FDA - A Brief Overview of the Food and Drug Administration - FDA
The Food and Drug Administration (FDA) is the oldest public health agency in America. It is responsible for ensuring that products such as foods, drugs, cosmetics, and medical devices are safe and effective and that these products are accurately and honestly presented to the public.
The FDA is under the Department of Health and Human Services (DHHS) within the executive branch of the US government.
The head of the FDA is the Commissioner of the FDA and is appointed by the President of the United States. The FDA employees many professionals; Lawyers, Pharmacists, Biologists, Veterinarians, Physicians, Pharmacologists, and Chemists.
The lead office for the FDA’s field activities is The Office of Regulatory Affairs (ORA). ORA headquarters is comprised of four offices. The ORA is responsible for inspecting regulated companies to ensure that they are complying with the laws and regulations governing the products that they make. The field staffs of ORA are responsible for inspecting companies within their region. The ORA has divided the United States into 5 regions and the field staff is responsible for regulating the companies within the states of their region.
The FDA’s non-field activities are organized into Centers. Each center specializes in one of the products that FDA is responsible for regulating.
The center that is responsible for ensuring food and cosmetic safety is FDA CFSAN (Center for Food Safety and Applied Nutrition). CFSAN oversees US food manufacturers, processors, and warehouses to ensure that the food supply is safe, sanitary, wholesome, and properly labelled. The US Department of Agriculture (USDA) not the FDA regulates meat and poultry. CFSAN also works with other governments to ensure that imported food meet the US food requirements. CSAN is responsible for ensuring the accuracy of the information listed on food labels. CFSAN also ensures the safety of special nutritional products such as infant formula and medical foods.
CFSAN is also responsible for cosmetic safety and labelling. CFSAN can only regulate cosmetic products after they are sold to the public. One way the CFSAN regulates cosmetics is by monitoring adverse reactions that may occur. CFSAN is responsible for certifying the colors used in cosmetics and for ensuring that only certified colors are used.
The center that is responsible for ensuring that prescription, over-the-counter, and generic drugs are safe and effective and work correctly is FDA CDER (Center for Drug Evaluation and Research). CDER regulates a wide range of products from fluoride toothpaste to aspirin from sunscreens to cancer treatments. They oversee new drug development, manufacturing, approval, post market performance, drug labelling, and drug promotional information. CDER analyzes the data that drug manufactures submit to them to determine if the drug works according to its intended use. If CDER determines that the drug is safe and effective they will approve the drug. CDER also has the authority to take action if unexpected risks occur after a drug has been approved. These actions include informing the public, having the label changed, or removing the product from the market.
The center that is responsible for overseeing biological products such as blood, vaccines, allergenics, and therapeutics is FDA CBER (Center for Biologics Evaluation and Research). CBER ensure that biologic products, medical devices used for collecting and processing blood products, and drugs closely related to biologics are safe and effective. CBER analyzes data submitted by the manufacturer in the form of an investigational new drug application (IND) to determine if the product is safe and effective for its intended use. If CBER determines that the product is safe and effective they will approve the license application. After approval the products are subject to official lot release. This means that each lot of product is required to have certain tests performed on it prior to being released for distribution. The test results and sometimes a sample of the product, are submitted to CBER for review and approval. Once a biological product is approved for use CBER will continue to monitor the product for safety and stability. If significant problems arise CBER has the authority to have the manufacturer recall or stop manufacturing the product.
The center that is responsible for ensuring that medical devices are safe and effective and that radiating admitting devices are safe is FDA CDRH (Center for Devices and Radiological Health). Medical devices are classified into three classes; Class I, Class II, Class III. The stridency of the regulations varies depending on the class level with Class III medical devices being the most highly regulated. Class III device manufacturers require premarket approval by CDRH prior to distribution of their medical device. Class II device manufacturers are required to submit a 510 K (Premarket Notification) to CDRH which in turn will clear the manufacturer for distribution. Most Class I device manufacturers are exempt from 510(K) filings but are required to register their establishment with CDRH. CDRH is also responsible for monitoring devices through their lifecycles via a postmarket surveillance system.
FDA CVM (Center for Veterinary Medicine) is the center that is responsible for ensuring that animal drugs and medicated feed are safe and effective, that human food derived from animals, including genetically modified animals, is safe for consumption by humans. CVM is responsible for regulating the manufacturing and distribution of food additives and drugs that are given to animals, for approving animal drug products, and for post market monitoring of approved animal drug products. Over the counter drugs as well as veterinarian prescribed drugs for animals are both approved by CVM. Before approving an investigational new animal drug (INAD) the CVM evaluates the drug’s safety and effectiveness on animals as well as on the environment and on humans (who may consume the animal that has consumed the drug). Once the drug has been proven to be safe and effective the CVM will approve the New Animal Drug Application (NADA) and the drug may be marketed.
The FDA Office of Combination Products (OFP) serves as the focal point for combination product issues. The OFP assigns the FDA center (CBER, CDRH, or CDER) that will have the primary responsibility for the review, regulation, and approval of the combination product.
The FDA National Center for Toxicological Research (NCTR) reviews the scientific data that companies submit to the FDA, prior to obtaining approval of their products, and provides expert technical advice to the FDA on their findings.
FDA Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the United States Federal Government. The CFR is divided into 50 titles. The title that pertains to the FDA is Title 21 – Food and Drugs. Title 21 of the CFR is divided into Parts 1 to 1499. Notable parts of 21 CFR are:
- CFR Part 58: is for GLP (Good Laboratory Practices)
CFR Part 202: Prescription Drug Advertising
CFR Part 203: Prescription Drug Marketing
CFR Part 210: Current Good Manufacturing Practice in Manufacturing, Processing, Packaging, or Holding of Drugs: General.
CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals.
CFR Part 312: Investigational New Drug Application.
CFR Part 510: New Animal Drugs
CFR Part 600: Biological Products: General
CFR Part 820: Quality System Regulation
