Alcohol

Is the FDA Banning Drinks or Censoring Speech?

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Today, as expected, the Food and Drug Administration announced that Four Loko violates the Food, Drug, and Cosmetic Act because the caffeine in it is not "generally recognized as safe" (GRAS) in this context. In addition to Phusion Products, the Chicago-based company that produces Four Loko (which has already said it will no longer make the drink with caffeine), the FDA is sending warning letters to just three other companies: United Brands of La Mesa, California, which makes Joose, a direct Four Loko competitor; Oregon's Charge Beverages, which makes Core, a similar product; and Boston's New Century Brewing Company, which makes Moonshot, a light lager with added caffeine. By contrast, Michigan's list (PDF) of newly forbidden "alcohol energy drinks" includes 55 product varieties made by 10 companies. Moonshot did not make the list, although a beer brewed with the caffeine-containing herb yerba maté did (to the consternation of its brewer).

The concerns expressed in the FDA's warning letters are familiar:

Reports in the scientific literature have described behavioral effects that may occur in young adults when energy drinks are consumed along with alcoholic beverages….Studies suggest that the combined ingestion of caffeine and alcohol may lead to hazardous and life-threatening situations because caffeine counteracts some, but not all, of alcohol's adverse effects….Because caffeine alters the perception of alcohol intoxication, the consumption of pre-mixed products containing added caffeine and alcohol may result in higher amounts of alcohol consumed per drinking occasion, a situation that is particularly dangerous for naive drinkers.

So why just these four companies? One criterion seems to be that they directly add caffeine to malt beverages, as opposed to using ingredients (such as coffee or yerba maté) that happen to contain caffeine (although that exception also would apply to guarana, one of the caffeine sources in Four Loko). The warning letters refer to "caffeine that has been directly added to an alcoholic beverage and packaged in combined caffeine and alcohol form." But the main factor distinguishing the companies that made the FDA's list from the ones that didn't is marketing (citations omitted):

GRAS status is not an inherent property of a substance, but must be assessed in the context of the intended conditions of use of the substance. The assessment includes a consideration of the population that will consume the substance. Therefore, the scientific data and information that support a GRAS determination must consider the conditions under which the substance is safe for the use for which it is marketed. Reports in the scientific literature have raised concerns regarding the formulation and packaging of pre-mixed products containing added caffeine and alcohol. For example, these products, presented as fruity soft drinks in colorful single-serving packages, seemingly target the young adult user. Furthermore, the marketing of the caffeinated versions of this class of alcoholic beverage appears to be specifically directed to young adults. FDA is concerned that the young adults to whom these pre-mixed caffeine and alcohol products are marketed are especially vulnerable to the adverse behavioral effects associated with consuming caffeine added to alcohol, a concern reflected in the publicly available literature.

In short, a caffeinated alcoholic beverage targeted at "young adults" is "adulterated," while exactly the same beverage targeted at middle-aged drinkers is not. The FDA is not really banning drinks; it is censoring speech.

In the April issue of Reason, Greg Beato argued that the message sent by Four Loko's marketing, as opposed to the caffeine in the can, was the real source of controversy.

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  1. If the FDA wants to ban things that could cause harm, it needs to review the side effects of many of the drugs it approves.

  2. Unrelated: Bernake says QE2 could creat 700,000 jobs. Just thought you should know.

    1. The key word is “could”. I could have a threesome with Scarlett Johansson and Christina Hendricks.

      1. No you couldn’t.

      2. Look, there’s wishful thinking, and then there’s unadulterated fantasy.

        1. Scarlett Johansson and Christina Hendricks may be young enough for it to be considered “adulterated” by the FDA.

        1. With Vera, I suppose?

    2. Create or save?

      1. You mean there’s a difference. Because Obama told me that there isn’t a difference.

        1. There is no difference. I’m only employed thanks to the government’s magic pixie dust.

          Obama also saved 300 million lives by not launching nukes against the U.S. Be thankful.

    3. Unrelated: Bernake says QE2 could creat 700,000 jobs.

      WTF why not just print $6 trillion more and end the depression already.

  3. “Not generally recognized as safe” by whom, exactly? Based on what scientific studies?

    And what difference does it make if the caffeine molecule is isolated first, or introduced along with other substances present in, say, coffee or guarana? What other substances magically convert the caffeine from presumptively unsafe to safe? If I’m lawyering for Joose or 4Loko, I want to find out what we need to mix with our caffeine before we put it in our swill to get the FDA off our backs.

    And I’m still wondering why these drinks are targeted, but an Irish coffee mixed in a bar that has more caffeine and more alcohol is perfectly fine.

    1. Look RC, if ObamaCare taught us anything it’s that we are all chidren until we reach the new age of majority, 26.

      1. You do understand that Oklahoma has banned this drink already, right? Not exactly an Obama loving paradise.

    2. “Not generally recognized as safe” by whom, exactly? Based on what scientific studies?

      It’s not that they’re generally recognized as unsafe, just that they’re not generally recognized as safe. That is, the default condition of an article absent studies is not GRAS.

      And what difference does it make if the caffeine molecule is isolated first, or introduced along with other substances present in, say, coffee or guarana?

      Coffee and guarana are foods, and foods don’t have to be GRAS to be marketed. That is, the presumption is the other way. Isolated substances by contrast are food additives. It’s just the way the statute is written.

      And I’m still wondering why these drinks are targeted, but an Irish coffee mixed in a bar that has more caffeine and more alcohol is perfectly fine.

      Mixed in the bar, it’s not in interstate commerce. And the Act does specify “interstate commerce”, not some bogus category like affecting interstate commerce. FDA has no jurisdiction under the FFDCA over bars, restaurants, pharmacies, clinics, etc., although sometimes they’ve acted on the basis of products therein having been received in interstate commerce.

      So it comes down to scratching where they can.

    3. As I argued in the previous post, it’s because drinks like Four Loko are consumed by the Snooki Class, and it’s OK to show bigotry toward the Snooki Class.

  4. Yep. The busybodies in charge basically don’t like the idea of alcohol being marketed as a party-time substance. It’s only for responsibly consumption under the supervision of… well, someone.

  5. Here’s a thought: what if they still marketed it as an alcohol/energy drink combo, but just added a bunch of vitamins and herbs to it instead of caffeine? What are the chances that would still be seen as verboten somehow?

    1. The FDA fears that SevenLoko, a beverage that mixes alcohol with vitamins and herbs, could be seen as a nutritious substance by some.

      “I see kids drinking this stuff, they think it’s a dietary supplement,” said a spokesperson for a concerned industry. “They don’t realize how dangerous this drink can be.”

      The FDA is currently reviewing SevenLoko but several key personnel say it’s likely that the drink will be banned as unsafe.

  6. This makes no sense at all. As everyone keeps pointing out, mixing caffeinated beverages with alcoholic ones is a very old tradition. It’s clearly not very dangerous, or we’d have had bodies on the streets all along.

    In addition, what about people who take, say, Excedrin while drinking? Not only does that have the evil caffeine, it also contains acetaminophen, which actually can be a problem because of its potential (along with the booze) to damage your liver.

    Can’t help but think this is yet (and only) another outcry about kids drinking too much. Parents maybe can try to limit that sort of abuse, but the government simply cannot do a thing about it.

    1. You have to drink a LOT and take a LOT of acetaminophen to damage your liver.

      Of course too much of *anything can be a bad thing; I suppose that it’s easier to just ban everything but water and berries.

      * Still trying to discover the down side of too much money and too much sex, but I am sure that there has to be a downside somewhere.

      1. Right, that’s why I said potential. There’s not even that in the case at hand.

      2. * Still trying to discover the down side of too much money and too much sex, but I am sure that there has to be a downside somewhere.

        Paternity suits?

      3. Uh, some berries are poisonous, and sometimes people basically drown from drinking too much water, so no, we’ll just have to ban everything.

      4. Water, if you drink a large quantity in a short time, will kill you.

        1. Especially if you snort a lot of it.

      5. You have to drink a LOT and take a LOT of acetaminophen to damage your liver.

        The overdose level is a lot lower than is allowed in newly approved drugs.

        Nitroglycerin gets a nice grandfathering too.

      6. fuck off, cunt

        1. What the hell is your problem, dipshit?

      7. Watch out for the purple berries; they taste like burning.

      8. * Still trying to discover the down side of too much money and too much sex, but I am sure that there has to be a downside somewhere.

        The chafing hurts like a mofo…

        1. Ask some christians about the downside to too much sex. Obviously, it’s STDs, and obviously, they are clear evidence that their god doesn’t want us having any fun.

          1. I am a Christian. God says as long as it’s with you wife, have at it.

            NOTE: The Bible says it prettier, but that basically it.

          2. Well, as the Onion put it.

            Besides, Science demonstrates that religious women report having more orgasms. The more conservative and fundamentalist the religion, the more orgasms the women report. Atheist women report the fewest orgasms.

            1. When University of Chicago researchers set out to discover which religious denominations have the best sex, they learned that the faithful don’t do all their shouting in church.

              AMEN! Now where’s my wife!

  7. And I’m still wondering why these drinks are targeted, but an Irish coffee mixed in a bar that has more caffeine and more alcohol is perfectly fine.

    Bartenders aren’t Big Malt Liquor’s competitors.

    1. But when did BML get so much clout with the FDA?

  8. So has anyone seen that movie “Beer Wars”? I imagine that lady’s hair is all gone now, after “Moonshot” got banned.

    1. This is what I thought too. The way Moonshot was portrayed in that movie…it doesn’t make sense that it would be a target of this.

  9. Like child satanic ritual abuse, suicide-inducing music lyrics and razor blades in halloween candy, caffinated alcohol is just the latest completely retarded media panic.

  10. In short, a caffeinated alcoholic beverage targeted at “young adults” is “adulterated,” while exactly the same beverage targeted at middle-aged drinkers is not.

    A lot of the hysteria is generated by the fact that there have been a few sudden and violent deaths in the Loko target demographic, but almost none in the single malt Scotch demographic.

    Of course, the Loko demographic is prone to sudden violent deaths, whereas the single malt Scotch demographic usually just slowly fade away from alcohol-related illnesses.

    The only solution, therefore, is to ban youth. Harsh, but I’m afraid it must be done. For the children.

    1. A lot of the hysteria is generated by the fact that there have been a few sudden and violent deaths in the Loko target demographic, but almost none in the single malt Scotch demographic.

      Really? Is anyone keeping statistics?

      1. So what’s the death rate difference between Red Label and Blue Label Johnnie Walker…

      2. C’mon, you know Loko’s not being served in country club master’s tournaments.

  11. the FDA is sending warning letters

    SHUT THE FUCK UP FOUR LOCO!

  12. I work in flavor development, and this is absolutely devastating to a number of startups on our client list (and therefor, to me). That’s what we get for underestimating the FDA I guess.

    1. The FDA exists to ruin your day. I suggest you lobby your congressman about this.

      1. Great idea! [Looks up congressman…]

        John Yarmuth?!? Fuck me.

  13. What they need to ban is hybrid cars:

    The three-alarm blaze that caused $1.1 million in damage to a warehouse filled with rock legend Neil Young’s music equipment and memorabilia appears to have started in a one-of-a-kind hybrid car stored at the site, a fire official said Monday.

    Flames began in a 1959 Lincoln Continental dubbed LincVolt, which runs on electric batteries and a biodiesel-powered generator, and then spread to the warehouse at 593 Quarry Road in the early morning of Nov. 9, according to Belmont-San Carlos Fire Marshal Jim Palisi and a website devoted to the car.

    http://www.mercurynews.com/san…..ck_check=1

    1. I think they need to ban 1959 Lincolns converted to hybrids by potheads.

  14. Since when do fear mongering local news reports count as scientific literature?

  15. FDA is concerned that the young adults to whom these pre-mixed caffeine and alcohol products are marketed are especially vulnerable to the adverse behavioral effects associated with consuming caffeine added to alcohol, a concern reflected in the publicly available literature.

    I daresay most H&R commenters are “concerned” about the FDA. But we’re especially sensitive to the adverse behavioral effects associated with consuming statist propaganda.

  16. So, we’re gonna get a ban on alcoholic energy drinks, eh? How long until police start raiding bars and arresting everyone drinking J?gerbombs? How long until a swat team storms into my aunt Mildred’s house, shoots her toy poodle, ransacks her home, and throws her in jail because she enjoys adding a dash of Bailey’s to her coffee on a lazy Sunday afternoon?

    You can call me crazy for asking those questions, but based on the War on Drugs I think it’s exactly where we’re headed.

  17. My Dad has a bourbon and coke every night, since forever ago. I’ll let him know he is drinking liquid death next time I talk to him.

  18. The FDA IS banning a product, but using the rationalization that the marketing (speech) is the source of the behavioural side effects. This argument of marketing and advertizing somehow short circuiting all reason and common sense is an age old tactic. It fits into their view that business is the source of social ills and that they are the protectors of the gullible masses.

  19. I’m the last person who wants any action whatsoever taken on this issue, but why isn’t this the ATF’s thing? Alcohol’s right there in their name, for crying out loud. Is there a potential benefit to trying to keep both the ATF and the FDA busy by sparking a turf war between then?

  20. Do they really need a logical justification? I mean the government still sells marijuana as TEH MOST DANDRUS DRUG EVAR!!!!! without any scientific support whatsoever.

    The only scientific reasoning they need is their own justification.

  21. Since you can buy powdered caffeine Loko should just take it out of the drink and stick a little packet of it to the side of the can.

  22. With all the hysteria over this stuff the past few days, I think I’m going to go buy a can tonight just to see what the hell people are talking about.

    Being an adult in my late 30’s and and all, I can still do that… Right?

  23. Attend Four Loko for Freedom.
    http://www.facebook.com/event……8914657475

  24. The FDA needs to ban the SBA.

    “In 2005, three college friends from The Ohio State University had the entrepreneurial idea to start their own company. They took out a Small Business Administration loan and put their financial resources on the line to launch Chicago-based Phusion Projects, LLC. Over the past five years, Phusion Projects, LLC has become a successful alcoholic beverage company that sells its products ? Four Loko, Four MaXed and Earthquake ? in more than 45 states.”

    1. “…in more than 45 states.”

      So say in 46, or 47, or 48, or 49 states. Or say in more than 40 (a round number) states.

  25. It is difficult to imagine a world where the cockroaches employed by the FDA would be of any value. When one notices a cockroach scurrying across the kitchen floor, what is one’s first reaction? Get out the spray. Isn’t that what one does when a vermin crosses one’s path? Whatever you might believe, they are not anthropoids, but vermin. Once again. Vermin.

  26. The FDA is not really banning drinks; it is censoring speech.

    But this is how almost everything under the Food, Drug and Cosmetic Act works. Unlike the Controlled Substances Act, it targets not materials but articles of commerce, which are categorized by their intended use, which is determined by their labeling and other representations made for them. And this is true for most other state and federal regulatory laws regarding commerce in the USA and elsewhere. It nearly always comes down to the speech.

  27. So…they have to ban Kahlua

  28. Wow, the government is sticking it’s grubby little hands into every aspect of our lives.
    I have one warning for them. Leave bacon alone or people will die.

  29. This ban might be unconstitutional under the 21st amendment to the constitution.

    See here for my full argument:

    http://patterico.com/2010/11/1…..beverages/

  30. It is precisely the unabashed marketing of this product and its half-hearted attempts at concern for public safety that have gotten the company here. Also the fact that the product is a hospital visit waiting to happen didn’t exactly make a great case for healthy consumption.

    Read more about Four Loko’s marketing at: http://luminositymarketing.com/blog/?p=2027

  31. you know, people can decide whether or not to buy a certain product. Guns are not banned for you can purchase guns and ammo. there are days that i would love to have a drink at work under the guise of a soda. good ness

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