Food and Drug Administration
U.S. Food and Drug Administration
The United States FDA (Food and Drug Administration) belongs to the health and human service department of United States. FDA regulates all health related activities in United States. They are responsible for setting the standards for food, medicine, vaccine and other health related products being involved in causing trouble to human. They all deal with sanity, adulteration, level of hygiene. In addition, they not only check sanitation of human but also that of animals.
FDA Division of Functionalities
The functionality is divided into numerous subdivisions. These subdivisions are responsible for focusing on a single subject. They must have their attention only for the subject they are specified with. This would give a complete organization of the entire FDA maintaining all sorts of issues around. The functional areas include the following,
1. OC (Office of the Commissioner)
2. CDER (Center for drug Evaluation and Research)
3. CBER (Center for Biologics Evaluation and Research)
4. CFSAN (Center for Food Safety and Applied Nutrition)
5. CDRH (Center for Devices and Radiological Health)
6. CVM (Center for Veterinary Medicine)
7. NCTR (National Center for Toxicological Research)
8. ORA (Office of Regulatory Affairs)
FDA Association
The Food and Drug Administration do not do the work alone. They have a lot of association with several other organizations. Some of the other organizations that have association with FDA are,
1. Department of Agriculture
2. Drug Enforcement Administration
3. Customs and Border Protection
4. Consumer Product Safety Commission
5. The local and state government agencies also work in association with the FDA.
These work together to have inspections in the food and medicines.
Standards Involved
FDA has fixed standards and regulations for each food and drug product to be used. This is mainly to avoid harm to all living beings in the world. A product used some of the activities include labeling the instructions to use and the chemical being contained in them as per the labeling. Testing for any harmful effects in laboratory that is not partial. The only issue with the FDA would be that they just set standards for the labeling in cosmetics but never tested them on laboratory to make a check that they exactly contain what is written in the label.
Food Products
FDA maintains all regulations about the food and dietary supplements .This functionality belongs to the Center for Food Safety and Applied Nutrition. They set standards for the food products. If any adulteration found it is immediately reported. Every food product is checked to meet the standard mentioned for it. It must in no way cause any harm to the living beings at world. This includes bottled or tinned food products too. They not only check for adulteration in the products that they also make a check of the nutrition being involved in it. The food must be nutritious especially when considering children food and elderly food. This applied to even tinned-food. This council checks for the quality and the mortality if every food product. The expiry dates are sealed as per the testing results.
Food products that involve meat and other animal or domestic flesh involve other councils. They do not follow the Center for Food Safety and Applied Nutrition. They tend to follow the United States Department of Agriculture and the Food Safety and Inspection Service. When the food product especially contains wholesome meat then these councils will take charge to set standards and regulations. If they contain meat only in meager quantity then the FDA may check them.
Beverages and other drinks, which include alcohol, belong to Bureau of Alcohol, Tobacco, Firearms, and Explosives in the Department of Justice. Other cold beverages including the bottled water or canned water would come under United States Environmental Protection Agency (EPA).when the product contains more than 7% alcohol then it would be totally organized by these councils mentioned above.
Drugs
FDA set standards for drugs too. When the drug is for animals then the association being involved would be the Center for Veterinary Medicine. There are many types of drugs. However, FDA classifies drugs into three main types,
1. new drugs
2. generic drugs
Cosmetics
As already, mentioned cosmetics are reviewed just with the labeling and no more than that. The branch meant for food products maintains them. Every cosmetic is subject to testing just by their own company. If there is warning that they may cause certain illusions then the companies must include a warning in the label being fixed.
Devices
When devices used to emit radiations are used, they also come under the monitor of FDA. The branch that considers this would be Center for Devices and Radiological Health (CDRH).Right from a simple pin to great electronic devices being used in surgeries are also reviewed and certified by FDA.
AIDS
FDA has taken several concern in AIDS as an epidemic .Though it showed a huge delay in approving its drugs, due to the trigger it received from several health care agencies it set up new rules, called IND. these were later used to approve the medicine being used primarily for AIDS today.
Legal authority
Most federal laws administered through the FDA are codified into the Food, Drug and Cosmetic Act, also called Title 21, Chapter 9 of the United States Code. Other significant laws enforced by the FDA include the Public Health Service Act, Controlled Substances Act, and Federal Anti-Tampering Act.
Important enabling legislation for the FDA includes:
• 1902 – Biologics Control Act
• 1906 – Pure Food and Drug Act
• 1938 – Federal Food, Drug, and Cosmetic Act
• 1944 – Public Health Service Act
• 1951 – Food, Drug, and Cosmetics Act Amendments
• 1962 – Food, Drug, and Cosmetics Act Amendments
• 1966 – Fair Packaging and Labeling Act
• 1976 – Medical Device Regulation Act
• 1987 – Prescription Drug Marketing Act
• 1988 – Anti–drug Abuse Act
• 1990 – Nutrition Labeling and Education Act
• 1992 – Prescription Drug User Fee Act
• 1994 –Dietary Supplement Health and Education Act
• 1997 – Food and Drug Modernization Act
• 2002 – Bioterrorism Act
• 2002 – Medical Device User Fee and Modernization Act
• 2003 – Animal Drug User Fee Act
