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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]
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 Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
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]
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.
The primary international agency with a focus on food policy is the Food and Agriculture Organization (FAO) of the United Nations, established in 1945 with four express purposes: to improve nutrition and living standards in member nations, improve the efficiency of production and distribution of all food and agricultural products, better the conditions of rural populations, and expand the ...
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