U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. Report a Problem to the FDA
  1. Safety

Report a Problem to the FDA

What products does FDA regulate?

Consumers can play an important public health role by reporting to FDA any adverse reactions or other problems with products the agency regulates. FDA is responsible for ensuring that foods are safe, wholesome, and correctly labeled. It also oversees medicines, medical devices (from bandages to artificial hearts), blood products, vaccines, cosmetics, veterinary drugs, animal feed, and electronic products that emit radiation (such as microwave ovens and video monitors), ensuring that these products are safe and effective. FDA also regulates tobacco products.

Why should I report?

The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale. Some problems can remain unknown, only to be discovered when a product is used by a large number of people.

When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals, and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.

For Use By Form

Health Professionals, Patients, and Consumers
Easy online, voluntary reporting for health professionals, patients, and consumers.

Online Reporting Form

Health Professionals
For use by health professionals, consumers, and patients. Instructions for Completing Form FDA 3500

Form FDA 3500 - Voluntary Reporting (pdf)

Patients and Consumers
A consumer-friendly version of the 3500 reporting form.

Form FDA 3500B - Voluntary Reporting for Consumers (pdf)

Industry (Mandatory)
Reporting by IND reporters, manufacturers, distributors, importers, user facilities personnel. 

These particular reports must be submitted in an electronic format that FDA can process, review, and archive.  See the guidance for industry “Providing Submissions in Electronic Format —Postmarketing Safety Reports”.

Pacientes y consumidores
Para uso de pacientes y consumidores.

Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B (pdf)

Regulated Medical Product  Website

Tobacco, Cigars, E-cigarettes/Vaping and Chewing Tobacco
For use by health professionals, consumers, and patients.

Safety Reporting Portal

Vaccines
For use by health professionals, consumers, and patients. 
Vaccine Online Reporting

Animal and Veterinary Products
For use by industry, health professionals and consumers.

Find safety information on animal & veterinary products.