If there is any perfect example of how supplement makers get away with murder, this is it.
So-called "energy" drinks are currently in the news because the FDA is investigating whether the deaths of 5 people who drank concoctions with names like Monster and Red Bull, are related to the caffeine content in the drinks. The FDA isn't talking yet, but the idea is certainly plausible. Here's why.
In addition to caffeine, coffee and tea also contain smaller amounts of a nearly identical drug called theophylline. If you are an asthmatic, this name probably sounds familiar, because prior to the discovery of prophylactic inhalation therapies (such as Advair), theophylline--a bronchodilator was the mainstay of asthma management.
Theophylline is no longer the first line treatment for asthma. This is because it has a very narrow therapeutic index (the difference in dose between efficacy and toxicity). So when it was used, it had to be used carefully. So much so, that patients (and I was one of them) regularly needed to have their blood checked to make sure that their theophylline levels weren't too high.
Caffeine and theophylline are very similar in structure and function (in fact, when caffeine is metabolized in the body, it forms theophylline). Their pharmacological profiles are similar, although theophylline is 5 times more toxic than caffeine.
Symptoms of theophylline (or caffeine) overdose include nausea, diarrhea, an increased heart rate, and arrhythmias (irregular heartbeats). Sometimes it gets worse--seizures and death can also occur. And this can be triggered by taking as little as twice the recommended dose--an example of a very narrow therapeutic index.
The recommended daily dose of theophylline is 200-600 mg per day. The highest allowable dose is 900 mg per day (and you wouldn't like this one bit). Suffice it to say that theophylline is not the safest drug in the world. And therefore neither is caffeine in sufficiently high doses. How high?
The LD50 (the dose that is lethal to 50 percent of the population) for caffeine in humans is estimated to be 5000 mg. But in the presence of certain drugs that block caffeine metabolism, this amount can decrease by up to five-fold. There are about 80 drugs, including antibiotics, antidepressants and decongestants) that can do this.
So, in a worst-case scenario, 1000 mg of caffeine (equivalent to 10 No Doz pills) can be very harmful--even fatal.
Yet, a 24 ounce can of Monster Energy Drink supposedly (we'll get to this later) contains between 240 and 550 mg of caffeine. Assuming the higher amount, it is not difficult to see why a 14-year old girl weighing 90 pounds and taking Cipro could end up in the emergency room (or worse) by drinking two cans of the stuff.
Now for the idiocy. How much caffeine is actually in two cans of Monster Energy Drink? No one really knows. This is because these drinks are considered to be supplements and are therefore exempt from FDA labeling requirements.
Perhaps I'm being picky, but I'm pretty sure that a drink that has enough caffeine such that two cans of it can possibly kill you really ought to have a label letting you know exactly how much caffeine you're getting. Cosmetics labels list dozens of harmless chemicals, yet Red Bull doesn't have to reveal anything? Welcome to Bizzaro World.
Can anyone in his right mind really call this a supplement? No. Because it's not a supplement. It's a drink containing an unknown amount of a drug that can be really dangerous at high doses. There is nothing "supplemental" about these drinks--they are sugar and water with some number of No Doz pills chucked in.
This is just another example of the pure insanity spawned by the Dietary Supplement Health and Education Act of 1994, sponsored by Senator Orin Hatch of Utah--coincidentally where many supplement companies are based. My editorial in The American Spectator discusses this law in more detail.
Well, congratulations, Senator--you did some damn fine work letting this (and other) garbage be sold with virtually no restriction. Your law is pure Red Bull _ _ _ _. And it might be killing kids.