Food and Drug Administration
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Food and Drug Administration
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services (HHS). The FDA’s responsibilities include protecting the health of the public by assuring safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and all products emitting radiation. Other FDA responsibilities include advancing public health by speeding the development of innovations that make food and drugs safer, more affordable and effective, and to increase knowledge of medicines and foods the public use through accurate, science-based information.
The FDA’s website is located at http://www.fda.gov/default.htm
Food and Drug Administration Organization
The FDA consists of various offices and centers:
• Office of the Commissioner
• 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 Tobacco Products
• Center for Veterinary Medicine
• National Center for Toxicological Research
• Office of Regulatory Affairs
What the FDA Regulates
The FDA is the federal agency the public trusts to regulate and ensure our food is safe, nutritious and sanitary, that human and veterinary drugs, biological products, and medical devices are effective and safe, that cosmetics we use are safe, and that any electronic products emitting radiation are safe. Specific FDA responsibilities in these areas include:
Biologics – Product and manufacturing establishment licensing; safety of the nation’s blood supply; research to establish product standards and develop improved testing methods
Cosmetics – Safety and labeling
Drugs – Product approvals; over-the-counter (OTC) and prescription drug labeling; drug manufacturing standards
Foods – Labeling; safety of all products (except meat and poultry); bottled water
Medical Devices – Premarket approval of all new devices; manufacturing and performance standards; tracking reports of malfunctioning devices and adverse reactions of a serious nature
Radiation-Emitting Electronic Products – Radiation performance standards for cabinet X-ray systems (such as airport baggage X-ray machines); diagnostic X-ray equipment; laser products; mercury vapor lamps; microwave ovens; sunlamps; television receivers; ultrasonic therapy equipment
Veterinary Products – Livestock feeds; pet foods; veterinary drugs and devices
Areas Not Regulated by the FDA
FDA regulation does not include the following:
• Advertising – This is regulated by the Federal Trade Commission (FTC), with the exception of advertising for prescription drugs and medical devices.
• Alcohol – Labeling and quality of alcoholic beverages are regulated by the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) of the U. S. Department of Justice.
• Consumer Products – While the FDA regulates a large portion of the consumer products Americans buy, it does not have jurisdiction over many household products. The Consumer Product Safety Commission (CPSC) maintains responsibility to ensure consumer goods such as household appliances (except those that emit radiation), paint, child-resistant packages, and toys are safe.
• Drugs of Abuse – Illegal or street drugs with no approved medical purpose, such as heroin, are under the jurisdiction of the Drug Enforcement Administration (DEA). The FDA assists the DEA on deciding how stringent DEA controls should be on medically-accepted drugs that have a strong potential for abuse. The DEA puts annual limits on the number of these high-potential prescription abuse drugs permitted to be manufactured.
• Health Insurance – The FDA does not regulate health insurance, cost of health care products or procedures, or reimbursements for medical and health expenses. Consumers with questions about Medicare should contact the Centers for Medicare and Medicaid Services.
• Meat and Poultry – The Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA) is responsible for the labeling and safety of traditional meats and poultry. Game meats, such as venison, snake, and ostrich are regulated by the FDA.
• Pesticides – Regulation of pesticides is shared by three U.S. agencies: the FDA, USDA, and the Environmental Protection Agency (EPA). The EPA determines chemical safety and effectiveness and establishes tolerance levels for residues on feed crops, raw and processed foods. FDA and USDA monitor the food supply to ensure pesticide levels do not exceed allowable limits.
• Restaurants and Grocery Stores – Local county health departments typically handle the licensing and inspection of restaurants and grocery stores.
• Water – Both the EPA and the FDA regulate water, with responsibilities divided between the two agencies. The EPA develops national standards for drinking water from municipal water supplies, while the FDA regulates bottled water safety and labeling.
Information on the FDA Website
The FDA website is well-designed for easy access to topical information and includes the following:
• An A to Z subject index
• News and events – including newsroom, meetings, testimony and speeches.
• Public health focus - such as 2009 H1N1 flu, reforming the food safety system, and safe use initiative.
• Updates, recalls and safety alerts
• Warning letters
• New products approved
• News for consumers, industry and health professionals
• Regulatory information – including how to comment on proposed regulations, code of federal regulations, dockets management, FDA federal registers, laws FDA enforces.
• Report a problem – drugs and medical devices (MedWatch), emergency, non-emergency, suspected criminal activity, and reportable food registry for industry.
• Science and research (such as combination products, critical path initiative, clinical trials, pediatrics, rare diseases, and toxicological research).
• Safety tips
• Specific topics are spotlighted, such as recent reports on influenza antiviral information, electronic cigarettes, and strategic plan for risk communication.
• Multimedia available includes consumer multimedia, drug safety podcasts, and FDA patient safety news.
• In addition, the broad responsibility categories of food, drugs, medical devices, vaccines, blood and biologics, animal and veterinary, cosmetics, radiation-emitting products and tobacco products each have links from the FDA website’s home page to articles and resources on key topics, consumer resources and industry resources.
• Other information includes international programs, criminal investigations, emergency preparedness and response, reports, manuals and forms, publications available in Spanish, and more.
Contacting the FDA
Consumers can contact the FDA through the Contact Us page on the FDA website, by calling the main FDA phone number for general inquiries at 1-888-INFO-FDA (1-888-463-6332) or by mail to:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
--Suzannekane 21:35, 29 December 2009 (UTC)
