The Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.

Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

What does FDA regulate?

The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.

In general, FDA regulates:

Foods, including:

• dietary supplements
• bottled water
• food additives
• infant formulas
• other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)

Drugs, including:

• prescription drugs (both brand-name and generic)
• non-prescription (over-the-counter) drugs

Biologics, including:

• vaccines
• blood and blood products
• cellular and gene therapy products
• tissue and tissue products
• allergenics

Medical Devices, including:

• simple items like tongue depressors and bedpans
• complex technologies such as heart pacemakers
• dental devices
• surgical implants and prosthetics

Electronic Products that give off radiation, including:

• microwave ovens
• x-ray equipment
• laser products
• ultrasonic therapy equipment
• mercury vapor lamps
• sunlamps

Cosmetics, including:

• color additives found in makeup and other personal care products
• skin moisturizers and cleansers
• nail polish and perfume

Veterinary Products, including:

• livestock feeds
• pet foods
• veterinary drugs and devices

Tobacco Products, including:

• cigarettes
• cigarette tobacco
• roll-your-own tobacco
• smokeless tobacco

The following contact information is for government agencies that have functions related to that of FDA. (Contact information is given for agency headquarters offices, which are located in the Washington, D.C., area. Local offices, listed in the phone book under U.S. Government, may be available to provide assistance as well.)

Advertising

The Federal Trade Commission is a federal agency that regulates many types of advertising. The FTC protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace. Consumers may write to FTC at 6th St. and Pennsylvania Ave., N.W., Washington, DC 20580; telephone (202) 326-2222.

Alcohol

The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau(TTB) regulates aspects of alcohol production, importation, wholesale distribution, labeling, and advertising. Consumers may write to TTB at 1310 G St. N.W., Box 12, Washington, DC 20005; telephone (202) 453-2000 or see the TTB Contact page.

Consumer Products

The Consumer Product Safety Commission (CPSC) works to ensure the safety of consumer products such as toys, cribs, power tools, cigarette lighters, household chemicals, and other products that pose a fire, electrical, chemical or mechanical hazard. Consumers may send written inquiries to CPSC, Washington, DC 20207. CPSC operates a toll-free hot line at (800) 638-2772 or TTY (800) 638-8270 for consumers to report unsafe products or to obtain information regarding products and recalls.

Drugs of Abuse

The Department of Justice’s Drug Enforcement Administration (DEA) works to enforce the controlled substances laws and regulations of the United States, including as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances. Inquiries regarding DEA activities may be sent to the Drug Enforcement Administration, Office of Diversion Control 8701 Morrissette Drive Springfield, VA 22152; telephone (202) 307-1000.

Meat and Poultry

The U.S. Department of Agriculture's Food Safety and Inspection Service regulates aspects of the safety and labeling of traditional (non-game) meats, poultry, and certain egg products. Consumers with questions regarding meat or poultry, including safe handling and storage practices, should write or call the Food Safety Inspection Service's Meat and Poultry Hotline, Room 2925S, Washington, DC 20250; telephone (800) 535-4555.

Pesticides

The Environmental Protection Agency (EPA) regulates many aspects of pesticides. EPA sets limits on how much of a pesticide may be used on food during growing and processing, and how much can remain on the food you buy. Public inquiries regarding EPA should be mailed to U.S. Environmental Protection Agency, Office of Pesticide Programs Public Docket (7506C), 3404, 401M St., Washington, DC 20460; telephone (202) 260-2080.

Vaccines for Animal Diseases

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service(APHIS), Center for Veterinary Biologics, regulates aspects of veterinary vaccines and other types of veterinary biologics. Public inquiries regarding APHIS’s Center for Veterinary Biologics should be mailed to Center for Veterinary Biologics, 1920 Dayton Ave, P.O. Box 844, Ames, Iowa, 50010; telephone (515) 337-6100 or see the APHIS Contact page.

Water

The Environmental Protection Agency (EPA) regulates aspects of drinking water. EPA develops national standards for drinking water from municipal water supplies (tap water) to limit the levels of impurities. Browse EPA's frequently asked questions page or submit a question.

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