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                FDA Basics

FDA Basics

                        FDA Fundamentals


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          What does FDA regulate?FDA Basics What does FDA regulate?
  
  	
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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.

Related Resources

Is It Really FDA Approved?
	FDA Acronyms and Abbreviations
	FDA Office of Regulatory Affairs

                                                                                  Content current as of:
      01/18/2022
              
              
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                        FDA Fundamentals


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