this suggests TTB was looking into it further.
Last week’s U.S. Supreme Court decision, Pom v. Coca-Cola, is not just about juice. It has massive implications for small brewers, big distillers and all other alcohol beverage marketers. It shows that TTB rules and other agency rules set a floor, not a ceiling, on how companies need to market their products. It shows that the government is only a part of the web of review, in concert with competitors. Just as we predicted that Pom would win this case, we now predict that some alcohol beverage companies will soon take legal action against others, even though such cases, other than trademark cases, were very rare in the past 50 years.
It was bad enough for Coke when Pom called out Coke for going quite a bit too far in posing its apple juice as pomegranate juice. It got even worse when various Supreme Court Justices suggested, orally, that Coke was trying to trick people. And on June 12, 2014 it got even worse, when the Supreme Court unanimously disagreed with Coke’s position. In Pom v. Coca-Cola, the Court said, if there is trickery on food labels, and it hurts a competitor, of course they can do something about it, even if FDA (for whatever reason) does not.
Pom and the Supreme Court have made it clear that one company can go after another for dubious labeling, and the government no longer has all the authority in this area.
The Court said, rather than the Food, Drug & Cosmetic Act (FDCA) knocking out the Lanham Act, the two Acts can happily coexist, complement each other, and provide synergy. The former protects consumers as to health and safety. The latter protects competitors as to commercial interests.
We have lots more coverage of this important case, and the background, in this post from earlier this year.
Coke went astray fairly early in the multi-year litigation, trying to invent a theory under which FDA “approved” the label at issue. FDA did no such thing. To approve is an act, and FDA’s posture here was the opposite of an act. FDA did not condone, approve or disapprove the label at issue. Perhaps FDA was busy with many other pressing concerns, or it was a gray area. This is in stark contrast to how TTB handles most labels — with a rigorous, case-by-case, and explicit pre-market approval regime. To say that FDA approved the Minute Maid label is like Donald Trump getting one $500 haircut per week, every week, calling it a business expense and taking an IRS deduction for 10 years — then saying the IRS approves of his hairstyle and his deduction. The IRS would, of course, have done no such thing. Rather, it would be the case that the IRS, simply, had so far refrained from any adverse action. To use the terms in the opinion, there is a difference between approving something and merely tolerating it.
There are not a lot of juicy quotes in the opinion, but the case does have massive implications. The Court noted, in a realistic way, that:
FDA … does not have the same perspective or expertise in assessing market dynamics that day-to-day competitors possess. Competitors who manufacture or distribute products have detailed knowledge regarding how consumers rely upon certain sales and marketing strategies. Their awareness of unfair competition practices may be far more immediate and accurate than that of agency rulemakers and regulators. Lanham Act suits draw upon this market expertise by empowering private parties to sue competitors to protect their interests on a case-by-case basis.
It is very refreshing to see Washington give some credit to those who work in an industry long-term, every day. The huge implications of this case would seem to be:
- A massive shift of enforcement authority, from bureaucrats in Washington, to private parties all around the world. Professor John Duffy noted: “A second important point about POM is that the reasoning in the decision shows the Supreme Court’s increasingly ambivalent approach to administrative regulation. More than a century ago, administrative agencies were often cast in nearly heroic terms; they were thought to be wise experts who could bring intelligent, centralized regulation to remedy the abusive marketplace tactics. In yesterday’s decision, however, the Court shows just how little is left of that notion.” Duffy nails it, saying: “It is … hard not to think that some of the reasoning in this case reflects a new skepticism – or perhaps it should be described as a healthy realism – about the capabilities of administrative agencies.”
- Justice Roberts, in the oral arguments, actually said, in reference to misleading labels: “What does the FDA know about that? I mean, I would understand if it was the FTC or something like that, but I don’t know that the FDA has any expertise in terms of consumer confusion apart from any health issues.”
- The ready ability of Coke to police Pepsi’s business practices, Bud to police Coors, Gallo to police other wine companies, Bacardi to regulate Diageo — on and on. Not only can the big regulate the big, but the small can regulate the big and vice versa. It could be a free-for-all. Duffy explained that this case, along with another: “is almost certain to produce a significant expansion in competitors bringing Lanham Act claims against each other over false or misleading statements.”
- Even more, this means little craft brewers and distillers can go after big guys with a claim that: “you are BS’ing about craft, and it hurts us.”
- An advertising law expert said: “It opens the floodgates to increased litigation. The message to marketers is now that compliance with the FDA is only a first step and is by no means insurance against other types of claims.”
- This will give us a bit of a taste of what libertarian-style government might look like, and a bit of relief from command-and-control government, perhaps.
- Even though there is affirmative pre-market approval for alcohol beverages, and this is not the case for most foods and other beverages, it would seem that the same basic principles apply. It would seem that the FAA Act was likewise not intended to impair or preclude the Lanham Act.
- On behalf of food clients, food lawyers now get to serve as mini-FDAs, and private TTB lawyers have been deputized to serve as mini-TTBs (on behalf of any aggrieved beverage company clients).
- This makes it easy for TTB and FDA to deflect many complaints, and remind the aggrieved that they have a ready means for self-help.
- After many decades to the contrary it may turn out that the federal food and beverage laws are a floor, rather than a ceiling. CSPI said: “The Court recognized that companies don’t have a safe haven from being sued for deception just by complying with FDA’s minimal regulations.”
It will be ironic indeed when a competing food company goes after Pom. But Pom seems more than able to protect itself and I have rarely seen a better example of a company being on the defensive, after the various FTC inquiries — and turning it into such a major victory. There should be a cliche about turning bitter fruits into profitable fruit juices.
The U.S. Supreme Court, on January 10, 2014, agreed to hear Pom’s argument that Coke’s fruit beverage labels (such as the one at right) are misleading. The excellent FDA Law Blog has good coverage of the controversy here. Coke’s Minute Maid product only has a tiny amount of pomegranate juice — less than 0.5% — and so Pom (rather than the government) argues that this is misleading especially inasmuch as the labels show pictures of pomegranates.
This is a classic false advertising case. Pom and Coca-Cola compete directly in the market for pomegranate juices. Pom sells juices that—as purchasers would naturally expect—overwhelmingly contain actual pomegranate juice, which is sought by healthconscious consumers. Pom’s products include a pomegranate-blueberry juice. Coca-Cola sells and aggressively markets its competing “POMEGRANATE BLUEBERRY” juice, which it colors a deep purple and sells with a label containing a large image of each fruit. … Coca-Cola’s misleading label causes consumers to believe that the juice actually contains significant amounts of those fruits when in fact it contains only trivial amounts: 0.3% pomegranate juice and 0.2% blueberry juice. … Pom introduced survey evidence showing that consumers are in fact seriously misled.
Pom also quotes a key part of the government’s brief: “Further, the ‘FDA does not approve juice labels, and its failure to initiate an enforcement action cannot be construed as such an approval.'” Other juicy tidbits courtesy of Pom include: FDA and the FDC Act “sets a ‘floor’—not a ceiling—on federal regulation of labels.” Pom explains the sweeping importance of this case, and why it is so ripe for review:
Even if it were limited to food products, the ruling below grants tens of thousands of food and juice producers sweeping immunity with respect to countless products from liability under the Lanham Act for even knowingly misleading consumers. … The government recognizes that the court’s “deference to FDA’s available but unexercised authority would arguably preclude a Lanham Act challenge to the label of any food,” including “the many foods that FDA’s regulations do not specifically address at all.” … As the GAO has confirmed, the FDA “generally does not address misleading food labeling because it lacks the resources to conduct the substantive, empirical research on consumer perceptions.'”
By contrast, Coke not surprisingly argues “the FDA has adequate resources to regulate the content of food and juice labels.” Coke further argues:
whether a multi-fruit juice name or label is deceptive is not only within the FDA’s expertise, but is a topic that the FDA has already addressed in detailed and specific regulations. … As the United States correctly observes, the regulation “reflect[s] the agency’s balance of competing considerations in a specific setting that could easily be upset by the intrusion of a general private remedy such as that provided under Section 43(a) of the Lanham Act.”
Getting deep into the nitty gritty of the labels at issue and the rules, Coke proudly proclaims “Here, the letters ‘FLAVORED BLEND OF 5 JUICES’ comply with this specific regulation because, as is clear from the image …, they are more than one-half the height of the words ‘POMEGRANATE BLUEBERRY.'” Coke claims it is a big (“hyperbolic”) exaggeration to say FDA lacks sufficient resources to regulate food labels.
If Pom wins this battle, it will seem to be another sign that the government, step by step, as it gains powers in some areas, continues to relinquish power in other areas, to allow large segments of statutory and agency mandates to be effectively privatized (or libertarianized). For example, as here, Pom and other Coke competitors would become the reviewers of Coke’s labels every bit as much or more compared to what FDA might have done in the past. This case could have enormous implications far beyond FDA labels, and could extend all the way over to TTB labels, TTB formulas, excise taxes, TTB permits, to almost every area that alcohol beverage regulators have firmly controlled in the past. In other news, this case provides a wonderful forum for Pom to beat up on Coke, and remind everyone that Pom has more juice, up and down the U.S. court system, year after year (since at least 2008). I wonder how the cost of this lawsuit compares to or relates to an old-fashioned ad campaign in the paid media.
From our perspective, working with thousands of labels and hundreds of such questions (from the trivial to the weighty) on a yearly basis (as opposed to an appellate litigator or a judge dealing with this from time to time when it flares up big) it seems clear that such tricky questions will inevitably get “litigated.” The only question is whether they will get litigated in an agency proceeding (as has been common in the past), the media, amongst lawyers battling apart from a court or agency proceeding, or in the courts (as was fairly rare in the past). To the extent that Pom wins, we can expect a huge shift from the first to the last.