U.S. Food and Drug Administration

1. U.S. Food and Drug Administration

2. Speakers • Introduction & Food and federal Act by : TaranehBahramian • Food by : NehAtefor • Drugs By : Fate Abbasi • Cosmetics & Medical devices by : Hayley Anderson

3. History of Food and Drug Administration (FDA) Federal Food and Drug Act 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

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. FDA’s 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 it’s 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 it’s 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 FDA’s 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. 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 Development & Approval Process

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 (FD&C 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) • FDA’s 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/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm • http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm • http://www.fda.gov/Food/ • http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm • http://www.fda.gov/AboutFDA/WhatWeDo/History/Milestones/default.htm • http://en.wikipedia.org/wiki/Food_and_Drug_Administration • Images from www.google.com/Images