A recent workshop sponsored by the Institute of Medicine on caffeine and its effect in consumer products such as energy drinks was helpful in making clear the points of view of the various stakeholders, according to observers. What was less clear was what the data presented at the event actually show.
“I think there are passionate voices on both sides of the issue. What the IOM conference did was get the issues out on the table so that they can be debated and discussed in a more open, transparent manner,” Rick Kingston, one of the attendees of the workshop held last week in Washington DC, told NutraIngredients-USA.
“We got a much clearer understanding of what the folks who are critical of including caffeine in beverages, really what their arguments are,” said Kingston, who is a pharmacist and toxicologist and the president of scientific and regulatory affairs for Safety Call International.
“You need to know what the arguments are what data they are basing that on so that you can come to some sort of consensus. If we didn’t have that opportunity to do it the only way that would happen is to watch the medical literature to see what the responses are on it,” he said.
“The big picture is that are a lot of different opinions and there is a lot of dialogue that needs to take place,” said John Endres, ND, chief scientific officer of AIBMR Life Sciences who also attended the meeting that was held in conjunction with the Food and Drug Adminstration.
Picking and choosing data
Kingston took issue with the way some of the data generated by poison control centers was presented at the workshop. He said presentation, which was based on a journal article using the same data set, paints an overly dire picture of the effect caffeinated beverages are having on children. Many calls to poison control centers are in effect either false alarms or involve exposures so minor that no noticeable effects will result, Kingston said, and these categories were left out of the presentation.
“It’s clear to me the way they depicted the data was inaccurate,” he said.
In his written comments to the panel, Kingston wrote: “It’s disappointing that two of the most important outcome categories in the entire database; the asymptomatic outcomes of no follow-up non-toxic and no follow-up, not-more-than minor effects possible, were left out of the data presentation.
“When including these outcomes for the non-alcoholic energy drink exposures that involved children <6y, although they had the highest exposure rate, it demonstrates that they also had the lowest incidence of any adverse effects including the fact that there was no serious outcomes. In fact, 85% of the cases were either non-toxic in nature or resulted in no adverse consequences. In those cases where adverse effects were reported, almost all were minor in nature. When including 6-12y populations the non-toxic events were still >80% and serious outcomes were rare (0.1%). Leaving out these two outcome categories distorts the denominator and exaggerates the overall relative percentage of adverse effects in all populations,” he wrote.
More work needs to be done
Both Kingston and Endres said the workshop did point out some areas where more work needs to be done, both by researchers and companies.
“I do think there are issues that need to be sorted out. We need to have a much more focused post market surveillance effort to identify which products might be giving rise to adverse events, whether they are unique in the marketplace and what to do to mitigate those effects,” Kingston said.
But Kingson said that these efforts are being hampered with the imprecise way the term ‘caffeinate beverages’ is being tossed around.
“You can’t do that with the way that the data has been sliced and diced. They lump all of these products into ‘caffeinated beverages.’ It could be just about anything. You could have different concentrations of caffeine, you could have different ingredients. The way it’s being presented now it is just a shotgun kind of effect saying, there are a lot of products that have caffeine out there and it appears that kids and adolescents are being exposed to them,” he said.
And Endres said the picture is complicated, too, by the fact that energy drinks are supplying a known ingredient in new ways. Gathering data on what that might mean is complicated by the supplement/conventional food divide that these products straddle, he said.
“If you are adding anhydrous caffeine to an energy drink is that different than drinking a beverage with caffeine as it occurs in nature? Then there is the conundrum of energy drinks being labeled as dietary supplements as well as foods. There is data collected in surveys on consumption of foods but not on supplements. If you go by the surveys, there is little exposure to caffeine in energy drinks. But we know that’s not the case; it’s just that the data is not there,” Endres said.
Companies should be on data front lines
If a product is labeled as supplment, it is subject to mandatory adverse event reporting (though some might argue how well companies comply with that requirement). If it’s a food, no such mandatory requirement exists. Nevertheless, it is incumbent on companies selling consumer products to know what effect those products are having on consumers, whether they are required to forward that information on to FDA or not, Kingston said.
“I think the companies need to do a better job to understand how their individual product is performing. They have the opportunity to get much more specific data on their particular product and whether or not there may be issues,” he said.
“When you delegate (this data generation) to the overall marketplace you get what we’ve got, which is substantial overgeneralization.”