Food and Drug Administration


The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed, and veterinary products.
The FDA's primary focus is on enforcing the Federal Food, Drug, and Cosmetic Act. However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers, cellular phones, and condoms. In addition, the FDA takes control of diseases in contexts varying from household pets to human sperm donated for use in assisted reproduction.
The FDA is led by the commissioner of food and drugs, appointed by the president with the advice and consent of the Senate. The commissioner reports to the secretary of health and human services. Marty Makary is the current commissioner.
The FDA's headquarters is located in the White Oak area of Silver Spring, Maryland. The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
File:FDA Bldg 31 - Exterior.jpg|thumb|upright|FDA Building 31 houses the Office of the Commissioner and the Office of Regulatory Department of Health and Human Services. The agency consists of fourteen centers and offices.|alt=

Organizational structure

[Headquarters]

FDA 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 employees and facilities on of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland. In 2001, the General Services Administration 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. the FDA campus has a population of 10,987 employees housed in approximately of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner, the Office of Regulatory Affairs, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research and offices for the Center for Veterinary Medicine.
With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 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, and construction is expected to be completed by 2035, dependent on GSA appropriations.

Field locations

Office of Regulatory Affairs

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, 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. The 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

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, 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.

Other locations

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.

Scope and funding

As of 2021, the FDA had responsibility for overseeing $2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews.
According to Forbes, pharmaceutical firms provide 75% of the FDA's drug review budget.

Regulatory programs

Emergency approvals (EUA)

Emergency Use Authorization 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.

Regulations

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.
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". One of the guidelines includes the Intentional Adulteration rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable.
The FDA also uses tactics of regulatory shaming, 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.
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.

Food and dietary supplements

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, and dietary supplements. Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids, and enzymes. 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, 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.
The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. 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.