by Marion Nestle
Nov 17 2010

FDA and FTC get tough on caffeine-alcohol drinks!

The FDA held two conference calls today to announce action on caffeine-alcohol beverages. It is sending warning letters to four companies that make this collection of caffeinated alcoholic beverages:

  • Core High Gravity HG Green
  • Core High Gravity HG Orange
  • Four Loko
  • Joose
  • Lemon Lime Core Spiked
  • Moonshot  (This product is labeled as “premium beer with caffeine”)
  • Max

The FDA says:

The manufacturers of these products have failed to show that the direct addition of caffeine to their malt beverages is “generally recognized as safe” by qualified experts.  Rather, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern….The agency has given the firms 15 days to respond to the warning letters and then may proceed to court to stop their sale. In addition, other alcoholic beverages containing added caffeine may be subject to agency action in the future if scientific data indicate that the use of caffeine in those products does not meet safety standards.

The FTC issued similar warnings to the same four companies because “marketing of such beverages may constitute an unfair or deceptive practice that violates the FTC Act.  Companies receiving letters include: United Brands Co (Joose and Max), Phusion Products (Four Loko and Four Maxed), Charge Beverages Corporation (Core High Gravity, Core Spiked, and El Jefe), and New Century Brewing Company (Moonshot).

What this is about:

Ever ahead of the game, the New York Times announced yesterday that the FDA would soon be doing something about the caffeinated alcohol beverages that have caused so much trouble on college campuses recently (see previous post on this).

Today, Four Loko says it will voluntarily take the caffeine out of Four Loko.

Why?  In a statement, Phusion Projects, the maker of Four Loko explains:

We are taking this step after trying – unsuccessfully – to navigate a difficult and politically-charged regulatory environment at both the state and federal levels….We have repeatedly contended — and still believe, as do many people throughout the country — that the combination of alcohol and caffeine is safe…If it were unsafe, popular drinks like rum and colas or Irish coffees that have been consumed safely and responsibly for years would face the same scrutiny that our products have recently faced….By taking this action today, we are again demonstrating leadership, cooperation and responsible corporate citizenship.

Yeah, right.  Irish coffees are hardly considered party drinks.

Phusion Projects is acting because it is being forced to.   FoodSafetyNews has kept score, based on data collected by the Marin Institute, which has been on top of this issue for years (thanks to Michele Simon and others).

So far, Oklahoma, Michigan, Utah, and Washington have banned drinks that combine caffeine with alcohol.  New York’s largest beer distributors have stopped selling the drinks. And several colleges have banned the drinks on campuses.

And where are the regulatory agencies in all this?  Alcohol beverages are not regulated by the FDA.  They are regulated by theTobacco Tax and Trade Bureau (TTB) of the Treasury department.  From the government’s standpoint, alcohol is about tax revenues, not health.  As Phusion Projects explains, all this is TTB’s fault:

If our products were unsafe, we would not have expected the federal agency responsible for approving alcoholic beverage formulas – the Tobacco Tax and Trade Bureau (TTB) – to have approved them.   Yet, all of our product formulas and packaging were reviewed and approved by the TTB before being offered to consumers.

Why is the FDA involved in this at all?  Because it regulates food additives—like caffeine and the other supplements put into energy drinks.

If this incident illustrates anything, it’s that alcohol beverages require the same kind of scrutiny given to any other food product and their regulation needs to move to an agency that cares about their effects on health.

Additions, November 18: The California Department of Health Services says caffeine-alcohol beverages can no longer be sold in the state.  And TTB has come out with its own warnings.

Addition, November 23: I’ve been sent the Saturday Night Live skit on Four Loko, and particularly appreciate the comment on portion size—120 servings per can!

  • Thanks, Marion. Just so folks know, it’s actually my organization, Marin Institute that has been “keeping score” on state action and I wrote a report on this topic back in 2007. Today is a great day for advocates on this issue and to show what government can do.
    See for more details.

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  • Sam

    Michele, thanks for posting here, would you comment on the Institute’s stance on the use of whole foods (coffee, chocolate, tea) in alcoholic beverages? I know there is concern in the craft beer community on styles that have traditional been brewed with these ingredients (coffee porters, chocolate stouts, etc) and if this advocacy was aimed at eliminating them too or if this was just to address the “food additive” aspect where some companies directly add purified caffiene to their products.

  • Anthro

    Being old, I have not even heard of these products! How much caffeine is in them, anyway? What is the objective of drinking them, and what happens when they are consumed in excess (which is why colleges–and states–have banned them, I presume)?

    The analogy of the company to other drinks is shameless. I daresay that slamming down numerous rum and cokes or Irish coffees would not be a good idea either. From what I read, binge and “party” drinking is a serious problem on many campuses, so the allusion to “responsible” drinking by the company is also disingenuous.

  • Anthro

    I managed to answer my own question with one google:

    – (AFP) – Regularly consuming high-caffeine energy drinks significantly increases the risk of becoming alcohol-dependent and engaging in bouts of heavy drinking, a study published Tuesday found.
    The study of more than 1,000 students at a US university found that those who consumed caffeinated energy drinks on a weekly or daily basis drank alcohol more often and in greater quantities, and were more likely to become alcohol dependent than students who used energy drinks occasionally or not at all.
    High consumers of energy drinks also had greater risk for alcohol-related problems such as blackouts or missing class because they were hung over, and were more susceptible to self-injury than non- or light users of energy drinks, said the study, led by University of Maryland researcher Amelia Arria.


    I used to find these lying around the house of an alcoholic that I know! She has become much worse since drinking this stuff along with her booze. I feel terribly ignorant to just be finding out about this crap, but that’s what happens when you don’t ever visit the “beverage” section of the supermarket or shop only at health food markets–or watch TV.

  • Sam, we do not care about naturally occurring caffeine in those sorts of products and frankly, this is just a distraction from the real problem: products being marketed FOR the caffeine content.

    Today is a great day to restore our faith in the ability of the federal government to act in the public’s interests. Kudos to everyone who helped make this happen, especially the state attorneys general.

    Also, Marion is quite right that TTB is to blame for approving these products in the first place, and that jurisdiction needs to shift to an agency that cares about health and not taxes, such as FDA.

  • Pete

    They didn’t have caffinated drinks when I was in school (late 90s), but that didn’t stop the mazing amount of binge drinking that was going on. Kids would pop mini-thins (caffeine & ephedra) or crush them up an snort them and party (and even study) all night. There are also some really effective designer prescription drugs right now like Adderol and the like that are most certainly being used as party drugs. We should be careful that we don’t drive kids to do something even more dangerous like:

    The comments are frightening.

  • Sam

    Michelle, what stops those companies from reformulating with natural sources of caffeine if it’s deemed acceptable by the FDA in other alcoholic products, which from the FDA’s Q&A release it appears that it is? I’m sure that in a year, when all this has quieted down, we’ll see a new wave of “naturally” caffeinated products. So either caffeine (no matter the source) and alcohol is always unsafe or it’s not. If it’s unsafe the FDA must ban all of them from chocolate stouts to starbucks coffee liquors. If your concern is not safety but that you don’t like the marketing, you should be pushing then to ban the mention of caffeine on the label but not the products.

    Also what’s with TTB bashing? Unlike the FDA, the TTB actually reviews ever label of the products under its jurisdiction and reviews every formula for any product that has added ingredients and flavors. The FDA does not do that, and considering the change in congress, will not have the ability in the foreseeable future. So by moving regulation to the FDA you will see a loss of control, not more. Further more the TTB did put limits on caffeine (200 pm) in these products so as not to exceed what would be found via natural sources of caffeine. The TTB limit puts the level of caffeine in a 16 oz can at roughly 100 mg well short of the 320 mg you report ( ) in a similar serving size (Grande) of Starbucks coffee. So if 100 mg of caffeine combined with alcohol is dangerous, an irish coffee made from starbucks is too and should be stopped. I’m sorry but your dismissal of irish coffees and “naturally” caffeinated beers makes it appear that CSPI’s goal is not really consumer safety.

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