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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.
Charges against the owner were filled, and six months later, a law called the Food, Drug, and Cosmetic Act of 1938 was signed. This law forced all new food, drugs, and cosmetics to be certified by the FDA before being put on the market. [17] This act granted the FDA with enforcing and legal power that has helped regulate food and drugs ever since.
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.
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.
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]
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 ...
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.