U.S. Food and Drug Administration

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U.S. Food and Drug Administration
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Speakers

• Introduction Food and federal Act by Taraneh
  Bahramian
• Food by Neh Atefor
• Drugs By Fate Abbasi
• Cosmetics Medical devices by Hayley Anderson

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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
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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

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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

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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

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FOOD
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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.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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DRUGS
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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

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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.

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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

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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

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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

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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

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Cosmetics
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What is a Cosmetic?

• Articles intended for
• Cleansing (except some soap)
• Beautifying
• Promoting Attractiveness
• Altering Appearance

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What are Some Examples of Cosmetics?

• Makeup
• Fragrances
• Skin Care
• Shaving
• Suntan Preparations
• Oral Hygiene
• Manicuring Preparations
• Hair Products

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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.

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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

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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.

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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

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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

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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

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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

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Medical and Radiation-Emitting Devices
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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

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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.

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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

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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.

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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