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To provide comprehensive instructions for the systematic handling of adverse events, including medical side effects, associated with our products, covering post-customer support steps, compliance review, and follow-up assignments.
Adverse Event (AE)
Adverse Event (AE)
Any undesired or harmful medical occurrence associated with the use of a dietary supplement, including side effects, whether or not considered product-related. Unfavorable and unintended medical symptoms or effects resulting from the use of a product.
Examples:
“This caused me to have severe abdominal pain”
“This product gave me diarrhea”
“This product caused my blood pressure to increase/ decrease”
“This product gave me persistent headaches”
“I broke out in hives”
Characteristic-type complaint: These complaints can be possible within a small population of consumers based on the product type and did not result in medical treatment of any kind as defined in SAE below.
Examples:
Gastrointestinal issues not resulting in medical treatment (e.g., nausea, bloating, constipation, diarrhea, abdominal pain) headaches, dizziness, and similar experiences may be considered characteristic complaints of a gut health product.
These should be considered Adverse Events and must be documented but are not considered mandatory to report to the FDA and customers should be encouraged to return unused products.
Serious Adverse Event (SAE)
Serious Adverse Event (SAE)
An adverse event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth; or requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above.
Examples where probing should be done to identify potential SAE:
“I had to go to the hospital”
“This caused me to have a blockage”
“I went to the ER”
Any mention of seeking medical care
Adverse Events Handling Process
Adverse Events Handling Process
Abbreviations:
AE: Adverse Event
SAE: Serious Adverse Event
Resources:
Adverse Event (AE) - Single-Pack Orders
Adverse Event (AE) - Single-Pack Orders
Advise the customer to keep or discard the product and process a refund.
Lodge the details to the Adverse Events Incident Log Form.
Probe for lot number and other details using the macro [Return] Adverse Event Probe.
If the customer replies with additional information update the incident log form.
Adverse Event (AE) - More than 1 Pack
Adverse Event (AE) - More than 1 Pack
Provide a return label.
Lodge the details to the Adverse Events Incident Log Form.
Probe for lot number and other details using the macro [Return] Adverse Event Probe.
If the customer replies with additional information update the incident log form.
Serious Adverse Event (SAE)
Serious Adverse Event (SAE)
For all suspected SAE a full refund should be processed, regardless of the number of items. A return label can be provided should the customer wish to send the items back, but we do not require them to do so.
Respond to the customer using the [Return] Adverse Event Probe.
Escalate the concern to Leadership.
SOP: Adverse Events Handling Process
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