Food and Drug Administration

What It Means

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services that is responsible for protecting public health. By enforcing various laws and regulations, the agency guarantees the safety and effectiveness of foods, human and veterinary drugs, biological products (such as vaccines, blood products, and gene therapy), cosmetics, and products that emit radiation (including X-ray equipment, cellular phones, and microwave ovens). The agency may regulate products and substances by banning them completely, limiting their distribution, or placing restrictions on the way they can be marketed (or advertised). The FDA also strives to promote public health by funding scientific research and providing Americans with the accurate, science-based information they need to make important medical and dietary decisions.

In 2006 it was estimated that the agency oversaw the production and distribution of $1 trillion worth of goods per year, an operation that cost approximately $3 per taxpayer.

When Did It Begin

The FDA was created in 1906, when President Theodore Roosevelt (1858–1919) signed into law the Pure Food and Drug Act. Fraudulent (fake or ineffective) drugs and impure foods had long been a problem in the American marketplace, but in the late nineteenth century there was a marked rise in the prevalence of such misrepresented and adulterated (or tainted) goods. For example, many mothers unknowingly gave their sick children morphine, and grocers often simply deodorized rotten eggs. Such goods posed a threat to public safety, and legitimate manufacturers also feared that their own businesses would be ruined by a widespread loss of consumer confidence.

Before the FDA was created, such matters were addressed by the Division of Chemistry (later renamed the Bureau of Chemistry), which President Lincoln had established in 1862 as a part of the U.S. Department of Agriculture. While the division could investigate and conduct scientific studies into adulterated food and drug products, however, it did not have the authority to set and enforce rules (which in the U.S. government is called regulatory power).

A number of factors contributed to the establishment of the FDA as a regulatory agency in 1906. With the appointment of chemist Harvey Washington Wiley (1844–1930) as head of the Division of Chemistry in 1883, the government began to take a more aggressive role in identifying and studying the chemical additives and preservatives contained in food and drugs. Published between 1887 and 1902, Wiley’s 10-part study Foods and Food Adulterants generated considerable public outcry as well as demand for a federal law to prohibit the use of dangerous adulterants in, and the inaccurate branding of, food and drugs. Public concern was further inflamed by the muckrakers, investigative journalists who exposed the deceitful practices and appalling sanitary conditions of certain American businesses. Two landmark publications that led to the passage of the Pure Food and Drug Act (also known as the Wiley Act) were “The Great American Fraud,” a series of articles by Samuel Hopkins Adams (1871–1958) analyzing some of the country’s most popular medicines, which appeared in Collier’s magazine in 1905; and The Jungle (1906) by Upton Sinclair (1878–1968), a shocking portrait of a Chicago meatpacking plant.

The next major milestone in FDA history was the passage of the Federal Food, Drug, and Cosmetic Act in 1938. For several years Congress had been under pressure to make important modifications and updates to the Pure Food and Drug Act of 1906. Still, it was not until a medical disaster occurred in 1937 (wherein an untested antibiotic called Elixir Sulfanilamide resulted in the deaths of more than 100 people, mostly children) that the legislature was forced to act. Although it has been updated and amended considerably over the last several decades, the 1938 law still forms the foundation of the FDA’s jurisdiction and duties.

More Detailed Information

The FDA is headed by a commissioner, who is appointed by the president and confirmed by Congress. The agency is composed of five major centers: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM). The FDA as a whole is staffed by about 9,000 employees who work in and around Washington, D.C., as well as in field offices throughout the country.

The FDA’s activities fall into five major categories. The first of these is new product review, the process by which the agency tests the safety and effectiveness of a new product before it is approved for sale. This review is conducted for new human drugs and biological products (also known as biologics), complex medical devices, food and color additives, infant formulas, and animal drugs. Second, the FDA is responsible for monitoring these products after they reach the market (become available for sale), to make sure that they continue to be safely manufactured and transported and that no new health risks arise.

Third, the FDA establishes regulations and safety standards to guide manufacturers in the requirements for maintaining product safety and keeping citizens and the health-care community accurately informed. It requires that manufacturers provide truthful and informative labels on packaging for foods, over-the-counter medicines, dietary supplements, and other products, so that consumers can see the ingredients of a product, understand safe dosages, and have ready access to any other information they might need for safe and effective use of the product. The agency also works with foreign governments to make sure that products imported into the United States meet the FDA’s safety standards.

A fourth area of FDA activity is scientific research, which is conducted by the agency’s biologists, chemists, physicians, biomedical engineers, pharmacologists, veterinarians, toxicologists, and other specialists. Their findings are used as the basis for the FDA’s regulatory actions, to establish safety standards, to weigh the risks associated with potential “breakthrough” drugs (new products that may change the way certain diseases are treated), and to inform and educate the public. Although the FDA does not develop new products itself, its scientific findings certainly influence the advancements of the food, drug, medical, cosmetic, and veterinary industries.

Finally, the FDA engages in various enforcement activities. For example, in cases where one batch of a product turns out to be defective because of a manufacturing error, or unforeseen side effects are discovered in a product that was thought to be safe, the FDA may take one or more of the following measures. It may ask the manufacturer to recall the product (a recall is a public request for consumers to return a product that has been found to be contaminated, defective, or otherwise unsafe); it may officially withdraw approval (of a drug, for example); it may require changes to the product’s labeling; and it may issue warnings to doctors or other health-care professionals. If necessary, the FDA can also take legal action against those who deliberately violate the law.

Recent Trends

At the turn of the millennium, technological advances in food production, pharmaceuticals, genetic engineering, and other areas were occurring at a rapid pace. As a result, the FDA faced major challenges in protecting public health and safety. The agency was also concerned about developing preventative and response mechanisms for potential sudden health crises, which might include the spread of a dangerous foodborne illness like E. coli bacteria, the emergence of strains of antibiotic-resistant bacteria, and acts of biological terrorism that would introduce deadly agents such as anthrax or smallpox into the population. The continued growth of international commerce also presented new challenges for the FDA, requiring the agency to place a new emphasis on monitoring imports and cooperating with foreign regulators.