Durbin (D-IL) had sent a previous letter to FDA on the issue back in April, requesting the agency take action on the issue after a 14-year-old Maryland girl died in December after reportedly consuming Monster beverages. FDA responded on Aug. 10, laying out the agency’s reasons why it believed immediate action was not necessary.
Justin Prochnow, a Denver-based shareholder in the law firm Greenberg Traurig told NutraIngredients-USA: “It’s not surprising that (this latest) letter came so quickly after the FDA response because the basic consensus in the community was that FDA said to Durbin ‘Thanks for sending us something, we are not going to do anything.’ ”
The Durbin/Blumenthal letter raises the issue of the mixture of ingredients, some of which might have a stimulant effect. “Your letter did not address one of our greatest concerns which include the potential interactions and cumulative effects of additives with stimulant properties in energy drinks with high levels of caffeine,” the letter says.
AHPA's position on caffeine
“It’s not surprising to the American Herbal Products Association (AHPA) that Sen. Durbin has taken this position and is being persistent in his communication with FDA on this matter,” said Michael McGuffin, AHPA president.
AHPA’s position on caffeine is contained within its Code of Ethics and Business Conduct. AHPA recommends putting the amount of caffeine per serving on the supplement’s label, and recommends a warning advising against the use by anyone under the age of 18 of certain high-dose caffeine products.
The letter mentions also two ingredients, taurine and guarana, that have GRAS status in beverages as flavoring agents. The letter goes on to imply that these ingredients are used for purposes other than for flavor, and asks FDA to provide safety data on the use of these ingredients in this way in the presence of caffeine.
“Most people would agree that (guarana and taurine) are not used as flavoring agents in these products. They are added for the specific content,” Prochnow said.
“That still doesn’t mean they are not permissible ingredients. They could very easily be GRAS ingredients, as long as the companies each made their own determinations,” he said.
Marc Ullman, of the New York-based law firm Ullman, Shapiro and Ullman, was a bit more blunt in his assessment of the letter writers’ apprehension of the regulatory complexities surrounding energy products.
“The letter shows a profound lack of understanding of the regulatory status of food ingredients, the concept of self GRAS which has been in place for decades,and Durbin’s typical knee-jerk reaction to any issue with a call for more regulation,” he said.
Focus on underage consumers
The senators also raised again the issue that these beverages are often consumed by underage consumers, and references a recommendation by the American Academy of Pediatrics, which says adolescents should consume less that 100 mg of caffeine a day. FDA’s response to the senators’ previous letter referenced the commonly accepted 400mg/day permissible level, which the senators said applies to adults, not children.
“I think again it’s what they tried to say in April. In other words, these products are damaging to children and we have to do something about it,” Prochnow said.
Focusing on safety, especially the safety of children, is the quickest way to get the agency to get off of the dime, Prochnow said.
"The way that the FDA takes action the quickest is there is some sort of safety issue. That’s what happened with the Four Loko products a couple of years ago. There was a lot of discussion about these but until some kids got sick at parties . . . once that started happening the action was pretty swift,” he said.
The latest letter seems to be part of Durbin’s wider campaign to alter the dietary supplement regulatory picture, Prochnow said.
“Clearly Durbin has focused on energy drinks and energy supplements as his next avenue into trying to make some change in the supplement industry,” he said.