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Serious Adverse Events: Are SAEs as underreported as GAO suggests? (Part I)

In Part I of this two-part series, background will be provided regarding the origin and reason for the reporting system that is currently in place for serious adverse events (SAEs) associated with dietary supplements: the reason an investigation by the Government Accountability Office (GAO) was initiated and its reported findings, a brief description of the American Association of Poison Control Centers (AAPCC), the pertinent points of its reporting system, and an initial look at what the AAPCC appears to report as adverse events due to dietary supplements.

The 2006 Dietary Supplement and Nonprescription Drug Consumer Protection Act went into effect on December 22, 2007. The 2006 act amended the Federal Food, Drug, and Cosmetic Act by mandating that firms (i.e., manufacturers, packers or distributors whose names appear on the label) provide adverse event reports (AERs) of SAEs[1] associated with the ingestion of dietary supplements to the U.S. Federal Drug Administration (FDA) within 15 business days of receiving a complaint from consumers, health care professionals, or others.

The requirement for mandatory reporting of SAEs has its roots in the banning of botanical ephedrine alkaloids from use in dietary supplements. FDA banned the substances in 2004 due to numerous SAEs, including several deaths attributed to ingestion of the herbal ingredients in weight loss supplements. The 2006 act was created in partial response to the nearly ten years it took FDA to progress from speculation regarding the ephedrine alkaloids to FDA’s concluding that the alkaloid ingredients presented a significant or unreasonable risk of illness or injury when used as directed  to the final action by rule-making that removed the ingredients from the market (GAO-03-1042T).[2]