Home > government and politics, safety, U.S. Food and Drug Administration > CFSAN Adverse Event Reporting System: Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy, and Rockstar Energy Drink (January 1, 2004 through October 23, 2012 )

CFSAN Adverse Event Reporting System: Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy, and Rockstar Energy Drink (January 1, 2004 through October 23, 2012 )

November 16, 2012

CFSAN Adverse Event Reporting System: Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy, and Rockstar Energy Drink (January 1, 2004 through October 23, 2012) (PDF)

Source: U.S. Food and Drug Administration

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) collects reports about adverse health events and product complaints related to CFSAN-regulated products, including conventional foods, dietary supplements, and cosmetics. Based on a search of CAERS, this document summarizes the adverse events reported to FDA in connection with products under the labels 5-Hour Energy, Monster, and Rockstar between January 1, 2004 and October 23, 2012. These products are currently marketed as dietary supplements.

CAERS includes voluntary reports for cosmetics and conventional foods, and both voluntary and mandatory reports for dietary supplements. Mandatory reports are those required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. Specifically, dietary supplement manufacturers, packers, and distributors must notify FDA if they receive reports about serious adverse events in connection with the use of their products. This law defines a serious adverse event as an adverse health-related event that is associated with the use of a dietary supplement and that results in death, a lifethreatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent one of those outcomes. The requirement to report serious adverse events to FDA applies only to dietary supplements and not to beverages, other conventional foods, or cosmetics.

Medical officers with the agency’s Dietary Supplement Program staff review all serious adverse events reported to FDA about dietary supplements as part of the normal process of assessment and categorization. In addition to these mandatory reports, the CAERS system also contains adverse events (both serious and non-serious) that are voluntarily reported to FDA by consumers and health care providers.

Individual adverse event reports about a particular product and the total number of adverse event reports for that product in CAERS only reflect information AS REPORTED and do not represent any conclusion by FDA about whether the product actually caused the adverse events. Because CAERS is constantly updated with new information, the number of reports for a given product and the content of individual reports may change over time.

Even with mandatory reporting of serious adverse events for dietary supplements, generally only a small fraction of adverse events associated with any product is reported. On the other hand, there may be duplicate reports in CAERS for the same adverse event because multiple people (such as an injured consumer and a health care provider who treated him or her) may have submitted reports.

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