Nutrition News & Views August 6, 1997 Reporting Problem Products to the FDA Have you had a problem with a food, drug, cosmetic, medical device, radiation­emitting electronic product, or veterinary drug?   Did it cause you an injury or was it insanitary or improperly labeled?   Perform a public service and report the problem to the Food and Drug Administration. The FDA welcomes reports from the public alerting it to problems with products that it regulates.   The reports help the 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 follow­up is needed.   Depending on the seriousness of the problem, the FDA will either investigate it immediately or during the next inspection of the facility responsible for the product. What to Report 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 Was the product old or outdated?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 the FDA will be of any benefit.   Nevertheless, you should, of course, get proper medical care for your injury, if necessary.   Otherwise, report the following: Food 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. [Note: In Mississippi, for meat and poultry, contact Compliance Officer at (334) 279­3492.] Drugs Report products whose appearance is unusual examples are a capsule that is cloudy or contains crystals when it should be clear; a package that has a part or parts of its tamper­evident safeguards missing or broken; a capsule or pill that is chipped, broken or off­color; or any product that is contaminated with foreign matter, such as hair or mold.   Also, report any drug that has caused an injury or illness. Cosmetics Report products that contain filthy or harmful substances, are decomposed or spoiled, or have caused an injury. Medical Devices Report products that do not perform according to claims and instructions, have false or misleading labels, are labeled as sterile but have broken seals, or caused an injury. Radiation­Emitting Electronic Products (such as microwave ovens or video display terminals) Report incidents in which an injury either has occurred or may occur from products that give off radiation. Veterinary Drugs and Feed Report the same problems with animal feed (including pet food) and veterinary drugs that would be reported for human foods or drugs. Where to Report Complaints may be made by telephone or in writing.   Contact the FDA office nearest you by checking the blue pages of your telephone directory under U.S. Government, Department of Health and Human Services, Food and Drug Administration. [Note:   In Mississippi, contact Department of Health and Human Services at (601) 364­2666 or Food and Drug Administration at (601) 965­4581.]    You may contact the FDA's headquarters:      Food and Drug Administration      5600 Fishers Lane (HFC­160)      Rockville, MD 20857 Or phone the FDA's emergency number (staffed at all times):   (301) 443­1240. How to Report 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. Limits of Authority The FDA does not regulate prices of products or sales practices of stores.   The FDA cannot control the selection of food or sanitation in schools, prisons, or other institutions.   The 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. [Note:   In Mississippi, contact Better Business Bureau of Consumer Affairs at (601) 987­8282.] What to Report to Other Agencies Complaints about the following should be made to the agencies listed.   Consult your local telephone directory or public library for specific information. [Note:   In Mississippi, contact agencies at numbers listed.] Meat and poultry products:   U.S. Department of Agriculture   Meat and Poultry Inspection Operations:     Compliance Officer (334) 279­3492 Sanitation in restaurants and cafeteria:   Local or State Health Departments   Food Protection Branch (601) 960­7689 Unsolicited products in the mail:   U.S. Postal Service   Customer Service (601) 351­7372 Accidental poisonings:   Poison control centers or hospitals   Poison Control (601) 354­7660 Pesticides, air, and water pollution:   U.S. Environmental Protection Agency   (Region 4 Office in Atlanta)     (404) 562­9900 Hazardous household products (including appliances, toys and chemicals):   Consumer Product Safety Commission     1­800­638­2772 Exposure to hazardous materials in the workplace:   Occupational Safety and Health   Administration of the U.S. Department of Labor     (601) 965­4606 Advertising and warranties:   Federal Trade Commission (except advertising for prescription drugs, which is regulated by FDA)    (404) 656­1399 Dispensing and sales practices of pharmacies:   State Board of Pharmacy   (601) 354­6750 Medical practice:   State Board of Medicine   (601) 354­6645 Source: FDA Backgrounder Upated 5/9/96; updated 10/16/96 Mississippi information added by Kim Smith, Mississippi State University, Dietetic Intern, 8/6/97 Prepared by: Kim Smith Mississippi State University, Dietetic Intern Submitted by: Barbara McLaurin, Ph.D., R.D., L.D. Human Nutritionist Specialist

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