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FDA Backgrounder
May 3, 1999
Updated August 5, 2002
From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848. The following chronology describes some of the milestones in the history of food and drug regulation in the United States.
Eleven physicians meet in Washington, D.C., to establish the U.S. PHARMACOPEIA, the first compendium of standard drugs for the United States.
DRUG IMPORTATION ACT passed by Congress requires U.S. Customs Service inspection to stop entry of adulterated drugs from overseas.
PRESIDENT LINCOLN appoints a chemist, Charles M. Wetherill, to serve in the new Department of Agriculture. This was the beginning of the Bureau of Chemistry, the predecessor of the Food and Drug Administration.
PETER COLLIER, chief chemist, U.S. Department of Agriculture, recommends passage of a national food and drug law, following his own food adulteration investigations. The bill was defeated, but during the next 25 years more than 100 food and drug bills were introduced in Congress.
DR. HARVEY W. WILEY becomes chief chemist, expanding the Bureau of Chemistry's food adulteration studies. Campaigning for a federal law, Dr. Wiley is called the "Crusading Chemist" and "Father of the Pure Food and Drugs Act." He retired from government service in 1912 and died in 1930.
TEA IMPORTATION ACT passed, providing for Customs inspection of all tea entering U.S. ports, at the expense of the importers.
Association of Official Agricultural Chemists (now AOAC International) establishes a COMMITTEE ON FOOD STANDARDS headed by Dr. Wiley. States begin incorporating these standards into their food statutes.
The BIOLOGICS CONTROL ACT is passed to ensure purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.
Congress appropriates $5,000 to the Bureau of Chemistry to study CHEMICAL PRESERVATIVES AND COLORS and their effects on digestion and health. Dr. Wiley's studies draw widespread attention to the problem of food adulteration. Public support for passage of a federal food and drug law grows.
The original 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.
Shocking disclosures of insanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.
First CERTIFIED COLOR REGULATIONS, requested by manufacturers and users, list seven colors found suitable for use in foods.
In U.S. v. JOHNSON, the Supreme Court rules that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug.
Congress enacts the SHERLEY AMENDMENT to over come the ruling in U.S. v. Johnson. It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.
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."
In U.S. v. LEXINGTON MILL AND ELEVATOR COMPANY, the Supreme Court issues its first ruling on food additives. It ruled that in order for bleached flour with nitrite residues to be banned from foods, the government must show a relationship between the chemical additive and the harm it allegedly caused in humans. The court also noted that the mere presence of such an ingredient was not sufficient to render the food illegal.
THE HARRISON NARCOTIC ACT requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.
In U.S. v. 95 BARRELS ALLEGED APPLE CIDER VINEGAR, the Supreme Court rules that the Food and Drugs Act condemns every statement, design, or device on a product's label that may mislead or deceive, even if technically true.
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.
McNARY-MAPES AMENDMENT authorizes FDA standards of quality and fill-of-container for canned food, excluding meat and milk products.
The name of the Food, Drug, and Insecticide Administration is shortened to FOOD AND DRUG ADMINISTRATION (FDA) under an agricultural appropriations act.
FDA recommends a complete revision of the obsolete 1906 FOOD AND DRUGS ACT. The first bill is introduced into the Senate, launching a five-year legislative battle.
ELIXIR OF SULFANILAMIDE, containing the poisonous solvent diethylene glycol, kills 107 persons, 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 (FDC) ACT of 1938 is passed by Congress, containing new provisions:
Under the WHEELER-LEA ACT, the Federal Trade Commission is charged with overseeing advertising associated with products otherwise regulated by FDA, with the exception of prescription drugs.
FIRST FOOD STANDARDS issued (canned tomatoes, tomato purée, and tomato paste).
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.
INSULIN AMENDMENT requires FDA to test and certify purity and potency of this lifesaving drug for diabetes.
In U.S. v. DOTTERWEICH, the Supreme Court rules that the responsible officials of a corporation, as well as the corporation itself, may be prosecuted for violations. It need not be proven that the officials intended, or even knew of, the violations.
PUBLIC HEALTH SERVICE ACT is passed, covering a broad spectrum of health concerns, including regulation of biological products and control of communicable diseases.
PENICILLIN AMENDMENT requires FDA testing and certification of safety and effectiveness of all penicillin products. Later amendments extended this requirement to all antibiotics. In 1983 such control was found no longer needed and was abolished.
MILLER AMENDMENT affirms that the Federal Food, Drug, and Cosmetic Act applies to goods regulated by the Agency that have been transported from one state to another and have reached the consumer.
FDA publishes 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."
In ALBERTY FOOD PRODUCTS CO. v. U.S. , a court of appeals rules that the directions for use on a drug label must include the purpose for which the drug is offered. Therefore, a worthless remedy cannot escape the law by not stating the condition it is supposed to treat.
OLEOMARGARINE ACT requires prominent labeling of colored oleomargarine, to distinguish it from butter.
DELANEY COMMITTEE starts congressional investigation of the safety of chemicals in foods and cosmetics, laying the foundation for the 1954 Miller Pesticide Amendment, the 1958 Food Additives Amendment, and the 1960 Color Additive Amendment.
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.
In U.S. v. CARDIFF, the Supreme Court rules that the factory inspection provision of the 1938 FDC Act is too vague to be enforced as criminal law.
FDA CONSUMER CONSULTANTS are appointed in each field district to maintain communications with consumers and ensure that FDA considers their needs and problems.
FEDERAL SECURITY AGENCY becomes the Department of Health, Education, and Welfare (HEW).
FACTORY INSPECTION AMENDMENT clarifies previous law and requires FDA to give manufacturers written reports of conditions observed during inspections and analyses of factory samples.
MILLER PESTICIDE AMENDMENT spells out procedures for setting safety limits for pesticide residues on raw agricultural commodities.
First large-scale RADIOLOGICAL EXAMINATION OF FOOD carried out by FDA when it received reports that tuna suspected of being radioactive was being imported from Japan following atomic blasts in the Pacific. FDA begins monitoring around the clock to meet the emergency.
HEW SECRETARY OVETA CULP HOBBY appoints a committee of 14 citizens to study the adequacy of FDA's facilities and programs. The committee recommends a substantial expansion of FDA staff and facilities, a new headquarters building, and more use of educational and informational programs.
The DIVISION OF BIOLOGICS CONTROL became an independent entity within the National Institutes of Health, after polio vaccine thought to have been inactivated is associated with about 260 cases of polio.
FOOD ADDITIVES AMENDMENT enacted, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals.
FDA publishes in the Federal Register the first list of SUBSTANCES GENERALLY RECOGNIZED AS SAFE (GRAS). The list contains nearly 200 substances.
U.S. CRANBERRY CROP 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 FDA on a food product.
COLOR ADDITIVE AMENDMENT enacted, requiring manufacturers to establish the safety of color additives in foods, drugs and cosmetics. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in humans or animals.
FEDERAL HAZARDOUS SUBSTANCES LABELING ACT, enforced by 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 passed to ensure drug efficacy and greater drug safety. For the first time, drug manufacturers are required to prove to FDA the effectiveness of their products before marketing them. The new law also exempts from the Delaney proviso animal drugs and animal feed additives shown to induce cancer but which leave no detectable levels of residue in the human food supply.
CONSUMER BILL OF RIGHTS is proclaimed by President John F. Kennedy in a message to Congress. Included are the right to safety, the right to be informed, the right to choose, and the right to be heard.
DRUG ABUSE CONTROL AMENDMENTS are enacted to deal with problems caused by abuse of depressants, stimulants and hallucinogens.
FDA contracts with the National Academy of Sciences/National Research Council to evaluate the EFFECTIVENESS OF 4,000 DRUGS approved on the basis of safety alone between 1938 and 1962.
CHILD PROTECTION ACT enlarges the scope of the Federal Hazardous Substances Labeling Act to ban hazardous toys and other articles so hazardous that adequate label warnings could not be written.
FAIR PACKAGING AND LABELING ACT requires all consumer products in interstate commerce to be honestly and informatively labeled, with FDA enforcing provisions on foods, drugs, cosmetics, and medical devices.
FDA BUREAU OF DRUG ABUSE CONTROL and Treasury Department Bureau of Narcotics are transferred to the Department of Justice to form the Bureau of Narcotics and Dangerous Drugs (BNDD), consolidating efforts to police traffic in abused drugs.
REORGANIZATION of federal health programs places FDA in the Public Health Service.
FDA forms the DRUG EFFICACY STUDY IMPLEMENTATION (DESI) to implement recommendations of the National Academy of Sciences investigation of effectiveness of drugs first marketed between 1938 and 1962.
ANIMAL DRUG AMENDMENTS place all regulation of new animal drugs under one section of the Food, Drug, and Cosmetic Act-Section 512-making approval of animal drugs and medicated feeds more efficient.
FDA begins administering SANITATION PROGRAMS for milk, shellfish, food service, and interstate travel facilities, and for preventing poisoning and accidents. These responsibilities were transferred from other units of the Public Health Service.
The WHITE HOUSE CONFERENCE ON FOOD, NUTRITION, AND HEALTH recommends systematic review of GRAS substances in light of FDA's ban of the artificial sweetener cyclamate. President Nixon orders FDA to review its GRAS list.
In UPJOHN v. FINCH the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy.
FDA requires the first PATIENT PACKAGE INSERT: oral contraceptives must contain information for the patient about specific risks and benefits.
The COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT replaces previous laws and categorizes drugs based on abuse and addiction potential compared to their therapeutic value.
ENVIRONMENTAL PROTECTION AGENCY established; takes over FDA program for setting pesticide tolerances.
PHS BUREAU OF RADIOLOGICAL HEALTH transferred to 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.
Artificial sweetener SACCHARIN, included in FDA's original GRAS list, is removed from the list pending new scientific study.
OVER-THE-COUNTER DRUG REVIEW 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 NIH to FDA.
THE U.S. SUPREME COURT upholds the 1962 drug effectiveness law and endorses FDA action to control entire classes of products by regulations rather than to rely only on time-consuming litigation.
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.
CONSUMER PRODUCT SAFETY COMMISSION created by Congress; takes over programs pioneered by FDA under 1927 Caustic Poison Act, 1960 Federal Hazardous Substances Labeling Act, 1966 Child Protection Act, and PHS accident prevention activities for safety of toys, home appliances, etc.
MEDICAL DEVICE AMENDMENTS passed to ensure safety and effectiveness of medical devices, including diagnostic products. The amendments require manufacturers to register with FDA and follow quality control procedures. Some products must have pre-market approval by FDA; others must meet performance standards before marketing.
VITAMINS AND MINERALS AMENDMENTS ("Proxmire Amendments") stop FDA from establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency.
SACCHARIN STUDY AND LABELING ACT passed by Congress to stop FDA from banning the chemical sweetener but requiring a label warning that it has been found to cause cancer in laboratory animals.
INFANT FORMULA ACT establishes special FDA controls to ensure necessary nutritional content and safety.
TAMPER-RESISTANT PACKAGING REGULATIONS issued by 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.
FDA publishes first RED BOOK (successor to 1949 "black book"), officially known as Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food.
ORPHAN DRUG ACT passed, enabling FDA to promote research and marketing of drugs needed for treating rare diseases.
FINES ENHANCEMENT LAWS of 1984 and 1987 amend the U.S. Code to greatly increase penalties for all federal offenses. The maximum fine for individuals is now $100,000 for each offense and $250,000 if the violation is a felony or causes death. For corporations, the amounts are doubled.
DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without repeating the research done to prove them safe and effective. At the same time, the brand-name companies can apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process.
AIDS TEST FOR BLOOD approved by FDA in its first major action to protect patients from infected donors.
CHILDHOOD VACCINE ACT requires patient information on vaccines, gives FDA authority to recall biologics, and authorizes civil penalties.
INVESTIGATIONAL DRUG REGULATIONS REVISED to expand access to experimental drugs for patients with serious diseases with no alternative therapies.
FOOD AND DRUG ADMINISTRATION ACT of 1988 officially establishes 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, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.
THE PRESCRIPTION DRUG MARKETING ACT bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT extends to veterinary products benefits given to human drugs under the 1984 Drug Price Competition and Patent Term Restoration Act. Companies can produce and sell generic versions of animal drugs approved after October 1962 without duplicating research done to prove them safe and effective. The act also authorizes extension of animal drug patents.
FDA issued a nationwide recall of all over-the-counter dietary supplements providing 100 milligrams or more of L-TRYPTOPHAN. The recall was instituted because of a clear link between the consumption of L-tryptophan tablets and its association with a U.S. outbreak of Eosinophilia-Myalgia Syndrome (EMS) in 1989. Symptoms of EMS include fatigue, shortness of breath, rash, swelling of the extremities, and in some cases congestive heart failure. By 1990, The Centers for Disease Control and Prevention confirmed over 1,500 cases of EMS with 38 deaths. Officials estimate that there may have been 3,000-10,000 unreported cases. Numerous trace levels of impurities were identified in the L-tryptophan implicated in many of the EMS case,s and the links between L-tryptophan and EMS are still being investigated in the laboratory. In 1990 FDA put an import alert in place prohibiting its importation.
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 law preempts state requirements about food standards, nutrition labeling, and health claims and, for the first time, authorizes some health claims for foods. The food ingredient panel, serving sizes, and terms such as "low fat" and "light" are standardized.
SAFE MEDICAL DEVICES ACT is passed, requiring nursing homes, hospitals, and other facilities that use medical devices to report to FDA incidents that suggest that a medical device probably caused or contributed to the death, serious illness, or serious injury of a patient. Manufacturers are required to conduct post-market surveillance on permanently implanted devices whose failure might cause serious harm or death, and to establish methods for tracing and locating patients depending on such devices. The act authorizes FDA to order device product recalls and other actions.
Regulations published to ACCELERATE THE REVIEW OF DRUGS for life-threatening diseases.
GENERIC DRUG ENFORCEMENT ACT imposes debarment and other penalties for illegal acts involving abbreviated drug applications.
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 FDA to use these funds to hire more reviewers to assess applications.
MAMMOGRAPHY QUALITY STANDARDS ACT requires all mammography facilities in the United States to be accredited and federally certified as meeting quality standards effective Oct. 1, 1994. After initial certification, facilities must pass annual inspections by federal or state inspectors.
DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT establishes specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This act defines "dietary supplements" and "dietary ingredients" and classifies them as food. The act also establishes a commission to recommend how to regulate claims.
FDA announces it could consider REGULATING NICOTINE in cigarettes as a drug, in response to a Citizen's Petition by the Coalition on Smoking OR Health.
URUGUAY ROUND AGREEMENTS ACT extends the patent terms of U.S. drugs from 17 to 20 years.
ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT allows veterinarians to prescribe extra-label use of veterinary drugs for animals under specific circumstances. In addition, the legislation allows licensed veterinarians to prescribe human drugs for use in animals under certain conditions.
FDA declares CIGARETTES to be "drug delivery devices." Restrictions are proposed on marketing and sales to reduce smoking by young people.
FEDERAL TEA TASTERS REPEAL ACT repeals the Tea Importation Act of 1897 to eliminate the Board of Tea Experts and user fees for FDA's testing of all imported tea. Tea itself is still regulated by FDA.
SACCHARIN NOTICE REPEAL ACT repeals the saccharin notice requirements.
ANIMAL DRUG AVAILABILITY ACT adds flexibility to animal drug approval process, providing for flexible labeling and more direct communication between drug sponsors and FDA.
FOOD QUALITY PROTECTION ACT amends the Food, Drug, and Cosmetic Act, eliminating application of the Delaney proviso to pesticides.
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.
MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT continues 1992 Act until 2002.
First phase to CONSOLIDATE FDA LABORATORIES nationwide from 19 facilities to 9 by 2014 includes dedication of the first of five new regional laboratories.
(BG 99-4)