How do you report problem products to FDA?

FDA welcomes reports from the public alerting it to problems with products that it regulates. The reports help FDA ensure that products on the market are safe, effective, and properly manufactured, stored and labeled.

Each report is evaluated to determine how serious the problem is and what follow-up is needed. Depending on the seriousness of the problem, FDA will either investigate it immediately or during the next inspection of the facility responsible for the product.

Before you report a product that you suspect caused an illness or injury, ask yourself the following:

• Did you use the product for other than its intended use?
• Did you fail to follow carefully the instructions for the product?
• Was the product old or outdated?
• Do you have an allergy or other medical condition that might have something to do with the suspected harmful effect?

If you answer yes to any of these questions, it's unlikely that reporting the problem to FDA will be of any benefit. Nevertheless, you should, of course, get proper medical care for your injury, if necessary. Otherwise, report the following:

Report any product, including seafood and dairy products (but not meat or poultry, which is regulated by the U.S. Department of Agriculture), if it is unsafe, decomposed, filthy, or defective; contains foreign substances or particles, such as hair or insects; is not properly labeled; is processed or stored under insanitary conditions; weighs less than its labeled weight; or has caused injury or illness.

Report the same problems with animal feed (including pet food) and veterinary drugs that would be reported for human foods or drugs.

Complaints may be made by telephone or in writing. Contact the FDA office nearest you by checking the blue pages of you telephone directory under U.S. Government, Department of Health and Human Services, Food and Drug Administration.

Report what happened as soon as possible after you've encountered the problem. Give names, addresses and telephone numbers of persons who were injured or made ill. Be sure to include your name, address, and phone number. Also provide the name and address of the doctor or hospital providing emergency medical treatment.

State clearly what the problem appears to be. Describe the product as completely as possible, particularly any codes or identifying marks that appear on the label or container (usually these are stamped or embossed on the lids of canned products.) Give the name and address of the store where the product was purchased and the date of purchase.

Keep any opened or unopened containers or packages of the product (don't open packages if you haven't already done so). You should also report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.

FDA does not regulate prices of products or sales practices of stores. FDA cannot control the selection of food or sanitation in schools, prisons, or other institutions. FDA cannot enforce terms of guarantees, warranties or coupons, nor can it require stores or manufacturers to give refunds or disclose product recipes or formulas. Your local Better Business Bureau of Consumer Affairs may be able to help with some of these problems.

Complaints about the following should be made to the agencies listed. Consult your local telephone directory or public library for specific information.

• Meat and poultry products: U.S. Department of Agriculture
• Sanitation in restaurants and cafeteria; Local or State health departments.
• Unsolicited products in the mail: U.S. Postal Service
• Accidental poisonings: Poison control centers or hospitals.
• Pesticides, air, and water pollution: U.S. Environmental Protection Agency.
• Hazardous household products (including appliances, toys and chemicals): Consumer Product Safety Commission.
• Exposure to hazardous materials in the workplace: Occupational Safety and Health Administration of the U.S. Department of Labor.
• Advertising and warranties: Federal Trade Commission (except advertising for prescription drugs, which is regulated by FDA).
• Dispensing and sales practices of pharmacies: State Board of Pharmacy.
• Medical practice: State Board of Healing Arts

Once you've reported a problem to FDA, investigators will follow up according to agency procedures.