Dietary Supplement Adverse Event Reporting

Common reasons dietary supplement adverse events are not reported to fda include the following.

Dietary supplement adverse event reporting. The dietary supplement adverse event reporting rate in the united states was estimated at 2 based on caers data. A mere 16 18 reported the adverse event to any source including only one physician reporting the adverse event to the food and drug administration. The findings show that the. Many consumers and health care providers do not know where or how to report the adverse event.

The electronic submission of dietary supplement adverse event information to us via the fda safety reporting portal has been approved under omb control no. The dietary supplement and nonprescription drug consumer protection act signed into law in december 2006 requires manufacturers to report to fda serious adverse events aers associated with dietary supplements whether or not a likely causal connection is established. 0910 0645 while submission of dietary. This study characterizes caers dietary supplement adverse event data for the 2004 2013 period and estimates a reporting rate of 2 for dietary supplement adverse events based on caers data.

Members of the dietary supplement industry may now use the reporting form on the safety reporting portal to meet the reporting requirements established in section 761 of the fd c act. Fda data of reported adverse events can be misconstrued says kingston. The consumer does not think it is important to report the adverse event to a health care provider. To facilitate the reporting of adverse events the labels of dietary supplements marketed in the united states must include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplement fdca 403 y.

Serious adverse event reporting for dietary supplements a definitions. The term serious adverse event is an adverse event that a results in i. The majority 73 81 of respondents had encountered an adverse event associated with dietary supplement use. Consumers may be less likely to report an adverse event.

The term adverse event means any health related event associated with the use of a dietary supplement that is adverse.