Dietary supplements: FDA may have opportunities to expand its use

development decisions, including the development of safety information,
and ultimately FDA’s enforcement burden in these areas may be reduced
as a result.
Recommendations for
Executive Action
To enhance FDA’s ability to use AERs and to oversee dietary supplement
products, we recommend that the Secretary of the Department of Health
and Human Services direct the Commissioner of FDA to take the
following five actions:
• Continue efforts to explore all possible options to obtain poison center
data if the agency determines that the data could inform FDA’s ability
to identify potential safety concerns from adverse event reports for
dietary supplements.
• Incorporate a mechanism to collect information on when AERs are
used to support and inform consumer protection actions (i.e.,
surveillance, advisory, and regulatory actions).
• Implement the agency’s efforts to facilitate industry reporting of
mandatory AERs electronically.
• Determine what additional information FDA can provide to the public
about dietary supplement AERs consistent with existing law and make
the information publicly available and readily accessible on its
website.
• Establish a time frame for issuing final guidance for the draft (1) NDI
guidance and (2) guidance clarifying whether a liquid product may be
labeled and marketed as a dietary supplement or as a conventional
food with added ingredients.
Agency Comments
We provided the Secretary of Health and Human Services with a draft of
this report for review and comment. We received a written response from
the Assistant Secretary for Legislation that included comments from FDA
and is reprinted in appendix III. FDA generally agreed with each of the
report’s recommendations. HHS also sent us technical comments on
behalf of FDA, which we incorporated as appropriate.
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GAO-13-244 Dietary Supplements