FDA Headquarters and Field Locations
- FDA headquarters are located in Montgomery County and Prince Georges County, Maryland.
- The FDA campus has a population of 10,987 employees.
- The campus houses various offices, including the Office of the Commissioner and the Center for Drug Evaluation and Research.
- The FDA plans to increase its employees by 64% over the next 15 years.
- The FDA is planning to add approximately 1,600,000 square feet of office and special use space to their existing facilities.
- The FDA has employees and facilities on 130 acres of the White Oak Federal Research Center.
- The campus houses various offices, including the Office of the Commissioner and the Center for Veterinary Medicine.
- Construction on the campus began in 2001 to consolidate the FDA's operations in the Washington metropolitan area.
- The FDA campus has approximately 3,800,000 square feet of space divided into ten offices and four laboratory buildings.
- The FDA plans to complete the construction by 2035, dependent on GSA appropriations.
- The Arkansas Laboratory in Jefferson, Arkansas is the headquarters of the National Center for Toxicological Research.
- The FDA has field offices located throughout the United States and international locations in China, India, Europe, the Middle East, and Latin America.
- The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts.
- Each district comprises a main district office and a number of Resident Posts, which are FDA remote offices.
- The FDA's Office of Criminal Investigations employs approximately 200 Special Agents nationwide.
Scope and Funding
- As of 2021, the FDA had responsibility for overseeing $2.7 trillion in food, medical, and tobacco products.
- 54% of the FDA's budget comes from the federal government.
- 46% of the FDA's budget is covered by industry user fees.
- Pharmaceutical firms pay fees to expedite drug reviews.
- Pharmaceutical firms provide 75% of the FDA's drug review budget.
Regulatory Programs
- Emergency Use Authorization (EUA) facilitates the availability and use of medical countermeasures during public health emergencies.
- The FDA regulates various products, including prescription drugs, cosmetics, and medical devices.
- FDA regulation of prescription drugs covers testing, manufacturing, labeling, advertising, marketing, efficacy, and safety.
- FDA regulation of cosmetics primarily focuses on labeling and safety.
- The FDA enforces published standards through facility inspections.
FDA and the U.S. Food Supply
- FDA released guidelines for food and drug manufacturers to protect against attacks on the U.S. food supply.
- Intentional Adulteration (IA) rule requires strategies to reduce vulnerability in food facilities.
- FDA uses regulatory shaming, such as online publication of non-compliance and warning letters.
- FDA collaborates with federal agencies like the Department of Agriculture and the Drug Enforcement Administration.
- FDA works with local and state government agencies for regulatory inspections and enforcement actions.
- FDA oversees the quality and labeling of food and dietary supplements in the United States.
- Subdivides substances into categories like foods, food additives, and dietary supplements.
- Standards and means to address violations differ for each category.
- FDA ensures manufacturers and distributors of dietary supplements meet requirements.
- FDA maintains a Dietary Supplement Ingredient Advisory List for further evaluation.
- FDA does not approve applied coatings used in the food processing industry.
- There is no review process for nonstick coatings, but FDA regulations cover their formulation and use.
- Materials like Polytetrafluoroethylene (Teflon) are FDA Compliant or FDA Acceptable.
Medical and radiation-emitting devices
- The Center for Devices and Radiological Health (CDRH) is responsible for the premarket approval of all medical devices.
- CDRH oversees the manufacturing, performance, and safety of medical devices.
- Medical devices range from simple toothbrushes to complex devices like implantable neurostimulators.
- CDRH also regulates non-medical devices that emit certain types of electromagnetic radiation.
- Examples of CDRH-regulated devices include cellular phones, airport baggage screening equipment, television receivers, microwave ovens, tanning booths, and laser products.
- Clearance requests are required for medical devices that are substantially equivalent to existing devices on the market.
- Approval requests are for new or substantially different devices that need to demonstrate safety and efficacy.
- Safety inspections may be conducted for new toxic hazards.
- Both safety and efficacy need to be demonstrated for approval.
- Submitters are responsible for providing the necessary evidence for proper procedures.
- Cosmetics are regulated by the Center for Food Safety and Applied Nutrition.
- Cosmetic products are generally not subject to premarket approval unless they make structure or function claims that classify them as drugs.
- Color additives used in cosmetics must be specifically FDA approved.
- The FDA regulates cosmetics labeling.
- Cosmetics that have not been safety tested must bear a warning.
- Dietary supplements are regulated by the FDA under the Dietary Supplement Health and Education Act (DSHEA).
- DSHEA requires manufacturers to ensure the safety of their products and make no false claims.
- The FDA monitors the market for safety concerns and takes action against unsafe products.
- The FDA can take action against dietary supplements that are adulterated or misbranded.
- Adverse event reports can be submitted to the FDA for dietary supplements.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
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| Agency overview | |
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| Formed | June 30, 1906 |
| Preceding agencies |
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| Jurisdiction | Federal government of the United States |
| Headquarters | White Oak Campus 10903 New Hampshire Avenue Silver Spring, Maryland 20993 39°02′07″N 76°58′59″W / 39.03533200°N 76.98311340°W |
| Employees | 18,000 (2022) |
| Annual budget | US$6.5 billion (2022) |
| Agency executives |
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| Parent agency | Department of Health and Human Services |
| Child agencies |
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| Website | fda |
The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from household pets to human sperm donated for use in assisted reproduction.
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Robert Califf is the current commissioner, as of 17 February 2022.[update]
The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
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