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Supplement AER Under-Reporting Marks Tip Of Compliance Iceberg – FDA

14 May 2012

FDA’s dietary supplement program chief raised eyebrows at a botanical products conference citing low estimates on rates of compliance with the good manufacturing practices final rule and the new dietary ingredient notification requirements, as well as adverse event reporting.

FDA’s dietary supplement program chief says the under-reporting of adverse events is “evidence of systemic issues” of noncompliance in the industry even though the number of AERs from manufacturers doubled in 2011 and could double again this year.

Division of Dietary Supplement Programs Director Dan Fabricant and other agency officials raised eyebrows April 17 at the Oxford (Miss