Dietary supplements: FDA may have opportunities to expand its use
Dietary supplements: FDA may have opportunities to expand its use
Dietary supplements: FDA may have opportunities to expand its use
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Appendix I: Objectives, Scope, and<br />
Methodology<br />
for products, reasoning that products with similar formulations and active<br />
ingredients should be grouped <strong>to</strong>gether beca<strong>use</strong> they would ca<strong>use</strong> similar<br />
reactions in consumers and <strong>may</strong> be manufactured in the same facility. 1 In<br />
some cases, we performed additional Internet research <strong>to</strong> verify the<br />
accuracy of a match between a firm or product name. We also reviewed<br />
and analyzed data on calls about adverse events related <strong>to</strong> dietary<br />
<strong>supplements</strong> <strong>to</strong> poison centers from annual reports of the American<br />
Association of Poison Control Centers (AAPCC) from 2008 through 2010.<br />
Beca<strong>use</strong> poison centers classify certain dietary supplement products<br />
differently than <strong>FDA</strong>, such as including homeopathic agents as dietary<br />
<strong>supplements</strong>, we worked with AAPCC and <strong>FDA</strong> officials <strong>to</strong> make the<br />
appropriate adjustments <strong>to</strong> the data <strong>to</strong> make them comparable <strong>to</strong> <strong>FDA</strong><br />
AERs. Similarly, beca<strong>use</strong> <strong>FDA</strong> officials <strong>to</strong>ld us that AERs are primarily<br />
associated with product <strong>use</strong> as directed, we adjusted the poison center<br />
data <strong>to</strong> include only those cases where an individual experienced an<br />
adverse reaction when using the product as directed and excluded<br />
reports resulting from mis<strong>use</strong>, ab<strong>use</strong>, or accidental ingestion. To assess<br />
the reliability of these data, we reviewed related documentation, reviewed<br />
internal controls, and worked with agency or AAPCC officials <strong>to</strong> identify<br />
any data problems. For the <strong>FDA</strong> data on serious AERs, which we<br />
received in disaggregate form, we examined the data <strong>to</strong> identify obvious<br />
errors or inconsistencies. We also reviewed <strong>FDA</strong>’s laws, rules, and<br />
regulations relevant <strong>to</strong> collecting and maintaining AERs. We determined<br />
the data <strong>to</strong> be sufficiently reliable for the purposes of this report.<br />
To determine actions <strong>FDA</strong> has taken <strong>to</strong> ensure that firms are complying<br />
with new reporting requirements, we reviewed <strong>FDA</strong>’s procedures,<br />
planning documents, and guidance and obtained and analyzed data on<br />
<strong>FDA</strong>’s oversight activities, such as inspections, advisory, and regula<strong>to</strong>ry<br />
actions, <strong>to</strong> identify which of these actions were related <strong>to</strong> moni<strong>to</strong>ring or<br />
enforcing firms’ compliance. Specifically, we obtained aggregate data on<br />
the number of dietary supplement inspections from January 1, 2008,<br />
through September 30, 2012 and analyzed record-level data on the type<br />
and results of dietary supplement inspections <strong>FDA</strong> conducted from 2008<br />
through 2011 from <strong>FDA</strong>’s Field Accomplishments and Compliance<br />
Tracking System. To determine the number of AER violations observed<br />
1 <strong>FDA</strong> officials <strong>to</strong>ld us their basis for grouping products <strong>to</strong>gether depends on the particular<br />
analytical need. For example, in some cases, products with the same active ingredient but<br />
different flavors would be grouped similarly and, in other cases, products with different<br />
flavors would be grouped separately.<br />
Page 48<br />
GAO-13-244 <strong>Dietary</strong> Supplements