Dietary Supplements and FDA Use of Adverse Event Reports


William M. Forsberg (Editor)

Series: Public Health in the 21st Century, Nutrition and Diet Research Progress
BISAC: MED060000

Manufacturers, packers, and distributors of dietary supplements in the United States are required to report information about serious adverse effects associated with the use of these supplements to the Food and Drug Administration (FDA). The FDA carefully considers all the available safety information submitted to the agency before a product is approved. However, unexpected and sometimes serious safety problems can emerge once a product goes to market and is used by millions of people. As a result, postmarket safety monitoring, that is, analyzing information on products once they go to market, is a critical part of the FDA’s responsibilities. The public provides an important source of such safety information. Health care facilities, practitioners, and patients submit reports to the FDA and to manufacturers on advise events, medical errors, and product quality problems observed during the use of a product. This book examines the number of adverse event reports the FDA has received since 2008; their source and types of products identified, and the actions the FDA has taken to ensure that firms are complying with adverse event report requirements. (Imprint: Novinka )

Table of Contents

Table of Contents


Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products

For Industry: Dietary Supplements – Reporting an Adverse Event At a Glance
(U.S. Food and Drug Administration)

Q&A on Dietary Supplements
(U.S. Food and Drug Administration)

The Public’s Stake in Adverse Event Reporting
(U.S. Food and Drug Administration)


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