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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.
FSMA-compliant Hazard Analyses address radiological hazards in addition to the chemical, biological and physical hazards covered by HACCP systems. [16] FSMA explicitly requires a Food Defense component, with both terrorism and Economically Motivated Adulteration addressed. Businesses with less than $10,000,000 a year in sales are exempt.
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]
Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent foodborne illness.The occurrence of two or more cases of a similar illness resulting from the ingestion of a common food is known as a food-borne disease outbreak. [1]
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.
Food and Drug Administration Amendments Act of 2007; Long title: To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Hatch's bill did not get very far, but it encouraged Congress to pass the Dietary Supplement Act of 1992 (Public Law 102-571), which blocked the FDA from applying its forthcoming labeling rules for conventional foods to dietary supplements for another year, until the end of 1993.