FDA: Convince Us That Caffeinated Alcoholic Beverages Are Safe And Legal

The FDA says that companies have 30 days to convince them that caffeinated alcoholic beverages are safe and legal, because they don’t seem to remember approving them.

The FDA says that in order for a substance to be intentionally added to food, its particular use has to have been approved by FDA regulation, subject to a prior sanction, or be Generally Recognized As Safe (GRAS). If it isn’t, adding it to food is unlawful.

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, says the FDA.

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.

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

Various attorneys general from 18 states have written the FDA to express their concerns about caffeinated alcoholic beverages.

From the letter:

Several recent scientific studies published in peer reviewed journals demonstrate the dangers of mixing caffeine and alcohol. As these studies show, stimulants such as caffeine appear to mask the intoxicating effects of alcohol, which may lead to increased risk-taking and other serious alcohol-related problems such as traffic accidents, violence, sexual assault, and suicide.

Do you miss “Bud Extra” and “Sparks?”

CAB Letter to FDA from Attorneys General (PDF) [FDA]
FDA To Look Into Safety of Caffeinated Alcoholic Beverages [FDA]

Comments

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  1. TheRealAbsurdist says:

    Any cola-based drink?
    Any coffee-based drink?
    Methinks the FDA is overreacting due to hysterical overreaction from some members of the public.

    • Aquasol says:

      @TheRealAbsurdist: How is this overreacting? It’s rather well-known that mixing a stimulant and a depressant will screw you over. They’re not banning people who mix on their own, they’re going for pre-mixed drinks made of stim/depressants.

      The main reason for the 30-day issue is because no one submitted anything to certify it as GRAS for sale in the US. I fail to see the problem.

    • KyleOrton says:

      @TheRealAbsurdist: Can a Canadian confirm this for me? I remember hearing at one time that Mt. Dew and similar drinks don’t have caffeine in Canada because they’re added artificially. I know that all Caffeine in regular sodas is added artificially, but I think the way they got away with it was that it would normally occur in original, natural colas.

      Just wonderin’

  2. Red says:

    Would this affect the premixed stuff such as Jack and Cola in the bottles since they are not adding caffine, just cola that contains caffine. One way or another, I’ll stick with my Goose and Red Bull.

  3. BrandonOBrien says:

    So no more Vodka and Red Bull? Sounds like every mixed drink in teh world containing coke, red bull, monster, etc would qualify this as GRAS

  4. nakkypoo says:

    I’m going to rush out and buy a case of Four before it’s pulled. I’d hate to have to start mixing my vodka and Redbull myself.

    • 89macrunner says:

      @nakkypoo: I got 5 free cases of that last year…i still have a case of it left. I cant give that stuff away. it tastes like cough medicine.

  5. 2 replies says:

    Jägerbombs, Jägerbombs, Jägerbombs.

  6. LJKelley says:

    The FDA is USELESS. They worry about what they shouldn’t and don’t worry about what they should. USELESS!

    • tsume says:

      @LJKelley: I agree, this is BS. I am a regular consumer of FOUR and I find it outrageous that someone else is going to dictate what I can and can’t drink just because of irrational fear.

  7. ReverendBrown says:

    No.

    Just no.

  8. Corydon says:

    God…it’s stupid crap like this that will keep the damn tea partiers in business for the next 20 years.

  9. AngryK9 says:

    Politics and bureaucracy. It’s what America was founded on.

  10. perfectoon_0901 says:

    What I want to know is things like Kahlua and other coffee based alcohol, are we going to see them go away? cause if that is the case, then the Dude is going to be PISSED

    • Kuchen says:

      @perfectoon_0901: Kahlua actually contains very little caffeine (<5 mg per 1.5 ounce serving, compared to 35-60-ish per soda serving, and around 100 per coffee serving). And this should only affect drinks to which caffeine is ADDED. The caffeine in Kahlua has not been added.

  11. celeb8 says:

    Yeah I’m a big fan of coffee and Bailey’s and Maker’s for exactly the reason they say it’s a health risk, basically I can get lit up without getting groggy (and the taste of course is just YUM!). To say that these beverages are somehow illegal really annoys me. The government should never be a prohibit-unless-we-say-otherwise entity, the whole point of our justice system is that it should work the other way around, only prohibiting things that are absolutely necessary to prohibit.

    This sounds more like a bunch of asses holding out their hands for brib… “lobbying”

    • thompson says:

      @celeb8: No one said it was illegal. The FDA is merely requesting that the companies specify which decision they relied on (aka their reasoning) when choosing to add the ingredient.

      Oh, and as for the “never be a prohibit-unless-we-say-otherwise”, I have some new Xanlytria 500mg pills that will, I kid you not, cure you of all your ills… and may also cause your face to melt off (oops!). The FDA doesn’t have to authorize it though, because we’re not a prohibit-unless-we-say-otherwise system.

  12. wundersmack says:

    Actually, the caffeine in Tilt and Sparks is really the least of our worries. Some varieties of these beverages have 8% alcohol — which is why I buy them. More bang for the buck.

  13. Al Swearengen says:

    Who’s to say they aren’t adding alcohol to caffeine drinks rather than adding caffeine to alcohol drinks?

    • mianne prays her parents outlive the TSA says:

      @Al Swearengen: Ah-ha! That must explain the reasoning behind the Cease & Desist order Monster Energy recently sent to the maker of the “Vermonster” wine.

      “It’ll pick you up, it’ll cool you down, it’ll make you mellow & smile like a clown!” — Monster Hard Energy*

      *Please note this as prior art, invalidating any patent, service mark, or trademark the Hansen Beverage company may attempt to establish using this slogan or name. Ditto (only double) for the Monster Cable company.

  14. Sneeje says:

    Are you all really missing the point or just being snarky? I can’t believe no one understands the difference between the FDA regulating a company selling a product that may have deleterious side effects versus someone making their own.

    Perhaps the FDA should just give up and let companies create drinks with alcohol and cocaine in them? Or how about vodka and H2SO4? I mean, why try, it’s just another dumb pointless government agency.

    • Jeff_McAwes0me says:

      @Sneeje: Well, since cocaine and sulfuric acid are already considered dangerous and illegal substances, your reductio ad absurdum is not exactly valid. Good try though.

      • Sneeje says:

        @Jeff_McAwes0me: Ok, except that caffeine is also considered by the FDA to be acceptable in only certain quantities and combined with certain other substances. So… good try yourself.

  15. vastrightwing says:

    Translation: You have 30 days to pay us not to regulate you to death. Fixed it for you.

  16. RonDiaz says:

    Who needs Sparks when you can get FOUR LOCO! The problem is these companies got out of control. Sparks is mild vs FOUR LOCO.

  17. mthorn82 says:

    I don’t think the FDA is trying to stop them from what there doing, there just honestly trying to figure out how much caffeine there putting in these drinks, health wise I doubt there is anything wrong with mixing caffeine and alcohol but the amount of mg they add to these drinks even has me wondering.

    I managed to try last week this new variant called Four or whatnot and after drinking half of a 24oz can I could feel my heart racing and that’s on top of the high % alcohol they use in it. I went to research the mg of caffeine in the drink only to find nothing since its not FDA regulated.

    So am I against them checking into this? no, let em see what happens and in the end I highly doubt there is anything bad about mixing them they just want some limit on the caffeine amount imo.

  18. StarVapor says:

    The big loophole in the consumption of caffeine and alcohol has already been overcome in the 20′s something drinkers by doing Red Bull and vodka shots.

  19. PsiCop says:

    Pedantry: Should’t the tag on this article be “Government,” not “Govenment”?

  20. zacwax says:

    I also like the rum and coke argument.

    But I think the FDA is more concerned with people “ODing” on energy drinks infused with alcohol.

    But then again, people can get redbull and vodka’s all the time.

    I bet this will all lead to an attempted ban on energy drinks

  21. pahncrd says:

    I take offense to the advertisement’s attack on marriage.
    Being married is the best thing in the world if you are with the right person. Being married is the worst thing in the world if you are with the wrong person.

  22. Covertghost says:

    How about the mixture of Alcohol and the human stomach FDA?

    Seems pretty dangerous to me…

  23. DragonThermo says:

    OMG! Now the gov’t is trying to take away my Vodka & Red Bull! Next they’ll say that adding fruit to alcohol is not GRAS and take away my Cosmopolitan and my Bud Light w/ Lime!

    So, we can have caffeinated beverages (soda, coffee, Red Bull) and we can have alcoholic beverages (mmm..beeer!) but we can’t put caffeine in our alcohol? I don’t get it. It’s not like we’re mixing chlorine and baking soda. There’s no chemical reaction when you add caffeine to alcohol.. other than a good time and embarrassing photos on Facebook.

    We can put peanut butter in our chocolate but not caffeine in our alcohol? This is another example of the oppression of the people by the Imperial Federal Gov’t!

  24. TouchMyMonkey says:

    @summerbee: First post, saying exactly what was going through my mind. Mix bourbon and Coke, and you have a caffeinated alcoholic beverage. If you really want to get loaded and wide awake at the same time, try Irish coffee. Hmm, whiskey and coffee. Interesting combo, to say the least.

  25. guaporico says:

    The decision is partly based on scientific studies that show mixing caffeine and alcohol can be dangerous — a stimulant and a depressant, no kidding! The FDA is putting the responsibility on the companies to show otherwise.

    Mixing drinks at home is an entirely different story, as it doesn’t need to be regulated. You could mix mouthwash and coffee if you really wanted, but it would be really stupid.

    New drugs go through extensive clinical trials to determine the effectiveness and side effects through several years. Long term effects can be masked — which is why it’s always wise to wait for several years before using a new drug. The number of drugs recalled due to issues is extremely small.

    I find it amusing how people brush off these sort of investigations when it uses chemicals they know (caffeine and alcohol), but go nuts when the FDA quickly approve the a vaccine that uses components that have been tested for years (H1N1)…

  26. GearheadGeek says:

    @HurtsSoGood: I prefer caffè corretto for that. Mmmmmm grappa.

  27. zacox says:

    @HurtsSoGood: Screw the rum and coke. Just how many Jager Bombs were poured in the USA yesterday?!

    I’m sorry, but the bit about caffeine masking the effects of alcohol, leading to poorer decisions, is baloney. Intoxication is so subjective from person to person, and even in the same person from day to day. It’s based on height, weight, gender, stomach contents,tolerance, licit and illicit drugs in the bloodstream, mood, and other non-trivial physical and emotional characteristics.

    I know there have been times that I’ve consumed four alcohol beverages and been well on my way, and there are other times I didn’t feel a thing.

    It’s a great thing we have the FDA to keep caffeine out of our alcohol instead of using those resources to better research prescription drugs that cause heart attacks or strokes or strange growths of feathers.

  28. Whyspir says:

    @HurtsSoGood:

    151 isn’t strong enough, go straight to the Everclear! (We sell them in 750ml now too!)

  29. Aquasol says:

    @HurtsSoGood: Time to start going for Thunderbird. D:

  30. ohenry says:

    @xtc46 – thinksmarter on twitter: I think that the FDA would be better off, then, by examining how much caffiene is safe. Obviousely some caffiene is safe; you don’t hear about an epidemic of people killing themselves after having rum and coke (or my favorite, souther comfort and Pepsi). The examples you give have red bull, which has much more caffiene than your average soda.

    So I guess I’m saying that the question shouldn’t be “can we add caffiene to alcoholic beverages”, but “how much caffiene is safe to add to alcoholic beverages”.

    That’s my thoughts, anyways.

  31. TheSkaAssassin - College Man says:

    @2 replies by: same concept as proving your innocent to be declared innocent.

  32. jamar0303 says:

    @zacox:
    *reads to last paragraph*
    Wait a minute, what? People are sprouting feathers?

  33. col1999 says:

    @jamar0303:
    *nods*
    Yep. Sprouting feathers. Of course it’s the strange growths of feathers that are really troubling.

  34. zacox says:

    @jamar0303: and @col1999: Haha, I wondered if anyone would catch that!

    The point was that the FDA tends to approve drugs for use when they don’t know all the side effects. Thalidomide comes to mind… also Vioxx, phenylpropanolamine (PPA), and a few others I can’t recall at the moment.

    So why the hysterics over a two drugs of which they do know all the side effects, and which tend to play nicely together.

  35. zacox says:

    @subtlefrog: Neat-O O-chem it is, alright. Did you know that the “safe” isomer is actually converted to the “harmful” one inside the body? No matter which chirality, there’s a danger if you’re pregnant. Safe as can be if you’re not though!

  36. pr0k says:

    @GearheadGeek:

    I actually I’m a big fan of Goose and Red Bull as well, and I have to say you can still taste the vodka in this mixed drink and the quality of vodka is a huge difference.

    I’ve had my share of “well” Red Bull and vodkas and I can’t say I’d ever drink one again.

  37. Megalomania says:

    @Whyspir: stocked up last time I was down in NC (can’t buy the 191 in this state : )

  38. ShadowFalls says:

    @guaporico:

    Well it isn’t just that. It is the amount of caffeine that needs to be taken into consideration as well.

  39. MikeM_inMD says:

    @guaporico:

    Mixing drinks at home is an entirely different story, as it doesn’t need to be regulated.

    But they mix alcohol and caffine at bars FOR SALE. Should the FDA tell all bars, taverns, etc. to stop selling Rum & Coke and Irish Coffee?

  40. perruptor says:

    @zacox: The FDA did not approve Thalidomide for any use until 1998. It has never been approved here for use by pregnant women, as it was in Europe until the deformed babies started showing up. The FDA has enough problems. Don’t blame them for stuff they didn’t do.

  41. GinaLouise says:

    @zacox: As perruptor mentioned, the FDA DID NOT approve thalidomide in the sixties. Thanks to one FDA employee in particular, Frances Oldham Kelsey, thalidomide was kept off the U.S. market. [en.wikipedia.org] It was only approved in the 1990s for leprosy and other stuff.

  42. Veeber says:

    @David in Brasil: Um what? So, the manufacturer of a new drug should be able to simply sell it until someone dies? Drugs by far should have be not safe by default.

  43. xredgambit says:

    @steads: I was wondering this as well. I still see sparks at gas stations where I’m at.

  44. azsumrg1rl says:

    @xredgambit: Technically, MillerCoors has until Jan. 10, 2010 to discontinue Sparks: [albany.bizjournals.com]