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Supplements Sector Adopts SAE Reports

February 1, 2008: 12:00 AM EST
The supplements industry now has to meet the same adverse event (SAE) reporting standards as the pharmaceutical industry. Serious adverse events reports must now be referred to the Food and Drug Administration, and supplements makers must now keep a record of less-serious events. Both the Natural Products Association and the Council for Responsible Nutrition support the move. However, the American Herbal Products Association has asked the FDA to clarify aspects of the ruling, particularly use of the term “injured person” rather than “patient” or “subject” in SAE reports.
"Supplements Industry Commits to Adverse-Event Reporting", Functional Ingredients, February 01, 2008, © Penton Media, Inc.
Food & Nutrition
Pills & Supplements
North America
United States of America
Legal, Legislation, Regulation, Policy
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