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Durbin seeks meeting with FDA following 5-Hour adverse events news

By Hank Schultz , 19-Nov-2012
Last updated on 19-Nov-2012 at 16:41 GMT

Durbin seeks meeting with FDA following 5-Hour adverse events news

Sen. Dick Durbin (D-IL) read a statement on the Senate floor late Thursday calling for FDA action on the safety of energy drinks in apparent reaction to the news that 92 adverse event reports have been received by FDA in the past four years citing 5-Hour Energy shot supplements.

Durbin’s statement repeated similar themes found in three letters he has sent this year to FDA asking that the agency look into the safety of caffeine containing energy drinks.  Durbin has also called on the agency to quickly finalize its draft guidance on liquid dietary supplements.

Durbin harped on the caffeine levels of 5 Hour Energy shots and Monster beverages in his statement, as he did in his three letters, two of which were written in conjunction with Sen. Richard Blumenthal (D-CN). “Compare that limit of 71 milligrams of caffeine in a 12-ounce can of soda or pop to the 215 to 242 milligrams of caffeine in this small two-ounce bottle of 5-Hour Energy, or the 135 milligrams in a 12-ounce can of Monster Energy,” Durbin said on the Senate floor.

Durbin also cited what he called “loopholes” that are exploited by the manufacturers of these products.

“Most energy drinks avoid oversight by marketing their product not as beverages but dietary supplement . . . because as a dietary supplement they're not regulated,” he said.

Durbin ended his address with a call to action: “Today Senator Blumenthal and I asked the FDA commissioner to meet us after thanksgiving to discuss the steps the FDA is taking to ensure the safety of energy drinks. Every other week we're seeing mounting evidence that energy drinks pose safety risks."

Statement on regulation just plain wrong

Michael McGuffin, president and CEO of the American Herbal Products Association, said Durbin is seemingly misinformed.

“Let’s take this statement 'supplements are not regulated.’ That’s not true.  That’s an error.  I don’t know how Sen. Durbin could believe that they are not regulated. He knows that they are regulated,” he told FoodNavigator-USA.

“I’m frankly confused. I’ve worked with Sen. Durbin and he’s a very smart man.”

Durbin is also presenting only a portion of the story as it concerns caffeine consumption, McGuffin said.

“The focus is on energy beverages vs. soda. What he has failed to do is to include the primary vector by which you and I received our caffeine each day, which is coffee. If the issue is caffeine, where is the outrage about coffee?”

But McGuffin said Durbin’s reaction to the news about 5-Hour Energy was not unexpected.

“This statement is not in the least bit surprising. Dick Durbin has been very clear for over a decade that dietary supplements are inappropriately regulated.”

“He’s demagogueing the issue. Again,” said attorney Marc Ullman of Ullman, Shapiro and Ullman LLC. “He won’t be happy until there is a system in place that proves the need for pre-market approval of dietary supplements.”

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