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64 Food & Drug L.J. 503 (2009)
Dietary Supplement Adverse Event Reports: Review and Analysis

handle is hein.journals/foodlj64 and id is 523 raw text is: Dietary Supplement Adverse Event Reports: Review and Analysis ASHISH R. TALATI* ABHisHEK K. GURNANI** INTRODUCTION The Food and Drug Administration (FDA) works actively to ensure that all the dietary supplements currently in the market are safe for the public. Existing policies are often remodeled and new regulations are developed periodically. A recent change t9 supplement regulations includes the implementatign of a system that allows consumers to contact the FDA or product manufacturer directly to report an adverse reaction as a result of dietary supplement consumption. FDA has employed an adverse event reporting (AER) system that is aimed to police postmarketing effects of dietary supplements. This article will shed light on the importance of tracking serious adverse events with respect to dietary supplements that have already been marketed. Various data from the FDA database will be quantified to identify the most common dietary supplement products, companies and adverse events that were reported to FDA's AER program between October of 2007 and February of 2009. Manufacturers and distributors will gain valuable feedback that will allow them to enhance safety and effectiveness measures. Using this data, dietary supplement companies will be able to take the necessary steps to ensure that their products remain safe for the public by removing problematic ingredients from their products and engaging in more effective labeling and product disclaimer practices. In January of 2009, a Freedom of Information Act (FOIA) Request was submit- ted to FDA to obtain the records of all dietary supplement adverse reports received between October 2007 and February 2009. A total of 711 reports were dissected, and information regarding manufacturers, products, ingredients and adverse events experienced were reviewed and quantified for further analysis. I. APPLICABLE LAW AND FDA GUIDANCE In December of 2006, Chapter 7 of the Food, Drug and Cosmetic Act (FDCA)' was amended to include the Dietary Supplement and Nonprescription Drug Con- sumer Protection Act2 (Act). The Act required the reporting of serious adverse events occurring as a result of consuming dietary supplements. The Act further required labels of supplements marketed in the United States to include a domestic address or domestic phone number through which the responsible person ... could receive a report of a serious adverse event with such a dietary supplement.3 The Mr. Talati is a Partner and Chair of the Food and Drug Law practice group at Amin Talati, LLC, Chicago, IL. Mr. Gurnani is a first year Associate at Amin Talati, LLC, Chicago, IL. FDCA, 21 U.S.C. 371 et seq. 2 Dietary Supplement and Non Prescription Drug Consumer Act, Public Law No: 109-462. 3 21 U.S.C. 343(y). 503

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