1. Discuss the Food and Drug Administration’s (FDA) regulatory duties for products under its jurisdiction.

  2. Recognize the historical factors leading to the official establishment of the present day Food and Drug Administration (FDA).

  3. Describe the milestones in the history of the regulations that govern the scientific and ethical conduct of clinical research.

  4. Define the process the FDA follows when writing a regulation.



    Food and Drug Administration    


    Center for Drug Evaluation and Research    


    Center for Biologic Evaluation and Research    


    Center for Device and Radiological Health    


    Department of Health and Human Services    


Food and Drug Administration (FDA): The FDA is the oldest consumer protection agency regulating a variety of products. Five types of activities can describe the FDA’s regulatory approach: (1) new product review; (2) post-market surveillance; (3) setting standards and writing regulations; (4) scientific research; and (5) regulatory enforcement and corrective action.

Product Labeling: Product labeling is the information specifying ingredients, chemical composition, administration, indication, pre-cautions, cautions, interactions, and risks.

Efficacy Data for an Investigational New Drug: The efficacy data is collected to document proof of effectiveness of an investigational drug for a specific indication, route of administration, dosing schedule and dosage amount.

Safety Data for an Investigational New Drug: The safety data is collected to document the safety profile of an investigational drug, such as common adverse effects, drug interactions, and drug disease interaction.

Code of Federal Regulation (CFR): The regulations written and enforced by a federal agency to enforce legislation (laws) passed by Congress.

Department of Health and Human Services (DHHS): The Department of Health and Human Services is the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.


The Food and Drug Administration (FDA) is a public health agency located within the Department of Health and Human Services. The FDA is one of the nation’s oldest consumer protection agencies and has the dual function of law enforcement and scientific research. It has been a law enforcement agency for over 90 years, and a scientific institution since 1862. The FDA has approximately 9,000 employees nationwide to monitor the manufacturing, importing, transporting, storage, and the sale of $1 trillion worth of products (annually). The staff working in the Washington, D.C. area focuses on new product review and approval, writing regulatory policy, and safety surveillance of products on the market.

The FDA performs its duties by writing regulations (CFR: Code of Federal Regulations) from legislation passed by Congress, for the products under its jurisdiction. The FDA Code of Federal Regulations determine the product standards in manufacturing, distribution, labeling, and proving safety and efficacy. As a law enforcement agency, the FDA enforces the Code of Federal Regulations (CFRs) that determine these standards and perform on-site inspections of manufacturers, distributors, and the research entities such as investigator sites, institutional review boards, contract research organizations, and sponsors to assess their adherence to the applicable FDA regulations. The FDA has the jurisdiction to mandate corrective actions for regulatory non-compliance. As a scientific institution, the FDA analyzes products for contamination such as illegal substances, and it reviews the scientific test results of products requiring FDA approval. After approval, the FDA monitors products for their ongoing safety while in use.


The products that the FDA regulates are medicinal (drugs, biologics, complex medical devices), radiation-emitting, food (including pet and livestock feed), cosmetics, and the nation's blood supply. The extent of the FDA's responsibility varies based on the product regulated.


SAFE AND EFFECTIVE MEDICINAL PRODUCTS - The FDA is responsible for protecting the public from unsafe and ineffective medicinal products. This is accomplished by the FDA's system requiring manufacturers to establish and submit scientific proof of an investigational medicinal product's safety and efficacy for its review and determination of approval. After a medicinal product has been granted approval the FDA has a post-marketing surveillance system used to assess the product's ongoing safety while in use.

SAFE CONSUMER AND MEDICAL RADIATION PRODUCTS - The FDA has the responsibility to ensure that radiation-emitting products such as cell phones and microwaves meet certain performance standards to protect the public from unnecessary radiation exposure.

SAFE WHOLESOME AND SANITARY FOODS - The FDA assesses our food supply to verify that it is free from contaminants. They detect and prevent the spreading of food related infections. The FDA reviews new food additives for safety before they can be used and sold to the public. They also monitor the safety of dietary supplements, infant formulas, and medical foods. The FDA is not responsible for regulating meat and poultry products as this falls under the jurisdiction of the United States Department of Agriculture (USDA).

SAFE COSMETICS - The FDA monitors cosmetics for proper labeling and their safety while in use. However, the FDA does not mandate safety testing of cosmetic ingredients, nor do these ingredients require approval prior to their use.

SAFE AND EFFECTIVE ANIMAL DRUGS - The FDA scientifically reviews and evaluates the safety and efficacy data on animal drugs used by Veterinarians and either approves or disapproves their use. The FDA also evaluates the safety of drugs used with livestock and their effects on the environment and the consuming publics' health.

TRUTHFUL AND INFORMATIVE LABELING - The FDA is responsible for ensuring that the products under its jurisdiction have labeling information that is truthful as well as understandable so that the consumer or health care provider can adequately use it.

SAFER BLOOD SUPPLY - The FDA develops initiatives to improve the safety procedures in the blood banking and plasma industries. They attempt to continuously improve and develop accurate testing for donor screening, methods used in detecting hazards in the nation's blood supply, and the quality control procedures that should be used in blood donation and blood banking.


The FDA’s regulatory approach varies based on the respective product. There are five types of activities that can describe its approach. The activities consist of new product review, surveillance, setting standards and writing regulations, performing scientific research, regulatory enforcement, and mandating corrective action.


NEW PRODUCT REVIEW - The core of the FDA’s public health duties is reviewing new products such as drugs, biologics, complex medical devices, and food additives. The FDA's regulatory approach for reviewing new medicinal products can be divided into two types of activities: its pre-approval review and post-approval surveillance. The pre-approval activities involve performing a scientific review and evaluation of the safety and efficacy data submitted in a manufacturer's medicinal product marketing application. The FDA evaluates the study results of laboratory, animal, and human testing to determine whether the resulting benefits outweigh the risks associated with the use of the product. The post-approval activities involve the use of the FDA's post-marketing surveillance system to assess the approved medicinal product's ongoing safety while it is in use (Refer to Surveillance Description). In addition, the FDA performs a safety review and grants approval for new food and color additives, infant formulas, medical foods, and animal drugs.

SURVEILLANCE - The FDA performs two types of surveillance activities on products approved for marketing. One is through its post-marketing surveillance reporting system and the other is through its on-site facility inspections. The post-marketing surveillance reporting system consists of the manufacturers mandatory reporting requirements and the voluntary reporting by consumers and health care providers of adverse experiences and product problems. Every year the FDA receives approximately 400,000 of these reports for its review and management. The FDA performs on-site inspections of manufacturers to verify that the products produced have met the appropriate quality control manufacturing standards.

Based on these surveillance activities the FDA may require a product's recall such as an infant formula manufactured with a contaminate, rescinding product approval such as Drug A is associated with multiple cases of liver failure and death, product label change such as Drug B interacts with Antibiotic C resulting in decreased effectiveness, and/or the sending of warning letters to physicians and health care practitioners. The warning letters can provide information on a product's label change, recall, or rescinding of approval.

STANDARDS AND REGULATIONS - The FDA establishes regulations and product quality control standards to set “benchmarks” in defining the requirements for manufacturers to conduct valid and ethical scientific research, manufacture quality products, adequately label products, and the mandatory reporting of a products ongoing safety while in use. Before product approval the regulations set scientific standards in the conduct, implementation, monitoring, and evaluation of research in humans. It establishes ethical standards and safeguards for research involving human participants. After product approval it sets standards in the mandatory reporting requirements of adverse events and product problems to the FDA. In addition, the FDA assists foreign governments in producing and importing products that have met standards equivalent to those enforced in the United States.

RESEARCH - The FDA performs scientific research to provide the basis for its regulatory decisions and to establish the methods necessary to assess risks. The research results guide the FDA in setting standards and writing regulations.

ENFORCEMENT AND CORRECTIVE ACTION - As part of the FDA's law enforcement function, it performs on-site inspections of the manufacturer's facilities to assess their regulatory adherence. The FDA's action against manufacturers in violation of the regulations depends on the severity of the violation. One action involves working with the manufacturer to correct the problem voluntarily. If voluntary corrections do not occur, or the violation is more severe, the FDA can impose legal remedies, such as product recall, product seizure by federal marshals, detaining of imports, or criminal penalties.


Figure 1.1 illustrates the milestones of the Food and Drug Administration (FDA) establishment and designation as an agency in the United States Federal Government.

FDA Designation and Location TimeLine - Figure 1.1

The FDA resides under the Department of Health and Human Services. Within the FDA there are several centers with specialized functions for a particular area. Figure 1.2 illustrates the centers responsible for the review and approval of medicinal products.

Department of Health and Human Services Medicinal Product Centers - Figure 1.2
Overview of the Food and Drug Administration

  • The FDA is the nation’s oldest consumer protection agency;

  • The FDA has the dual function of law enforcement and scientific research;

  • The FDA’s primary concern is the protection of the American consumer;

  • The FDA regulates food, medicinal products, cosmetics, radiation-emitting products, and the nation's blood supply.

FDA Regulatory Duties

Five types of activities describe the FDA’s regulatory duties:

  • New product review and approval;

  • Post-marketing surveillance;

  • Setting standards and writing regulations;

  • Scientific research;

  • Regulatory enforcement and corrective action.

The FDA evaluates scientific data for safety and efficacy to determine whether it will approve or disapprove of new drugs, biologics, and complex medical devices. A pivotal part of the approval process is determining whether the resulting benefits outweigh the risks associated with the use of the product.

Establishment of the FDA

  • In 1862, President Lincoln appoints a chemist by the name of Charles M. Wetherill, to serve in the new Department of Agriculture. This led to the beginning of the Bureau of Chemistry, which is the predecessor to the Food and Drug Administration.

  • In 1883, Dr. Harvey W. Wiley becomes the chief chemist and expands the Bureau of Chemistry's studies on food adulteration. Because of his belief in a federal law to protect the public, he was known as the "Crusading Chemist" and "Father of the Pure Food and Drugs Act."

  • In 1930, the name “Food and Drug Administration (FDA)” is formally established.

  • In 1988, the FDA becomes an official agency of the Department of Health and Human Services (DHHS).