United States · Supplements

Adverse Event Reporting in the United States

A practical guide to Adverse Event Reporting for supplements sold in the United States: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Brands and importers of food supplements and nutraceuticals; Online sellers listing supplements for buyers in the United States

Authority

U.S. Food and Drug Administration

Legal basis

21 CFR Part 390

Local representative

A local notifying entity is required

Timeline

Before sale; notification review takes weeks

Cost

Dossier and testing costs vary by ingredient

If you do not comply

Seizure, fines, and listing removal

Who needs this

Brands and importers of food supplements and nutraceuticals
Online sellers listing supplements for buyers in the United States

Documents you need

Ingredient and dosage review
Product information file
GMP certificate
Local-language label artwork

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Ingredient and dosage review
Product information file
GMP certificate
Local-language label artwork

How to comply

Check whether ingredients are permitted locally
Prepare the product information file
Register or notify where required
Label with permitted claims

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: Adverse Event Reporting — United States
Product category: Supplements
Authority: U.S. Food and Drug Administration
Legal basis: 21 CFR Part 390

Documents we already have:
  1. Ingredient and dosage review
  2. Product information file
  3. GMP certificate
  4. Local-language label artwork

Questions:
  1. Does our product fall under Adverse Event Reporting in the United States?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before sale; notification review takes weeks.

Dossier and testing costs vary by ingredient.

Common rejection reasons

Ingredient not permitted
Claims too strong for the category
Label missing required warnings
GMP certificate missing

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.

Official sources

FAQ

Who needs Adverse Event Reporting in the United States?

Brands and importers of food supplements and nutraceuticals. Online sellers listing supplements for buyers in the United States. The importer of record normally holds the evidence.

What documents do I need for Adverse Event Reporting?

Ingredient and dosage review; Product information file; GMP certificate; and local-language label artwork.

What is the first step for Adverse Event Reporting?

Check whether ingredients are permitted locally, then prepare the product information file. Before sale; notification review takes weeks.

How long does Adverse Event Reporting take?

Before sale; notification review takes weeks.

How much does Adverse Event Reporting cost?

Dossier and testing costs vary by ingredient.

What happens if I sell without it?

Seizure, fines, and listing removal.

Who regulates Adverse Event Reporting in the United States?

U.S. Food and Drug Administration.