Food and Drug Administration
Ensures safety of food, drugs, medical devices, and cosmetics
Mission & Role
Overview
The FDA has regulatory oversight over a large array of products that affect the health and life of American citizens.[102] As a result, the FDA's powers and decisions are monitored by several governmental and non-governmental organizations. A $1.8million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.[132][158]
History
History
Main article: History of the Food and Drug Administration
Up until the 20th century, there were few federal laws regulating the contents and sale of domestically produced food and pharmaceuticals, with one exception being the Vaccine Act of 1813.[100] The history of the FDA can be traced to the latter part of the 19th century and the Division of Chemistry of the U.S. Department of Agriculture,[101] which itself derived from the Copyright and Patent Clause. Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market.[101] Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era.[102] The Biologics Control Act of 1902 was put in place after a diphtheria antitoxin derived from tetanus-contaminated serum caused the deaths of thirteen children in St. Louis, Missouri. The serum was originally collected from a horse named Jim who had contracted tetanus.[103]
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Harvey W. Wiley, chief advocate of the Food and Drug Act
In June 1906, President Theodore Roosevelt signed into law the Pure Food and Drug Act of 1906, also known as the "Wiley Act" after its chief advocate.[102][101] The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated".[101] The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopeia or the National Formulary.[104][101]
The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.[102] Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent.[102] In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide Administration.[105] This name was shortened to the Food and Drug Administration (FDA) three years later.[106]
By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, mascara that could cause blindness, and worthless "cures" for diabetes and [tuberculosis](h
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Programs & Activities
Regulatory programs
Emergency approvals (EUA)
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.[19]
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.[20]
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".[21] One of the 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.[22][23]
The FDA also uses tactics of regulatory shaming,[24] 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.[25]
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.[26]
Food and dietary supplements
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 (human-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.[27] 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.[28]
The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that some
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Agency overview, history, and program data sourced from Wikipedia (CC-BY-SA 3.0).
Key Regulations
Current Good Manufacturing Practice and Hazard Analysis for Human Food
Requires food facilities to implement preventive controls for food safety including hazard analysis.
Applications for FDA Approval to Market a New Drug
Establishes the process for gaining FDA approval to sell new drugs, requiring proof of safety and effectiveness.
Medical Device Classification Procedures
Classifies medical devices into three risk categories with increasing regulatory requirements for each class.
Food Labeling Requirements
Requires packaged foods to display a standardized Nutrition Facts label and ingredient list.
Tobacco Product Restrictions for Minors
Restricts the sale of tobacco products to minors and limits marketing practices.
Investigational New Drug Application
Requires FDA approval before new drugs can be tested on humans in clinical trials.
Current Good Manufacturing Practice for Dietary Supplements
Establishes manufacturing quality standards for dietary supplement producers to ensure product safety.
Enforcement Actions
No enforcement actions found for FDA in the current dataset.