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Product Safety Recalls

Not hearing about a product recall can have dangerous, even deadly consequences. And too many consumers don’t get the message. Learn what you can do so you don’t miss these important notices.

• Getting the Message Out
• Consumer Goods
• Watch out for used products
• Food Products
• Health Products (Biologics, Cosmetics, Medical Devices and Medication)
• Animal Products (Pet Food and Vaccines)
• Other Resources
• E-mail this Information to A Friend
• Other Topics in the Consumer Focus Archive

Posted: November 19, 2007

Getting the Message Out

On March 15, 2007 the American public first heard about a massive pet food recall. In August 2007 over 9 million toys were recalled due to a lead poisoning hazard. And both of these recalls grew over several weeks to include additional products. Fortunately these dangerous products made the news, and consumers knew to dispose of these harmful items.

However, some recalls never make major headlines - the majority get little or no news coverage, and many dangerous products linger in homes well after they have been pulled from stores. Almost one-third of all recalled vehicles – more than half of all toys, clothes, appliances, tools, and electronics gear, and three-fourths of child car seats – are never repaired or returned to stores.

With so many recalls each year, coming from different agencies that have their own rules and procedures, it is difficult for anyone to keep up or know where to go for assistance.

That’s why the Federal Citizen Information Center (FCIC) has put this article together so you can prevent incidents and injuries from dangerous products by using these resources. Check out these websites, sign up for email alerts, and considering registering products with the manufacturer. The FCIC also maintains a recalls page on a variety of consumer products.

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Consumer Goods

The Consumer Product Safety Commission (CPSC) is charged with protecting the public against unreasonable risks of injuries and deaths associated with consumer products. CPSC has jurisdiction over about 15,000 types of consumer products, from clothing, jewelry and toys to automatic-drip coffee makers and lawn mowers.

Unfortunately, each year 33.1 million people are injured by consumer products in the home. Some hazards are from products the agency has warned about for years; others come from new products and technologies.

Some of the products CPSC regulates include:

Watch out for used products

Recalls may get products off store shelves but it is more difficult to get them out of people’s homes when they are resold at garage sales, discount or “dollar” stores, swap meets and on the Internet.

Many recalled children’s products are resold in online auction sites, often years after they were deemed dangerous. Even experienced and reputable sellers, may not know a product has been recalled. And it is difficult for online bidders to check for a recalled product since many listings do not include a serial number or manufacturer date. Use the resources below from the CPSC to thoroughly check out a product before you sell or buy.

Finding information on recalled consumer products

• Consumer Product Safety Commission product recalls database
• Sign up for CPSC alerts (also available in Spanish)
• ATVSafety.gov – ATV recalls listed by manufacturer
• Consumers should check out a manufacturer’s website for product information.

Reporting a problem with a product to the CPSC

To report an unsafe consumer product or a product-related injury or find product information, contact the Consumer Product Safety Commission online or call the CPSC toll-free hotline at 800-638-2772 (English/Spanish) or 800-638-8270 for the hearing and speech impaired.

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Food Products

Separate government agencies are responsible for protecting different segments of the food supply. If you have experienced a problem with a food product, be sure to contact the appropriate agency.

Some of the food products the Food and Drug Administration (FDA) regulates include:

Some of the products the Food Safety and Inspection Service (FSIS) regulates include:

Finding information on food-related recalls

For non-meat products:

• Food and Drug Administration’s (FDA) recall database.
• Contact the FDA’s Center for Food Safety and Applied Nutrition at 888-723-3366.

For products containing meat:

• USDA/Food Safety and Inspection Service (FSIS) recall information center
• USDA email subscription service. The email alert service provides automatic and customized access to selected food safety news and information.
• Call the USDA Meat and Poultry Hotline at 888-674-6854; for the hearing-impaired (TTY) 800-256-7072. The hotline is staffed by food safety experts weekdays from 10 a.m. to 4 p.m. Eastern time. You can listen to food safety recordings 24 hours a day using a touch-tone phone.

Reporting a problem with a food product

For non-meat products:

• To report problems, including adverse reactions, related to any food except meat and poultry (such as cereal, fruit juice, pastas, fish, etc) contact the district coordinator for your geographic area.

For products containing meat:

• For help with meat, poultry and egg products, call the USDA Meat and Poultry Hotline at 888-674-6854 (hearing impaired can contact TTY at 800-256-7072)

For assistance with restaurant food problems:

• Contact your city, county or state Health Department.

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Health Products

This category includes a wide variety of products – all of which can be regulated by several federal agencies.

Although medical products are required to be safe, safe does not mean zero risk. A safe biological product is one that has reasonable risks, given the patient's condition, the magnitude of the benefit expected, and the alternatives available. The choice to use a biological product involves balancing the benefits to be gained with the potential risks.

Some of the medical products the Food and Drug Administration (FDA) regulates include:

Medical Devices

These are only some of the products FDA’s Center for Devices and Radiological Health (CDRH) regulates - contact lenses, hearing aids, blood glucose strips and meters, breast pumps and many more devices.

A medical device recall occurs when a device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the device needs to be checked, adjusted, or fixed. Examples of the types of actions that may be considered recalls: inspecting the device for problems, repairing the device, re-labeling, adjusting settings on the device, or destroying the product. In most cases, a company recalls a medical device on its own, but the Food and Drug Administration can as well. The FDA classifies recalls into three categories, representing the potential risk to public health: Class I (high risk), Class II (less serious risk), and Class III (low risk).

Finding information on medical device related recalls

• Center for Devices and Radiological Health recalls database.
• Get additional information sent to you by signing up for the free CDRH email subscription service.

Reporting a problem with a medical device to CDRH

• MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems and product use errors with human medical products, such as drugs and medical devices. If someone in your family has experienced a serious reaction to a medical product, you are encouraged to report the incident.

Biologics, Blood and Vaccines

FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety and efficacy of blood and blood products, vaccines, and allergenics.

Blood
CBER regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply.

Vaccines
CBER also regulates vaccine products. Many of these are childhood vaccines.

Finding information on related product recalls

• Visit the CBER website for recalls, withdrawals, notifications and other information.
• CBER has established three automated e-mail lists to distribute information within CBER and to the public.
• CBERINFO - Members of this list will receive all BLOODINFO and TISSUEINFO documents, as well as all other new documents, including guidelines, rules, and other CBER information.
• BLOODINFO - Members of this list will receive blood-related documents.
• TISSUEINFO - Members of this list will receive tissue-related documents.
• Voice Information System - Direct access to a Consumer Safety Officer or Public Affairs Specialist contact 800-835-4709 (or 301-827-1800).
• For information about a medical product, consumers can call the FDA's toll-free information line, 888-INFO-FDA (888-463-6332).

Note: If you have questions or are unable to find the information you need, consumers can contact: Center for Biologics Evaluation and Research, Office of Communication, Training & Manufacturers Assistance at 800-835-4709 or 301-827-1800, or email octma@cber.fda.gov.

Reporting a problem with a product to CBER

• CBER and the Centers for Disease Control & Prevention (CDC) jointly manage the Vaccine Adverse Event Reporting (VAERS). VAERS collects information about side effects of US licensed vaccines. VAERS welcomes reports from all concerned individuals: patients, parents, health care providers, pharmacists, and vaccine manufacturers.
• Report suspected unlawful sale of medical products on the Internet online.
• If you find a Website you think is illegally selling human drugs, animal drugs, medical devices, biological products, foods, dietary supplements or cosmetics over the Web, please select one of the three options below to report to FDA. If your report:
• involves a life-threatening situation due to an FDA-regulated product you purchased from a Website, call 301-443-1240 immediately. (Also contact your health professional for medical advice.)
• involves a serious reaction or problem with an FDA-regulated product, fill out FDA's MedWatch reporting form. (Also contact your health professional for medical advice.)
• report e-mails promoting medical products that you think might be illegal, forward the email to webcomplaints@ora.fda.gov.

Cosmetics

FDA defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, and deodorants, as well as any material intended for use as a component of a cosmetic product.

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) is the federal agency that regulates cosmetic products. Federal regulations prohibit the marketing of adulterated or misbranded cosmetics. Improperly labeled or deceptively packaged products are considered misbranded and subject to regulatory action. FDA has no authority to order a recall of a cosmetic, although it can request that a firm recall a product.

Some of the cosmetic-related products CFSAN (FDA) regulates include:

A cosmetic is adulterated if:

• it contains any poisonous or harmful substance which may cause injury to users under the conditions of use as stated in the labeling,
• it consists in whole or in part of any bad or decomposed substance,
• it has been prepared, packed, or stored under unsanitary conditions,
• its container is composed, in whole or in part, of any harmful or poisonous substance, or if
• it is or contains a color additive which is unsafe.

A cosmetic is considered misbranded if:

• its labeling is false or misleading,
• its label does not include all required information,
• if the required information on its label is not adequately prominent and conspicuous, or
• its container is so made, formed, or filled as to be misleading.

Finding information on cosmetic product recalls

• FDA issues general information about recalls through a weekly publication, the FDA Enforcement Report.
• Visit the FDA website for recalls and safety alerts on cosmetic related products
• Call CFSAN toll-free at 888-723-3366 10:00 a.m. to 4:00 p.m. Eastern Time, Monday through Friday.

Reporting a problem with a cosmetic product

• Report non-emergencies, including bad reactions to any cosmetic product to:
• The nearest FDA district office. Their phone numbers are on FDA's Web site and in the Blue Pages of the phone book under United States Government/Health and Human Services.
• FDA's Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS) by phone at 301-436-2405 or by email at CAERS@cfsan.fda.gov.
• Situations that do not require immediate action can be reported either to the appropriate consumer complaint coordinator or to the FDA office that handles the product.
• Report an emergency that requires immediate action to:
• CFSAN’s main emergency number, staffed 24 hours a day, 301-443-1240.
• The FDA consumer complaint coordinator in your geographic area.

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Animal Products

The Center for Veterinary Medicine (CVM), of the U.S. Food and Drug Administration, regulates the manufacture and distribution of food additives and drugs that will be given to animals. These include millions of animals from which human foods are derived, as well as food additives and drugs for more than one hundred million pets.

Some of the animal products CVM regulates include:

Pet Foods

The CVM regulates that can of cat food, bag of dog food, or box of dog treats or snacks in your pantry. The regulation of pet food is similar to that for other animal feeds. The law requires that pet foods, like human foods, be pure and wholesome, safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.

Animal Feed, Feed Ingredients, and Additives

A safe animal feed supply helps ensure healthy animals and people. To that end, CVM monitors and establishes standards for feed contaminants, approves safe food additives, and manages medicated feed and pet food programs.

Finding information on animal products recalls

• Visit the Center for Veterinary Medicine website
• Subscribe to CVM Updates - Members receive CVM Updates as they are released. CVM Updates are brief news releases issued on developments of interest to our stakeholders and the public.

Reporting a problem with an animal product

• To report complaints about pet food (and other animal feed), please contact your state FDA’s Consumer Complaint Coordinator(s).
• Veterinary Drug Adverse Reaction Reporting – Veterinarians and animal owners are encouraged to report Veterinary Adverse Drug Experiences (ADEs) and suspected product failures by calling 888-FDA VETS.

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Other Resources

This is just a brief overview. For more information, check out these resources:

Read these publications online or order them from FCIC:

• Consumer Action Handbook -- (Guía del Consumidor)
• Internet Auctions

Websites*

• ATVSafety.gov
• FDA Center for Veterinary Medicine
• ConsumerAction.gov
• Consumer Product Safety Commission
• Food and Drug Administration
• Federal Citizen Information Center
• Food Safety and Inspection Services
• Recalls.gov
• U.S. Department of Agriculture

* Names of resources and organizations included in this online article are provided as examples only, and their inclusion does not mean that they are endorsed by the Federal Citizen Information Center or any other Government agency. Also, if a particular resource or organization is not mentioned, this does not mean or imply that it is unsatisfactory.

*If you click on these links, you are leaving FCIC's website. Please bookmark us before you leave so you can return easily. FCIC is not responsible for the content of these websites.

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We will not retain or use this information for any other purpose.

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For more information on other popular consumer issues check out FCIC's Consumer Focus Archive.

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