The FDA announced today that they’ve sent a letter to almost 30 manufacturers of alcohol drinks that also contain caffeine. The FDA is giving these companies 30 days to essentially prove that they’re safe. The move is undoubtedly motivated by a bullying letter sent to the FDA in September by 18 state Attorneys General. That letter was itself the product of pressure brought to bear by neo-prohibitionist groups at the state and local level.
From the press release:
“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.
Of the combined use of caffeine and alcohol among U.S. college students in the few studies on this topic, the prevalence was as high as 26 percent.
Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS. For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.
The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned. To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million. It has not approved caffeine for use at any level in alcoholic beverages.
The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned. FDA’s letter informed each company that if FDA determines that the use of caffeine in the firm’s alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace.
Notice that the press release outlines the rationale for the safety check because of “increasing popularity” by “college students” along with “reports of potential health and safety issues,” also known as anecdotes and stories people made up to scare other people. That’s about as flimsy a reason as I can imagine. They don’t seem concerned about older adults, us post-college folks which suggests to me that it’s not really about safety at all.
I think what bothers me about this is simply how obviously it’s the FDA bowing to pressure from anti-alcohol groups. Last time I checked, caffeine was legal. Alcohol is also legal if you’re the “right” age. People have been drinking alcohol and caffeine concurrently, myself included, for centuries. I’m drinking Tejava (my daily ritual) as I write this and by lunchtime I’ll be ready for a beer, followed by more caffeine this afternoon to fend off the mid-afternoon urge to nap. More recently — though even this was years ago — Red Bull and vodka became a very popular cocktail, mixing the two chemicals caffeine and alcohol. Certain people were worried then, too, but I’ve never heard of any real danger posed from that drink and the many imitations and variations it spawned. Even if they banned every alcohol and caffeine drink, people can, and probably will, go right on mixing them on their own. What’s to stop them? Actually, banning them would likely cause an increase in combination drinking, because people love a taboo.
All that would happen, really, is the harming of a few dozen alcohol companies, which I suspect is the Anti-Alcohols (or AnAl’s) game. Even in the unlikely event that they declare the pairing of the two substances a danger, it won’t, and they can’t, stop people from mixing them on their own. Even if it was made illegal, people would never stop having a few drinks followed by a cup of coffee. It’s absurd, really, like they’re trying to remake the world in the image of a Kafka novel.
Any word on if this affects Mateveza’s products? Coffee Stouts?
Nothing specific yet, the FDA didn’t release a list of the manufacturers who were sent a letter. The key phrase from the press release is that the caffeine must be “added intentionally” so you could argue, one supposes, that coffee or tea that is added for flavor doesn’t meet that test, and the caffeine is just a by-product and not an intentional ingredient.
I was wondering why we got a call from the FDA asking for our fax # yesterday and another from the LA Times asking for comment about this today. I guess Ithaca Beer Company is one of the 30. I like your “added for flavor” argument….
“Anti-Alcohols (or AnAl’s)”
Well-played, sir.
I’m no neo-prohibitionist. In fact, I’m a certified Cicerone and I get paid to organize and facilitate beer tasting events. I evangelize about good beer with a passion. However, in my other life I am a substance abuse educator on college campuses. I just felt that I should offer some perspective from the other side.
You say that they are not concerned about “about older adults, us post-college folks”. Statistics show a significant drop in stupid drinking behavior post-college. That’s not to say that there aren’t some idiotic adult drinkers out there, but the number of them as a percentage of the whole population drops. College students are a bigger concern than adults.
Add to that that college students, already more prone than the general population to overuse, use these caffeinated and often high alcohol beverages to enable them to stay awake so that they can drink even more. Given the rising number of hospitalizations and deaths on campuses from alcohol poisoning and the increasing number of other kinds of alcohol related deaths, injuries, and sexual assaults on college campuses, it seems prudent to me to take some kind of steps to curb or at least discourage this behavior.
Is the FDA move a step too far? Perhaps. Should we just say that idiots are responsible for their own idiocy? Perhaps. But the facts of what is happening on college campuses nowadays should offer some perspective.
Thanks, I appreciate your perspective. I’m sure you’re correct that the problems of over-indulgence are rampant in the college setting, but I believe that the fault for that (along with the cure) lies elsewhere than regulation/prohibition of certain products that young people may prefer. I strongly believe it’s unfair to punish these companies and the adults who don’t abuse the drinks just because kids might. To me, that’s just the wrong way to go about it. Raising the drinking age would, I believe, help (eventually) and so would education. Prohibition has never been shown to be an effective deterrent and that’s essentially what the FDA is attempting.
As for my saying “they are not concerned about ‘about older adults, us post-college folks'” that was meant to be a little funny, and point out that, as I said, I don’t believe the fact that younger people might abuse something is a rational reason to remove it from all society. Anything can be abused, but that doesn’t mean we prohibit those things for everybody, in effect punishing the people who DON’T abuse it.