Introduction to the U.S. Food and Drug Administration (FDA)

Food and Drug Administration Introduction to the U.S. FDA The U.S. Food and Drug Administration (FDA or USFDA) is a federal agency of the U.S. Department of Health and Human Services. The FDA protects and promotes public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation-emitting devices (ERED), cosmetics, animal foods and feed, and veterinary products. The FDA's primary responsibility is to enforce the Federal Food, Drug, and Cosmetic Act (FD&C Act). In addition, the agency enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations. Many of its regulatory and enforcement activities do not directly involve food or drugs, but also include the regulation of lasers, cell phones, condoms, and the like. In addition, the FDA is responsible for disease control across many areas, from household pets to human sperm used for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, who is appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. As of January 24, 2025, Sara Brenner was Acting Commissioner, succeeding Commissioner Robert Califf, who resigned on January 20, 2025. The FDA's headquarters is located in the White Oak area of Silver Spring, Maryland. The agency has 223 field offices and 13 laboratories across the 50 U.S. states, the U.S. Virgin Islands, and Puerto Rico. Since 2008, the FDA has begun stationing staff in overseas countries including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. Organizational Structure Department of Health and Human Services Food and Drug Administration Office of the Commissioner (OC) Office of the Chief Counsel (OCC) Office of the Executive Secretariat (OES) Office of the Counselor to the Commissioner Office of Digital Transformation (ODT) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Center for Drug Evaluation and Research (CDER) Center for Food Safety and Applied Nutrition (CFSAN) Center for Tobacco Products (CTP) Center for Veterinary Medicine (CVM) Oncology Center of Excellence (OCE) Office of Regulatory Affairs (ORA) Office of Clinical Policy and Programs (OCPP) Office of External Affairs (OEA) Office of Food Policy and Response (OFPR) Office of Minority Health and Health Equity (OMHHE) Office of Operations (OO) Office of Policy, Legislation, and International Affairs (OPLIA) Office of the Chief Scientist (OCS) National Center for Toxicological Research (NCTR) Office of Women's Health (OWH) Locations Headquarters The FDA's headquarters facilities are currently located in Montgomery County and Prince George's County, Maryland. White Oak Federal Research Center Since 1990, the FDA has had staff and facilities at the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland, covering 130 acres (53 hectares). In 2001, the U.S. General Services Administration (GSA) began constructing new buildings on the campus, aimed at consolidating the FDA's 25 operating sites in the Washington metropolitan area, its headquarters in Rockville, and several scattered office buildings. The first building, the Life Sciences Laboratory, was completed and put into use in December 2003, initially with 104 employees. As of December 2018, the FDA campus had 10,987 employees and about 3.8 million square feet (350,000 square meters) of office and laboratory space, divided into 10 offices and 4 laboratory buildings. The campus houses the Office of the Commissioner (OC), Office of Regulatory Affairs (ORA), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), and Center for Veterinary Medicine (CVM) office areas. Under the 2017 FDA Reauthorization Act, the FDA expects its staff to grow 64% over the next 15 years, reaching 18,000, and plans to add about 1.6 million square feet (150,000 square meters) of office and special-use space. In December 2018, the National Capital Planning Commission approved this expansion plan, with construction expected to be completed by 2035 with GSA funding support. Field Office Locations Office of Regulatory Affairs The Office of Regulatory Affairs is considered the FDA's "eyes and ears," responsible for most of the field work. Its staff, called consumer safety officers and commonly known as investigators, are responsible for inspecting production and storage facilities, investigating complaints, disease outbreaks, and the like, and reviewing documents related to products such as medical devices, drugs, and biologics that are difficult to physically inspect or sample. The Office of Regulatory Affairs is divided into five regions, further subdivided into 20 districts, which roughly correspond to the geographic divisions of the federal courts. Each district has a main office area and several resident posts, which are the FDA's remote offices serving specific geographic areas. The Office of Regulatory Affairs also includes the agency's network of regulatory laboratories, responsible for analyzing collected physical samples. Although most samples are food, some laboratories have the capability to analyze drugs, cosmetics, and radiation-emitting devices. Other Locations The FDA has multiple field offices across the United States, and additionally has offices in international regions such as China, India, Europe, the Middle East, and Latin America. Scope of Responsibility and Funding As of 2021, the FDA was responsible for overseeing food, medical, and tobacco products with a total value of $2.7 trillion. 54% of its budget comes from the federal government, and 46% is covered by industry user fees - for example, pharmaceutical companies pay fees to expedite drug review. Forbes reported that pharmaceutical companies bear 75% of the FDA's drug review budget. Regulatory Programs Emergency Use Authorization (EUA) The Emergency Use Authorization mechanism is designed to facilitate the supply and use of medical countermeasures (including vaccines and personal protective equipment) during public health emergencies, such as the Zika virus, the Ebola epidemic, and the COVID-19 pandemic. Regulations Safety regulation programs vary greatly depending on the product type, potential risk, and the regulatory authority granted to the agency. For example, the FDA regulates almost every aspect of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety - however, the FDA's regulation of cosmetics focuses mainly on labeling and safety. The FDA regulates most products through a set of published standards and enforces these standards through a small number of facility inspections. Inspection observations are recorded on Form 483. In June 2018, the FDA issued a statement containing new guidelines designed to help food and drug manufacturers "implement protective measures to prevent potential attacks on the U.S. food supply." One of the guidelines includes the "Intentional Adulteration (IA) Rule," which requires the food industry to develop strategies and procedures to reduce the risk of compromise at highly vulnerable facilities and processes. The FDA also uses the tactic of regulation by shaming, primarily by publishing non-compliance situations, warning letters, and "shame lists" online. Regulation through shaming leverages companies' sensitivity to reputational damage. For example, in 2018, the agency published an online "blacklist" listing dozens of brand-name drug companies accused of using illegal or unethical means to try to block competition from generic drug companies. The FDA frequently collaborates with other federal agencies, including the Department of Agriculture, the Drug Enforcement Administration, Customs and Border Protection, and the Consumer Product Safety Commission. They also often work with local and state government agencies to conduct regulatory inspections and enforcement actions. Food and Dietary Supplements Food Safety Modernization Act (FSMA) According to the latest data from the U.S. Centers for Disease Control and Prevention, about 48 million people (1 in 6) in the United States get sick from foodborne illnesses each year, 128,000 are hospitalized, and 3,000 die. This is a significant and largely preventable public health burden. The Food Safety Modernization Act (FSMA), implemented by the FDA, is transforming the national food safety system, shifting the focus from responding to foodborne illness to prevention. Congress passed the FSMA to respond to dramatic changes in the global food system and to the increased understanding of foodborne illness and its consequences, including the recognition that preventing foodborne illness is both a major public health issue and a threat to the economic health of the food system. The FDA has developed several rules to implement the FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility across many points in the global supply chain of food for both humans and animals. The FSMA rules specify the specific measures that must be taken at each point to prevent contamination. The FDA's regulation of food and dietary supplements is governed by various laws enacted by the U.S. Congress and interpreted by the FDA. Under the Federal Food, Drug, and Cosmetic Act and its accompanying regulations, the FDA has the authority to oversee the quality of food sold in the United States and to monitor claims made on labels about food ingredients and health benefits. The FDA subdivides the food it regulates into various categories, including food, food additives, added substances (man-made substances not intentionally added to food but that end up in it), and dietary supplements. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids, and enzymes. The specific standards the FDA adopts vary by category. In addition, legislation gives the FDA various means to address violations of standards by specific substance categories. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients comply with current requirements. These manufacturers and distributors must not promote their products in an adulterated manner, and they are responsible for evaluating the safety and labeling of their products. The FDA has a "Dietary Supplement Ingredient Advisory List," which includes ingredients that sometimes appear in dietary supplements but require further evaluation. An ingredient is added to this list when it appears to be excluded from use in dietary supplements, not an approved food additive or considered safe, and/or subject to a premarket notification requirement that has not been met. Cosmetics Under U.S. law, cosmetics and their ingredients do not require FDA approval before going to market. The only exception is color additives (except for coloring materials used in coal-tar hair dyes), which must be approved for their intended use. Companies and individuals who market cosmetics have a legal responsibility to ensure the safety of their products. To take action against cosmetics on the market for safety reasons, we need reliable information demonstrating that the product poses a safety hazard when used by consumers according to label directions or customary usage. The following resources relate to cosmetics that people often ask about. For information on cosmetic ingredients, see Cosmetic Ingredients. Aromatherapy; disposable wipes; hair products (hair dyes, straighteners, removers, and cleaning products); makeup; nail products; soaps and lotions (soap maker FAQs, anti-aging products, slimming care, etc.); tanning products; tattoos and permanent makeup. Drugs The Center for Drug Evaluation and Research has different requirements for three major categories of drugs: new drugs, generic drugs, and over-the-counter drugs. A drug is considered a "new drug" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes a major change. Requirements are strictest for entirely new molecular entities - that is, drugs not based on existing drugs. Medical Countermeasures (MCMs) Medical countermeasures (MCMs) are biologics and drugs that can prevent or treat the health effects of chemical, biological, radiological, or nuclear (CBRN) attacks. MCMs can also be used to prevent and diagnose symptoms associated with CBRN attacks or threats. The FDA operates a program called the "FDA Medical Countermeasures Initiative" (MCMi), federally funded to support relevant agencies and organizations in preparing for public health emergencies that may require MCMs. New Drugs Before a new drug is approved by the FDA, it undergoes rigorous review, a process called the New Drug Application (NDA). During President Donald Trump's administration, the agency worked to speed up the drug approval process. However, critics argue that the FDA's standards are not strict enough to prevent unsafe or ineffective drugs from being approved. By default, new drugs are available by prescription only. Switching to over-the-counter (OTC) status is a separate process, and the drug must first be approved through an NDA. An approved drug is considered "safe and effective when used as directed." Drugs made by new manufacturers can be approved through two faster processes: the Abbreviated New Drug Application (ANDA) or the 505(b)(2) regulatory pathway for complex generics or biosimilars. In rare cases, under the principle of compassionate use, limited exceptions can be allowed to the multi-step process involving animal experiments and controlled clinical trials. This was the case during the 2015 Ebola epidemic with the prescription and authorized use of ZMapp and other experimental therapies. Exceptions can also be made for new drugs that can be used to treat debilitating and/or very rare diseases for which there is no satisfactory existing therapy or drug, or for which there has been no progress for a long time. These studies are gradually extended, increasing the number of participants over several years as the research progresses from Phase I to Phase III, and typically involve pharmaceutical companies, governments and their laboratories, and often medical schools, hospitals, and clinics. However, any exceptions to the above process are subject to rigorous review, inspection, and conditions, and are granted only when substantial research and at least some preliminary human trials show that they are considered somewhat safe and likely effective. (See the FDA's Special Protocol Assessment for Phase III trials.) FDA Post-Market Drug Safety Monitoring Although clinical trials provide important information about a drug's efficacy and safety, it is impossible to obtain complete information about a drug's safety at the time of approval. Despite the rigorous steps of the drug development process, limitations remain. Therefore, the true picture of a product's safety actually emerges gradually over the months or even years the product is on the market. The FDA reviews problem reports for prescription and over-the-counter drugs and can decide to add warnings to dosage or usage information, as well as other measures for more serious problems. Supplemental Applications If a developer wishes to make any major changes to the original NDA, a supplemental application must be submitted. Generally, any change to the formulation, labeling, or dosage strength must be approved by the FDA before it is made. IND for Marketed Drugs If a sponsor wants to further develop an approved drug for a new use, dosage strength, new dosage form, or different dosage form (for example, an injection or oral liquid as opposed to a tablet form), or wants to conduct other clinical research or post-market safety studies, they will do so under an IND. Manufacturer Inspections FDA officials conduct regular inspections of drug production facilities within the United States, and also inspect foreign drug production facilities if approved products are made overseas. Manufacturers may be notified of inspections in advance, or inspections may be unannounced. Inspections may be routine or triggered by specific issues or concerns. The purpose of these inspections is to ensure that developers follow good manufacturing practices. If minimum standards are not met, the FDA can shut down a plant. Drug Advertising The FDA regulates prescription drug advertising and promotional labeling. The law prohibits developers from promoting their products for unapproved uses. All advertising, such as product claims or reminder advertisements, must not be false or misleading. They must contain truthful information about the drug's effectiveness, side effects, and prescribing information. These advertisements can be found in medical journals, newspapers, and magazines, as well as on the internet, television, or radio. Promotional labeling differs from drug advertising in how it is distributed. Pharmaceutical companies distribute brochures or other promotional materials to doctors or consumers. The drug's prescribing information must be provided along with the promotional labeling. Generic Drugs A new drug is protected by patent when it is approved for market. This means only the sponsor has the right to exclusively sell the drug. Once the patent expires, other drug manufacturers can develop the drug, which will be called the generic version of the drug. A generic drug is comparable to the brand-name drug and must have the same: dosage form; strength; safety; quality; performance characteristics; and intended use. Because generic drugs are comparable to drugs already on the market, generic manufacturers do not have to conduct clinical trials to prove the safety and effectiveness of their products. Instead, they conduct bioequivalence studies and submit an Abbreviated New Drug Application (ANDA). For a pharmaceutical company to be approved to produce a generic drug, the FDA requires scientific evidence demonstrating that the generic is interchangeable with or therapeutically equivalent to the original drug. Currently, about 80% of prescription drugs sold in the United States are generics. Reporting Problems The FDA has several programs that allow manufacturers, health professionals, and consumers to report problems related to approved drugs. MedWatch is the portal for reporting problems with medical products (drugs and medical devices) and for learning about new safety information; you can subscribe to regular MedWatch safety alerts. The Medical Product Safety Network (MedSun) monitors the safety and effectiveness of medical devices; the FDA recruited 350 healthcare providers across the United States to report any medical device problems that cause serious injury or death, and the FDA publishes a monthly MedSun newsletter providing consumers with important information about medical device safety. Active Surveillance Under the "Sentinel Initiative," the FDA is developing a new national system to detect possible safety issues more quickly. The system will use very large existing electronic health databases - such as electronic health record systems, administrative and insurance claims databases, and registries - to monitor the safety of approved medical products in real time. This tool will be added to the FDA's existing post-market safety assessment tools but will not replace them. Generic Drugs (Off-Patent Drugs) The Generic Drug Scandal In 1989, a major scandal broke out involving the FDA's procedures for approving generic drugs for sale. In 1988, during an extensive congressional investigation of the FDA, allegations of corruption in generic drug approvals first emerged. The Oversight Subcommittee of the U.S. House Energy and Commerce Committee was established based on a complaint against the FDA by Mylan Laboratories of Pittsburgh. Believing it had been discriminated against because its generic drug production applications were repeatedly delayed by the FDA, Mylan began a private investigation of the agency in 1987. Mylan eventually sued two former FDA employees and four pharmaceutical companies, alleging that corruption within the federal agency led to racketeering and antitrust violations. Mylan claimed that "the approval order for new generic drugs was determined by FDA employees before drug manufacturers submitted applications," an illegal process designed to favor certain companies. In the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, and Walter Kletch) admitted to criminal charges of accepting bribes from generic drug manufacturers, and two companies (Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to bribery.