Understanding FDA’s complaint reporting systems

If you have a complaint about a product regulated by the U.S. Food and Drug Administration (FDA), the agency wants to hear about it.

The FDA offers a number of ways to report a complaint. Two of the main reporting systems available to consumers are the Consumer Complaint Reporting system and MedWatch.

1. Consumer Complaint Reporting

As a part of FDA modernization efforts for field operations, all of our Centers now directly receive reports of problems or adverse reactions with FDA-regulated products. Please direct concerns to the appropriate FDA center by visiting our SmartHub webpage, which will guide you to the appropriate webform or phone number.

If you are not able to use the SmartHub, you may also call 1-888-INFO-FDA and follow the prompts to report a problem. If you require the use of a Relay Service, please call the Federal Relay Services at 800-877-8339. This is a toll-free relay service to call federal agencies from TTY devices.

NOTE: The ORA consumer complaint coordinator telephone numbers previously available on this page are no longer in use.

Some examples of complaints that the FDA wants to hear about are:

• food-related illnesses, especially when a specific food is suspected
• allergic reactions when a person has a known allergy to a food ingredient not identified on the product label
• problems related to infant formula
• problems related to baby food
• swollen or leaking canned goods
• suspected product tampering
• adverse events after taking dietary supplements
• problems related to prescription or over-the-counter medications
• problems related to pet food and treats

Reporting problems can spur action

The FDA takes seriously reports of illnesses or injury that appear likely to have been caused by an FDA-regulated product. As few as one or two complaints can make a difference. Depending on the seriousness of the problem, an FDA investigator may visit the person who made the complaint, collect product samples, and initiate inspections.

Complaints of a less serious nature, or those that appear to be isolated incidents, are monitored and the information may be used during a future inspection of a company to help the FDA identify problem areas in a production plant. The complaints are also discussed with company management during these inspections.

2. MedWatch reporting

MedWatch receives reports from the public and, when appropriate, publishes safety alerts for FDA-regulated products such as:

• prescription and over-the-counter drugs
• biologics, such as blood components, blood/plasma derivatives, and gene therapies
• medical devices, such as hearing aids, breast pumps, and pacemakers
• combination products, such as pre-filled drug syringes
• special nutritional products, such as medical foods, and infant formulas
• cosmetics, such as moisturizers, makeup, shampoos, hair dyes, and tattoos
• food, such as beverages, and ingredients added to foods

Other products that the FDA regulates, such as tobacco products, vaccines, animal drugs and devices, and pet food and livestock food, utilize different reporting pathways, and it is recommended that reports concerning these products be submitted directly to the appropriate portals. Adverse events associated with dietary supplements should be reported via the online Safety Reporting Portal.

When the FDA approves a drug, the agency has determined that the benefits of the product outweigh the risks, but every product that the FDA approves carries some risk. Sometimes there are risks that come to light only after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Because unanticipated adverse events may occur after a product is on the market, the FDA encourages people to report problems they think they've experienced from a product the FDA regulates.

Every MedWatch report is important and is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public. Remember, reporting can help you, a family member, or someone else avoid harm, serious illness, or even death.

How to report to MedWatch

Reporting to MedWatch is easy, confidential, and secure. You provide information about your experience on a MedWatch form. The FDA encourages you to have your health care professional either complete the form for you or help you complete the form yourself.

"Health care professionals may have other clinical information, such as test results or a medication profile, that will help us evaluate the report," says CAPT Beth Fritsch, Senior Advisor for Stakeholder Engagement.

Reporting by health care professionals is voluntary. If they choose not to report, or if you'd rather file the report yourself, you may use one of these methods:

• Online: Use the interactive form at FDA Form 3500. FDA encourages online reporting because it is the quickest and most direct route.
• Fax: Get the form (as above) and fax to 1-800-FDA-0178.
• Phone: Call 1-800-FDA-1088 Monday-Friday between 8 a.m. and 4:30 p.m. EST.

If you or your health care professional do not want to complete a MedWatch report, you may report a problem with a health care product to your CCC. The FDA realizes there are instances when consumers want to explain their problem and have the agency record the complaint. This allows the FDA to ask questions and obtain important information that we might not get if the consumer only filled out a MedWatch report.

CCC's and MedWatch are for reporting problems; neither provides medical advice. If you experience an adverse event, you should contact your health care professional first and then report the problem to FDA.

What happens after a report is made to MedWatch?

FDA staff enter the report into a database so that it is available for review and comparison to other reports.

• An FDA safety evaluator, often a pharmacist, doctor, or nurse, reviews the report and examines the database for similar reports.
• The FDA monitors the data for trends and conducts an investigation, if appropriate.
• The FDA takes necessary action to protect public health.

FDA actions may include:

• issuing safety alerts with recommendations to monitor a product's use, adjust the way it is used, or stop using it
• updating the product labeling to reflect new warnings
• inspecting the manufacturer
• requiring a product to have a Medication Guide—a consumer-friendly instruction sheet provided to patients each time they fill a prescription to help them use the drug safely
• requesting a change in the product's design, manufacturing process, packaging, or distribution
• requesting a company to recall a product
• requiring a manufacturer to conduct further studies to demonstrate the product's safety prior to allowing the product back on the market

3. Safety Reporting Portal

The Safety Reporting Portal is another reporting tool. It is the primary way for people to report problems with any tobacco product, human dietary supplements, pet food or pet treats, and livestock food—all of which are regulated by the FDA.

The portal also has a routing page. If you have concerns about a product and are not sure where to go to report it, the routing page will direct you to the appropriate federal resource.