In Canada, most food products, pharmaceuticals, cosmetic products and medical devices are subject to federal regulation pursuant to the Food and Drugs Act (FDA) and other related legislation. Similar to the U.S. regulatory scheme, the Canadian regime is administered and enforced by the federal regulatory authorities. However, U.S. manufacturers who sell regulated products in Canada may be surprised to learn that compliance with the FDA and associated regulatory frameworks has not historically served as a defense to product liability claims.