As reported last Friday, the FDA announced that they’d sent letters to almost 30 manufacturers of alcohol drinks that also contain caffeine. The FDA gave these companies 30 days to essentially prove that they’re safe. On the beer side, some of the breweries that received letters include Ithaca Beer Co. (Ithaca Eleven Malt Beverage with Coffee), New Century Brewing (Moonshot) and Thomas Creek Brewery (Mobius Lager). Here’s the full list.
My friend and colleague, Harry Schuhmacher, who writes Beer Business Daily, has some interesting insights into this move by the FDA. Beer Business Daily reports daily on the beer business. If you don’t subscribe to it, you should, especially if you’re a brewery owner or work for one on the business side.
Here’s his take on a few relevant portions of the FDA letter.
FDA: “FDA has not made a determination regarding the GRAS status [GRAS stands for 'generally regarded as safe'] of the use of caffeine in alcoholic beverages.”
BBD: True, although the FDA has determined that caffeine, even in doses much higher than what are in the alcohol beverages in question, isn’t unsafe. The fact is that caffeine and alcohol have been mixed safely for hundreds of years. But does that mean that the manufacturer should do it for us? Read on.
FDA: “Nor are we aware of a basis for concluding that your use of caffeine in these beverages is prior sanctioned.”
BBD: This doesn’t make sense to us at first blush. The TTB, the federal agency charged by the FAA Act with regulating alcoholic beverages, has certainly “sanctioned” these products by their approval of their formulas, their labels, and even vetted their marketing practices. The TTB has guidelines about adding caffeine to alcohol beverages — ironically based on FDA guidelines on caffeine — and all of the products on the market fall within these guidelines. In fact, these beverages are at caffeine levels well below what the FDA deems as unsafe. So while these beverages haven’t received prior sanction from the FDA, they have received a sort of de facto “sanction” from the TTB, which is just as much a part of the United States government as the FDA.
The crux here I suppose is in the idea of caffeine + alcohol. The FDA operates under the Federal Food, Drug, and Cosmetic Act, while the TTB operates under the Federal Alcohol Administration Act. FDA governs food and non-alc beverages (and caffeine in such), while the TTB governs beverage alcohol. Methinks there is a land grab going on here, and the TTB isn’t too pleased about it, we hear. The FDA says it has jurisdiction because the Federal Food, Drug and Cosmetics Act gives it authority over “articles used for food or drink” and “thus includes alcoholic beverages,” says the FDA. This is probably news to the TTB.
The FDA has guidelines for caffeine in non-alc beverages, and the TTB has guidelines for alcohol in general. So the TTB naturally put the FDA caffeine guidelines with their alcohol guidelines, looked at the products in question, and deemed them safe. But the FDA is now reaching out beyond its historical bounds by placing the onus on the bev-alc manufacturers to prove that putting alcohol and caffeine together in one beverage is safe. More on that below.
He’s been inundated with questions and earlier today gave his thoughts to the most popular ones. With his permission, here are several of the questions and his answers to them:
WHAT’S THE DEAL? The FDA, under pressure from several state Attorneys General (who we hasten to add could make these drinks illegal in their respective states tomorrow either through legislation, regulatory ruling, and/or by AG fiat, but would rather make the feds do the heavy lifting) is formally tackling the issue of caffeine intentionally added to alcohol beverages. It says it has providence when a food or beverage intentionally adds a substance to it that is “unsafe” unless its use has been approved by the FDA, is generally recognized as safe (as caffeine is), or is “subject to a prior sanction.” If the additive is “unapproved” then it is subject to “seizure” if deemed unsafe. The FDA has not “issued a food additive regulation to approve the use of caffeine in alcoholic beverages, and FDA is not aware of a basis to conclude that this use of caffeine is GRAS or subject to a prior sanction by FDA. By law, any person can make a GRAS determination but that determination must meet the GRAS criteria for safety and general recognition.” In other words, call in your best lawyers, because this is going to be a legal war of words just as much as it is a scientific one.
Historically, the FDA has listed caffeine as generally safe in cola-type beverages in lower doses, but there are no “regulations that permit the addition of caffeine, at any level, in alcoholic beverages.” That doesn’t mean it’s unsafe, it just means there aren’t any regulations. But as we mentioned above, the TTB has guidelines, based on the fact that the FDA hasn’t deemed caffeine as unsafe even in larger doses. Can you say turf war? In fact, the FDA and the TTB have a “Memorandum of Understanding” between them outlining what actions each should take under certain circumstances when there is overlap in their jurisdiction. We quote from it: “When FDA learns or is advised that an alcoholic beverage is or may be adulterated, FDA will contact ATF [Ed. Note: that's the old name for the TTB].” The memorandum unhappily doesn’t mention what happens when a seemingly safe substance like caffeine has found to be “adulterating” alcoholic drinks. One would think the action would be the same as for other alleged adulterations: FDA should contact the TTB, make them aware of it, and let them take care of it. Instead they called a press conference. Politics are involved as usual, and we’ll get to that.
The FDA says it is “unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is” generally recognized as safe. But I know of one basis: the fact that the TTB says it was okay. The two agencies must not read each other’s websites. I hear the Internets are slow this time of year in DC. But still, the FDA says that in order for caffeine AND alcohol together to be classified as “Generally Regarded as Safe”, even if they’re safe apart, it must past two tests: 1. Publicly available science must show that caffeine in alcohol is safe, and 2. there is a “consensus among qualified experts regarding the safety of caffeine for this use.” In other words, what the FDA is trying to do is come up with a new substance it can regulate, a substance that is the combination of both caffeine and alcohol. We can call it CafAlc. And CalfAlc, the FDA says, needs to be classified under FDA rules as GRAS or sanctioned. Here’s my beef with this reasoning: If CalfAlc comes under FDA jurisdiction, does that mean that plain old “Alc” isn’t too far behind? Slippery slopes and victory by inches, my friends.
[Ed. Note: This isn't the first time the FDA has reached into the alcohol beverage business. Because of the strict legal wording of the what the TTB has authority over, gluten free beers like A-B's Redbridge and Saki fall under FDA authority, because of how they're made. Technically, it's legal for gluten free beers to have slotting fees, as a result].
This is extremely unusual. The last time the FDA formally asked a manufacturer to prove their substance is GRAF was back in 2001, when it asked the manufacturers of Echinacea to prove it was GRAS or prior sanctioned for use in conventional foods. So this is a bid deal.
WHAT ABOUT KAHLUA AND CUBA LIBRES? This was a common cry from distributors. Consumers and manufacturers have been mixing alcohol with caffeine for many years. “This FDA action is not directed at products that are flavored with coffee,” says the FDA. So Kahlua isn’t illegal ….. yet. Also, for the time being, the bartender that serves you a Jack and Coke is also safe from arrest, as the FDA is “focusing its attention on products in which caffeine has been intentionally added to alcoholic beverages by the manufacturers. Other products containing added caffeine may be subject to agency review if the available scientific data and information indicate that added caffeine may pose a safety concern, or is being unlawfully used, under the conditions of its use in other products.” So stay tuned. Cuba libres may be next.
HOW HARD IS IT TO GET GRAS STATUS? The FDA says that there must be “technical evidence of safety and a basis to conclude that this evidence is generally known and accepted by qualified experts.” That includes establishing that the beverage’s “intended use” be safe and that it’s not harmful under “probable consumption” and the “cumulative effect of the ingredient in the diet.”
This is kind of bizarre, because as we’ve said, caffeine hasn’t been deemed unsafe. But there’s a reason that alcohol is regulated by a different agency, because by its very nature it is a different type of product — it can be intoxicating — and as such the guidelines of “safe” are a different animal. Here’s my point: If there was no such thing as alcohol on earth, and an alien suddenly landed in Des Moines and introduced the miracle of vodka to us, I doubt the FDA would approve it as GRAS. But the fact remains that alcohol has been on earth for thousands of years, and the voters won’t be denied it. The government once tried to “take away its GRAS status” in 1919, but that didn’t work out so well. We’ll let the lawyers grapple with that. We are in unchartered territory, and while we’re not talking about alcohol alone, but rather CafAlc, the consequences of going down this legal road could still be significant to the industry at large. If CafAlc is deemed unsafe by our protectors at the FDA, and yet caffeine is considered safe, then where does that leave Alc?
WHAT’S THE TIME FRAME? While the FDA gives the producers of these beverages 30 short Winter days to prove they are safe, it gives itself an indeterminate amount of Summer days to respond. “The timeframe is difficult to predict and it will depend on the amount and quality of data and information that the FDA receives from manufacturers and that are otherwise available to the agency and upon the complexity of scientific issues that may be encountered in the course of its review,” writes the FDA. “The FDA’s decision regarding the regulatory status of caffeine added to various alcoholic beverages will be a high priority for the agency; however, a decision regarding the use of caffeine in alcoholic beverages could take some time.”
BIG BREWERS’ HAND IN THIS? A few readers have suggested that A-B and MillerCoors probably have a hand in these latest developments, as it would kill a growing competitive threat while also fitting their crowns with bright white halos (and the added “benefit” of putting the NBWA on its heels). Perhaps, but there are several competing factors in that equation. You can imagine that their marketing people aren’t unhappy about what’s happened, as these indie manufacturers were operating under the radar and taking share and shelf space from castrated Sparks and Tilt. And at the same time I don’t think their government affairs people, who trump almost everything at both those companies, like having any malt-based products out there that cast a bad light on the industry at large — it puts a tax and regulation target on everybody’s back. Still, I also don’t think they’re particularly happy about the FDA getting into the alcohol business. I happen to know that they haven’t been in contact with the FDA about it, in fact. But they do seem to favor federal regulation over state-based regulation. So take all that for what it’s worth.
OUR TAKE. So what’s likely to happen? That’s anybody’s guess, as you can never predict what government agencies will do. But that won’t stop us from conjecturing. The larger producers will likely fold like lawn chairs on Labor Day. Constellation already killed their caffeinated alcohol drink, even though it’s still listed in the FDA’s hit list. I expect Diageo will kill Smirnoff Raw Tea in about sixty seconds if they haven’t already (one source says they already discontinued Raw Tea), as they also want that white halo that A-B and MC have. We note Boston Beer’s Twisted Tea didn’t get a love letter from the FDA.
The smaller producers like Four Loko and Joose, who have everything to lose, have already lawyered up, we hear. One thing that jumps out at us is that 30 days is a ridiculously short time frame for the FDA to expect anybody to prepare a defense. They’ll get extensions on that, you can almost be sure. And you have to think they may have a pretty decent case. There’s no evidence we’ve seen that caffeine and alcohol are dangerous to your health per se, or any more dangerous than either one apart. People have been quaffing rum and Cokes for years. The evidence will be vetted, and in the end, if indeed caffeine and alcohol aren’t any worse for you than drinking coffee and vodka separately, or together to your health, then the FDA will ultimately be satisfied and can report back to the AGs that they did their job.
But I think this is important: The FDA cites a letter provided by the AGs of a group of university scientists showing evidence that alcohol and caffeine may keep people up longer into the night, so there’s more of a chance of them consuming more and getting into dangerous mischief. But one would think this is beyond the scope of the FDA. They’re food regulators, not behavior police. Also, the fact that these products are high in alcohol and taste sweet, and so could be construed to appeal to young people, would also seem to be out of the FDA’s wheelhouse. But I’m no Perry Mason.
THE COLD HARD TRUTH. Having said all that, the fact remains that the Big Boys in our industry — brewers and distillers alike — in the alcohol industry don’t want these drinks to exist. Neither do the control states, neither do the license state regulators, neither do the AGs, neither do parents, neither do some chain retailers, and neither do the fun bunchers [Note: "fun bunchers" is Harry's term for neo-prohibitionists —J]. These products have been painted with a tar brush — nobody wants to touch them. Even if Joose and Four Loko have great legal representation, there are a lot of big forces against them, including the beer, wine, and spirits industry at large in which they operate. While they may have a legal case against the FDA, this tide is a strong one to swim against.
Worst case scenario for these producers: Caffeine and taurine and other stimulants are deemed to be dangerous in conjunction with alcohol, so Joose and Four Loko and their ilk will have to reformulate without stimulants, but with other vitamins or whatever, and ultimately they get placed on the same playing field as Sparks and Tilt, and we move on down the road. Book it.