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.