USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers Graham and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
The Food and Drug Modernization Act of 1997 , Pub Law 105 – 115 The regulation of food, drugs, medical devices and cosmetics was reformed to include: • off-label use of drugs and medical devices; • risk-based regulation of medical devices; • elimination of pre-market approval for food pack - aging; and • monitoring healthcare claims for foods. The Family Smoking Prevention and Tobacco Control Act of 2009 ( TCA ), Pub L 111 – 31 , 123 Stat 1776 This law authorises the FDA to regulate the manufac - ture, distribution and marketing of tobacco products in the USA. Transportation The Federal Aviation Act of 1958, 49 USC Sec- tion 40101 et seq (repealed and recodified in 1994) The Federal Aviation Act of 1958 established the Fed - eral Aviation Agency (FAA) to provide for the safe and efficient use of national airspace and to regulate safety in the aviation industry. The FAA Reauthorization Act of 2024, Pub L 118-63 reauthorised the FAA and aims to increase consumer protection, accelerate new technology integration and modernise airspace. The National Traffic and Motor Vehicle Safety Act ( VSA ) of 1966 , Pub L 89 – 563 , 80 Stat 718 This law establishes federal motor vehicle safety standards (FMVSS) for all new domestic and imported vehicles, addresses concerns about tyre safety, and requires manufacturers to notify consumers of safety- related defects and pay for the repairs. The Highway Safety Act of 1970 , 23 USC Section 401 et seq This law established the National Highway Traffic Safety Administration (NHTSA) and charged it with setting and enforcing safety performance standards for motor vehicles and related equipment, and with investigating safety defects in motor vehicles.
The Transportation Recall Enhancement , Accountability , and Documentation ( TREAD ) Act , 49 USC Sections 30101 – 30170 The TREAD Act requires vehicle and equipment man - ufacturers to periodically report to the NHTSA safety recalls in the USA and safety campaigns in foreign countries, and to report information that could indi - cate the existence of a potential safety defect. The Act imposes criminal liability on vehicle manufacturers that intentionally violate reporting requirements. Toxic substances The Toxic Substances Control Act of 1976 ( TSCA ), 15 USC Section 2601 et seq The TSCA granted the Environmental Protection Agency (EPA) the power to impose reporting, record- keeping and testing requirements, as well as restric - tions relating to chemical substances and mixtures. The TSCA addresses the production, importation, use and disposal of specific chemicals. Food, drugs, cos - metics and pesticides are excluded from the TSCA. The Lautenberg Chemical Safety Act , Pub L 114 – 182 , 130 Stat 448 ( 2016 ) The Lautenberg Act revised the TSCA to permit more rigorous vetting of chemicals before they are allowed on the market, and updated the EPA’s risk analysis for chemicals already on the market, including a risk- based safety standard that excludes cost considera - tions. The Asbestos Information Act of 1988 , 15 USC Section 2607 ( f ), Pub L 100 – 577 , 102 Stat 2901 This law requires companies that make certain asbes - tos-containing products to report production to the EPA. Children’s safety Several federal statutes address safety measures for products dangerous to children: • the Federal Hazardous Substances Act of 1960, 15 USC Section 1261 et seq; • the Poison Prevention Packaging Act of 1970, 15 USC Section 1471 et seq; • the Child Safety Protection Act, Pub L 103–267, 108 Stat 722 (1994);
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