Product Safety Issues
If a manufacturer determines that a product placed in the marketplace is dangerous and can cause injury, whether to individuals or their pets, that product should be quickly removed from sale. There are specific requirements and guidelines for conducting recalls, whether those recalls are voluntary or mandated by law. The Consumer Products Safety Commission (CSPC) oversees the safety and recall procedures for consumer products. The US Food and Drug Administration (FDA) regulates and oversees the recall procedures for food and drugs, including pet food and treats, and the US Department of Agriculture (USDA) regulates meat, poultry and processed eggs. The US Environmental Protection Agency (EPA) is responsible for overseeing the safety of pesticides, repellants, and insecticides.
The following is a brief summary of procedures to follow when a manufacturer discovers that there is a safety problem with one of its products. Also provided are links to the Web sites of the appropriate administrative agency with oversight of that product safety issue. In addition to recalls, there may be other requirements for ensuring that a product is safe such as specific labeling requirements, or providing child resistant packaging.
In addition to removing the product from the marketplace, or reporting the problem to the proper authorities, a manufacturer should be aware of the potential liability for any damages caused by the product. To assist our members we provide a short discussion of the elements of a product liability lawsuit. However, we strongly urge our members to contact their attorney immediately upon discovering that your product is deemed to be unsafe. Also included in this outline is information related to animal safety.
FDA Reportable Food Registry-You are now required to report certain cases of food adulteration to the FDA through an Electronic Reportable Food Registry For additional information see the FDA’s Guidance for Industry Document . You are required to report when the circumstances are similar to a Class 1 recall, or when there is the potential to cause serious adverse health effects or death from the adulteration.
Consumers also have a portal on the FDA Web Site where they can report a complaint about a pet food product.
FDA Recalls -There are three types of FDA recalls– all are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.
The FDA regulates foods, including pet foods, treats, and chews, as well as, supplements, remedies and drugs. In 2011 the Federal Congress enacted the Food Safety Modernization Act (FSMA) which now allows the FDA to order a mandatory recall if a food product if exposure to the food will cause serious adverse health consequences or death to humans or animals. Civil penalties may be issued if a food manufacturer refuses to issue a recall.
FDA has issued guidelines for companies to follow when undertaking recalls.
In April 2019 the FDA issued a Draft Guidance on the Initiation of Voluntary Recalls.
These are published in Title 21 of the Code of Federal Regulations, Part 7.
There is also a ``Guidance for Industry: Using Electronic Means to Distribute Certain Product Information.” The guidance explains that manufacturers can distribute certain product information, such as for recalls and drug safety, by electronic means. FDA encourages the use of electronic communications for conveying all such important product safety information.
These guidelines indicate that FDA expects companies to take full responsibility for recalls; including follow-up checks to assure that the recalls are successful.
Companies must notify FDA when recalls are started; they must make progress reports to FDA, and they must undertake recalls when asked to do so by the Agency.
The guidelines call on manufacturers to develop contingency plans for product recalls to be put in place when needed.
Recalls fall into three classes depending on the severity of the hazard involved. For each class of recall, FDA's involvement or how extensively it will check the recall will differ.
- Class I - for dangerous and defective products that could cause serious health problems or death. This could include food with undeclared allergens or if it contains the botulinal toxin.
- Class II - for products that could cause temporary health problems or pose a slight threat of a serious nature.
- Class III - for products that are unlikely to cause adverse health reaction but that violate FDA's labeling or manufacturing regulations. Examples might be a container defect, or off-color or taste.
FDA seeks publicity about a recall only when it believes the public needs to be alerted about a serious hazard. The US Government Web page on food recalls has additional information.
The Centers for Disease Control and Prevention (CDC) tracks and responds to outbreaks of human disease. Similarly, the United States Department of Agriculture (USDA) tracks and responds to outbreaks of foreign animal diseases and endemic diseases of economic importance to livestock. However, no federal agency is responsible for monitoring, tracking, or responding to outbreaks of food-borne disease in companion animals (ex. dogs and cats). PETNet is a secure, web based network that allows information to be exchanged more freely and efficiently between FDA, and other Federal and State regulatory agencies. PETNet allows the exchange of information about pet-food related incidents, such as illness associated with the consumption of pet food or pet food product defects. PETNet gives equal data access to all members. Using the shared information, State and Federal agencies can work together to quickly determine what regulatory actions are needed to prevent or quickly limit adverse effects associated with pet food products.
USDA Recalls - USDA recalls are voluntary. The USDA regulates meat, poultry and processed eggs.
Recalls are to remove meat, poultry or eggs from commerce when there is reason to believe it may be adulterated (injurious to health or unfit for human consumption) or misbranded (false or misleading labeling and/or packaging.)
If a company refuses to voluntarily recall a product then the USDA Food Safety and Inspection Service (FSIS) has the authority to detain and/or seize the product in commerce when there is reason to believe it is hazardous to the public health or if other consumer protection requirements are not met.
FSIS will conduct a preliminary investigation to determine whether a recall is necessary.
FSIS will monitor the effectiveness of the recall procedures and will provide scientific and technical advice.
The recall will be classified dependent on the health risk.
- Class I- the recall involves a health hazard where there is a reasonable probability that eating the food will cause health problems or death.
- Class II- the recall involves a potential health hazard situation where there is a remote probability of adverse health consequences from eating a food.
- Class III - the recall involves a situation where eating the food will not cause adverse health consequences, but the food may be improperly labeled.
The US Government has instituted a web site for FDA and USDA regulated products that are recalled.
The Federal Consumer Product Safety Commission (CPSC) regulates product safety for consumer products. Consumer products are products used in and around the home, and therefore, CSPC has authority for the safety of a wide number of pet products. Virtually any pet product may be overseen by CPSC, unless the product is regulated by another agency. The Federal Food and Drug Administration (FDA) is responsible for overseeing the safety of pet food, pet treats and chews, as well as, drugs and remedies. One exception is that CPSC is responsible for overseeing child-resistant caps for some FDA-regulated products. The Environmental Protection Agency (EPA) oversees the safety of insecticides, pesticides and repellants. If there are safety concerns with any other product, the CPSC has authority to take some kind of action.
Pet products that may fall under the safety concerns of CPSC include leashes, cages, chemicals that are not covered under FIFRA (pesticides, insecticides and repellants), aquarium supplies, pet toys, electric fences and any other product that is used in or around the home that may present safety concerns.
Generally the CPSC has not focused much attention on the safety of pet products, and its emphasis has been on safety concerns of pet products that are a danger to people rather than pets. A review of past recalled products in the CPSC database reveals that very few, if any, pet products have been involved in product recalls. Nonetheless, CPSC has broad authority to:
- Issue mandatory safety standards,
- Ban products where a standard is not feasible,
- Recall dangerous or violative products,
- Seize products that violate mandatory standards,
- Seek civil and criminal penalties,
- Work with industry to develop voluntary standards,
- Educate consumers on the safe use of products, and
- Educate industry on rules and regulations relating to safe products.
Three laws overseen by the CPSC may be relevant to pet products. These are:
- Consumer Product Safety Act (CPSA)
- Federal Hazardous Safety Act (FHSA)
- Poison Prevention Packaging Act (PPPA)
The most significant aspect of these laws for pet product manufacturers and distributors, which is discussed in more detail below, is the obligation to report substantial physical injuries arising out of the use of the product to the CPSC. In addition, manufacturers should be aware of the need to use child resistant packaging for certain products.
The CPSC's Web site has reports on unsafe products, recalls, the regulations and laws as well as, general information on the CPSC. The CSPC encourages manufacturers and distributors to request information from the Commission, under the Freedom of Information Act (FOIA) to see whether there are any complaints or investigations in the files for their products. Data relating to product injuries and incidents are posted on the CSPC's website.
Cautionary Labeling - Any product that contains a hazardous substance is required to have a cautionary statement on its label or outer container. The label must provide information as to safe handling and use of the product, as well as, information on first aid in the event an accident occurs.
Hazardous Substances include products that are toxic, corrosive, flammable or combustible, irritants, strong sensitizers, or that generate pressure through decomposition, heat, or other means, and, if the product may cause substantial personal injury or substantial illness during or as a proximate result of any customary or reasonable foreseeable handling or use, including reasonable foreseeable ingestion by children. If a product meets these criteria a warning must be provided.
Evaluation is specific to the individual product, and considerations must include consumer exposure to the product during reasonable foreseeable use and handling, as well as, how the consumer will use the product and how it will be stored.
Labeling must include (on the principle display panel) a signal word such as WARNING, CAUTION, DANGER, OR POISON (for caustic poisons). There must be an affirmative statement of principal hazards, i.e. "Harmful if Swallowed," "Corrosive."
If not included on the principal display panel, the back of the label must include, the manufacturer's name and place of business, the common or usual name or chemical name, precautionary measures to follow, first aid instructions, if appropriate, instructions for handling and storage, and the phrase "Keep out of the reach of children."
There are specific labeling requirements for certain substances, as well as, suggested label formats. This link provides a fact sheet on the FHSA requirements, as well as information in determining whether your product meets the criteria for requiring a cautionary statement,
FHSA allows the Commission to ban a hazardous substance if it determines that a product is so dangerous that a cautionary warning is inadequate to protect the public. Under the Act, toys or other articles intended for children may be banned if they present a mechanical, electrical or thermal hazard, or if they contain a hazardous substance and the child can gain access to the substance.
When a pet is injured or dies - Traditionally when a pet is injured or dies as the result of an intentional or negligent act of another, the owner of the pet is entitled to the value of the loss of the pet, which is the market value of the pet. If the pet is a mixed breed, it may have little or no market value. Unlike traditional tort law, in which families may be compensated for loss of companionship, or intentional infliction of emotional distress when a person is killed or injured, damages for a loss of a pet are generally viewed as loss of property. However, a number of states are changing laws, and some court precedent is modifying that view, and in some states non-compensatory damages may be considered when a pet is injured. In those cases, damages may include loss of companionship, emotional distress and mental anguish. This may be the case even when the pet is injured as the result of a negligent act as opposed to an intentional act.
Animal Poison Hotline
ASPCA Animal Poison Control Center - The ASPCA Animal Poison COntrol Center has specially trained veterinary toxicologists on-duty around the clock to provide diagnostic and treatment recommendations. They charge a $50 consultation fee. The poison control hotline number is (888) 426-4435. Their web site is: http://www.aspca.org.
PROSAR's Product Safety Call Center is a company that helps manufacturers manage consumer health and safety inquiries for humans and animals. Healthcare professionals staff the call center to manage such inquiries 24/7 for the animal health products industry. Their website has additional information on their services.The Animal Poison Hotline at 888-232-8870 sponsored by North Shore Animal League America and PROSAR International Animal Poison Center (IAPC) charges $35 per case and responds to approximately 35,000 calls per year regarding animals that have been exposed to toxic substances..
CDC Healthy Pets Web Site
The National Center for Disease Control (CDC) maintains a Web site relating to pet safety and health at http://www.cdc.gov/healthypets/.
American Red Cross
The American Red Cross maintains a Web site with information on first aid for pets.
Product liability is the area of law that may hold a manufacturer, manufacturer of component parts, distributor or retailer of a product responsible for injuries resulting from dangerous and defective products. A product that is unreasonably dangerous for its intended use would be considered defective. There are 3 types of product defects that may incur liability to manufacturers. In each case it must be proved that the product is defective for the plaintiff to prevail.
Types of Defects:
- Design Defects- defects which exist in the design which exist before the product is manufactured,
- Manufacturing defects- defects resulting from the construction and production phase, and
- Defects in marketing - defects that are created when improper warnings or instructions are provided regarding the dangers inherent in the product.
Theories of Product Liability:
- Strict Liability- Many product liability cases are considered strict liability offenses. In those cases liability does not depend on any wrongdoing. The defendant (manufacturer) is liable solely by proving the product is defective and that it caused harm. It is irrelevant whether the manufacturer exercised great care in the design or manufacture of the product.
- Negligence- For a negligence claim, the injured party must show that the manufacturer had a duty to exercise reasonable care in the manufacturing or selling of the product, but failed to fulfill that duty, resulting in injury to the plaintiff. Negligence consists of doing something that a person of ordinary prudence would not do under the same or similar circumstances. Negligence can consist of negligence in designing the product, in failing to provide adequate warning labels or any other aspect of the manufacture or distribution process where due care is not used.
- Breach of warranty - A warranty is essentially a contract of fitness between a manufacturer and a customer. Under breach of warranty the injured party claims that the defect rendered the product unfit for the purpose intended. Like strict liability, the injured party does not need to show that there was any negligence (failure to use due care) on the part of the manufacturer.
Child-Resistant Packaging - If a product requires child resistant packaging, the packaging must be significantly difficult for children under five years of age to open within a reasonable time, and not difficult for normal adults to use properly. Although most products manufactured for pets are not required to have child resistant caps, certain chemical, cosmetic, drug and dietary supplement products, as well as, some mouthwashes, may require child resistant packaging. Click on link for more business information on Poison Prevention Packaging
If the product is required to have child resistant packaging, there are certain test protocols required to assure that children under five cannot open the packages, but that it is easy for older adults to open the packages.
Adverse Event Reporting - The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires pesticide product registrants to submit adverse effects information about their products to the EPA. For additional information as to what, when, and how adverse events on pets or domestic animals are reported access the EPA's Web site on reporting pesticide exposure on pets or domestic animals.
Reporting Requirements - Section 15 of the Act requires that if a manufacturer of a consumer product obtains information which supports the conclusion that a product contains a defect which creates a substantial risk of injury to the public; either because of the pattern of the defect, the number of defective products distributed in commerce, the severity of the risk, the vulnerability of the population affected, or creates an unreasonable risk of serious injury or death, the manufacturer must immediately report that defect or risk to the Commission. Reporting is also required when a product fails to meet a consumer product safety rule promulgated by CPSC.
For additional information on reporting requirements and for the reporting form click here . The pattern of defect may be a design flaw, an engineering problem, quality control, labeling issue, or assembly defect. If the Commission determines that the product presents a substantial product hazard, they may order the manufacturer to:
- Give public notice of the defect;
- Notify the distributors and retailers of the product;
- Notify each known purchaser;
- Repair the defective condition;
- Replace the product with a safer one; and/or
- Refund the purchase price of the product.
The Commission requires that manufacturers, distributors and retailers maintain records relating to defective products, and may inspect these records if the question of product safety arises.
CPSC may obtain knowledge of consumer product defects that present a substantial product hazard by consumer complaints, or data collected by hospital emergency rooms. Many hospitals regularly present injury data to the Commission.
If the Commission learns of a product defect, it will use CPSC's technical staff, as well as, outside experts to evaluate a product's safety and make a preliminary determination as to whether a substantial product hazard exists.
After reporting a substantial product hazard, within 5 to 7 days a full report must be provided to the Commission with what provisions will be taken to get the defective product out of the hands of the consumer.
The Commission may impose civil penalties against retailers, distributors or manufacturers for failing to report product hazards.
There is a "Fast Track Recall" program. If a company reports a defect under section 15 of the Act, and is ready to conduct a recall within 20 days, the CSPC does not need to conduct its own investigation. The incentive for manufacturers to use the Fast Track program is that there is no letter in the company's files from the government regarding the safety of the product, which is preferential if there is a product liability lawsuit.
Product Liability Lawsuits - There are also reporting requirements under Section 37 of the Act. If the product is subject to 3 or more civil actions for death or grievous bodily injury and the actions result in a final settlement in favor of the plaintiff within a defined 24-month period, the company must report to the Commission within 30 days of the final settlement in the third action.
Recall Requirements - If your product is subject to a recall, the goal is to reach as many owners of the recall products as possible and provide incentives for them to stop using the defective product.
Examples of consumer notification include:
- Press releases, including broadcast version;
- Point of Purchase Posters displayed in several visible locations for 120 days, minimum;
- Providing a Web site for additional information;
- Specialty posters at repair centers or doctors offices;
- Direct consumer notification resulting from product registration cards, extended warranty purchases, or parts and accessories purchases;
- Toll free numbers.
Consumer incentives can include:
- A bounty or reward, such as a gift/certificate or cash;
- Postage paid to return item;
- Free or substantial contribution toward accessory products.