FDA Offers “At-a-Glance” Outline on Supplements AERs

August 18, 2011

The guidelines include information on who must report an AER, which events must be reported, how to submit an AER, and how long AER records must be kept.

FDA has created a new, concise “At-a-Glance” outline on adverse-event reporting (AER) for dietary supplements. The guidelines include information on who must report an AER, which events must be reported, how to submit an AER, and how long AER records must be kept.

Manufacturers, packers, and distributors are responsible for submitting AERs no later than 15 business days after receiving notice of an AER.

Nutritional Outlook thanks Harry Rice, PhD, for the tip.

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