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The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011. The FSMA has given the Food and Drug Administration (FDA) new authority to regulate the way foods are grown, harvested and processed. The law grants the FDA a number of new powers, including mandatory recall authority, which the agency had ...
In the area of drugs, the law codifies the agency's current practice of allowing in certain circumstances one clinical investigation as the basis for product approval. The act, however, does preserve the presumption that, as a general rule, two adequate and well-controlled studies are needed to prove the product's safety and effectiveness.
The United States has three federal and two state governmental organizations that are in control of food safety within the United States: the Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS), the Center for Disease Control and Prevention (CDC), the State Department of Public Health, and the State Department of Agriculture. [14]
The Food Safety Modernization Act (FSMA), enacted by Congress in 2011, is a comprehensive update of federal food safety laws. It addresses preventable foodborne illness, monitors the global food supply chain, and ensures human and animal food safety. Rather than a system that responds to foodborne illness, FSMA works to prevent it.
Retrieved from "https://en.wikipedia.org/w/index.php?title=Food_Safety_and_Modernization_Act&oldid=602747602"
The 1200 series consists of rules primarily based in laws other than the Food, Drug, and Cosmetic Act: 1240 Rules promulgated under 361 of the Public Health Service Act on interstate control of communicable disease, such as: Requirements for pasteurization of milk; Interstate shipment of turtles as pets.
A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. [3] In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of ...
This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. [1] It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate. [2]