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Introduction
History
Responsibility of USFDA
Organization
Constitution
FDA Advisory committee
Scope and Fundings
Legal Authority of FDA
Mission
What USFDA regulates?
What USFDA does not regulates?
Recent Update
References
This name was shortened to the Food and Drug Administration (FDA) three years
later.
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with
the advice and consent of the Senate.
The Commissioner reports to the Secretary of Health and Human Services.
The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as
Commissioner since February 2009.
FDA consists of six product centers, one research center, and two offices
Center for Biologics Evaluation and Research - which regulates products such as
vaccines, blood, and gene therapy.
Center for Devices and Radiological Health - which regulates medical devices
ranging from thermometers to kidney dialysis machines, and electronic products that give
off radiation, such as microwave ovens.
USFDA has over 11516 employees, located in 167 U.S. cities. Among
its staff, FDA has chemists, microbiologist, and other scientists, as well
as investigators and inspectors who visit 16000 facilities a year as part
of their oversight of the business that FDA regulates.
The FDA has its headquarters at Silver Spring, Maryland and has 223
field offices and 13 laboratories located throughout the 50 states, the
United States Virgin Islands, and Puerto Rico.
Although the committees provide advice to the agency, FDA makes the
final decisions.
This includes $466 billion in food sales, $275 billion in drugs, $60
billion in cosmetics and $18 billion in vitamin supplements.
Much of the expenditures is for goods imported into the United States;
the FDA is responsible for monitoring a third of all imports.
Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic
Act,(first passed in 1938 and extensively amended since) and are codified in Title
21, Chapter 9 of the United States Code.
Other significant laws enforced by the FDA include the Public Health Service Act,
parts of the Controlled Substances Act, the Federal Anti-Tampering Act, as well as
many others. In many cases these responsibilities are shared with other federal
agencies.
Important enabling legislation of the FDA includes :
1902 Biologics Control Act
Food,
16 1951Sagar Kishor Drug,
Savale and Cosmetics Act Amendments 7/29/2017
1962 Food, Drug, and Cosmetics Act Amendments
Biologics
Food additives
Dietary supplements
Product standards and develop improved testing's methods
Cosmetics
Labeling
OTC and prescription drug labeling
Drug manufacturing standards
Foods
Safety of all food products ( except meat and poultry)
Medical devices from simple items like tongue depressors, to complex
technologies such as heart pacemakers
Health Insurance
Meat and Poultry - except for game meats, such as venison, ostrich, an
22 Sagar Kishor Savale
snake 7/29/2017
Pesticides
Water
water (FDA regulates the labeling and safety of bottled water, while the
Environmental Protection Agency develops national standards for
drinking water from municipal water supplies)
Overall, the authors called for an increase in the regulatory powers, funding,
and independence of the FDA.
The law authorizes the Food and Drug Administration (FDA) and the
Secretary of Health and Human Services (HHS) to increase
inspections of many domestic food facilities, enhance detection of
food borne illness outbreaks, and order recalls of tainted food
products.
The law requires most food companies to write and implement new
safety protocols to mitigate potential hazards.
It is the most significant update of American food safety laws since the Federal Food,
Drug, and Cosmetic Act in 1938.
www.fda.gov
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