Nov 14 2009

FDA “looking into” safety of caffeinated booze

The FDA announced today that it has sent letters to 30 makers of caffeinated alcoholic beverages warning them that caffeine is not approved as an additive to booze:

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….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 asked the companies to provide evidence that the products are safe.  It also opened up a new web page on caffeinated alcoholic beverages.  This gives samples of letters, the list of manufacturers, and letters to FDA from attorneys general and scientists.  There is also a Q and A.  For example:

Q3. What happens if the industry doesn’t share its data in the next 30 days? What options are available to FDA?

A3. If FDA determines that the use of caffeine in an alcoholic beverage is not GRAS or subject to a prior sanction, FDA has a range of regulatory options available to it, from the issuance of a warning letter to seizure. It is the manufacturer’s continuing responsibility to ensure that the foods they market are in compliance with all applicable legal and regulatory requirements. FDA intends to exercise all options that are appropriate for the product in question.

As Michele Simon of the Marin Institute puts it, “It seems the sleeping giant has awaken!

Indeed it does.  You don’t think this counts for much?  Ask the makers of some of these drinks.  A couple of companies already have “voluntarily” removed the caffeine.  I’m willing to bet that others will soon follow?

  • Marisa

    I’m just a little confused. The rule states that the substance (caffeine) must be GRAS, but then the FDA states that the PROCESS of adding caffeine to alcohol must be GRAS. So which is it? Can the companies simply argue that caffeine is a substance GRAS and should be allowed?

  • Marisa

    Another thought: maybe the solution of caffeine and alcohol is the substance in question? They should be more specific.

  • Anthro

    Could someone give an example of one of these beverages? Also, what is the reason that the companies would add the caffeine and how much caffeine is in these drinks anyway? I’m dense, I guess, because I don’t get the whole thing.

  • Anthro

    I forgot to say that Michelle Simon is one of my heroes, right up there with the great Ms. Nestle, Michael Pollan, and Wendell Berry.

    I heartily recommend her book, “Appetite For Profit”. She takes on the food marketers–in court.

  • http://www.appetiteforprofit.com Michele Simon

    I have written an entire report about these products, called Alcohol Energy Drinks and Youth: A Dangerous Mix, which you can find here: http://www.marininstitute.org/site/campaigns/alcoholic-energy-drinks.html. (It’s from 2007 and since then, some products have changed; Miller’s Sparks no longer contains caffeine thanks to legal pressure from state attorneys general.) One of the most concerning products is called Joose (www.joose.com) because it is so obviously aimed at youth, as most of these products are. They are designed to mimic soft drinks such as Red Bull and Monster.

    How much caffeine is in them and why? The popularity of Red Bull et al is why, kids love them! And they are marketed with a wink and a nod that you can stay longer and drink more. In fact one product, PINK (spirits based) calls itself “the perfect party spirit”. We do not know how much caffeine is in them because alcohol companies don’t even have to list ingredients, like food companies do, let alone provide anything resembling a nutrition facts label. In 2008, one local TV station tested Sparks (the Miller product) and found very high levels, more than the FDA would allow in soft drinks.

    Why is this of concern? What little science there is on combining alcohol with caffeine shows that people mistakenly believe they are OK, but their motor skills are still impaired, a recipe for disaster. Also, youth who combine alcohol and caffeine are at higher risk for injury, getting into a car with a drunk driver, and having risky sex.

    As to what FDA is asking, it’s not enough to show that caffeine is GRAS on its own. They are asking companies to show that ADDING caffeine to alcohol is GRAS, for which there is NO scientific evidence whatsoever. So as I told one reporter, I cannot imagine what these companies are going to come up with!

    The FDA has an excellent page for this topic here:
    http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm
    It includes a list of the 27 companies and their brands here:
    http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190448.htm

    I must say I am thrilled to see FDA take this action. Happy to answer any more questions!

  • Subvert

    Very interesting that this is coming up. Reg’s for alcohol have for the most part been more related to the collection of taxes, and a few adulteration items related to trade (added colors, flavors). Imagine all the other things that are in alcoholic drinks, you could have a field day with it…but then again, we’re really not having a drink to be healthy, and really alcohol is just a solvent, no? Will be interesting to see how the large alcohol industry responds to this.

  • Daniel

    To answer Anthro’s questions: The combination of Alcohol and energy drinks is really popular at colleges. The most popular brand was Sparks (Miller Brewing) which was discontinued last year. These grain alcohol/energy drink combos are tredny due to the popularity of their more expensive counterparts (think Redbull and Vodka). Energy drinks are really just soda with more caffeine (and often times more sugar as well) so it shouldn’t come as a surprise that they make good mixers.

    Interestingly enough when you google “caffeine alcohol” an article published in 2005 about the dangers of consuming caffeine with alcohol (http://media.www.quchronicle.com/media/storage/paper294/news/2005/04/27/Lifestyles/Studies.Show.That.Combining.Caffeine.And.Alcohol.Can.Have.Harmful.Effects-939144.shtml). Why did it take 4+ years for the FDA to respond?

  • John Senner

    Would this category extend to such old-time drinks as Irish Coffee and Kalua? They probably don’t have “added” caffine, but surely are not being made with decaffinated coffee.

  • http://www.appetiteforprofit.com Michele Simon

    To make one correction, Sparks was not discontinued but rather it was reformulated to remove caffeine and other stimulants. This is important because the product is popular because, well, it looks and tastes like orange soda, and guess who that appeals to?

    No, this would not extend to mixed drinks such as Irish coffee or even premixed Kalua. This is about adding caffeine to alcohol. As to why it took FDA so long, the simple answer is that no one asked them before. As you can imagine, the previous administration wasn’t exactly the most responsive. A new day has truly dawned in DC.