United States Food & Drug Administration Agency

A study report by P. Sri Lalita Chaithanya

Index
1. What is FDA
2. What does FDA Regulates
3. Organization of USFDA
4. Organizations under FDA
5. Regulations for Drugs & Pharmaceuticals
6. What FDA does not regulate
7. What are FDA Functions
8. FDA Legal Acts
9. FDA Evaluation Process
10. Med Watch
11. Drug Recall & Market Withdrawal
12. What is Docket
13. FDA Globalization
14. FDA in India

WHAT IS FDA? The Food and Drug Administration (FDA or USFDA) is an agency of the United
States Department of Health and Human Services (HHS)

• Responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines,
biological medical products, blood products, medical devices, radiation-emitting devices, veterinary
products, and cosmetics.
• The FDA has its headquarters located at White Oak, Maryland
• Margaret A. Hamburg, M.D., is the present Commissioner of Food and Drugs Administration
• The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States
Virgin Island, and Puerto Rico
• In 2008, the FDA started opening offices in foreign countries, including China, India, Costa Rica, Chile,
Belgium, and United Kingdom
• Advisory Committees provide FDA with independent advice from external experts on issues related to
Human & Veterinary Drugs, Vaccines and other biological products, medical devices and food

WHAT DOES FDA REGULATE?

• FOOD
• DRUGS
• MEDICAL DEVICES
• VACCINES, BLOOD and BIOLOGICS
• ANIMAL and VETERINARY
• COSMETICS
• RADIATION EMITTING PRODUCTS
• TOBACCO PRODUCTS

Organization of USFDA The Food and Drug Administration (FDA) to regulate above mentioned areas
has following organisational bifurcation for effective implementation
Six Product Centers-(CBER, CDRH, CDER, CFSAN, Centre for Tobacco Products, Centre for Veterinary Medicines)
One Research Center - (NCTR)
Two Offices-(ORA, OCI)
Organisation under FDA
• Centre for Biologics Evaluation and Research (CBER), which regulates products such as vaccines,
blood and gene therapy
• Centre for Radiological Devices and Health (CDRH), which regulates medical devices ranging from
thermometers to kidney dialysis machines, and electronic products that give off radiation, such as
microwave ovens
• Centre for Drug Evaluation and Research (CDER), which regulates over-the-counter and
prescription medications
• Centre for Food Safety and Applied Nutrition (CFSAN), which regulates most foods (except meat
and poultry, which are regulated by the U.S. Department of Agriculture), food additives, infant
formulas, dietary supplements, and cosmetics
• Centre for Tobacco Products, which regulates cigarettes, cigarette tobacco, roll-your-own tobacco
and smokeless tobacco
• Centre for Veterinary Medicines, which regulates feed and drugs and devices used in pets, farm
animals, and other animals
• National Centre for Toxicological Research (NCTR), which supports FDA’s product centres by
providing innovative scientific technology, training, and technical expertise
• Office of Regulatory Affairs (ORA), which conducts inspections and enforces FDA regulations
• Office of Criminal Investigation (OCI), which provides leadership and direction to FDA’s product
centres, research centre, and Office of Regulatory Affairs

REGULATIONS for Drugs & Pharmaceuticals

The FDA regulates almost every face of prescription drugs, including
• Testing
• Manufacturing
• Labeling
• Advertising
• Marketing
• Efficacy
• Safety

WHAT FDA DOES NOT REGULATE?

The FDA doesn’t regulate following:
• Advertising (except for prescription drugs, medical devices and tobacco products).
• Alcoholic beverages
• Some consumer products, such as paint, child-resistant packages, baby toys, and household appliances
(except for those that give off radiation).
• Illegal drugs of abuse, such as heroin and marijuana
• Health insurance
• Meat and poultry (except for game meats, such as venison, ostrich, and snake)
• Restaurants and grocery stores

WHAT ARE FDA FUNCTIONS?

FDA is responsible for following:
-Protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labelled
-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 labelled
-Regulating tobacco products
-Advancing the public health by helping to speed product innovations
-Helping the public get the accurate science-based information they need to use medicines, devices, and foods to
improve their health
FDA Legal Acts
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 (MDUFMA)
2003 – Animal Drug User Fee Act
2007 – Food and Drug Administration Amendments Act of 2007
FDA Evaluation Process for Regulated Products

Regulations on Cosmetics

FDA’s Office of Cosmetics and Colours evaluates the safety of cosmetics

-Under the Federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not require FDA approval
before they go on the market
-The exception is colour additives (other than those used in most hair dyes)
-Companies and individuals who market cosmetics have the legal responsibility to ensure the safety of their
products.
Safety Data for Cosmetics
FDA can only act after a cosmetic is on the market and then must first establish that the product is harmful to
consumers when used as intended

FDA for Consumers - Med Watch

What is MED WATCH?
-Med Watch is the FDA Safety Information and Adverse Event Reporting Program
-FDA gateway for clinically important safety information and reporting serious problems with human medical
products
-Med Watch alerts provide timely new safety information on human drugs, medical devices, vaccines and other
biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both
treatment and diagnostic choices for healthcare professional and patient.
What can MEDWATCH provide for general public?
-MEDWATCH provides following resources for Consumers
-Report a Serious Medical Product Problem Online
-Reporting Unlawful Sales of Medical Products on the Internet
-Current Drug Shortages
-Index to Drug-Specific Information
-Identifying Recalled Products
-An FDA Guide to Drug Safety Terms

Drug Recall & Market Withdrawal Why Drug Recall & Market Withdrawal?
-When a product is removed from the market or a correction is made to the product because it is either defective or
potentially harmful.
-Sometimes a company discovers a problem and recalls a product on its own.
-Other times a company recalls a product after FDA raises concerns over any issue related to the drug.
Examples include:
On 11/09/2011 Kotex tampoons- Enterobacter sakazakii -Kimberly-Clark
On 11/18/2011 Maumee Valley Vending Co. -Buffalo Chicken Wedge Sandwiches -Maumee Valley Vending Company
On 11/16/2011 Smucker's -Natural Peanut Butter Chunky -Salmonella J.M. Smucker CompanyOn 11/16/2011 Avaira
-Contact Lenses -Presence of silicone oil residue- Cooper Vision
What is a Docket?
-FDA maintains a docket - a public record of proposed regulations or other actions - related to the agency’s
regulation of products.
-FDA encourages public participation in the federal rulemaking process by allowing consumers to view and comment
on proposed actions.
-FDA considers these comments when it draws up a final rule or regulation.

FDA Globalisation

Globalization is a fact of 21st century economic life. It has resulted in United States markets being composed of a
myriad of imported goods that consumers want and need
Factors of setting up Global Presence:
-volume of imported products from specific areas
-problems that have been associated with products over the years
-value to be derived from leveraging the activities and resources of trusted foreign counterpart regulatory
authorities
U.S. FDA Presence across Globe:
U.S. FDA has identified following countries from which most of Food & Drugs are imported.
Keeping in view of above factors U.S. FDA established permanent in-country presence in following
Countries/Continents:
China
India
Europe
Latin America
Middle East
North Africa

U.S. FDA in INDIA

U.S. FDA’s activities in India are to ensure that food and medical products exported from India to the U.S. are safe,
are good quality, and are effective
To this end, FDA activities in India include:
-Engaging with Indian counterpart regulatory authorities to ensure the timely exchange of information regarding
clinical trials that are conducted that support marketing applications in the U.S.
-partnering with Indian counterpart agencies
-working with regulated product industries in India that wish to export their products to the U.S. to assure their
understanding of US FDA standards and expectations regarding FDA-regulated products
-coordinating and collaborating daily on product quality and safety issues with other U.S. government agencies
-increased FDA inspections of relevant high-risk facilities
-working with private and public-sector entities that wish to engage with FDA on third-party certification efforts
regarding these products