The Food and Drug Administration (FDA) has responded to Senator Dick Durbin’s (D-Ill.) letter requesting that the agency take regulatory action “to address the rising health concerns around energy drinks” purportedly containing high levels of caffeine and other ingredients such as taurine, guarana and ginseng. Among other matters, in its August 10, 2012, letter, FDA suggests that research to date shows that “even when the consumption of energy drinks is considered, most of the caffeine consumed [in the United States] comes from what is naturally present in coffee and tea.”

For most healthy adults, according to FDA, caffeine intake up to 400 mg per day is not associated with untoward health effects. Additional details about Durbin’s letter appear in Issue 435 of this Update.

FDA’s generally recognized as safe (GRAS) regulation for caffeine applies to cola-type beverages; the agency “has not challenged the use of caffeine in other beverages at levels comparable to the prior-sanctioned use level of 200 ppm.” The agency acknowledged a 2011 report indicating that energy drinks contained caffeine at levels ranging from 160 to 500 mg per serving and is following up “regarding [the] source data to better assess whether any of the incidents cited in the report involved products marketed as dietary supplements and, if so, whether there were adverse event reports sent to the FDA on those incidents.” FDA will use the information to determine whether gaps in the oversight system exist.

FDA also discusses the differences between conventional foods and liquid
dietary supplements, noting how regulatory requirements depend on how a
product is marketed. The agency attributes any confusion over the definition
of conventional foods to statutory language that requires FDA to “consider
multiple factors to determine whether or not a product is ‘represented’ as
a conventional food. This is a more difficult standard for FDA to meet.” The
agency indicates that a drinks draft guidance that is under development “once
finalized, will help both FDA and industry to draw a line between beverages
and liquid dietary supplements.” The agency concludes with references to
the person who died allegedly as a result of consuming an energy drink—the
incident which led Durbin to write to FDA—and notes that it has received a
voluntary adverse event report from Monster Energy Drink and the family. The
investigation is apparently ongoing.

About The Author


For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.

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