Skip to main content

AERs and Product Recalls: Data, Observations, Obligations, and Analysis

The Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006 placed new responsibilities on certain companies that sell dietary supplements and nonprescription (over-the-counter) drugs to receive adverse events associated with their products used in the U.S., and to submit to the Food and Drug Administration (FDA) any reports that meet the law’s definition of “serious.” These obligations went into effect in December 2007, and FDA published Guidance for Industry in June 2009 to describe the minimum data elements that should be included when reporting serious adverse event reports (SAERs) associated with dietary supplements submitted to FDA. Dr. Rick Kingston, an industry expert with more than 35-years of experience, will present on SAER data and observations. He will be joined by Justin Prochnow, an industry attorney who will review legal and regulatory SAER obligations.
Dr. Merle Zimmermann will analyze recent FDA recall data, and will identify if any of the recorded recalls initiated were Class I recalls (the most serious recall class). FDA is responsible for the safety of most foods including dietary supplements, drugs (both prescription and nonprescription OTC drugs), biologics, medical devices, radiation-emitting products, cosmetics, veterinary products, and tobacco products. These regulatory activities include tracking and reporting on product recalls. He will also analyze the reasons for these recent supplement product recalls.