FDA Complaint Reporting Systems: Navigating the Regulations for Effectiveness and Compliance

If you have an issue with a product overseen by the U.S. Food and Drug Administration (FDA), they want to know about it. The FDA provides several channels for lodging complaints, two of which are particularly accessible to consumers: the Consumer Complaint Reporting system and MedWatch.

Consumer Complaint Reporting

To align with their efforts at modernizing field operations, all FDA Centers now receive reports directly on issues or adverse reactions involving products under their jurisdiction. To file a complaint, visit the SmartHub webpage, which will direct you to the appropriate webform or phone number based on your concern. For those unable to use the SmartHub platform, call 1-888-INFO-FDA and follow the prompts. If you require assistance from a Relay Service for accessibility purposes, contact 800-877-8339, a toll-free relay service enabling communication with federal agencies via TTY devices.

NOTE: The ORA consumer complaint coordinator telephone numbers previously listed are no longer in use.

The FDA is keen on hearing about various complaints, including:

• Food-related illnesses, especially when a specific food item is suspected
• Allergic reactions to food ingredients not clearly labeled
• Issues with infant formula and baby food
• Swarmed or leaking canned goods
• Suspected product tampering
• Negative effects from dietary supplements
• Problems related to prescription and over-the-counter medications
• Issues with pet food and treats

Lodging complaints can prompt action. The FDA takes such reports very seriously, as even a single or two reports could make a significant difference. Depending on the severity of the problem reported:

• An investigator may visit the complainant to collect samples and conduct inspections.
• Milder issues, or what appear to be isolated incidents, are monitored for future reference during company inspections. This information is used to help identify potential production problems within a facility.

MedWatch Reporting

MedWatch handles reports from the public and may issue safety alerts regarding FDA-regulated products such as:

• Prescription and over-the-counter drugs
• Dietary supplements (except tobacco-related)
• Pet food or treats
• Livestock food

To submit a report, you have several options:

• Online: Use the interactive form available at FDA Form 3500. This is encouraged as it’s the quickest and most direct method.
• Fax: Download the form and fax it to 1-800-FDA-0178.
• Phone: Call 1-800-FDA-1088 from Monday through Friday, between 8 a.m. and 4:30 p.m., EST.

If you prefer not to complete the MedWatch report or if your healthcare professional is involved in reporting, you may use Customer Complaint Coordinators (CCCs). CCCs allow for more detailed explanations but do not offer medical advice.

What Happens After a Report Is Made?

When a report is submitted to MedWatch:

• FDA staff enter the complaint into their database, making it available for review and comparison with other reports.
• A safety evaluator reviews the report and checks the database for similar complaints.

The FDA monitors trends in reported issues and conducts investigations as needed. Depending on the findings:

• They may issue safety alerts with recommendations to monitor use, adjust usage methods, or cease using a product.
• Product labeling might be updated to include new warnings.
• The manufacturer could undergo inspection.

Safety Reporting Portal

The Safety Reporting Portal is another tool for reporting problems related to tobacco products, human dietary supplements (except those mentioned under MedWatch), pet food or treats, and livestock food—all of which are regulated by the FDA. The portal includes a routing page that helps direct you to the appropriate federal resource if you’re unsure where to report your concern.