Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services that is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States.
The FDA was established in 1930 as a part of the US Department of Health and Human Services (HHS), regulates products accounting for roughly 25% of the United States gross national product.
The United States Food and Drug Administration (FDA) has issued two interim final regulations, requiring registration of food facilities and prior notice of food imports to FDA. These interim final regulations are the first two of four FDA regulations implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act).
The regulations affect most U.S. and foreign entities that manufacture, hold, process, distribute, grow, or import food products for the United States market. “Food” is defined very broadly in these regulations to cover all human and animal food regulated by FDA, including food ingredients, dietary supplements, fresh produce, fish and seafood, alcoholic beverages, live animals to be processed into food, animal feed, and pet food. It does not include food contact substances, such as food packaging.
The FDA regulates an enormous number of companies. As of November 2000, the FDA's Official Establishment Inventory, the FDA's database of establishments regulated by the agency, included 135,885 firms including these :
In addition, there are about 1,500 dietary supplement manufacturers, ingredient suppliers, and wholesalers.
Some establishments, such as drug and medical device firms, are required to register with the FDA. Other companies such as dietary supplement manufacturers, warehouses, and, until recently, food firms are not required to register with the FDA. These numbers are subject to fluctuation. Indeed, a report from the HHS Office of the Inspector General took the agency to task after a telephone survey of 100 randomly selected firms suggested that as many as 16% of the businesses listed in the Official Establishment Industry (21,742 firms) may no longer be in operation.
The Office of the Inspector General (OIG) also pointed out that some firms that belong in the inventory may not be included, although the OIG's study did not directly address this issue. New requirements that food establishments register with the FDA and new information technology may help reduce inaccuracies in the database.
FDA requirements vary depending on the type of product being produced. Regulations pertaining to some of the key FDA-regulated commodities are discussed here.
The FDA recently announced plans to take several steps to improve the agency’s review of "innovative" biologic, drug, medical device and veterinary products (FDA, Improving Innovation, 2003).
The FDA ho its efforts will facilitate the use of advanced technology and speed the agency's review and approval of new types of medical treatments. The agency plans to take a number of steps, including publishing information for manufacturers about the "design and execution of clinical trials" for cancer, diabetes, and obesity treatments; attempting to reduce delays in the review of new products by improving communication with manufacturers early in the review process; and providing additional guidance about "three emerging areas of technology": cell and gene therapies, "novel drug delivery systems" or treatments that take advantage of improved scientific understanding about how an individual’s genetic makeup impacts the effectiveness of the medications they are taking (pharmacogenomics)."
More than 115 million Americans consume dietary supplements. Millions of others buy these products for their friends or family. Supplement sales exceeded $17 billion in 2000, according to the FDA. According to CFSAN, It is defined as "[a] dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet." Amino acids, botanical products (herbs), minerals, and vitamins as well as extracts and concentrates are some examples of "dietary ingredients" cited by CFSAN.
Supplements may come in a variety of forms but "whatever their form may be, the Dietary Supplements Health and Education Act (DSHEA) places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement" so that they are not confused with "conventional food[s]" (CFSAN, Overview of Dietary Supplements, 2001).
Until the 20th century, drugs were regulated primarily by state and local governments. Drugs "could be bought and sold like any other consumer good" (US Regulatory Affairs History, Chapter 1). Regulation became more stringent as medical technology improved and high-profile incidents highlighted the need for at least some degree of government monitoring of these products.
Virus-Toxin Law of 1902: One of the first such incidents was associated with a vaccine. After patients suffered injuries from diphtheria vaccine "contaminated with tetanus," Congress passed the Virus-Toxin law (also referred to as the Biologics Control Act), that required licensing of biologics establishments, inspections of vaccine manufacturers, and premarket approval of vaccines and other products (Hyman, 1998; CBER, Commemorating, 2002; CBER, CBER Vision, 2002). This law also is referred to as the Biologics Control Act.
Drugs are defined in section 201(g) of the FD&C Act as (1) articles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to these compendia; (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; (4) ingredients of these products.