USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers Graham and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
FDA The FDA regulates and safeguards food, cosmet - ics, drugs, biological products, medical devices and tobacco products. The FDA’s regulations are set forth in the CFR, Title 21. NHTSA The NHTSA regulates highway and vehicle safety, establishes and enforces FMVSS, and issues motor vehicle and component part recalls. The NHTSA regu - lations can be found in the CFR, Title 49. EPA The EPA regulates chemical products, pesticides, air - line emissions, and air and water quality standards. The EPA’s regulations are set forth in the CFR, Title 40. 1.3 Obligations to Commence Corrective Action Corrective action, such as product recalls, can be requested or required by the CPSC, FDA and NHTSA. CPSC If the CPSC makes a preliminary determination that a product defect creates a substantial risk of injury, corrective action is required. It classifies product dangers depending on the likelihood and severity of death, injury or illness as either Class A, Class B or Class C Hazards. Each Hazard Class requires correc - tive action, which may include a recall, public notice and remedies for consumers. Corrective action may also include steps to mitigate a potential hazard, such as changes to design, manufacturing materials, qual - ity control, warnings or marketing, or discontinuing a product. Companies must work with the CPSC to prepare a plan for communicating a recall to consumers. Requirements for recall notices are set forth in CFR Title 16, Section 1115.27. The CPSC has established the Fast-Track Product Recall Program, under which a company may avoid a preliminary determination by the CPSC that a product creates a substantial risk of injury if it reports the potential defect, meets other requirements for a timely recall, and works with the CPSC to implement a corrective action plan.
• the Children’s Gasoline Burn Prevention Act, 5 USC Section 553, 15 USC Section 2058 (2008); • the Child Nicotine Poisoning Prevention Action of 2015, 15 USC Section 1471 et seq; • the Safe Sleep for Babies Act of 2021, Pub L 117–126, 136 Stat 1208; • Reese’s Law, Pub L 117–171, 136 Stat 2094 (2022) (mandating federal safety requirements for button cell or coin batteries); and • the Stop Tip-overs of Unstable, Risky Dressers on Youth (STURDY) Act, HR 2617 (2022) (imposing mandatory furniture tip-over standards). Consumer protection The Federal Trade Commission Act ( FTCA ), 15 USC Section 41 et seq The FTCA established the Federal Trade Commission (FTC) and empowered it to: • prevent unfair methods of competition or unfair and deceptive acts and practices affecting commerce; • seek relief for conduct that harms the public; and • prescribe rules defining and preventing unfair or deceptive acts or practices. State laws Product safety laws at the state level can vary widely and may be enforceable both by private action and through state attorneys general. 1.2 Regulatory Authorities for Product Safety The main regulators of product safety in the USA are the CPSC, FAA, FDA, NHTSA, FTC and EPA. Their authority to regulate product and consumer safety is defined by statute. CPSC The CPSC regulates consumer products by develop - ing standards and issuing recalls and bans on prod - ucts in the USA under certain circumstances. Its regu - lations are set forth in the Code of Federal Regulations (CFR), Title 16. FAA The FAA regulates airworthiness standards for aircraft and aircraft equipment. Its regulations can be found in the CFR, Title 14.
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