The Chambers Global Practice Guide: Product Liability & Safety (2019), Law and Practice chapter is published here with permission.
1. Product Safety
1.1 Legal Framework
The main laws and regulations governing product safety in the United States include:
- The Consumer Product Safety Act of 1972, 15 U.S.C. § 2051 et seq, created the Consumer Protection Safety Commission (CPSC) and authorises the CPSC to develop product safety standards, pursue product recalls, and ban products from the U.S. market under certain circumstances. Subsequent amendments have expanded the CPSC’s authority. The CPSC issues regulations (Code of Federal Regulations, Title 16) that define certain standards that particular classes of products must meet to ensure the safety of consumer products (eg, products used in homes, schools or otherwise).
- The Consumer Product Safety Improvement Act of 2008, Pub. L. 110-314, 122 Stat. 3017 (2008), imposed safety standards for a broad category of children’s products and gave the CPSC additional enforcement authority.
- Other statutes require safety measures for products intended for use by, or posing a danger to, children, including: Children’s Gasoline Burn Prevention Act, 15 U.S.C. § 2056; Federal Hazardous Substances Act, 15 U.S.C. § 1261; Child Safety Protection Act, 15 U.S.C. § 1261; Poison Prevention Packaging Act, 15 U.S.C. § 1471; Child Nicotine Poisoning Prevent Act of 2015, 15 U.S.C. § 1471.
- Additional statutes require labelling and safety measures for specific products, including: Flammable Fabrics Act, 15 U.S.C. § 1191; Labeling of Hazardous Art Materials Act, 15 U.S.C. § 1277; Refrigerator Safety Act, 15 U.S.C. § 1211; Virginia Graeme Baker Pool and Spa Safety Act, 15 U.S.C. § 8001; Drywall Safety Act of 2012, 15 U.S.C. § 2051.
- The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq, authorises the Food and Drug Administration (FDA) to regulate food and drug safety and approve new drugs and medical devices. Among other things, the FDCA prohibits adulteration or misbranding of food, drugs, devices or cosmetics. 21 U.S.C. § 331. The FDA issues regulations (Code of Federal Regulations, Title 21) to ensure safety of products including food, drugs, medical devices, cosmetics and tobacco products.
- The FDCA and subsequent amendments require new drugs and devices to be approved by the FDA through an established process, and authorise the FDA to evaluate these products’ risks. The FDA has issued comprehensive regulations governing review and approval of these products (Code of Federal Regulations, Title 21).
- The Food Modernization and Safety Act, Pub. L. 11-353, 124 Stat. 3885 (2011), seeks to prevent, detect and respond to food safety issues. The FDA has issued rules to accomplish these goals.
- The Highway Safety Act of 1970, 23 U.S.C. § 401, created the National Highway and Traffic Safety Administration (NHTSA) to oversee traffic and vehicle safety standards and programmes. The NHTSA issues regulations (Code of Federal Regulations, Title 49) to prevent and reduce vehicle crashes.
- The National Traffic and Motor Vehicle Safety Act, 15 U.S.C. § 1381, imposes vehicle safety standards, which motor vehicle manufacturers must follow.
- The Transportation Recall Enhancement, Accountability and Documentation (TREAD) Act, 49 U.S.C. § 30101, requires the NHTSA to issue regulations concerning tires and child restraints, and requires vehicle or equipment manufacturers to report claims to the NHTSA so the agency can identify potential safety issues.
- The Federal Aviation Act of 1958, 49 U.S.C. § 40101, created the Federal Aviation Administration (FAA) and gives the FAA authority to regulate the airline industry. The FAA issues regulations (Code of Federal Regulations, Title 14) imposing airworthiness standards for planes and parts.
- The Clean Air Act, 42 U.S.C. § 7401; Federal Environmental Pesticide Control Act, 7 U.S.C. § 136; Clean Water Act, 33 U.S.C. § 1251; and other statutes impose environmental protections and are administered by the Environmental Protection Agency (EPA). The EPA regulates pesticides and other chemical products to protect the environment and public health (Code of Federal Regulations, Title 40).
1.2 Regulatory Authorities
The main U.S. agencies regulating product safety are the FDA, the CPSC and the NHTSA. Agency authority to regulate products is defined by statute.
The FDA is responsible for safeguarding and advancing public health. It regulates food; drugs; medical devices; radiation-emitting products; vaccines, blood and biologics; animal and veterinary; cosmetics; and tobacco products. The FDA’s authority is defined by the FDCA, which authorises the FDA to regulate drug safety, issue food-safety standards, and inspect factories.
The CPSC regulates over 15,000 consumer products to prevent unreasonable risk of injury or death. Its authority is outlined by the CPSA, which authorises the CPSC to develop safety standards and initiate product recalls and bans.
The NHTSA enforces Federal Motor Vehicle Safety Standards for vehicles and component parts. The NHTSA regulates vehicle and highway safety to reduce deaths, injuries and motor-vehicle accident costs. The NHTSA’s scope of power is found in the National Traffic and Motor Vehicle Safety Act, which authorises the NHTSA to issue safety standards and recall vehicles and component parts.
1.3 Corrective Actions
The FDA, CPSC and NHTSA can request or require corrective action, including removing a product from market - known as a recall. The standards governing manufacturers’ obligations to commence the recall process vary by agency.
The FDA recalls involve correction or removal. There are three types of FDA recalls, based on the potential danger posed by a defective or potentially harmful product: Class I for products that predictably could cause serious harm; Class II for products that might cause harm; and Class III for products unlikely to cause harm. Most recalls are voluntary, but the FDA can request recalls. If a company concludes that a recall is necessary, it will notify the FDA that it intends to implement a recall and will propose a recall plan. The FDA supervises a company’s recall strategy and effectiveness, and examines whether the company has made reasonable efforts to remove or fix the product (eg, by providing enhanced warnings or making repairs or adjustments). The FDA issues a weekly recall report and may publicise recalls to inform the public.
When the CPSC receives a report that a product is defective, poses harms or fails to comply with safety standards, as required by the CPSA section 15, it classifies the danger as follows: a Class A Hazard exists when death or grievous injury is likely or very likely, or serious injury is very likely; a Class B Hazard exists when death or grievous injury is possible, serious injury is likely, or moderate injury is very likely; and a Class C Hazard exists when serious or moderate injury is possible. Each class requires corrective action, such as a recall to recover, repair or replace the product. After the CPSC and the company agree to a recall, they work together to develop an implementation plan for the recall and to monitor the company’s efforts. As part of the recall process, companies must inform the public so consumers can act accordingly. Public notice may include press releases, information on the company’s website or social media, or advertisements, among other methods. When the company believes the recall has been successfully implemented, it can request that the recall no longer be monitored. Other remedial actions ("corrective action plans") include returning the product for a refund, repairing the product, or notifying the public of the hazard. The CPSC has a Fast Track Product Recall Program that permits expedited recalls if, among other criteria, the company can implement a recall or corrective action within 20 days of submitting its report to the CPSC. The benefit of the programme is that the CPSC will not make a finding that the product is defective.
If the NHTSA receives multiple complaints about a product, it may investigate whether a defect exists or a recall should be recommended. A recall is issued when a vehicle or product poses an unreasonable safety risk. If a recall is issued, the company must inform owners within 60 days. The company must provide a free remedy, such as repairing, replacing, refunding or repurchasing the vehicle or product. Most recalls are voluntary, but the NHTSA can require a recall.
1.4 Notification to Regulatory Authorities
The triggers for reporting product safety issues to regulating authorities vary by agency. Some reporting is risk-based; some is incident-based.
The FDA has different reporting requirements for different products. For example, for pharmaceutical products, drug, biologic and device manufacturers; device importers; and certain health care facilities must report adverse events or product problems via Form FDA 3500A or in electronic form. Specifically, if a drug or biologic manufacturer learns of a serious adverse event associated with its product, such as death, disability or life-threatening injury, it must inform the FDA within 15 days of receiving the information. 21 C.F.R. §§ 310.305, 314.80, 600.80. Under the Medical Device Reporting regulations (Code of Federal Regulations, Title 21, Part 803), medical device manufacturers and importers and certain health care facilities must inform the FDA of adverse events and product problems, as follows: manufacturers and importers must report to the FDA within 30 days of learning their device could have contributed to or caused serious injury or death, 21 C.F.R. §§ 803.40, 803.50; manufacturers must inform the FDA within 30 days of discovering malfunctions that could contribute to or cause serious injury or death, 21 C.F.R. § 803.5; manufacturers must sometimes report events requiring corrective action within five days, 21 C.F.R. § 803.53; health...
