The report, from the offices of Rep. Ed Markey, D-MA and and Sens. Dick Durbin, D-IL and Richard Blumenthal, D-CN, was compiled from the responses of questionnaires they sent to a number of manufacturers of energy drinks. The three said they found inconsistencies in the labeling and classification of energy drinks, extensive marketing to adolescents and young adults through social media and events, and caffeine levels that “exceed what is considered safe in soda by the Food and Drug Administration.”
While not falling in line with all of the conclusions and recommendations in the report, Rend Al-Mondhiry, regulatory counsel at CRN, said the report mirrors much of what CRN has already said in its public position paper on caffeine in foods and beverages.
“Generally what we are providing in our recommended guidelines is very close to what is it the report,” Al-Mondhiry told NutraIngredients-USA.
“What we’ve said before is that caffeine we believe is a very safe ingredient and it can even have some health benefits. We do support that consumers should be able to make informed choices about caffeine in their diet.
“But we don’t see energy drinks in general posing a specific risk,” she said.
Report based on manufacturers' responses
The report was based on data garnered from the 14 manufacturers that responded to the questionnaires the lawmakers sent. Among its conclusions were these:
“Nearly identical drinks are both classified as conventional beverages and dietary supplements, leading to consumer confusion; caffeine disclosure is uneven, and nearly always above the FDA’s safe level for soda beverages, a comparable category; companies are focusing on youth-oriented social media and other marketing campaigns, including products meant to mimic frequently consumed alcoholic beverages.”
The report recommends labeling of caffeine in energy drinks, warning labels for products with higher amounts of caffeine, a cessation of markeintg of energy drinks to young consumers, and the gathering of adverse events reports related to energy drink use.
“In local convenience and grocery stores around the country, energy drinks are sold right next to soda and other well-known beverages. Any consumer would assume that the high levels of caffeine and novel ingredients in energy drinks have been rigorously tested by the FDA to ensure safety. Unfortunately, that is rarely the case,” said Sen. Durbin in a statement that accompanied the report’s release.
Soft drink caffeine level is not absolute limit
Al-Mondhiry took issue with the assumption in the report that the level of caffeine that is GRAS for soft drinks—71 milligrams per 12 oz.—is a defining benchmark for the whole category.
“We think that this is inaccurately portrayed as a limit. We would say that the law sets that level as a safe harbor for use in soft drinks. It does not really limit how much caffeine can be used. Manufacturers of these products can use higher levels as long they they self-affirm that they are safe for use,” she said.
Dissatisfaction with GRAS process
Durbin’s statement, which reflects several portions of the report, seems to demonstrate dissatisfaction with the process by which GRAS status is self-affirmed for ingredients. It’s true that FDA does not physically evaluate the safety of ingredients in these cases, but that is not to say that no one does; compliant companies are supposed to assemble a qualified cadre of experts to evaluate their safety data for GRAS self affirmations.
And in any case it seems pointless to criticize companies or FDA for complying with the laws as they now exist, said Marc Ullman, an attorney with law firm Ullman, Shapiro & Ullman.
“They’ve identified a situation in which they think the law has a huge loophole, and that’s self GRAS,” Ullman said. “If you have these concerns about GRAS, then drop a bill (to amend the law). And then give FDA the resources to do what you want it to do.”
Ullman also noted that the recommendation about the collection of adverse event reports on energy drinks seems to run counter to another finding of the report, that marketing such beverages as supplements causes confusion. Only supplements, Ullman said, are required to submit AERs; no such requirement exists for foods or beverages.
It begs the question of what exactly the term ‘energy drink’ means. Could the lawmakers be angling to create a new category of regulated products?
“I don’t think that there needs to be a separate category of energy drinks. I think it’s really fact-specific,” Al-Mondhiry said.
“It can be either a food and beverage or a dietary supplement. I don’t see a need for a separate category. I think those categories are adequately regulated. We agree with the (lamakers’) finding that FDA should finalize its guidance on liquid dietary supplements. That would help clear up that confusion,” she said.