The short answer
The responsible person for a dietary supplement — the manufacturer, packer or distributor whose name is on the label — must send every serious adverse event report it receives about the product used in the U.S. to FDA within 15 business days, on a MedWatch form (21 U.S.C. 379aa-1). Records of all adverse event reports must be kept for 6 years.
And every supplement label needs a domestic U.S. address or domestic U.S. phone number where consumers can report — a website or email alone is not enough.
What is a “serious” adverse event?
An adverse event associated with a dietary supplement that results in:
- death, or a life-threatening experience
- inpatient hospitalization
- a persistent or significant disability or incapacity
- a congenital anomaly or birth defect
- or that requires, based on reasonable medical judgment, medical or surgical intervention to prevent one of these outcomes
Supplements vs cosmetics: key differences
| Item | Dietary supplements | Cosmetics (MoCRA) |
|---|---|---|
| Deadline | 15 business days | 15 business days |
| Follow-up information | New medical information within 1 year — sent within 15 business days | Same |
| Record keeping | 6 years | 6 years (3 years for small businesses) |
| Label contact | Domestic address or domestic phone number; website or email only in addition | Domestic address, phone or electronic contact such as a website |
| Retailer on label | May authorize the manufacturer or packer to submit reports by agreement | See cosmetic reporting |
Setting up adverse event handling
- 1Put the U.S. contact on the labelStreet address or P.O. box with city, state and ZIP, or a U.S. phone number with area code. FDA recommends a clear statement telling consumers they can report serious adverse events there.
- 2Route every reportFrom the U.S. contact, Amazon, your website, distributors and social media to one person who decides if it is serious.
- 3Submit serious reportsWithin 15 business days on MedWatch Form 3500A, with a copy of the label.
- 4Send follow-upsNew medical information received within 1 year, within 15 business days.
- 5Keep records 6 yearsSerious and non-serious reports alike, available for FDA inspection.
Example: a supplement brand from Australia
An Australian brand sells a pre-workout powder on Amazon US. Its label had only an Australian phone number and a website, so it adds a U.S. phone number and the line “Report serious adverse events to the number above.” When a customer reports being hospitalized with a fast heart rate after use, the brand files a MedWatch report within 15 business days, attaches the label and keeps the record for 6 years.
Standard label review (Supplement Facts and structure/function claims) $550. FDA facility registration with U.S. Agent from $300. FSVP program from $400 per supplier.
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP agent service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
How long do I have to report a serious supplement adverse event?
15 business days from when the responsible person receives the report.
Can I use a website as the adverse event contact on a supplement label?
Only in addition to a domestic U.S. address or domestic U.S. phone number, which is required.
How long must supplement adverse event records be kept?
6 years.
Who is responsible for reporting?
The manufacturer, packer or distributor whose name appears on the label. A retailer named on the label can, by agreement, authorize the manufacturer or packer to submit reports.
Sources
- 21 U.S.C. 379aa-1 — Serious adverse event reporting for dietary supplements
- FDA — Guidance: Labeling of dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (September 2009)
Requirements checked on November 12, 2026. This article is general information, not legal advice.