Food and Drug Administration

FDA Organization and Locations

  • FDA headquarters located in Montgomery County and Prince Georges County, Maryland.
  • The agency has 223 field offices and 13 laboratories across the United States, United States Virgin Islands, and Puerto Rico.
  • FDA employees are also posted in foreign countries such as China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
  • FDA Building 31 houses the Office of the Commissioner and the Office of Regulatory Affairs.
  • FDA Building 66 houses the Center for Devices and Radiological Health.
  • FDA employees and facilities are located on 130 acres of the White Oak Federal Research Center in Silver Spring, Maryland.
  • The FDA campus has a population of 10,987 employees and approximately 3,800,000 square feet of space.
  • The FDA plans to increase its employees by 64% and add 1,600,000 square feet of office and special use space by 2035.
  • The Arkansas Laboratory in Jefferson, Arkansas serves as the headquarters of the National Center for Toxicological Research.
  • The Office of Regulatory Affairs (ORA) is divided into five regions and 20 districts, based on the geographic divisions of the Federal court system.
  • The Office of Criminal Investigations (OCI) was established in 1991 to investigate criminal cases related to FDA-regulated industries.

FDA Scope, Funding, and Regulatory Programs

  • The FDA is responsible for overseeing $2.7 trillion worth of food, medical, and tobacco products.
  • The FDA's budget is funded by the federal government (54%) and industry user fees (46%).
  • Pharmaceutical firms contribute 75% of the FDA's drug review budget.
  • The FDA's regulatory programs cover a wide range of products, including emergency approvals (EUA) for medical countermeasures during public health emergencies.
  • Emergency Use Authorization (EUA) facilitates the availability and use of medical countermeasures during public health emergencies.
  • FDA regulations vary depending on the type of product and its potential risks.
  • The FDA regulates prescription drugs comprehensively, including 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, with inspection observations documented.

Food and Dietary Supplements

  • FDA regulates food and dietary supplements based on statutes enacted by Congress.
  • The FDA oversees the quality and labeling claims of substances sold as food in the US.
  • Substances regulated as food include foods, food additives, added substances, and dietary supplements.
  • Dietary supplements can include vitamins, minerals, herbs, amino acids, and enzymes.
  • The FDA has specific standards and means to address violations in each category.


  • FDA has different requirements for new drugs, generic drugs, and over-the-counter drugs.
  • New drugs undergo extensive scrutiny before FDA approval through a new drug application (NDA).
  • The Trump administration has worked to expedite the drug approval process.
  • Critics argue that FDA standards may not prevent unsafe or ineffective drugs from approval.
  • New drugs are initially available only by prescription, with a separate process for OTC status.

Advertising and Promotion

  • FDA's Office of Prescription Drug Promotion (OPDP) reviews and regulates prescription drug advertising.
  • OPDP conducts surveillance activities and issues enforcement letters to pharmaceutical manufacturers.
  • Advertising and promotion for OTC drugs are regulated by the Federal Trade Commission.
  • FDA engages with third-party enforcer-firms for regulatory oversight.
  • FDA expects pharmaceutical companies to comply with advertising and promotion regulations.

Food and Drug Administration Data Sources

Reference URL
Knowledge Graph