In this short video, FDA compliance attorney Lisa Capote of Capote Law Firm covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hi there. I’m Lisa Capote, an FDA compliance attorney. Today’s topic is adverse event reporting for dietary supplements — a compliance area that many manufacturers overlook.
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, dietary supplement manufacturers, packers, and distributors who receive a serious adverse event report are required to submit that report to the FDA within 15 business days.
What qualifies as a serious adverse event? It includes events that result in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability, a congenital anomaly, or require medical or surgical intervention to prevent such outcomes.
You also need to maintain records of all adverse events — serious or not — for at least six years. And if you receive follow-up information about a previously filed serious adverse event, that follow-up report needs to be submitted within 15 business days as well.
This is a mandatory legal obligation — not optional. Failure to report serious adverse events can result in significant regulatory consequences.
If you’re a manufacturer or distributor and you’re not sure whether your adverse event reporting system is up to date, now is the time to review it. We can help you build or audit your reporting process. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 871-5680.