U.S. Food and Drug Administration
By: Cameron Bornholm, Angela Jenkins,
and Cherelle Waters
What is the FDA?
I.
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The job of the FDA
II.
Who makes up the FDA
III. FDA’s mission statement
II.
Brief History of the FDA
III.
Sectors of the FDA
IV.
Recent Recalls and Alerts
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The U.S. Food and Drug Administration (FDA) is an
agency of the US Department of Health and Human
Services that is responsible for the safety regulation of:
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most types of foods
drugs
vaccines
blood products
medical devices
dietary supplements
biological medical products
radiation-emitting devices
veterinary products
cosmetics
The FDA is the U.S. Government agency that
oversees most foods and medical products.
Its job is to make sure that:
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food is safe, healthy, and clean
medicines and medical devices are reasonably safe
and effective
cosmetic products are safe
animal foods and drugs are safe
food and medical products have proper labels
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The FDA is within the Department of Health and
Human Services and consists of nine divisions:
◦ Center for Biologics Evaluation and Research
◦ Center for Devices and Radiological Health
◦ Center for Drug Evaluation and Research
◦ Center for Food Safety and Applied Nutrition
◦ Center for Veterinary Medicine
◦ National Center for Toxicological Research
◦ Office of Chief Counsel
◦ Office of the Commissioner
◦ Office of Regulatory Affairs
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The FDA consists of employees drawn from a
wealth of science and public health professions
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biologists, physicians, chemists, biomedical
engineers,
toxicologists,
pharmacologists,
veterinarians, and specialists in the public
health education and communication
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FDA employs approximately 9,000 people who
work in locations around the United States
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To promote and protect the public health by
helping safe and effective products reach the
market in a timely manner
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To monitor products for continued safety
after they are in use by the public
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To help the public get the accurate, sciencebased information needed to improve health
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Food and Drugs Act of 1906 laid the foundation for the
modern food and drug law
Safety of food additives was previously tested by the
“Poison Squad”
In 1937, it was discovered that the drug Sulfanilamide
contained a poison which killed 107 people
The previous law did not require testing for drug safety
before putting them on the market.
The next year Congress passed the Federal Food,
Drug, and Cosmetic Law.
FDA combines law and science to protect consumers
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Food
Drugs
Biologics, Blood, and Vaccines
Animal & Veterinary
Cosmetics
Medical Devices
Radiation-Emitting Products
Combination Products
FDA monitors the nation’s food supply by
making sure that all ingredients used in foods
are safe, and that food is free of contaminants
like disease-causing organisms, chemicals, or
other harmful substances
*Meat & poultry products are regulated by USDA*
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The agency must approve new food additives
before they can be used in foods
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FDA monitors the safety of dietary supplements
and the content of infant formulas
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Prescription drugs
◦ Undergo New Drug Application Process
◦ Orange Book lists all FDA approved prescription
drugs, updated monthly
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Over-the-counter drugs
◦ Benefits outweigh the risks
◦ OTC drug monographs cover acceptable
ingredients, doses, formulations, testing, and
labeling
◦ Products conforming to OTC monograph may go on
market without pre-approval from FDA
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OTC drugs range from acne drug products to
weight control drug products
Potential for improper use must be low,
consumer can use them for self- diagnosed
problems, health practitioners are not needed
for safe and effective use
OTC drug monographs contain information
on acceptable ingredients, doses,
formulations, labeling, and testing
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FDA is responsible for ensuring safety of our nation’s bloody supply
and regulation of vaccine products
Blood Action Plan initiated in 1997 to increase the effectiveness of its
scientific and regulatory actions
◦ Addresses areas such as emergency operations, response to emerging
diseases, and updating of regulations.
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Clinical development of vaccines follow the same general pathway
as drugs
Vaccine approval requires adequate product labeling for health care
providers to understand proper use
According to the CDC vaccines has reduced preventable infectious
diseases tremendously
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FDA regulates drugs and devices used for
animals (both pets and animals that produce food)
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Before manufacturers can market animal drugs
(including drugs used in animal feeds), they must
gain FDA approval by providing proof of their
safety and effectiveness
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Veterinary medical devices do not have to be preapproved by FDA before marketing, but they still
must be safe, effective, and properly labeled
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Livestock drugs are evaluated for their safety to
the environment and to the people who eat the
animal products.
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“Mad Cow Disease”
Progressively neurological disease known as
transmissible spongiform encephalopathy's
FDA published two rules in 1997 and 2008 to
protect animals and consumers against BSE
by prohibiting the use of most mammalian
protein in the manufacture of animals feeds
given to ruminant animals and by removing
high-risk materials from all animal feeds
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In 2001 the FDA requested that livestock
producers keep food produced from animal
clones and their offspring out of food supply
FDA had conducted thorough evaluation on
safety of food from these animals and animal
health risks
◦ In January 2008 the FDA confirmed that meat and
milk from cow, goat, and pig clones are safe
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"articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or
otherwise applied to the human body...for
cleansing, beautifying, promoting
attractiveness, or altering the appearance"
[FD&C Act, sec. 201(i)].
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The two laws pertaining to Cosmetics are:
◦ Federal Food, Drug, & Cosmetic Act
◦ Fair Packaging and Labeling Act
FDA's legal authority over cosmetics is different from other
products regulated by the agency, such as drugs, biologics,
and medical devices.
◦ Cosmetic products and ingredients are not subject to FDA
premarket approval authority, with the exception of color
additives. * Puts the obligation on the corporation
◦ FDA may pursue enforcement action against violative
products, or against firms or individuals who violate the
law.
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Cosmetics from other countries are subject to
review by the FDA at the time of entry at US
Customs
Cosmetic companies are not required to file
any information with the FDA, but are
encouraged to file a Cosmetic Product
Ingredient Statement with the Voluntary
Cosmetic Registration Program
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Some companies claim "CRUELTY-FREE" or "NOT
TESTED ON ANIMALS" in their labeling or advertising.
There is no legal definition for these terms.
Claims applied solely to their finished cosmetic
products
Many raw materials, used in cosmetics, were tested
on animals years ago when they were first
introduced. A cosmetic manufacturer might only use
those raw materials and base their "cruelty-free"
claims on the fact that the materials or products are
not "currently" tested on animals.
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A medical device is an object which is useful for
diagnostic or therapeutic purposes.
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Devices at FDA
◦ Provides a search program to obtain info on any device
approved by the FDA
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Examples of some medical devices are:
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Breast Implants
Contact Lenses
Lasers for Lasik Eye Surgery
Laboratory Tests
Home Testing
 Glucose
 Pregnancy
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Medical Imaging
◦ Medical X-Rays
 CT (Computed Tomography)
 Fluoroscopy
 Mammography
◦ Ultrasound Imaging
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The FDA Center for Devices and Radiological Health (CDRH)
collaborates with the Conference of Radiation Control
Program Directors (CRCPD) in a unique federal-state
partnership to characterize the radiation doses patients receive
and to document the state of the practice of diagnostic
radiology.
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Each year NEXT survey program selects a particular radiological
examination for study and captures radiation exposure data
from a nationally representative sample of U.S. clinical
facilities. CDRH staff compiles, analyzes, and publishes survey
results on population exposure, radiographic and fluoroscopic
technique factors, diagnostic image quality, and film processing
quality.
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Future: NEXT will evaluate digital imaging technology and
whether or not facilities using digital x-ray systems have lower or
higher patient exposure levels compared to those employing
standard film systems.
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The FDA protects the public from unnecessary
exposure to radiation from electronic products
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Products include: microwave ovens, cell phones,
lasers, MRI machines, x-ray equipment, medical
ultrasound machines, and many other consumer,
industrial, and medical products
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Cabinet X-Ray Products
Cell Phones
CT (Computed Tomography)
Fluoroscopy
Lasers - Non-medical (Includes Lasers for Industrial, Scientific and
Consumer use. Also, Laser Light Shows and Laser Pointers)
Mammography
Medical Lasers
Medical Ultraviolet Lamps and Products
Medical X-Rays
Mercury Vapor Lamps
Microwave Ovens
Radiofrequency and Microwave Products Other than Microwave Ovens
Sunlamps and Sunlamp Products (Tanning Beds/Booths)
Televisions and Video Display Monitors
Ultrasound Imaging
Ultrasound Products Other than Diagnostic or Therapy
Ultrasound Therapy
X-Ray & Particulate Products other than Medical Diagnostic or Cabinet
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Cell Phones
◦ FCC ensures that all wireless phones sold in the US follow
safety guidelines that limit radiofrequency (RF) energy. FDA
monitors the health effects of wireless telephones. Each
agency has the authority to take action if a wireless phone
produces hazardous levels of RF energy.
◦ FDA derives its authority to regulate wireless telephones
from the Radiation Control provisions of the Federal Food,
Drug, and Cosmetic Act (originally enacted as the
Radiation Control for Health and Safety Act of 1968).
◦ FCC derives its authority to regulate wireless telephones
from the National Environmental Policy Act of 1969
(NEPA) and the Telecommunications Act of 1996
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Definition of a combination product includes:
◦ A product comprised of two or more regulated
components that are combined to produce one entity
◦ Two or more separate products packaged together as a
unit and comprised of drug and device products, device
and biological products, or biological and drug products
◦ A drug, device, or biological product that is packaged
separately, but is intended to be used with an approved
individually specified regulated product
Examples:
 Transdermal patch for attention deficit hyperactive
disorder (ADHD) (April 10, 2006)
 Transdermal Patch for Depression (February 28, 2006)
 Inhaled Insulin Combination Product for Diabetes
(January 27, 2006)
 Dental Bone Grafting Material with Growth Factor
 Surgical Mesh with Antibiotic Coating
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FDA works with manufacturers when problems arise
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If that fails, FDA asks manufacturer to recall the
product while federal marshals seize the products
(if the recall is not voluntary)
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FDA can ask the courts to prosecute those in
violation of the law
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Frozen cooked mussel products made by Bantry
Bay Seafoods, imported from Ireland, may be
contaminated with azaspiracid toxins
12oz boxes of Vanilla Wafers with a code date of
030409A, may contain undeclared soy
Whole Foods Market: 365 Organic Everyday
Value Popcorn, Lightly Salted, may contain
undeclared milk ingredients
Pharmacy alert in Baltimore, consumers may have
received expired or suspected counterfeit drugs
FDA Website www.fda.gov
Wikipedia Website www.wikipedia.com