Caffeinated Beers Get Scrutinized

FDA puts burden of proof on caffeinated alcohol brands to prove ‘safety’

The Food and Drug Administration on Friday notified nearly 30 caffeinated alcohol manufacturers that they provide documentation that their products are safe. Drink makers have 30 days to respond to the FDA request.

Some of the companies notified are familiar names, most notably New Century Brewing Company which produces Moonshot. New Century is owned by Rhonda Kallman who was featured prominently in the recent movie ‘Beer Wars.’ Others in the craft/specialty/regional category are Thomas Creek Brewery, Cold Spring Brewing Company and Ithaca Beer Co.

The FDA never has approved the addition of caffeine to an alcoholic beverage, and a task force of state attorneys general and other officials has urged the agency to scrutinize the combination. The task force argues that the caffeine can mask the intoxicating effects of alcohol, possibly leading to an increase in drunk driving, sexual assault and other destructive behavior.

Miller and Anheuser-Busch removed caffeine from their brands Sparks and Tilt last year.

In the absence of FDA approval, the burden of proving that a new combination of food or drink is safe falls on the manufacturer, said Joshua Sharfstein, the agency’s principal deputy commissioner.

“We’re asking for their side of the story,” he said. “Why they consider adding caffeine to be safe or legal.”

If the FDA determines that caffeine in the alcoholic drinks is unsafe, it could force them off the market.

The companies and brands that were notified are:

Charge Beverages Corporation
Products: Liquid Charge, Liquid Core, High Gravity Core

United Brands Company, Inc
Products: Joose, Max Vibe, Max Fury, Max Live, 3Sum

Phusion Projects LLC
Products: Four, Four Loko, Four Maxed

Point Blank Beverages Co.

Products: Torque

Hard Wired Brewing Company, LLC
Products: Hard Wired

Mix Master Beverage Co
Products: 24/7

Catalyst Beverage Company
Products: Catalyst

New Century Brewing Company
Products: Moonshot

Melanie Brewing Co
Products: Evil Eye

Thomas Creek Brewery, LLC
Products: Mobius Lager

Diageo North America, Inc
Products: Smirnoff Raw Tea Malt Beverage

Constellation Brands
Products: Wide Eye

The P.I.N.K. Spirits Company/Prohibition Beverage Inc
Products: P.I.N.K. Vodka, P.I.N.K. Tequila, P.I.N.K. Rum, P.I.N.K. Gin, P.I.N.K. White Whiskey, P.I.N.K. Sake

Delicious Brands Inc.
Products: Lotus Vodka

Sovereign Brands
Products: 3AM Vodka

Moet Hennessey/Millennium Import LLC
Products: Belevedere IX

Shotpak Vodka
Products: Gravity Vodka

Wingard USA (Importer)
Products: V2 Vodka with Caffeine, Everglo Vodka

LeVecke Corporation
Products: Vicious Vodka with Caffeine

Rocktail Drinks/Liquid Manufacturing LLC
Products: Slingshot Party Gel

Cold Spring Brewing Company/Atomic Brands
Products: A:M Carpe Noctern

808 Spirits Co.

Products: 808 Mango Beat

Gaamm Imports Inc.
Products: Booya Espresso Silver Tequila with Caffeine

Ithaca Beer Co.
Products: Ithaca Eleven Malt Beverage with Coffee

Gluek Brewing Company
Products: Gruv Malt Beverage with Guarana

MHW, Ltd and Niche Import Company
Products: Agwa De Bolivia

Rizer Spirits Inc
Products: XZO Vodka with Caffeine, Taurine, and Guarana

Comments

  1. Jephro says

    In other words it’s ok if the Bartender adds the caffeine, but not if the brewer does it. They have no problem with Jack & Coke, Irish Coffee, and you can do Jager Bombs until your heart explodes. Caffeine and Alcohol have been paired for a long time, why is it only now being scrutinized in the beer industry.

    Burden of Proof on the Brewer to prove safety. Some strange goings on in the FDA lately.
    -This could be a very slippery slope my friends.

  2. Jephro says

    In other words they can’t (or won’t) come up with a reason why it’s unsafe and it’s ok if the Bartender adds the caffeine, but not if the brewer/distiller does it. They have no problem with Jack & Coke, Irish Coffee, and you can do Jager Bombs until your heart explodes.

  3. gitchegumee says

    Totally agree with you Jephro. Of course it’s “safe”. Unless either one alone is considered unsafe. It’s a sad day when you can’t live in peace and follow the rules. Now it seems that you have to prove what you do is NOT ILLEGAL. The assumption is that everything is illegal unless proven otherwise. America the nanny state strikes another blow against common sense. Chalk one up to overreaction from the teetotaling, hand-wringing soccer moms. Brings to mind the Simpsons character who, in a crisis, always whines “Somebody think of the children!”

  4. Moonlight says

    To clarify, I don’t believe it is technically caffeinated “Beers” that are in question, as that is regulated by the TTB. However non-beer “Malt Beverages” are regulated by the FDA, and I believe this is the focus of scrutiny.
    Anyone else have better clarification?

  5. Jephro says

    Just found this FDA Q&A on this topic…

    It appears the FDA can step in on the TTB (see Q7). Looks like (NAAG) or the co-chairs of the National Association of Attorneys General Youth Access to Alcohol Committee are the party responsible for the list and prompted the FDA’s action. I think you nailed that one on the head Phillip!! Not really sure how caffeinated alcoholic beverages are linked with reducing underage drinking.

    Oh, and it’s Helen Lovejoy, the ministers wife, that always says “won’t somebody please think of the children”

  6. Moonlight says

    from the FDA letter:
    A10. This FDA action is not directed at products that are flavored with coffee. The beverages that are the subject of FDA’s request for information are characterized by the intentional addition of caffeine to alcoholic beverages by the manufacturer.

    So as I read this, then: Coffee Stouts are still just fine, as long as any contained caffeine comes from coffee, chocolate, yerba mate, or such- just not added in the chemical form.

    Because children don’t like coffee…???

  7. liammckenna says

    gitchegumee wrote:
    Of course it’s “safe”. Unless either one alone is considered unsafe.

    Both are considered unsafe in quantity. Also, the mixture of lot’s of caffeine (a stimulant ‘or’ upper) with lots of alcohol (a depressant or ‘downer’) is, IMHO, a bad idea, even dangerous. It is always very difficult to metabolize this combination and it can confuse a lot of systems in the body. This only makes sense. Ask a physician for details.

    However, as, Jephro points out, a lot of people do this already when mixing cocktails. I might also add energy drinks with pretty much any liquor you’ve heard of. Not sure why people do it. I really don’t see the appeal. But then again, I’m not a caffeine junkie like many (too many) people I know.

    In the last ten years I have witnessed a whole generation grow up with ‘energy’ drinks. It has now almost become societally acceptable for young people to become addicted to a stimulant like caffeine. Is this a good thing? Most definitely, it is not.

    Now these young adults are mixing quantities of caffeine and alcohol. Could this practice be prevented? Undoubtedly the answer is no.

    I do think, however, that ethical producers should know better. If we don’t respect alcohol and its inherent, recognized properties, who will. I’m waiting for the first series of lawsuits against producers. They should know better than to market such concoctions. AB and Miller seem to understand the liability issues.

    Pax.

    Liam

  8. gitchegumee says

    So much for my Wormwood Barleywine. Might as well toss my “Sacred and Herbal Healing Beers” text. So, did I hear this right that caffeine in alcohol is legal if it comes from coffee, but may not be if it is extracted from the bean and added discretely? Where’s the logic? And why should the burden of proof be up to producers instead of the government. I think the default should be on the regulatory agency to prove that a historic & traditional mix of caffeine and alcohol is dangerous. Liam, honestly if we’re talking about making ethical products then we (as a society) shouldn’t be making cigarettes, snuff, landmines, handguns, racecars, fireworks, whiskey or beer. None of them physiologically improve humans. That being said, I think we should grant ourselves the freedom to enjoy ourselves as we individuals see fit, within reason. I personally think that mixing guarana, coffee, yohimbe, or any number of herbs with alcohol can be legitimate. Unless you’re offering it in multiple case discounts at a kindergarten bakesale. Undoubtedly there will be some folks that can’t handle that responsibility. That doesn’t mean we should all be held to the least common denominator. Here in Palau you will never get the locals to stop chewing betel nut while drinking alcohol (or doing just about anything else–it’s quite pervasive). Certainly there is a synergistic effect with the two being mixed. It’s simply not my position to tell them that this is not in their best interests to chew & drink. I’m not their nanny. And I don’t want anyone to be mine. Just my two bits.

  9. liammckenna says

    gitchegumee wrote: Liam, honestly if we’re talking about making ethical products then we (as a society) shouldn’t be making cigarettes, snuff, landmines, handguns, racecars, fireworks, whiskey or beer. None of them physiologically improve humans.

    I think beer does improve humans somewhat. I’m not talking about these other items you mention. I’m talking about beer. Something we produce.

    So if I understand your logic, it is okay for you to produce a beer/alcoholic drink you know is dangerous so long as people are willing to buy it or have done so historically?

    The addition of pure caffeine (not coffee, yohimbe, guarana or other additives that could be considered foodstuffs) to alcohol, should be controlled and monitored in the very least. What if some mom & pop production facility added too much to a batch (easily done in low tech op’s) and some people died? Who would bear the responsibility for that? The consumers? I think not.

    If I added twice as much coffee to a batch, chances are my consumers would notice how strong it tastes and limit their consumption. If you truly wanted some significant effect from Artemisia spp. in your Wormwood Barley wine, it would, no doubt, be incredibly bitter and self limiting vis-a-vis consumption. The same cannot be said for the synthetic caffeine scenario.

    If I produced any such product (with pure caffeine added), I would include a very stong warning label suggesting consultation with a physician for anyone taking medication or suffering from any known issue prior to consuming the product. But that’s just me. No doubt, most physicians would counsel avoidance.

    Also, when the NAAG comes knockin’ , there’s obviously an emerging liability issue. Gun, fireworks, tobacco and landmine producers have all been involved in extensive liability suits for decades. For good reasons.

    Pax.

    Liam

  10. jarviw says

    Phillip,

    Alcohol is not an unethical product that only requires consumers’ own better judgment. There are lots of benefits, but as we all know, drawbacks from over drinking as well. I like to think, as an industry, we produce a product that brings more benefits to the society than costs. That said, it is justified, from a social policy point of view, we are liable (as an industry) for the social cost we incur, mostly likely in the form of tax. (I highly recommend Tremblay & Tremblay’s The US Brewing Industry for more detailed analysis on this topic.)

    But I think the core of the issue here is not about coffee in beer in the craft brewing artistic sense. Rather, it is about the aggressive marketing certain companies use to push for a product that promotes binge drinking and unhealthy life style. This is where the product become a social cost. (Just look at the list… all but two are some sort of “party drinks”.)

    However, it is a shame that because of these few irresponsible companies now they want to limit all of our artistic freedom in brewing. Sometimes it’s not about picking the fight, but picking the team you want to be with…

  11. brew4you says

    You can’t add vitamins either. I submitted a statement of process for a beer with taurine and vitamin b and they said it was denied as they “are currently reviewing” the issue of vitamins in beer. So I might just start packaging a bottle of beer and a pill instead – haha (that last part is a joke).

    I do disagree with the gov’t though. Guess we all have MADD and other prohibitionistas to thank for this.

    Though since pot is legal in cali – i wonder when someone will try to produce a medicinal beer? haha.

    liammckenna wrote: I think beer does improve humans somewhat. I’m not talking about these other items you mention. I’m talking about beer. Something we produce.

    So if I understand your logic, it is okay for you to produce a beer/alcoholic drink you know is dangerous so long as people are willing to buy it or have done so historically?

    The addition of pure caffeine (not coffee, yohimbe, guarana or other additives that could be considered foodstuffs) to alcohol, should be controlled and monitored in the very least. What if some mom & pop production facility added too much to a batch (easily done in low tech op’s) and some people died? Who would bear the responsibility for that? The consumers? I think not.

    If I added twice as much coffee to a batch, chances are my consumers would notice how strong it tastes and limit their consumption. If you truly wanted some significant effect from Artemisia spp. in your Wormwood Barley wine, it would, no doubt, be incredibly bitter and self limiting vis-a-vis consumption. The same cannot be said for the synthetic caffeine scenario.

    If I produced any such product (with pure caffeine added), I would include a very stong warning label suggesting consultation with a physician for anyone taking medication or suffering from any known issue prior to consuming the product. But that’s just me. No doubt, most physicians would counsel avoidance.

    Also, when the NAAG comes knockin’ , there’s obviously an emerging liability issue. Gun, fireworks, tobacco and landmine producers have all been involved in extensive liability suits for decades. For good reasons.

    Pax.

    Liam

  12. David Hicks says

    The question is, where will it stop?

    If alcohol and caffeine are so dangerous together where do you draw the line?

    Will we come to a point where bar tenders refuse to serve people who seem too awake? (“ma’am, did I just see you walk out of the starbucks? I’m afraid I can not serve you.”)

    Will restaurants have to say “no, you may have coffee OR port with your desert, not both”, or “Sorry, we cant serve you after-dinner coffee because you had a beer with your meal”

    I understand a push to prevent people from adding synthetic chemicals to drinks, but It should not be justified by “caffeine and alcohol are dangerous together”.

  13. beerking1 says

    David Hicks wrote: The question is, where will it stop?

    If alcohol and caffeine are so dangerous together where do you draw the line?

    Will we come to a point where bar tenders refuse to serve people who seem too awake? (“ma’am, did I just see you walk out of the starbucks? I’m afraid I can not serve you.”)

    Will restaurants have to say “no, you may have coffee OR port with your desert, not both”, or “Sorry, we cant serve you after-dinner coffee because you had a beer with your meal”

    I understand a push to prevent people from adding synthetic chemicals to drinks, but It should not be justified by “caffeine and alcohol are dangerous together”.

    Great points, but I think what they are really saying is “caffeine and alcohol have not been proved to be safe together.” Big difference in semantics, and how it gets enforced.

  14. brew4you says

    beerking1 wrote: Great points, but I think what they are really saying is “caffeine and alcohol have not been proved to be safe together.” Big difference in semantics, and how it gets enforced.

    guess no more rum and coke either then… haha. or irish coffee…

  15. KevinECB says

    is there anything new on this front?
    or is there a place i can search for that will post on it?