Insights on Adverse Event Reporting from the Dietary Supplements Regulatory Summit

The Dietary Supplements Regulatory Summit hosted briefings from FDA and industry experts. Check out part 2 for manufacturer and supplier best practices.

adverse event reporting dietary supplements safety

Washington, D.C.—The 7th annual Dietary Supplements Regulatory Summit, held in Washington D.C. and virtually on July 21, 2022, hosted briefings from the Food and Drug Administration (FDA), toxicologists in the field, legal professionals, and more. Speakers dissected trends in the nutritional supplements market and educated on pressing issues  for industry members, including FDA news, legal cases, and resources.

One key focus of the event: Adverse Event Reporting (AER)

Dr. Rick Kingston, PharmD, President of Regulatory and Scientific Affairs, SafetyCall, offered advice and best practices through post market surveillance. This included:

  • Understanding what’s being reported
  • Analyzing data
  • Keeping an organized data collection.

Taking these steps can help limit any SAER (Serious Adverse Event Reports) you submit to the FDA being taken out of context, according to Dr. Kingston.

Create a correlation scoring system with patient profiling to better understand what went wrong, Dr. Kingston suggested. Are the reported effects in any category preventable? Can they be mitigated through:

  • Education
  • Disclosure
  • Reformation
  • New manufacturing process
  • New product design
  • Dosage adjustment
  • Market withdrawal

Questions Manufacturers Should Be Able to Answer:

  • What is the benchmarked and expected incidence rate for any product, and are there systems in place to monitor significant deviations for minor, moderate, or major outcomes?
  • Is the observed incidence rate a true reflection of expected consumer reactions when using a given product or are they background noise?
  • Is the product actually causing consumers to have adverse effects; how serious are they and can they be mitigated? Do they represent an acceptable or unacceptable risk?

For more coverage from the event, read Claims & Labeling: 5 Key Takeaways from the Dietary Supplements Regulatory Summit.

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