U.S. Food and Drug Administration

U.S. Food and Drug Administration By: Cameron Bornholm, Angela Jenkins, and Cherelle Waters

Table of Contents • What is the FDA? • The job of the FDA • Who makes up the FDA • FDA’s mission statement • Brief History of the FDA • Sectors of the FDA • Recent Recalls and Alerts

What is the FDA? • 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: • most types of foods • drugs • vaccines • blood products • medical devices • dietary supplements • biological medical products • radiation-emitting devices • veterinary products • cosmetics

Job of the FDA The FDA is the U.S. Government agency that oversees most foods and medical products. Its job is to make sure that: • 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

FDA Organization • 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

Who Makes Up the FDA? • The FDA consists of employees drawn from a wealth of science and public health professions • biologists, physicians, chemists, biomedical engineers, toxicologists, pharmacologists, veterinarians, and specialists in the public health education and communication • FDA employs approximately 9,000 people who work in locations around the United States

FDA Mission • To promote and protect the public health by helping safe and effective products reach the market in a timely manner • To monitor products for continued safety after they are in use by the public • To help the public get the accurate, science-based information needed to improve health

Basic History of the FDA • 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

Sectors of the FDA • Food • Drugs • Biologics, Blood, and Vaccines • Animal & Veterinary • Cosmetics • Medical Devices • Radiation-Emitting Products • Combination Products

Safe, Healthy, Sanitary Foods • 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* • The agency must approve new food additives before they can be used in foods • FDA monitors the safety of dietary supplements and the content of infant formulas

Drugs • Prescription drugs • Undergo New Drug Application Process • Orange Book lists all FDA approved prescription drugs, updated monthly • 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

Over-The-Counter Drugs • 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

Safe Blood Supply and Vaccine Development • 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. • 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

Safe and Effective Animal Drugs • FDA regulates drugs and devices used for animals (both pets and animals that produce food) • 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 • Veterinary medical devices do not have to be pre-approved by FDA before marketing, but they still must be safe, effective, and properly labeled • Livestock drugs are evaluated for their safety to the environment and to the people who eat the animal products.

Bovine Spongiform Encephalopathy • “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

Animal Cloning • 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

Cosmetics • "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)].

Cosmetics • 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.

Cosmetics • 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

Cosmetics • 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.

Medical Devices • A medical device is an object which is useful for diagnostic or therapeutic purposes.

Medical Devices • Devices at FDA • Provides a search program to obtain info on any device approved by the FDA • Examples of some medical devices are: • Breast Implants • Contact Lenses • Lasers for Lasik Eye Surgery • Laboratory Tests • Home Testing • Glucose • Pregnancy

Medical Devices • Medical Imaging • Medical X-Rays • CT (Computed Tomography) • Fluoroscopy • Mammography • Ultrasound Imaging

Nationwide Evaluation of X-ray Trends (NEXT) • 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. • 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. • 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.

Safe Medical Radiation Products • The FDA protects the public from unnecessary exposure to radiation from electronic products • Products include: microwave ovens, cell phones, lasers, MRI machines, x-ray equipment, medical ultrasound machines, and many other consumer, industrial, and medical products

Radiation-Emitting Products • 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

Radiation-Emitting Products • 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

Combination Products • 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

Combination Products 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

Enforcement • FDA works with manufacturers when problems arise • If that fails, FDA asks manufacturer to recall the product while federal marshals seize the products (if the recall is not voluntary) • FDA can ask the courts to prosecute those in violation of the law

Recent Recalls and Alerts • 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

References FDA Website www.fda.gov Wikipedia Website www.wikipedia.com

U.S. Food and Drug Administration