U.S. Food and Drug Administration

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U.S. Food and Drug Administration

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FOOD SAFETY In order to ensure the safety of food, the FDA has a whole section and it s guidelines which contains information pertaining to: Food Transportation, ... – PowerPoint PPT presentation

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Title: U.S. Food and Drug Administration


1
U.S. Food and Drug Administration
2
Speakers
  • Introduction Food and federal Act by Taraneh
    Bahramian
  • Food by Neh Atefor
  • Drugs By Fate Abbasi
  • Cosmetics Medical devices by Hayley Anderson

3
History of Food and Drug Administration (FDA)
  • Food and Drug Act (1906)
  • Oldest comprehensive consumer protection agency
    in the U. S. federal government
  • Was triggered by serious abuses in the consumer
    product marketplace
  • Created for prevention of misbranded and
    adulterated foods, drinks and drugs

Federal Food and Drug Act
4
Food Safety is an important Public Health Issue
  • Each year in the U.S. there are
  • 76 million foodborne illnesses
  • 325,000 hospitalization
  • 5,000 deaths

5
Overview of FDA
  • An agency of the United States Department of
    Health and Human Services
  • One of the United States federal executive
    departments
  • Responsible for protecting and promoting public
    health
  • Regulation and supervision of food safety

6
FDAs Mission
  • Protect public health by assuring the safety and
    efficiency of
  • Human drugs
  • Biological products
  • Medical devices and products that emit radiation
  • Animal feed and veterinary drugs
  • Food and cosmetics
  • Advance public health by facilitating innovations
    that make medicines and foods more effective,
    safer and more affordable
  • Provide the public with accurate, science-based
    information on medicines and foods

7
FOOD
8
FOOD
  • In order to regulate the safety of food
    production, preservation and distribution, the
    FDA has broken this aspect down into eleven broad
    groups.
  • Seven of these will be highlighted in the
    subsequent slides.

9
FOOD SAFETY
  • In order to ensure the safety of food, the FDA
    has a whole section and its guidelines which
    contains information pertaining to
  • Food Transportation, Outbreaks (CORE Network),
    Food Safety Modernization Act, Food Safety
    Programs, Product-Specific Information, Food
    Allergens, Foodborne illness, Food Contaminants
    Adulteration, Hazard Analysis Critical Control
    Point (HACCP), Retail Food Protection, and Food
    Safety Widgets Apps.

10
BIOTECHNOLOGY
  • FDA recommends that developers consult with FDA
    about bioengineered foods under development.
  • The FDA provides a guidance for submission that
    these companies have to follow.
  • Since most bioengineered plants are considered
    regulated articles, companies are required to
    meet the regulations of Bioengineered Plants put
    forth by the Animal and Plant Health Inspection
    Service of the U.S. Department of Agriculture
    (APHIS/USDA)
  • Last but not the least, for Bioengineered plants,
    developers have to meet the Environmental
    Protection Agency (EPA) regulation of pesticidal
    substances.

11
FOOD INGREDIENTS PACKAGING
  • The main goal here is to ensure proper education
    of the consumer on the product.
  • Companies are regulated by the FDA to follow the
    guidelines in place to ensure the consumer is
    adequately educated on the products.
  • Products are labeled to indicate the ingredients
    used, ensure when and where the packaging is
    done, safety procedures, and the expiration date
    of the products.

12
DIETARY SUPPLEMENTS
  • FDA monitors the dietary supplement or dietary
    ingredient manufacturer to make sure they are
    responsible for ensuring that a dietary
    supplement or ingredient is safe before it is
    marketed.
  • This is in accordance with the Dietary Supplement
    Health Education Act of 1994 (DSHEA).

13
LABELING NUTRITION
  • The FDA has requirements for labeling and
    nutrition of products under the Federal Food Drug
    Cosmetic Act and its amendments.
  • Food labeling is required for most prepared foods
    such as cereals, bread, canned and frozen foods,
    while labeling is not a requirement for raw
    produce such as fish, fruits, and vegetables.

14
FOOD DEFENCE EMERGENCY RESPONSE
  • In order to reduce the risk of tampering with
    food and cosmetic supply, the FDA works with
    other organizations to guide against malicious,
    criminal or terrorist actions on the food and
    cosmetic supply.
  • This is done using tools and strategies such as
    ALERT, FREE-B, See Something Say Something
    Campaign, Mitigation Strategies Database,
    Vulnerability Assessment etc.

15
GUIDANCE, COMPLIANCE REGULATORY INFORMATION
  • FDA has made provision for
  • Food Guidance Documents which represent FDAs
    current thinking on a topic as far as food
    safety, production, handling, and distribution is
    concerned.
  • Current Good Manufacturing Practices (CGMPs)
  • Resources on Compliance, Enforcement, Inspection
    and Analysis which helps regulate the rules.

16
DRUGS
17
Development Approval Process
  • Access to the safest and most advanced
    pharmaceutical system in the world
  • Main consumer watchdog in this system is FDA's
    Center for Drug Evaluation and Research (CDER)
  • Ensures that drugs work correctly and that their
    health benefits outweigh their known risks

18
CDER Processing
  • 1. Drug company sends tests to CDER for safety
    and effectiveness of drug
  • 2. CDER team reviews the data and proposed
    labeling
  • 3. If health benefits outweigh the drug's known
    risks, the drug is approved
  • Conducts limited research on drug quality,
    safety, and effectiveness standards.

19
Stages of Drug Development and Review
  • 1) Animal Tests
  • Must show FDA results of preclinical testing on
    animals
  • Future plans for human testing
  • FDA whether approves at this stage to continue
  • 2) IND (Investigational New Drug) Application
  • Clinical trials on humans after an IND is
    reviewed by FDA and a local IRB (Institutional
    review board)
  • IRB approves protocol, objective, participants,
    schedule, medications, dosage, duration of study,
    etc.
  • Assures safety of participants
  • Mandates researchers for protection of patients

20
Stages of Drug Development and Review
  • 3) Phase 1 Testing (P1T)
  • Objective is safety
  • Determine the drug's most frequent side effects
  • Determine drug's metabolization and excretion
    process
  • Conducted on healthy volunteers
  • 4) Phase 2 Testing (P2T)
  • Objective is effectiveness
  • Initiate only if P1T don't reveal unacceptable
    toxicity
  • Obtain preliminary data on effectiveness of drug
    on people with the condition
  • Controlled trials, safety evaluation and
    short-term side effects are analyzed

21
Stages of Drug Development and Review
  • 5) Phase 3 Testing (P3T)
  • One of two most common meeting points prior to
    submission of a new drug application
  • Initiate only if effectiveness is proven in P2T
  • Gather more data on safety, effectiveness,
    various population studies and dosages, etc.
  • 6) Review Meeting
  • Postmarket requirement and commitment studies are
    required by sponsor after FDA has approved the
    product for marketing
  • FDA gathers more info about product's safety,
    efficiency and optimal use through this

22
Stages of Drug Development and Review
  • 7) NDA (New Drug Application)
  • Formal step for drug company to propose for FDA's
    approval of the product's marketing in the US
  • NDA includes
  • All animal data and analysis
  • All human data and analysis
  • Drug's behavior and effects in the body
  • Manufacturing procedure of the product
  • 8) Application Reviewed
  • After NDA submission, FDA has 60 days to decide
    whether to review the file.
  • FDA can refuse it if it's incomplete

23
Cosmetics
24
What is a Cosmetic?
  • Articles intended for
  • Cleansing (except some soap)
  • Beautifying
  • Promoting Attractiveness
  • Altering Appearance

25
What are Some Examples of Cosmetics?
  • Makeup
  • Fragrances
  • Skin Care
  • Shaving
  • Suntan Preparations
  • Oral Hygiene
  • Manicuring Preparations
  • Hair Products

26
What Is FDA Authority Over Cosmetics?
  • FDA regulates cosmetic labeling under the
    authority of the Federal Food, Drug, and Cosmetic
    Act (FDC Act) and the Fair Packaging and
    Labeling Act (FPLA). 
  • Cosmetic products and ingredients are NOT subject
    to FDA premarket approval authority, with the
    exception of color additives.
  • Companies and individuals who market cosmetics
    have the legal responsibility to ensure the
    safety of their products prior to marketing.

27
How Does FDA Monitor the Safety of Cosmetics?
  • Voluntary Cosmetic Registration Program
  • Inspections
  • Surveys of products
  • Cosmetic Ingredient Review (CIR) expert panel
  • Consumer complaints (Adverse events reports)
  • FDAs own research
  • Research by other organizations

28
Labeling
  • Important Labeling Terms
  • Labeling refers to all labels and other
    written, printed, or graphic matter on or
    accompanying a product.
  • Principal Display Panel (PDP) part of the label
    most likely displayed or examined under customary
    conditions of display for sale.
  • Information Panel refers to a panel other than
    the PDP that can accommodate label information
    where the consumer is likely to see it.

29
Labeling
  • Required labeling information
  • Principle Display Panel
  • Identity statement indicates nature and use of
    product.
  • Net quantity of contents weight, measure, and
    numerical count or a combination thereof.
  • Information Panel
  • Name place of business
  • Distributor statement Manufactured for or
    Distributed by
  • Material facts directions for safe use.
  • Warning and caution statements
  • Ingredients

30
Ways a Cosmetic Can Become Misbranded
  • Its labeling is false or misleading
  • Its label fails to provide required information
  • Its required label information is not properly
    displayed
  • Its labeling violates requirements of the Poison
    Prevention Packaging Act of 1970

31
What Can FDA Do if a Cosmetic Is Not Safe?
  • FDA is not authorized to require recalls of
    cosmetics.
  • FDA may take regulatory action if it has
    information to support that a cosmetic is
    adulterated or misbranded.
  • FDA can issue a public warning in the form of a
    Consumer Alert
  • Work with State authorities to embargo product
  • Product seizure by U.S. Marshals
  • Refuse importation into the U.S.
  • Request that the firm recall product
  • Inspect a firm for violative practices

32
What Are Some Examples of FDA Actions on Unsafe
Cosmetics?
  • Warning letters
  • safety and labeling violations
  • Brazilian Blowout
  • Seizures
  • 12,682 eye lash product applicator tubes
  • containing an drug ingredient

33
Medical and Radiation-Emitting Devices
34
What are Medical and Radiation-Emitting Devices?
  • Range from simple tongue depressors and bedpans
    to complex programmable pacemakers with
    micro-chip technology and laser surgical devices.
  • In vitro diagnostic products, such as general
    purpose lab equipment, reagents, and test kits,
    which may include monoclonal antibody technology.
  • Electronic radiation-emitting products
  • Diagnostic ultrasound products
  • X-ray machines
  • Medical lasers
  • Cell phones
  • Microwaves

35
What is FDA Authority Over Medical and
Radiation-Emitting Devices?
  • FDA responsible for the premarket approval of all
    medical devices, as well as overseeing the
    manufacturing, performance and safety of these
    devices.
  • FDA also oversees the safety performance of
    non-medical devices that emit certain types of
    electromagnetic radiation.

36
Medical Device Safety
  • FDA monitors reports of adverse events and other
    problems with medical devices and alerts health
    professionals and the public when needed to
    ensure proper use of devices and the health and
    safety of patients
  • FDA website contains lists of recent medical
    device recalls and other FDA safety communications

37
FDA-Cleared vs. FDA-Approved
  • Clearance requests are for medical devices that
    prove they are "substantially equivalent" to the
    predicate devices already on the market.
  • Approved requests are for items that are new or
    substantially different and need to demonstrate
    "safety and efficacy.

38
References
  • www.fda.gov
  • www.wikipedia.org
  • http//www.fda.gov/Drugs/DevelopmentApprovalProces
    s/HowDrugsareDevelopedandApproved/default.htm
  • http//www.fda.gov/Drugs/ResourcesForYou/Consumers
    /ucm143534.htm
  • http//www.fda.gov/Food/
  • http//www.fda.gov/AboutFDA/WhatWeDo/History/defau
    lt.htm
  • http//www.fda.gov/AboutFDA/WhatWeDo/History/Miles
    tones/default.htm
  • http//en.wikipedia.org/wiki/Food_and_Drug_Adminis
    tration
  • Images from www.google.com/Images
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