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  1. 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 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 (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 page.

Consumer Products

The (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 (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 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 (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 (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 page.

Water

The (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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