Executive Summary

FDA should define more clearly elements of its serious adverse event report guidance for dietary supplements, a food and drug attorney says. A. Wes Siegner, of Hyman, Phelps & McNamara in Washington, tells FDA his client Nutraceutical Corp. is concerned about the agency's recommendation that a person responsible for submitting AERs use "diligent efforts" to obtain data from a patient or reporter. Siegner's Nov. 23 1letter says, "If FDA intends to equate 'diligent efforts' with the use of health care practitioners or other methods to elicit the minimum data elements, FDA should" state its expectations. Siegner also takes issue with the agency's definitions of "identifiable patient," "initial reporter" and "serious" AERs in the June 2009 2guidance (3"The Tan Sheet" July 20, 2009)