Since 1990, the FDA has had employees and facilities on 130 acres (53 hectares) of the White

Oak
Federal Research Center in the White Oak area of Silver Spring, Maryland.[5][11] In 2001, the General
Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25
existing operations in the Washington metropolitan area, its headquarters in Rockville, and several
fragmented office buildings. The first building, the Life Sciences Laboratory, was dedicated and
opened with 104 employees in December 2003. As of December 2018, the FDA campus has a
population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square
metres) of space, divided into ten office and four laboratory buildings. The campus houses the Office
of the Commissioner (OC), the Office of Regulatory Affairs (ORA),  the Center for Drug Evaluation
and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for
Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary
Medicine (CVM).[5]
With the passing of the FDA Reauthorization Act of 2017, the FDA is projecting a 64% increase in
employees to 18,000 over the next 15 years, and would like to add approximately 1,600,000 square
feet (150,000 square metres) of office and special use space to their existing facilities. The National
Capital Planning Commission approved a new master plan for this expansion in December 2018,
[12]
 and construction is expected to be completed by 2035, dependent on GSA appropriations. [13]

Field locations[edit]

The Arkansas Laboratory in Jefferson, Arkansas is the headquarters of the National Center for Toxicological
Research

Office of Regulatory Affairs[edit]

The Office of Regulatory Affairs is considered the agency's "eyes and ears," conducting the vast
majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more
commonly known simply as investigators, inspect production and warehousing facilities, investigate
complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs,
biological products, and other items where it may be difficult to conduct a physical examination or
take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions,
which are further divided into 20 districts. Districts are based roughly on the geographic divisions of
the Federal court system. Each district comprises a main district office and a number of Resident
Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the
Agency's network of regulatory laboratories, which analyze any physical samples taken. Though
samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and
radiation-emitting devices.
Office of Criminal Investigations[edit]
Jamaica, Queens, NY Regional Office - USFDA

The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so,

OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are
armed, have badges, and do not focus on technical aspects of the regulated industries. Rather, OCI
agents pursue and develop cases when individuals and companies commit criminal actions, such as
fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate
commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States
Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as
defined in Chapter III of the FD&C Act. OCI Special Agents often come from other criminal
investigations backgrounds, and frequently work closely with the Federal Bureau of
Investigation, Assistant Attorney General, and even Interpol. OCI receives cases from a variety of
sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help
develop the technical and science-based aspects of a case.[citation needed]
Other locations[edit]
The FDA has a number of field offices across the United States, in addition to international locations
in China, India, Europe, the Middle East, and Latin America. [14]

Scope and funding[edit]

As of 2021, the FDA had responsibility for overseeing $2.7 trillion in food, medical, and tobacco
products.[15] Some 54% of its budget derives from the federal government, and 46% is covered by
industry user fees for FDA services.[15] For example, pharmaceutical firms pay fees to expedite drug
reviews.[15]

Regulatory programs[edit]
Emergency approvals (EUA)[edit]
Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability
and use of medical countermeasures, including vaccines and personal protective equipment, during
public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the
COVID-19 pandemic.[16]

Regulations[edit]
The programs for safety regulation vary widely by the type of product, its potential risks, and the
regulatory powers granted to the agency. For example, the FDA regulates almost every facet of
prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and
safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates
most products with a set of published standards enforced by a modest number of facility inspections.
Inspection observations are documented on Form 483.[citation needed]
In June 2018, the FDA released a statement regarding new guidelines to help food and drug
manufacturers "implement protections against potential attacks on the U.S. food supply". [17] One of
the new guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and
procedures by the food industry to reduce the risk of compromise in facilities and processes that are
significantly vulnerable.[citation needed]
The FDA also uses tactics of regulatory shaming,[18] mainly through online publication of non-
compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity
to reputational damage. For example, in 2018, the agency published an online "black list," in which it
named dozens of branded drug companies that are supposedly using unlawful or unethical means to
attempt to impede competition from generic drug companies.[19]
The FDA frequently works 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 in performing
regulatory inspections and enforcement actions.[citation needed]

Food and dietary supplements[edit]

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Main article: Regulation of food and dietary supplements by the U.S. Food and Drug Administration
The regulation of food and dietary supplements by the Food and Drug Administration is governed by
various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to
the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to
oversee the quality of substances sold as food in the United States, and to monitor claims made in
the labeling of both the composition and the health benefits of foods.
The FDA subdivides substances that it regulates as food into various categories—including
foods, food additives, added substances (man-made substances that are not intentionally introduced
into food, but nevertheless end up in it), and dietary supplements. Dietary supplements or dietary
ingredients include vitamins, minerals, herbs, amino acids, and. enzymes. [20] Specific standards the
FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a
variety of means to address violations of standards for a given substance category.
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 meet
the current requirements. These manufacturers and distributors are not allowed to advertise their
products in an adulterated way, and they are responsible for evaluating the safety and labeling of
their product.[21]
The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that
sometimes appear on dietary supplements but need further evaluation further. [22] An ingredient is
added to this list when it is excluded from use in a dietary supplement, does not appear to be an
approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market
notification without having a satisfied requirement. [23]
"FDA-Approved" vs. "FDA-Accepted in Food Processing"[edit]
The FDA does not approve applied coatings used in the food processing industry.[24] There is no
review process to approve the composition of nonstick coatings; nor does the FDA inspect or test
these materials. Through their governing of processes, however, the FDA does have a set of
regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence,
materials like Polytetrafluoroethylene (Teflon) are not, and cannot be, considered as FDA Approved,
rather, they are "FDA Compliant" or "FDA Acceptable".
Medical countermeasures (MCMs)[edit]
Further information: Biosecurity, Bioterrorism, and Biosecurity in the United States
Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that
can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN)
attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN
attacks or threats.[25] The FDA runs a program called the "FDA Medical Countermeasures Initiative"
(MCMi), with programs funded by the federal government. It helps support "partner" agencies and
organisations prepare for public health emergencies that could require MCMs.[25][26]

Medications[edit]
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FDA Building 51 houses the Center for Drug Evaluation and Research.

The Center for Drug Evaluation and Research uses different requirements for the three main drug
product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it
is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a
different purpose, or undergoes any substantial change. The most rigorous requirements apply
to new molecular entities: drugs that are not based on existing medications.
New medications[edit]
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New drugs receive extensive scrutiny before FDA approval in a process called a new drug
application (NDA).[27] Under the Trump administration, the agency has worked to make the drug-
approval process go faster.[28]: 10  Critics, however, argue that the FDA standards are not sufficiently
rigorous, allowing unsafe or ineffective drugs to be approved. [29] New drugs are available only by
prescription by default. A change to over-the-counter (OTC) status is a separate process, and the
drug must be approved through an NDA first. A drug that is approved is said to be "safe and
effective when used as directed".
Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical
trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola
epidemic with the use, by prescription and authorization, of ZMapp and other experimental
treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for
which no existing remedies or drugs are satisfactory, or where there has not been an advance in a
long period of time. The studies are progressively longer, gradually adding more individuals as they
progress from stage I to stage III, normally over a period of years, and normally involve drug
companies, the government and its laboratories, and often medical schools and hospitals and
clinics. However, any exceptions to the aforementioned process are subject to strict review and
scrutiny and conditions, and are only given if a substantial amount of research and at least some
preliminary human testing has shown that they are believed to be somewhat safe and possibly
effective. (See FDA Special Protocol Assessment about Phase III trials.)
Advertising and promotion[edit]
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The FDA's Office of Prescription Drug Promotion reviews and regulates prescription drug advertising
and promotion through surveillance activities and issuance of enforcement letters to pharmaceutical
manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal
Trade Commission. The FDA also empowers third-party enforcer-firms to engage in some regulatory
oversight, e.g. the FDA expects pharmaceutical companies to make sure that third-party suppliers
and labs abide by the agency's health and safety guidelines. [30]: 4 
The drug advertising regulation[31] contains two broad requirements: (1) a company may advertise or
promote a drug only for the specific indication or medical use for which it was approved by FDA.
Also, an advertisement must contain a "fair balance" between the benefits and the risks (side
effects) of a drug.
The term off-label refers to drug usage for indications other than those approved by the FDA.
Post-market safety surveillance[edit]
After NDA approval, the sponsor must then review and report to the FDA every single patient
adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug
events within 15 days, and other events on a quarterly basis.[32] The FDA also receives directly
adverse drug event reports through its MedWatch program.[33] These reports are called "spontaneous
reports" because reporting by consumers and health professionals is voluntary.
While this remains the primary tool of post-market safety surveillance, FDA requirements for post-
marketing risk management are increasing. As a condition of approval, a sponsor may be required to
conduct additional clinical trials, called Phase IV trials. In some cases, the FDA requires risk
management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that
require actions to be taken to ensure that the drug is used safely. [34][35] For example, thalidomide can
cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not
conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that
people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to
avoid addiction and diversion of drugs.[34] The drug isotretinoin has a REMS program
called iPLEDGE.[36]
Generic drugs[edit]
Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose
patents have expired.[37] Approved generic drugs should have the same dosage, safety,
effectiveness, strength, stability, and quality, as well as route of administration. In general, they are
less expensive than their name brand counterparts, are manufactured and marketed by rival
companies and, in the 1990s, accounted for about a third of all prescriptions written in the United
States.[37] For a pharmaceutical company to gain approval to produce a generic drug, the FDA
requires scientific evidence that the generic drug is interchangeable with or therapeutically
equivalent to the originally approved drug.[38] This is called an Abbreviated New Drug
Application (ANDA).[39] As of 2012, 80% of all FDA approved drugs are available in generic form. [citation
needed]
Generic drug scandal[edit]
In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic
drugs for sale to the public.[37] Charges of corruption in generic drug approval first emerged in 1988
during the course of an extensive congressional investigation into the FDA. The oversight
subcommittee of the United States House Energy and Commerce Committee resulted from a
complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh. When its application to
manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was
being discriminated against, soon began its own private investigation of the agency in 1987. Mylan
eventually filed suit against two former FDA employees and four drug-manufacturing companies,
charging that corruption within the federal agency resulted in racketeering and in violations
of antitrust law. "The order in which new generic drugs were approved was set by the FDA
employees even before drug manufacturers submitted applications" and, according to Mylan, this
illegal procedure was followed to give preferential treatment to certain companies. During the
summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded
guilty to criminal charges of accepting bribes from generic drugs makers, and two companies (Par
Pharmaceutical and its subsidiary Quad Pharmaceuticals)[40] pleaded guilty to giving bribes.
Furthermore, it was discovered that several manufacturers had falsified data submitted in seeking
FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which
sought approval of a generic version of the drug Dyazide, a medication for high blood pressure,
submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA
investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of
drugs were eventually suspended or recalled by manufacturers. In the early 1990s, the U.S.
Securities and Exchange Commission filed securities fraud charges against the Bolar
Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. [37]
Over-the-counter drugs[edit]
Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription.[41] The FDA
has a list of approximately 800 such approved ingredients that are combined in various ways to
create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously
approved prescription drugs now deemed safe enough for use without a medical practitioner's
supervision like ibuprofen.[42]
Ebola treatment[edit]
In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical
company Tekmira to the Fast Track program, but halted the phase 1 trials in July pending the receipt
of more information about how the drug works. This was widely viewed as increasingly important in
the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended
in June 2016.[43]
Coronavirus (COVID-19) testing