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.
The FDA is responsible for
Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective
Protecting the public from electronic product radiation
Assuring cosmetics and dietary supplements are safe and properly labeled
Regulating tobacco products
Advancing the public health by helping to speed product innovations
FDA's responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.
What Does the 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 for humans
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
Cigars
Hookah
E-cigarettes (tobacco and non-tobacco derived nicotine)
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.
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