The state of dietary supplement adverse event reporting in the United States.
OBJECTIVE
The Dietary Supplements Information Expert Committee (DSI-EC; the Committee) of the United States Pharmacopeial Convention (USP) reviews safety profiles of dietary supplements before development of USP-National Formulary (USP-NF) quality monographs. Because the veracity of dietary supplement adverse event reports (DS AERs) directly affects DSI-EC safety reviews, the Committee reviewed the current status of DS AER reporting in the US.


METHODS
DSI-EC reviewed PubMed searches, information from the US Food and Drug Administration's (FDA) MedWatch program, the Toxic Exposure Surveillance System (TESS) of the American Association of Poison Control Centers (AAPCC), and reports from US and other agencies. DSI-EC analyzed this information to identify key factors that affect the quality of DS AERs.


RESULTS
The overall incidence of DS AERs appears generally to be low. However, the primary reporting portal (FDA MedWatch) receives fewer AERs than do poison control centers (PCCs), and limited coordination exists among national and international surveillance programs for evaluating signals that may indicate potential public health risks. Both inadequate and poor-quality reporting of DS AERs are major limitations of DS safety monitoring in the US.


CONCLUSIONS
Based on its assessments, the Committee advances recommendations to improve the quality of reporting, monitoring, and assessing DS AERs. These include (1) enhanced data collection approaches, (2) improved coordination of AER surveillance programs, (3) strengthening of educational programs for public and health care sectors, and (4) conduct of research concerning the safety of DS. If taken, these approaches are expected to improve the health and well-being of DS users.
Gardiner
Paula
P
USP Dietary Supplements Information Expert Committee, Rockville, MD 02118, USA. paula.gardiner@bmc.org
Sarma
Dandapantula N
DN
Low Dog
Tieraona
T
Barrett
Marilyn L
ML
Chavez
Mary L
ML
Ko
Richard
R
Mahady
Gail B
GB
Marles
Robin J
RJ
Pellicore
Linda S
LS
Giancaspro
Gabriel I
GI
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data* / Q000639:trends; D019587:Dietary Supplements / Q000009:adverse effects*; D006801:Humans; D011039:Poison Control Centers / Q000706:statistics & numerical data / Q000639:trends; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data / Q000639:trends