This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. If you wish to discuss an alternative approach, please contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, you may call the telephone number listed at the end of this document.

What is an “Adverse Event” (AER)?

An “Adverse Event” is “any health-related event associated with the use of a dietary supplement that is abnormal.”

What is a “Serious Adverse Event” (SAER)?

An “Adverse Event” that results in death, a life-threatening experience, hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or any diagnosis, based on a reasonable medical judgement, that requires a medical or surgical intervention to prevent an outcome previously described. (More at FDA.gov: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event)

Why am I responsible for tracking/logging all Adverse Event Reports for my dietary supplements?

The Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462, 120 Stat. 3469) requires adverse event reporting and recordkeeping for dietary supplements and non-prescription drugs marketed without an approved application. These requirements apply to manufacturers, packers, and distributors of these product types.

What types of products are covered by the Dietary Supplement and Nonprescription Drug Consumer Protection Act?

All dietary supplements and non-prescription drugs (Over-The-Counter or OTC drugs) without an approved application. Currently, this law does not apply to cosmetic products, but the FDA still encourages and accepts all “adverse event” reporting for cosmetics products.

What is the FDA’s definition of a dietary supplement?

Dietary supplements are defined, in part, as products (other than tobacco) intended to supplement the diet that bear or contain one or more of the following dietary ingredients:

Further, a dietary supplement must be labeled as such and must be intended for ingestion.

If my product is a food, is it still mandatory to report Adverse Events?

The requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act do not apply to foods other than dietary supplements. However, there are other mandatory reporting requirements. Section 417 of the FD&C Act requires a “responsible party” to inform FDA of “reportable food,” which is defined as an “article of food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.”

Do I need to submit AERs to the FDA?

No. Only SAERs are required to be submitted to the FDA. It is still your responsibility, as the manufacturer or distributors, to log and record all AER reports received, but they do not need to be submitted to the FDA.

When must SAERs be submitted to the FDA?

Manufacturers/distributors are required to report “serious adverse event reports” no later than 15 days after the report has been received by the responsible person. Prompt submission of “serious adverse event reports” is important for public health reasons.

How is a “serious adverse event report for a dietary supplement submitted to FDA?

All mandatory reports are to be submitted to FDA using either the paper or electronic version of the MedWatch form (also referred to as Form FDA 3500A for the paper version and the FDA Safety Reporting Portal for the electronic version).

Instructions for completing this form are also included on the respective MedWatch page.

For the most current information, please visit FDA.gov: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary

Or contact: Office of Nutrition, Labeling, and Dietary Supplements
​Division of Dietary Supplement Programs, HFS - 810
​Center for Food Safety and Applied Nutrition
​Food and Drug Administration
​5001 Campus Drive
​College Park, MD 20740
​Phone: (240) 402-2375