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WHAT WE DO

The 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.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

WHAT FDA REGULATES

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency's specific responsibilities include:

Biologics

·        product and manufacturing establishment licensing

·        safety of the nation's blood supply

·        research to establish product standards and develop improved testing methods

Vaccines, blood, and biologics are regulated by FDA's Center for Biologics Evaluation and Research (CBER). CBER protects and advances the public health by ensuring that these products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of these products.

Do You Know… How FDA Assesses the Safety of Vaccines?

Vaccines undergo rigorous and extensive testing to determine their safety and effectiveness. Highly trained scientists and medical personnel at FDA carefully review all of the information in a marketing application before a vaccine can be approved for use by the public. Following approval, FDA also carefully monitors the quality of vaccines.

Cosmetics

·        safety

·        labeling

Cosmetic products are regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN). CFSAN is responsible for assuring that cosmetics are safe and properly labeled.

Do You Know… If FDA Approves Cosmetics?

FDA does not approve cosmetics, although we do approve color additives used in cosmetics. It is the responsibility of cosmetic manufacturers to ensure, before marketing their products, that the products are safe when used as directed in their label or under customary conditions of use.

Drugs

·        product approvals

·        OTC and prescription drug labeling

·        drug manufacturing standards

Over-the-counter and prescription drugs, including generic drugs, are regulated by FDA's Center for Drug Evaluation and Research (CDER). This work covers more than just medicines.

For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."

Do You Know… How a New Prescription Drug is Approved?

Drug companies seeking FDA approval to sell a new prescription drug in the United States must test it in various ways. First are laboratory and animal tests. Next are tests in humans to see if the drug is safe and effective when used to treat or diagnose a disease.

Foods

·        labeling

·        safety of all food products (except meat and poultry)

·        bottled water

The Center for Food Safety and Applied Nutrition (CFSAN) works to assure that the food supply is safe, sanitary, wholesome, and honestly labeled.

Do You Know… How Often FDA Inspects Food Manufacturing Facilities?

FDA inspects food facilities routinely, often in partnership with state regulatory agencies. The frequency is based on the type of facility, the type of food processed or handled at the facility, and the public health risk associated with the product.

Medical Devices

·        premarket approval of new devices

·        manufacturing and performance standards

·        tracking reports of device malfunctioning and serious adverse reactions

Companies that design, manufacture, repackage, relabel, and/or import medical devices into the United States are regulated by FDA's Center for Devices and Radiological Health (CDRH). 

The owner of the device/product could have designed it but then had it manufactured by a contract manufacturer.

What does it mean when FDA "clears" or "approves" a medical device?

When FDA review is needed prior to marketing a medical device, FDA will either

1.      "clear" the device after reviewing a premarket notification, otherwise known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or

2.      "approve" the device after reviewing a premarket approval (PMA) application that has been submitted to FDA.

Whether a 510(k) or a PMA application needs to be filed depends on the classification of the medical device.

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is "substantially equivalent" to a device that is already legally marketed for the same use.

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.

Radiation-Emitting Electronic Products

·        radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps

·        accrediting and inspecting mammography facilities

Radiation-emitting electronic products (medical and non-medical), such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions, are regulated by FDA's Center for Devices and Radiological Health (CDRH).

Do You Know… What a Radiation-Emitting Electronic Product Is?

A radiation-emitting electronic product is any product that uses electricity to power an electronic circuit that gives off any kind of radiation. Radiation means energy traveling across space.

Veterinary Products

·        livestock feeds

·        pet foods

·        veterinary drugs and devices

The manufacture and distribution of food additives and drugs that will be given to animals are regulated by the Center for Veterinary Medicine (CVM). These include animals used for human food, as well as food additives and drugs for pet (or companion) animals.

Do You Know… Where to Get Information on a Drug Your Veterinarian Prescribed?

The Animal Drugs@FDA database contains information regarding the drug’s indications (why you use it) along with dosage and safety information.

Another source of information is the animal drug’s Freedom of Information (FOI) Summary.

WHAT FDA DOES NOT REGULATE (and how to contact the other Agencies that do)

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 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 the federal agency which regulates all advertising, excluding prescription drugs and medical devices. FTC ensures that advertisements are truthful and not misleading for consumers. Consumers may write to FTC at 6th St. and Pennsylvania Ave., N.W., Washington, DC 20580; telephone (202) 326-2222.

Alcohol

The labeling and quality of alcoholic beverages are regulated by the Department of Justice's Bureau of Alcohol, Tobacco, Firearms and Explosives, Consumers can write to: Bureau of Alcohol, Tobacco, Firearms and Explosives, 99 New York Avenue, NE, Washington, D.C. 20226; telephone 1-800-800-3855 (Toll Free) - 202-648-7777 (Local Number).

Consumer Products

While FDA regulates a large portion of the products that consumers purchase, the agency has no jurisdiction over many household goods. The Consumer Product Safety Commission (CPSC) is responsible for ensuring the safety of consumer goods such as household appliances (excluding those that emit radiation), paint, child-resistant packages, and baby toys. 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

Illegal drugs with no approved medical use--such as heroin and marijuana--are under the jurisdiction of the Drug Enforcement Administration. FDA assists DEA in deciding how stringent DEA controls should be on drugs that are medically accepted but that have a strong potential for abuse. DEA establishes limits on the amount of these prescription drugs that are permitted to be manufactured each year. Inquiries regarding DEA activities may be sent to the Drug Enforcement Administration, U.S. Department of Justice, Washington, DC 20537; telephone (202) 307-1000.

Health Insurance

FDA does not regulate health insurance, the cost of health care products or procedures, or reimbursement for health and medical expenses. Questions about Medicare should be directed to the Centers for Medicare and Medicaid Services.

Meat and Poultry

The U.S. Department of Agriculture's Food Safety and Inspection Service is responsible for the safety and labeling of traditional meats and poultry. (FDA regulates game meats, such as venison, ostrich and snake.) 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

FDA, USDA, and the Environmental Protection Agency share the responsibility for regulating pesticides. EPA determines the safety and effectiveness of the chemicals and establishes tolerance levels for residues on feed crops, as well as for raw and processed foods. These tolerance levels (the amount of pesticide allowed to be present in a food product) are normally set 100 times below the level that might cause harm to people or the environment. FDA and USDA are responsible for monitoring the food supply to ensure that pesticide residues do not exceed the allowable levels in the products under their jurisdiction. 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.

Restaurants and Grocery Stores

Inspections and licensing of restaurants and grocery stores are typically handled by local county health departments.

Water

The regulation of water is divided between the Environmental Protection Agency and FDA. EPA has the responsibility for developing national standards for drinking water from municipal water supplies. FDA regulates the labeling and safety of bottled water.

LAWS ENFORCED BY FDA

Legislation

The Food and Drugs Act of 1906 was the first of more than 200 laws that constitute one of the world's most comprehensive and effective networks of public health and consumer protections. Here are a few of the congressional milestones:

The Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir killed 107 people, including many children. The FD&C Act completely overhauled the public health system. Among other provisions, the law authorized the FDA to demand evidence of safety for new drugs, issue standards for food, and conduct factory inspections.

The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.

The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.

Today, the FDA regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm.

CFR - Code of Federal Regulations Title 21

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

LEARN MORE ABOUT THE FDA BY VISITING THEIR WEBSITE:

http://www.fda.gov/AboutFDA/WhatWeDo/default.htm