Energy Drinks and Supplements: Investigations of Adverse Event Reports FDA: U.S. Food and Drug Administration November 16, 2012
Read the following passage: FDA takes every adverse event report seriously, and investigates and evaluates other possible causes before deciding whether a product actually caused a medical problem. An adverse event report does not necessarily mean the product identified in the report actually caused the event. The FDA assesses the relationship, if any, between a product or ingredient and the reported adverse event. Manufacturers, packers, and distributors of dietary supplements are required by law to report any serious adverse events to the FDA within 15 business days. They must also provide (within 15 business days) any additional medical information they obtain within a year of the adverse event report. However, the FFDCA does not require manufacturers, packers, or distributors of conventional foods to report serious adverse events to the FDA. Therefore, all adverse event reports the FDA receives are voluntary. Further, those who voluntarily report an illness or injury typically identify the product they believe may have caused the injury or illness. As a result, the FDA, as a scientific public health agency, must carefully investigate and evaluate other possible causes before concluding the product actually caused the medical problem. While FDA investigates all reports to the best of its ability, it does not always have access to all the information needed to determine the cause of the event. Some state medical privacy laws prevent FDA from obtaining medical records related to the adverse event report. The FDA cautions consumers that products marketed as energy shots or energy drinks are not alternatives to rest or sleep. Edited for clarity U.S. Food and Drug Administration: http://www.fda.gov/Food/NewsEvents/ucm328536.htm Which line from the text answers the research question "How does the FDA investigate adverse events"?
The FDA assesses the relationship, if any, between a product or ingredient and the reported adverse event.
Some state medical privacy laws prevent FDA from obtaining medical records related to the adverse event report.
An adverse event report does not necessarily mean the product identified in the report actually caused the event.
FDA takes every adverse event report seriously, …
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The answer is: The FDA assesses the relationship, if any, between a product or ingredient and the reported adverse event.
The option above describes how the FDA investigates reports of harmful cases after consuming certain product.
The rest of the alternatives are incorrect because the second refers to obstacles that impede the FDA access to medical records, the third option examines the cause of the event, and the last one makes reference to how seriously the FDA takes every case.
