Traditional Chinese Herbal Medicine (TCHM)

Mild Adverse Event (AE) Database Reporting Tool

Reporting Information

Serious Adverse Event (SAE) FDA Reporting Guidelines: In the United States, SERIOUS adverse events must be reported to the FDA no later than 15 business days after the responsible person receives the report. New information concerning the AE received within one year of the initial report must also be submitted to the agency. The MedWatch form, Form 3500, must be used to report an SAE to the FDA.  

“The submission of a SAER is not construed as an admission that the dietary supplement product involved caused or even contributed to the adverse event. Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event.”

The responsible party for submitting an adverse event report for a TCHM to the FDA is the manufacturer, packer, or distributor whose name appears on the label of a dietary supplement marketed in the United States. TCHM practitioners compounding and dispensing TCHM from their office are the responsible party for reporting AE.


according to: Dietary Supplement and Non-prescription Drug Consumer Protection Act PUBLIC LAW 109–462—DEC. 22, 2006


The term ‘serious adverse event’ is an adverse event that:
—‘‘(A) results in—

  1. death;
  2. a life-threatening experience;
  3. inpatient hospitalization;
  4. a persistent or significant disability or incapacity;
  5. a congenital anomaly or birth defect; or

—‘‘(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).


.—The term ‘adverse event’ means any health-related event associated with the use of a nonprescription drug that is adverse, including—

‘‘(A) an event occurring from an overdose of the drug, whether accidental or intentional;

‘‘(B) an event occurring from abuse of the drug;

‘‘(C) an event occurring from withdrawal from the drug;

‘‘(D) any failure of the expected pharmacological action of the drug.


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  8. Chiba T, Sato Y, Kobayashi E, Ide K, Yamada H, Umegaki K. Behaviors of consumers, physicians and pharmacists in response to adverse events associated with dietary supplement use. Nutr J. 2017 Mar 18;16(1):18. doi: 10.1186/s12937-017-0239-4. PMID: 28315635; PMCID: PMC5357328.
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AE Reporting Tool

This NON-reportable to FDA mild Adverse Events (AE) – reporting tool is intended for interprofessional data collection purposes.

  • Year/Month/Day
  • Year/Month/Day
  • Notate is weight in pounds or kilograms.
  • Note Laboratory facility name – e.g., LabCorp
  • Please use the standard terminology of ICD11-Chapter 26
  • If custom formula, use "Classic Base Formula Name modified", e.g. Xiao Yao San modified
  • Include lot # for each ingredient if formula compounded in your office