Per dietary supplement regulations, companies have to file Adverse Events Reports (AERs) with the U.S. Food and Drug Administration. Living Essentials, makers of the energy shot king 5-Hour Energy, has filed reports of 13 deaths over the last four years.
Since 2009, there have been 90 AER filings with the FDA related to caffeinated energy shots from all companies in that space, about a third of which were deemed life-threatening.
Senator Dick Durbin (D-IL) has sent seven letters to the FDA over the past Congressional session expressing his concern with caffeinated energy drinks because they tend to be marketed to minors and because many of them do not list on labels how much caffeine is in the product.
As Functional Ingredients reported yesterday, Sen. Durbin has an eye on taking the AER report and making hay out of it. What with eight of the 24 members of the dietary supplement caucus in Congress who will no longer be in office next term, the stakes are high and the defense weakened for the supplements lobby (such as it is).
Notably, just because a dietary supplement is associated with an adverse event report does not denote causality.
"Just the fact that an adverse event report is made doesn't make it actually true," said Justin Prochnow, attorney with Greenberg Traurig, a Denver firm that represents some energy drink companies. "But this plays into Durbin's hands. He'll take the media attention. As more attention gets pointed to this category, as what happened to Monster recently, it could force the FDA to do something about it."
Prochnow said the "No. 1 position energy drink companies will take" is that if the FDA decided to go after the 5-Hour Energies of the world because of caffeine issues, they'll have to go after the Starbucks of the world as well.
"That's the go-to argument," Prochnow said. "And it's a pretty good argument. Caffeine is caffeine. Are you going to check IDs of kids buying a six-pack of Coke because that's got 300 mg caffeine?"
The more likely direction is mandatory labeling of caffeine content—coffee or otherwise.
And this brings up a potential loophole for energy drink companies, over whether their proprietary blend of ingredients the likes of guarana and yerba mate will count as part of their caffeine declarations.
For start-up energy drink companies, the first thing on your agenda is to make sure you have filed a successful GRAS dossier. And then position your beverage as a dietary supplement. The GRAS filing, advises Prochnow, must "show your amount of caffeine on your product with your combination of ingredients is safe. Evidence of safety is crucial becasue you'll start to see lawsuits."
About 52 percent of the [hospital] visits were by patients between the ages of 18 to 25 who had used the energy drinks with alcohol or other drugs. Men were more likely to go to the emergency room, and their visits were more likely to be related to a combination of the energy drink with alcohol or illicit drugs. Females were more likely to visit due to a combination of energy drinks and pharmaceuticals.
However, Cleveland Clinic cardiac surgeon Dr. Marc Gillinov previously told CBSNews.com that in order to die from caffeine overdose, one would have to consume 10 grams of caffeine. For comparison, a tall cup of Starbucks brewed coffee is has about 260 milligrams of caffeine, while an average cup of tea only has 40 milligrams.
In a statement, 5-Hour Energy makers Living Essentials LLC claimed that their product was a "compact-sized energy shot intended for busy adults," not an energy drink or beverage. They said that each product contains about the same amount of caffeine as a cup of premium coffee and can be used as a dietary supplement if followed using their recommended use guidelines.
In addition, they stressed that it should not be used in conjunction with alcohol, and consumers should not drink more than two bottles a day spaced several hours apart.