On November 16, 2012, the U.S. Food and Drug Administration (“FDA”) issued a statement concerning the Agency’s ongoing investigation of reported illnesses and deaths linked to energy drinks and energy shot supplements. Found here, the Statement details the FDA’s efforts in this area, including its evaluation of adverse event reports. According to the FDA, it is currently in the process of determining whether there is an actual cause-and-effect relationship between the consumption of energy drinks and energy supplements and these medical problems.
Under the Federal Food, Drug and Cosmetic Act (“FFDCA”), manufacturers, packers and distributors of all dietary supplement products are required to report serious adverse events to the FDA within fifteen (15) business days and to provide the FDA with updates as to any medical information for the entire year following the initial report. Unlike the requirements pertaining to serious adverse event reporting for dietary supplements, federal law does not require manufacturers and distributors of conventional foods to provide the FDA with reports of serious adverse events. The FDA notes this distinction in its Statement, discussing how certain energy products are marketed as conventional foods and therefore their makers have not reported these adverse events to the Agency. Accordingly, the FDA says that it will continue to monitor issues surrounding energy drinks and supplements.
For more information about the FDA’s regulation energy drinks and dietary supplements generally, including how you may satisfy your adverse event reporting requirements, please feel free to contact us at firstname.lastname@example.org.