title: Dietary supplement adverse event reports: review and analysis.
abstract: 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 to supplement regulations includes the implementation 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. 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.
authors.affiliation: Amin Talati, LLC, Chicago, IL, USA.
authors.forename: Ashish R
authors.initials: AR
authors.lastname: Talati
authors.forename: Abhishek K
authors.initials: AK
authors.lastname: Gurnani
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D003625:Data Collection / Q000331:legislation & jurisprudence; D019587:Dietary Supplements / Q000009:adverse effects* / Q000592:standards; D062787:Drug Overdose; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D019221:Mandatory Reporting; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D014815:Vitamins / Q000008:administration & dosage / Q000009:adverse effects; D035141:Voluntary Programs
chemical_list: D014815:Vitamins