Online Dietary Supplement Adverse Event Reporting Initiated by FDA

January 2014

Online Dietary Supplement Adverse Event Reporting Initiated by FDA

As of January 13, 2014, the U.S. Food and Drug Administration is accepting voluntary and mandatory reports of dietary supplement adverse events online.

The secure reporting portal was implemented to simplify and allow for easy reporting of these events by manufacturers, distributers and the public. The FDA will also continue to accept paper 3500A and 3500 reporting forms.

The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires the manufacturer, packer, or distributor of a dietary supplement marketed in the United States to report to the FDA any serious adverse events received when their product is used in the United States. The FDA also strongly encourages physicians to file voluntary reports of adverse events experienced by their patients after using dietary supplements.

The new online reporting capability is now available through the Department of Health and Human Services’ Safety Reporting Portal. To submit a dietary supplement adverse event report, please visit www.safetyreporting.hhs.gov.

References

  1. Natural Standard: The Authority on Integrative Medicine. www.naturalstandard.com
  2. U.S. Food and Drug Administration. www.fda.gov

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2013 Natural Standard Inc. Commercial distribution or reproduction prohibited. Natural Standard is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.

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