USA Law and Practice Contributed by: Trevor Keenan, Michelle Byers and Curtis Berglund, Campbell Conroy & O’Neil, P.C.
1. Product Safety 1.1 Product Safety Legal Framework The legal framework governing product safety in the USA is discussed below. Overarching Federal Laws and Regulations Product safety The Consumer Product Safety Act of 1972 (CPSA), 15 USC Section 2051 et seq This legislation established the Consumer Prod - uct Safety Commission (CPSC), the independ - ent federal regulatory agency charged with protecting the public from unreasonable risks of harm from consumer products. The CPSC is authorised to develop standards, issue recalls and ban products in the USA under certain cir - cumstances. The Consumer Product Safety Improvement Act of 2008 (CPSIA), Pub L 110–314, 122 Stat 3016 The CPSIA amended the CPSA. It provided new regulatory and enforcement tools, and author - ised the CPSC to create SaferProducts.gov, a website database where the public can file and read complaints about products under the CPSC’s jurisdiction. Amendment to the Consumer Product Safety Improvement Act of 2008, Pub L 112–28, 125 Stat 273 (2011) The CPSIA was amended in 2011 to add require - ments for SaferProducts.gov, including: • expanding the information collected in prod - uct reports; • defining the timing for posting the reports to the database; and • expanding the CPSC’s authority and discre - tion to enforce product safety laws.
In addition, federal statutes impose safety and labelling requirements for specified products, such as: • the Flammable Fabrics Act, 15 USC Section 1191 et seq; • the Labeling of Hazardous Art Materials Act, 15 USC Section 1277; • the Refrigerator Safety Act, 15 USC Section 1211; • the Virginia Graeme Baker Pool and Spa Safety Act, 15 USC Section 8001 et seq; • the Drywall Safety Act of 2012, 5 USC Sec - tion 553, 15 USC Sections 2058, 2063; and • the Portable Fuel Container Act of 2020, 15 USC Section 2056d. Industry-Specific Laws Food and drugs The Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), 21 USC Section 301 et seq This law charges the Food and Drug Administra - tion (FDA) with ensuring the safety of the USA’s food supply, cosmetics and the safety, efficacy and security of drugs, biological products and medical devices. The law protects the pub - lic from adulterated and misbranded products manufactured and sold in the USA. 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 packaging; and • monitoring healthcare claims for foods.
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