Final answer:
The Federal Food, Drug, and Cosmetic Act (FD&C Act) is the federal statute that defined food, drug, cosmetic, dietary supplements, and devices in the United States. This Act, along with additional legislations like the Pure Food and Drug Act and the Public Health Service Act, give the FDA its regulatory authority. Regulation varies by product, focusing on aspects like safety, efficacy, and truthful labeling.
Step-by-step explanation:
The federal statute that defined food, drug, cosmetic, dietary supplements, and devices is the Federal Food, Drug, and Cosmetic Act (FD&C Act). Enacted in 1938, the FD&C Act was a significant expansion of the FDA's authority, allowing the agency to ensure the safety and efficacy of these products in the United States. The FDA's regulatory programs vary by product type but generally include enforcing standards through facility inspections and overseeing product labeling and marketing.
The FDA roles include the regulation of various product categories such as foods, food additives, added substances, and dietary supplements. For pharmaceuticals and medical devices, the FDA has comprehensive oversight powers - from testing to marketing, while for cosmetics, the focus is primarily on labeling and safety. The FDA also enforce other significant laws like the Public Health Service Act and the Controlled Substances Act.
Previously, standards, inspection, and sanitation of meatpackers were governed by the Pure Food and Drug Act of 1906. The regulation of biological products was established under the 1902 Biologics Control Act and the Public Health Service Act of 1944. Further advancements such as the Food and Drug Administration Amendments Act (FDAAA) of 2007 have added to the regulatory framework that the FDA operates within today.