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.