tailieunhanh - CFSAN Adverse Event Reporting System Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy, and Rockstar Energy Drink

Critical business systems and their associated technologies are typically held to performance benchmarks. In the security space, benchmarks of speed, capacity and accuracy are common for encryption, packet inspection, assessment, alerting and other critical protection technolo- gies. But how do you set benchmarks for a tool based on collection, normalization and corre- lation of security events from multiple logging devices? And how do you apply these bench- marks to today’s diverse network environments? . | . Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition 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 Introduction 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 .

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