Dietary supplements: FDA may have opportunities to expand its use

Consumers and Others
May Not Be Voluntarily
Reporting All Adverse
Events to FDA, but May Be
Contacting Poison Centers
about Some Events
FDA relies on consumers, health care practitioners, and others to
voluntarily report adverse events associated with dietary supplements to
FDA and to firms and, in turn, FDA relies on firms to submit to it any
serious AERs it receives from these individuals, as required by law.
However, FDA may not receive information on all adverse events that are
associated with dietary supplements because consumers and others may
not be voluntarily reporting these AERs—either directly or through firms,
as indicated by our analysis and interviews with FDA officials. We found
several potential reasons for this underreporting based on our review of
relevant studies and our prior work. For example, we and others have
reported that consumers, health care practitioners, or others may not
recognize the chronic or cumulative toxic effects of a dietary supplement,
or they may broadly assume dietary supplements to be safe and not
attribute negative effects to them. 31 Additionally, in an October 2012
report, the HHS Office of Inspector General found that 20 percent of a
judgmental sample of 127 weight loss and immune support dietary
supplements did not have contact information that would enable
consumers and health care practitioners to report adverse events. 32 The
HHS Inspector General study is not representative of the dietary
supplement industry but indicates that some firms may not be providing
consumers with the necessary information to report adverse events to
firms, which could lead to underreporting if consumers do not report the
adverse event directly to FDA. FDA officials said that they receive fewer
AERs than they would expect to given the number of dietary supplements
on the market and their widespread use. However, they said that, similar
to other voluntary reporting systems, the extent of underreporting is
unknown because the agency can only know about those adverse events
that are reported to it. 33
31 J.K. Glisson and L.A. Walker, “How physicians should evaluate dietary supplements,”
American Journal of Medicine 123, No. 7 (2010):577-582. M. Cellini et al., “Dietary
Supplements: Physician Knowledge and Adverse Event Reporting,” Medicine and Science
in Sports and Exercise, 45, No. 1 (2013): 23-28. GAO-09-250.
32 Department of Health and Human Services, Office of Inspector General, Dietary
Supplements: Companies May Be Difficult To Locate in an Emergency (Washington, D.C.:
Oct. 2012).
33 Underreporting to adverse event systems is not unique to dietary supplements. In our
prior work, we noted that similar problems exist for FDA’s adverse event reporting system
for pharmaceutical drugs. See GAO, Drug Safety: FDA Has Begun Efforts to Enhance
Postmarket Safety, but Additional Actions Are Needed, GAO-10-68 (Washington, D.C.:
Nov. 9, 2009).
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GAO-13-244 Dietary Supplements