It hasn't always been this way. If you take a historical perspective, the FDA has been in the game for nearly 200 years.
The FDA Now
Part of the FDA's significance comes from the financial muscle it flexes. The U.S. Food and Drug Administration oversees items accounting for 24 cents of every dollar spent by consumers. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a current staff of approximately 9000 and a projected 2009 budget of $2.4 billion, made up of chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers and others.
Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. Investigators and inspectors visit more than 16,000 facilities a year, and arrange with state governments to help increase the number of facilities checked.1
Roots in the 19th Century
Originally, the FDA was known as the Division of Chemistry and then the Bureau of Chemistry. The Bureau's name changed to the Food, Drug and Insecticide Administration in 1927 and in 1930, the name was shortened to the current version.
The first attempt at any kind of regulation occurred in 1820, when eleven doctors met to establish the U.S. Pharmacopeia (USP), the first compendium of standard drugs for the country. Only 217 drugs were admitted. Today, USP is an official public standards-setting authority for all prescription and over-the-counter medicines manufactured or sold in the United States.
In the 19th century, individual states controlled domestically produced and distributed foods and drugs and that control differed markedly from state to state. By this time, science had advanced enough to detect fraud in medicines and foodstuffs and legitimate manufacturers were becoming alarmed that deceitful vendors would damage their profit margins. Something had to change.
Change rolled into Washington in a horse and buggy in the form of Harvey Washington Riley. A big jovial man with a degree from Purdue University, he had an inquiring mind and a dynamic personality.
The Father of the Pure Food Laws
He was offered the position of Chief Chemist in 1882. Wiley brought to his work a practical knowledge of agriculture, sympathy for the problems of the country's agricultural industry and an innate flair for public relations.
His arrival in Washington announced a change in the way the government handled fraud in foods and medicines. Wiley illustrated the possibility of fraud in chemical preservatives through his well-publicized "poison squad" experiments, which drew national attention to the need for a federal food and drug law.
An article dated May 21, 1904 in the New York Times reported on the volunteer's reactions. The headline read, "Poison Squad Escapes Federal Food Experts. Been Eating Doctored Food Five Months and Don't Like It."
"Some of the so-called 'poison squad' of a dozen men have suffered in the course of the experiments on their digestive organs," the reporter writes. "The ill effects of eating drugs used in preserving articles of diet are said to be visible on all members of the squad, and one or two of them appear to be on the verge of breaking down."2
"What we tried to learn and did learn," said an official of the (Chemical Laboratory of the Department of Agriculture) department to-day, "was the effect of food preservatives upon the system. This effect was mildly injurious or deadly, according to the amount and character of the preservatives absorbed...As a result of the experiment we know now just where we stand."
The reporter went on to write: "The twelve young men of the poison squad ate boiled eggs, toast and chops and drank milk this morning in the department kitchen." They refused to discuss their experience but one remarked: "I've had all I want."
In 1906, President Roosevelt signed the Food and Drugs Act, known as the Wiley Act (from whence came the public nickname Father of the Pure Food Laws), which prohibited the transport of unlawful food and drugs under penalty of product seizure and/or prosecution. The basis for the law lay in regulating product labeling instead of pre-market approval.
"The fact that enforcement of the federal Pure Food and Drugs Act of 1906 was given to the Bureau of Chemistry rather than placed in the Department of Commerce or the Department of the Interior is a tribute to the scientific qualifications which the Bureau of Chemistry brought to the study of food and drug adulteration and misbranding. The first food and drug inspectors were hired to complement the work of the laboratory scientists, and an inspection program was launched which revolutionized the country's food supply within the first decade under the new federal law. Wiley's tenure, however, was marked by controversy over the administration of the 1906 statute which he had worked so hard to secure. Concerns over preserving chemicals, which had not been specifically addressed in the law, continued to be controversial."3
Political infighting got the better of Wiley; in 1912, he resigned, assuming leadership of the laboratories of Good Housekeeping Magazine, where he established the Good Housekeeping Seal of Approval.
Wiley was a colorful character and he got the ball rolling. Since 1906, there have been a number of other milestones that have led the FDA to its present position of oversight in the United States. These highlights include4:
The original Pure Food and Drugs Act is passed by Congress on June 30 and signed by President Theodore Roosevelt. It prohibits interstate commerce in misbranded and adulterated foods, drinks, and drugs. The Meat Inspection Act is passed the same day.
First Certified Color Regulations, requested by manufacturers and users, list seven colors found suitable for use in foods.
Congress enacts the Sherley Amendment to prohibit the labeling of medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.
The Gould Amendment requires that food package contents be "plainly and conspicuously marked on the outside of the package in terms of weight, measure, or numerical count."
The Bureau of Chemistry is reorganized into two separate entities. Regulatory functions are located in the Food, Drug, and Insecticide Administration, and nonregulatory research is located in the Bureau of Chemistry and Soils.
The name of the Food, Drug, and Insecticide Administration is shortened to the Food and Drug Administration (FDA) under an agricultural appropriations act.
Elixir Sulfanilamide, containing the poisonous solvent diethylene glycol, kills 107 people, many of whom are children, dramatizing the need to establish drug safety before marketing and to enact the pending food and drug law.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938, containing the new provisions that required new drugs to be shown to be safe before marketing, is passed by Congress.
The FDA transferred from the Department of Agriculture to the Federal Security Agency, with Walter G. Campbell appointed as the first Commissioner of Food and Drugs.
The Public Health Service Act is passed and covers a broad spectrum of health concerns, including regulation of biological products and control of communicable diseases.
The FDA publishes a guidance to industry for the first time. This guidance, "Procedures for the Appraisal of the Toxicity of Chemicals in Food," came to be known as the "black book."
The Durham-Humphrey Amendment defines the kinds of drugs that cannot be safely used without medical supervision and restricts their sale to prescription by a licensed practitioner.
The FDA carries out the first large-scale radiological examination of food after receiving reports that tuna suspected of being radioactive was being imported from Japan after atomic blasts in the Pacific. The FDA begins monitoring around the clock to meet the emergency.
The Food Additives Amendment, requiring manufacturers of new food additives to establish safety, is enacted. The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals.
U.S. cranberry crop is recalled three weeks before Thanksgiving for FDA tests to check for aminotriazole, a weedkiller found to cause cancer in laboratory animals. Cleared berries were allowed a label stating that they had been tested and had passed FDA inspection, the only such endorsement ever allowed by the FDA on a food product.
The Color Additive Amendment, requiring manufacturers to establish the safety of color additives in foods, drugs, and cosmetics, is enacted. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.
The Federal Hazardous Substances Labeling Act, enforced by the FDA, requires prominent label warnings on hazardous household chemical products.
Thalidomide, a new sleeping pill, is found to have caused birth defects in thousands of babies born in Western Europe. News reports on the role of Dr. Frances Kelsey, FDA medical officer, in keeping the drug off the U.S. market, arouse public support for stronger drug regulation.
Kefauver-Harris Drug Amendments are passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to the FDA the effectiveness of their products before marketing them.
Reorganization of federal health programs places the FDA in the Public Health Service (PHS).
The White House Conference on Food, Nutrition, and Health recommends systematic review of GRAS substances in light of the FDA's ban of the artificial sweetener cyclamate. President Richard M. Nixon orders the FDA to review its GRAS list.
The FDA requires the first patient package insert: oral contraceptives must contain information for the patient about specific risks and benefits.The Environmental Protection Agency is established and takes over an FDA program for setting pesticide tolerances.
The PHS Bureau of Radiological Health is transferred to the FDA. Its mission: protection against unnecessary human exposure to radiation from electronic products in the home, industry, and the healing arts.
National Center for Toxicological Research is established in the biological facilities of the Pine Bluff Arsenal in Arkansas. Its mission is to examine biological effects of chemicals in the environment, extrapolating data from experimental animals to human health.
Over-the-Counter (OTC) Drug Review is begun to enhance the safety, effectiveness, and appropriate labeling of drugs sold without prescription.Regulation of biologics--including serums, vaccines, and blood products--is transferred from the National Institutes of Health (NIH) to the FDA.
Low-acid food processing regulations issued, after botulism outbreaks from canned foods, to ensure that low-acid packaged foods have adequate heat treatment and are not hazardous.
Medical Device Amendments are passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with the FDA and to follow quality control procedures.Vitamins and Minerals Amendments ("Proxmire Amendments") stop the FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.
The Saccharin Study and Labeling Act is passed by Congress to stop the FDA from banning the chemical sweetener but requiring a label warning that it has been found to cause cancer in laboratory animals.
The Infant Formula Act establishes special FDA controls to ensure necessary nutritional content and safety.
Tamper-resistant packaging regulations are issued by the FDA to prevent poisonings such as deaths from cyanide placed in Tylenol capsules. The Federal Anti-Tampering Act, passed in 1983, makes it a crime to tamper with packaged consumer products.
The Orphan Drug Act, enabling the FDA to promote research and marketing of drugs needed for treating rare diseases, is passed.
The AIDS test for blood is approved by the FDA in its first major action to protect patients from infected donors.
The Food and Drug Administration Act of 1988 establishes the FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate.
The Nutrition Labeling and Education Act requires all packaged foods to bear nutrition labeling and all health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services.
The Prescription Drug User Fee Act requires drug and biologics manufacturers to pay fees for product applications and supplements, and other services. The act also requires the FDA to use these funds to hire more reviewers to assess applications.
Nutrition facts, basic per-serving nutritional information, are required on foods under the Nutrition Labeling and Education Act of 1990. The FDA and the Food Safety and Inspection Service of the Department of Agriculture re-create the food label to list the most important nutrients in an easy-to-follow format.
Revising a policy from 1977 that excluded women of childbearing potential from early drug studies, the FDA issues guidelines calling for improved assessments of medication responses as a function of gender. Companies are encouraged to include patients of both sexes in their investigations of drugs.
The Dietary Supplement Health and Education Act establishes specific labeling requirements, provides a regulatory framework, and authorizes the FDA to promulgate good manufacturing practice regulations for dietary supplements. This act classifies them as food.
The FDA declares cigarettes to be "drug delivery devices." Restrictions are proposed on marketing and sales to reduce smoking by young people.
The Food and Drug Administration Modernization Act reauthorizes the Prescription Drug User Fee Act of 1992 and mandates the most wide-ranging reforms in agency practices since 1938. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulate health claims for foods.
The FDA promulgates the Pediatric Rule, a regulation that requires manufacturers of selected new and extant drug and biological products to conduct studies to assess their safety and efficacy in children.
A final rule mandates that all OTC drug labels must contain data in a standardized format. These drug facts are designed to provide the patient with easy-to-find information, analogous to the Nutrition Facts label for foods.
The U.S. Supreme Court, upholding an earlier decision in Food and Drug Administration v. Brown & Williamson Tobacco Corp. et al., ruled 5-4 that FDA does not have authority to regulate tobacco as a drug.
The Best Pharmaceuticals for Children Act improves safety and efficacy of patented and off-patent medicines for children.
To help consumers choose heart-healthy foods, the Department of Health and Human Services announces that the FDA will require food labels to include trans fat content, the first substantive change to the Nutrition Facts panel on foods since 1993.
The Animal Drug User Fee Act permits the FDA to collect subsidies for the review of certain animal drug applications from sponsors, ensuring the safety and effectiveness of drugs for animals and the safety of animals used as foodstuffs.
Project BioShield Act of 2004 authorizes the FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the United States.
Passage of the Food Allergen Labeling and Consumer Protection Act requiring the labeling of any food that contains a protein derived from peanuts, soybeans, cow's milk, eggs, fish, crustacean shellfish, tree nuts, and wheat.
Formation of the Drug Safety Oversight Board, composed of FDA staff and representatives from the NIH and the Veterans Administration, is announced. The board advises the director of the FDA's Center for Drug Evaluation and Research and works with the agency in communicating safety information to health professionals and patients.
The FDA is here to stay. The new administration will appoint a new leader in 2009 who might be another Wiley, able to shake things up and foment change. It's possible that the new head of the FDA will be a proponent of the status quo. But one thing is clear: the agency's focus as a defender of public safety is not going away.
References1. Food and Drug Administration. 18 December, 2008 http://www.fda.gov/oc/history/historyoffda/default.htm>2. New York Times. "Poison Squad Escapes Federal Food Experts." 18 December, 2008 http://query.nytimes.com/mem/archive-free/pdf?_r=1&res=9E0DE5D91E3BE631A25751C2A9639C946597D6CF>3. Arlington National Cemetery Website. 18 December, 2008 http://www.arlingtoncemetery.net/hwwiley.htm>4. Food and Drug Administration. 18 December, 2008 http://www.fda.gov/fdac/features/2006/106_milestones.html>
Robyn Barnes is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).
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