| The Food and Drug Administration is the oldest comprehensive consumer protection agency in the U. S. federal government. It was founded in 1927 as an executive agency ‘Food, Drug, and Insecticide Administration’. The function of FDA is to establish safety standards for medical appliances, household utensils, chemicals, cosmetics, food additives, groceries, medicines, etc. It also examines, tests, approves the products based on the criteria.
FDA’s major business
FDA can restrict sales of untested products and take legal action to stop the sales of harmful products. It can also confiscate harmful products or accuses firms violating laws. FDA inspects and enforces legal regulation on production plants based on the safety and purity standards in compliance with ‘Federal Food, Drug & Cosmetic Act’. It also demands manufacturers to specify accurate information on the product with regulated size in compliance with ‘Fair Packaging and Labeling Act’. FDA has supervisory authority on vaccinations/serum and can conduct a sanitary inspection on milk pasteurization, restaurants/accommodations in compliance with ‘Public Health Act’. Also, FDA regulates radioactivity from X-ray machine, Television, microwave, etc. to protect consumers from radioactive contamination in compliance with ‘Radiation Control Act’.
Research Centers associated with FDA
* CFSAN; Center for Food Safety and Applied Nutrition
CFSAN regulates safety factors from all foods and cosmetics consumed in the United States. The center verifies the food production process in order to make sure the food was produced from completely pure and hygienic environment. In terms of cosmetics, the center regulates the components to be pure and the quality is properly managed. In order to reduce the food safety accident, the center introduced HACCP system which analyzes harmful ingredients and controls it. The system was initially operated for seafood industry then broadened to all food industries.
※ HACCP is a system which analyzes risk factors from food processing companies to prevent possible occurrence of hazards and to monitor the control measures. The results are periodically recorded.
* CDB; Center for Drugs and Biologics
CDB regulates all microorganism products and related medications/kits to enrich public health. The regulation on products measures purity, safety, effectiveness and availability based on the law and the science.
* CDRH; Center for Devices and Radiological Health
CDRH regulates the use of radiation based on mechanical experimental due to the potential risk embedded in radiation. The center introduced various means of measurement and tools to assess products with potential radioactivity. Medical appliances will be classified as class I, class II, class III based on the performance and safeness of the product. All appliances are required to be approved by CDRH before they are released to public. The center established standard on products with potential radioactivity in order to prevent unnecessary radiation exposure. It also conducts safety education on consumers and manufacturers to deliver detailed information about radiation related products.
* CVM; Center for Veterinary Medicine
CVM conducts safety inspection on effectiveness and safeness of medicine/feed for animals, drugs for animal care, and foods from animals for possible chemical residue. |
