It contain all the content related to food and drug

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2. Content
Introduction
History
Responsibilityof USFDA
Organization
Constitution
FDAAdvisorycommittee
Scopeand Fundings
LegalAuthorityof FDA
Mission
What USFDAregulates?
What USFDAdoesnotregulates?
Recent Update
References
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3. FDALogo
Formed
Preceding agencies
Agency overview
1906
Food,Drug, andInsecticideAdministration (July1927 to July 1930)
Jurisdiction
Head quarters
Employees
Annual budget
Agency executive
Parent agency
Website
BureauofChemistry (July1901 through July1927)
DivisionofChemistry, USDA(Established1862)
Federal government ofthe United States
10903NewHampshireAve,SilverSpring,MD20903
11,516
$2.3 billion
MargaretA. Hamburg, Commissioner ofFoodandDrugs
Department ofHealth andHuman Services
fda.gov
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4. INTRODUCTION
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The Food and Drug Administration (FDAor USFDA)is an agency of
the United States Department of Health and Human Services, one of
the United Statesfederal executive departments.
TheFDAisresponsiblefor protecting andpromoting publichealth
throughthe regulation andsupervisionoffood safety,tobacco
products, dietary supplements, prescription andover-the-counter
pharmaceuticaldrugs (medications), vaccines,biopharmaceuticals,
bloodtransfusions, medicaldevices,electromagnetic radiation
emitting devices(ERED),veterinary products, and cosmetics.
The FDAalso enforces other laws, notably Section 361 of the Public
Health Service Act and associated regulations, many of which are not
directlyrelated to foodor drugs.
Theseincludesanitationrequirements on interstate travelandcontrol
ofdiseaseon products rangingfrom certain householdpets to sperm
donation for assisted reproduction.
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5. HISTORY OF FDA
In June 1906, President Theodore Roosevelt signed into law the Food
and Drug Act, also known as the "Wiley Act" after its chief advocate.
The act applied penalties to the interstate marketing of "adulterated"
drugs, in which the "standard of strength, quality, or purity" of the active
ingredient was not either stated clearly on the label or listed in the
United States Pharmacopoeia or the National Formulary.
The act also banned "misbranding" of food and drugs. The responsibility
for examining food and drugs for such "adulteration" or "misbranding"
was given to Wiley's USDA Bureau of Chemistry.
Wiley used these new regulatory powers to pursue an aggressive
campaign against the manufacturers of foods with chemical additives,
but the Chemistry Bureau's authority was soon checked by judicial
decisions, as well as by the creation of the Board of Food and Drug
Inspection and the Referee Board of Consulting Scientific Experts as
separate organizations within the USDA in 1907 and 1908 respectively.
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6. A 1911 Supreme Court decision ruled that the 1906 act did not apply to false
claims of therapeutic efficacy in response to which a 1912 amendment added
"false and fraudulent" claims of "curative or therapeutic effect" to the Act's
definition of "misbranded.“
However, these powers continued to be narrowly defined by the courts, which
set high standards for proof of fraudulent intent.
In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a
new USDA body, the Food, Drug, and Insecticide organization.
This name was shortened to the Food and Drug Administration (FDA) three
years later.
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7. RESPONSIBILITYOF FDA
Protecting the public health by assuring that foods are safe, wholesome,
sanitary and properly labeled; human and veterinary drugs, and vaccines
and other biological products and medical devices intended for human use
are safe and effective.
Protecting the public from electronic product radiation.
Assuring cosmetics and dietary supplements are safe and properly labeled
Regulating tobacco products.
Helping the public get the accurate science-based information they need
to use medicines, devices, and foods to improve their health.
FDA’s responsibilities extend to the 50 United States, the District of
Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and
other U.S. territories and possessions.
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8. Margaret A.Hamburg, M.D.
Commissioner Of Food and Drugs
TheFDAisled bythe Commissioner ofFoodandDrugs, appointedbythe President with
the adviceandconsent ofthe Senate.
TheCommissioner reports to the SecretaryofHealth andHuman Services.
The21st andcurrent CommissionerisDr. MargaretA.Hamburg.Shehasservedas
CommissionersinceFebruary 2009.
FDA consists of six product centers, one research center, and two offices –
Center for Biologics Evaluation and Research - whichregulates products suchas
vaccines,blood, andgene therapy.
Center for Devices and Radiological Health - whichregulates medicaldevices
rangingfromthermometers to kidneydialysismachines, andelectronic products that give
offradiation, suchasmicrowave ovens.
ORGANIZATIONOFFDA
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9. Center for Drug Evaluation and Research - whichregulates over-the-counter
andprescription medications.
Center for Food Safety and Applied Nutrition- whichregulates most foods
(except meat andpoultry, whichare regulatedbythe U.S. Department of
Agriculture), foodadditives, infantformulas, dietary supplements, and cosmetics.
Center for Tobacco Products - whichregulates cigarettes,cigarette tobacco,
roll-your-owntobacco, andsmokeless tobacco.
Center for Veterinary Medicine _whichregulates feedanddrugs anddevices
usedinpets, farmanimals,andother animals.
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10. National Center for Toxicological Research- which supports FDA
’s
product centers by providing innovative scientific technology, training, and
technical expertise.
Office Of Regulatory Affairs- which conducts inspections and enforces
FDAregulations.
Office of the Commissioner-which provides leadership and direction to
FDA
’sproduct centers, research center, andOffice ofRegulatoryAffairs.
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11. CONSTITUTION
• 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 FDAregulates.
• 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.
• In 2008, the FDA started opening offices in foreign countries, including
China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
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• As of Oct. 1, 2009, FDA employs the following numbers of people
in its centers/offices:
Center for Biologics Evaluation and Research (CBER) 946
Center for Drug Evaluation and Research (CDER) 2,889
Center for Devices and Radiological Health (CDRH) 1,203
Center for Food Safety and Applied Nutrition (CFSAN) 877
Center for Tobacco Products (CTP)
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13. FDAADVISORYCOMMITTEE
Advisory committees provide FDA with independent advice from outside
experts on issues related to human and veterinary drugs, vaccines and
other biological products, medical devices, and food.
In general, advisory committees include a chair, several members, plus a
consumer, industry, and sometimes a patient representative.
Additional experts with special knowledge may be added for individual
committee meetings as needed.
Although the committees provide advice to the agency, FDA makes the
final decisions.
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14. How DOES AN INDIVIDUAL BECOME A
MEMBER OF AN FDA ADVISORY COMMITTEE?
Professional societies; industry, consumer, and patient advocacy groups;
or other interested people may nominate scientific members and
consumer, industry, and patient representatives. In addition, individuals
who want to serve on a committee may nominate themselves.
FDA requests that candidates provide detailed information regarding
financial holdings, employment, research grants and contracts, and other
potential conflicts of interest that may rule out membership.
The Food and Drug Administration, to assist in its mission to protect and
promote the public health, uses 49 committees and panels to obtain
independent expert advice on scientific, technical, and policy matters.
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15. SCOPE AND FUNDING
The FDA regulates more than $1 trillion worth of consumer goods,
about 25% of consumer expenditures in the United States.
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.
Sagar Kishor
Savale
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16. LEGAL AUTHORITY Of FDA
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 ControlAct
1906 – Pure Food and DrugAct
1938 – Federal Food, Drug, and CosmeticAct
1944 – Public Health ServiceAct
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17. 1962 – Food, Drug, and Cosmetics ActAmendments
1966 – Fair Packaging and LabelingAct
1976 – Medical Device RegulationAct
1987 – Prescription Drug MarketingAct
1988 – Anti–drug AbuseAct
1990 – Nutrition Labeling and EducationAct
1992 – Prescription Drug User FeeAct
SagarKishor Savale
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18. 1994 – Dietary Supplement Health and EducationAct
1997 – Food and Drug Administration ModernizationAct
2002 – BioterrorismAct
2002 – Medical Device User Fee and Modernization Act (MDUFMA)
2003 – Animal Drug User FeeAct
2007 – Food and Drug Administration Amendments Act of2007
2009 – Family Smoking Prevention and Tobacco ControlAct
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19. MISSION OF FDA
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To promote the public health by promptly and efficiently reviewing
clinical research and taking appropriate action on the marketing of
regulated products in a timely manner.
With respect to such products, protect the public health by ensuring
that the food are safe, Wholesome, sanitary, and properly labelled;
human and veterinary drugs are safe and effective; there is reasonable
assurance of the safety and effectiveness of devices intended for human
use; cosmetics are safe and properly labelled, and public health and
safety are protected from the electronic product radiation.
Participates through appropriate process with representatives of other
countries to reduce the burden of regulation, harmonize regulatory
requirements, and achieve appropriate arrangements.
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20. WHAT USFDA REGULATES?
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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
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21. Drugs (OTC and prescription drug )
Radiation-Emitting Electronic Products
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Radiation safety performance standards for microwave ovens,
television receivers, diagnostic x-rays equipment, cabinet x-ray
system ( such as baggage x-rays at airports ), Laser products,
ultrasonic therapy equipment, mercury vapour lamps
Veterinary drugs and devices
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22. WHAT USFDA DOES NOT REGULATE?
• Advertising - except for prescription drugs, medical devices, and
tobacco products
• Alcohol beverages
• Consumer Products - paint, child-resistant packages, baby toys, and
household appliances (except for those that give off
radiation)
• Drugs ofAbuse - heroin and marijuana
• Health Insurance
• Meat and Poultry - except for game meats, such as venison, ostrich, an
snake
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23. • Pesticides
• Restaurants and Grocery Stores
• Water
FDAsharesthe responsibility for regulating theseproducts with
other government agencies:
• pesticides (FDA, the U.S. Department of Agriculture, and the
Environmental Protection Agency )
• 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)
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24. RECENTUPDATE……
The FDA currently has regulatory oversight over a large array of products that
affect the health and life of American citizens. As a result, the FDA's powers
and decisions are carefully monitored by several governmental and non-
governmental organizations.
In 2006 Institute of Medicine report on pharmaceutical regulation in the U.S.
found major deficiencies in the current FDA system for ensuring the safety of
drugs on the American market.
Overall, the authors called for an increase in the regulatory powers, funding,
and independence of the FDA.
Nine FDA scientists appealed to then president-elect Barack Obama over
pressures from management, experienced during the George W. Bush
presidency, to manipulate data, including in relation to the review process for
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25. FDA Food Safety Modernization Act
The FDA Food Safety Modernization Act is a federal statutesigned
into law by President Barack Obama on January 4, 2011.
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.
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26. PresidentBarackObamasignsthe FDAFoodSafety
Modernization Actinto law
Also, imported food products face increased scrutiny under the law, including denial of
entry into the United States under certain circumstances.
It is the most significant update of American food safety laws since the Federal Food,
Drug, and Cosmetic Act in 1938.
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27. REFERENCES
Dr. B.S. Kuchekar, Mr.A.M. Khadatare, FORENSIC PHARMACY
7t
hEdition August 2007 Published By- NIRALI PRAKASHAN ,PP-17.8
to 17.11, 17.25 to 17.28
Sachin C. Itkar, PHARMACEUTICAL MANAGEMENT 3rdEdition
May 2007 Published By- NIRALI PRAKASHAN ,PP-18.1 to 18.4 ,
18.21 to 18.24
www.fda.gov
www.wikepedia.com
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28. SagarKishor Savale
28 04/28/16