From the beginnings of civilization, people are concerned about the quality and safety of foods and medicines.legislation, which addressed the provision of dependable smallpox vaccine to taxpayers, was passed in 1813. The following chronology describes some of the landmarks in the history of food and drug regulation in the United States.                                                       

1820

Eleven doctors meet in Washington, D.C., to launch that the U.S. Pharmacopeia, the first compendium of conventional medications for the United States.

 1848

Drug Importation Act passed by Congress requires U.S. Customs Service inspection to prevent the entry of adulterated drugs from overseas.

 1880

The bill was defeated, but throughout the next 25 years over 100 food and drug, bills were introduced in Congress.

 1902

The Biologics Control Act is passed to ensure the purity and safety of serums, vaccines, and similar products used to prevent or treat diseases in humans.

 1914

It ruled that to get bleached flour with nitrite residues to be banned from foods, the authorities must demonstrate a connection between the chemical additive as well as the injury that it allegedly caused in people. The court also noted that the mere existence of such an ingredient wasn't enough to leave the food illegal.

 1927

The Bureau of Chemistry is reorganized into two separate entities. 

 1930

The name of the Food, Drug, and Insecticide Administration is shortened to the Food and Drug Administration (FDA) under an agricultural appropriations act.

 1933

FDA recommends a complete revision of this obsolete 1906 Food and Drugs Act. U.S. Government begins the book of the Federal Register.

Elixir of Sulfanilamide

 1938

Extending management to cosmetics and therapeutic devices.

Requiring new drugs to be shown safe before marketing-starting a brand new system of drug regulation.

Supplying that secure tolerances be set for unavoidable poisonous substances.

Authorizing criteria of identity, quality, and fill-of-container for meals.

Authorizing mill reviews.

Including the treatment of court injunctions to the previous penalties of seizures and prosecutions.

 1939

First Food Standards issued (canned tomatoes, tomato purée, and tomato paste).

 1940

FDA transferred in the Department of Agriculture to the Federal Security Agency.

 1941

Insulin Amendment requires the FDA to check and certify purity and potency of this lifesaving medication for diabetes

 1943

In the U.S. the Supreme Court rules that the responsible officials of a company, as well as the company itself, might be prosecuted for offenses. It does not need to be demonstrated that the officials planned, or even knew of, the offenses.

 1944

Public Health Service Act is passed, covering a broad spectrum of health issues, including regulation of biological products and control of communicable diseases.

 1945

Penicillin Amendment necessitates FDA testing and testing of the effectiveness and safety of penicillin solutions. Later amendments extended this requirement to all antibiotics. In 1983 such control was discovered no longer needed and was abolished.

 1949

This advice, "Approaches for the Appraisal of the Toxicity of Chemicals in Food," was known as the"black book."

1952

In U.S. v. Cardiff, the Supreme Court rules the mill inspection provision of the 1938 FDC Act is too vague to be enforced since law.

FDA customer consultants are appointed in each area district to maintain communications with customers and ensure that FDA believes their needs and problems.

 1953

Federal Security Agency becomes the Department of Health, Education, and Welfare (HEW). Factory Inspection Amendment clarifies previous law and requires the FDA to give producers written reports of conditions observed during investigations and inspections of mill samples.

 1955

The committee recommends a significant growth of FDA personnel and facilities, a new headquarters building, and much more use of educational and informational programs.

The Division of Biologics Control became an independent entity in the National Institutes of Health after polio vaccine thought to have been inactivated is associated with roughly 260 cases of polio.

 1958

Food Additives Amendment enacted, requiring manufacturers of food additives to establish safety. The Delaney proviso prohibits the acceptance of any food additive shown to induce cancer in people or animals. The list contains nearly 200 substances.

 1959

U.S. cranberry crop remembered three weeks before Thanksgiving to get FDA tests to test for aminotriazole, a weedkiller discovered to cause cancer in lab animals. Cleared berries were permitted a tag stating that they had been tested and had passed FDA inspection, the only such endorsement ever allowed by FDA to a food item.

 1960

Color Additive Amendment enacted, requiring manufacturers to establish the safety of color additives in foods, cosmetics, and drugs. The Delaney proviso prohibits the approval of any color additive shown to induce cancer in people or animals.

 1962

Kefauver-Harris Drug Amendments passed to guarantee drug efficacy and greater drug safety. The new law also exempts in the Delaney proviso animal drugs and animal feed additives shown to cause cancer but that leaves no detectable levels of residue in the human food source.

Included are the right to security, the right to be educated, the right to choose, and also the right to be noticed.

1965

Drug Abuse Control Amendments are enacted to deal with issues brought on by abuse of depressants, stimulants, and hallucinogens.

1966

FDA contracts with the National Academy of Sciences/National Research Council to evaluate the efficacy of 4,000 medication approved on the grounds of security alone between 1938 and 1962.

1968

Reorganization of national health programs places FDA from the Public Health Service.

 1969

FDA starts administering Sanitation Programs for milk, shellfish, food assistance, and interstate travel facilities, also for preventing poisoning and injuries. These responsibilities have been transferred from other units of the Public Health Service. 

 1970

Back in Upjohn v. Finch the Court of Appeals upholds authorities of this 1962 drug effectiveness changes by ruling that commercial achievement alone does not constitute significant evidence of drug safety and effectiveness.

FDA requires the very first patient package insert: oral contraceptives need to include information for the patient about specific risks and benefits.

Drug Abuse Prevention and Control Act replaces preceding legislation and categorizes drugs based on abuse and addiction potential in contrast to their therapeutic value.

Environmental Protection Agency established; takes over FDA application for setting pesticide tolerances.

1971

PHS Bureau of Radiological Health transferred to FDA. Its mission: defense from unnecessary human exposure to radiation from electronic products in the home, business, and the healing arts. National Center for Toxicological Research is established from the biological facilities of the Pine Bluff Arsenal in Arkansas. Its mission is to examine the biological effects of chemicals in the environment, extrapolating information from experimental animals to human wellbeing.

1972

Over-the-Counter Drug Review began to enhance the safety, efficacy, and proper labeling of drugs marketed without prescription. Regulation of Biologics--including serums, vaccines, and blood products--has been transferred from NIH to FDA.

1973

Low-acid food processing regulations issued, after botulism outbreaks from canned foods, to make sure the low-acid packaged foods have sufficient heat treatment and aren't hazardous.

1976

Medical Device Amendments passed to guarantee the effectiveness and safety of medical devices, including diagnostic products. The amendments require producers to register with the FDA and follow quality control procedures. Some goods should have pre-market approval by the FDA; others must meet performance standards before marketing.

1979

In the hours after the Three Mile Island atomic emergency of March 28, 1979, FDA contracted with firms in Missouri, Michigan, and New Jersey to prepare and bundle enough doses of potassium iodide to protect people threatened with thyroid cancer when exposed to radiation. Nearly one-quarter of a thousand bottles-enough for every single family at the area-were delivered to Harrisburg, Pennsylvania over 72 hours.

1983

Orphan Drug Act passed, allowing FDA to market research and marketing of drugs needed for treating rare diseases.

1984

The maximum fine for individuals is now $100,000 for every offense and $250,000 if the breach is a felony or triggers death. For corporations, the amounts are doubled.

At the same time, the brand-name businesses can apply for up to five years extra patent protection for the new medications they developed to make up for time lost while their goods were going through FDA's approval procedure.

1985

AIDS test for blood approved by FDA in its first significant action to protect patients from infected donors.

1986

Childhood Vaccine Act demands patient information about vaccines, gives FDA authority to recall biologics, and authorizes civil penalties.

 1987

Investigational drug regulations revised to expand access to experimental drugs for patients with severe diseases with no alternative therapies.

 1988

Drug and food Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services using a Commissioner of Food and Drugs made by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for law enforcement, education, and advice.

The Prescription Drug Marketing Act prohibits the joys of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, sub potent, and counterfeit drugs to the general public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from different nations; and prohibits sale, purchase or trade of drug samples, and traffic or counterfeiting of redeemable drug coupons.

 1990

Also, a four-part definition of this class is established to allow new, black marketplace materials to be assigned to the class, and consequently subject to regulation as regulated materials. The food component panel, serving sizes, and conditions 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 events that indicate that a medical device probably caused. The act authorizes FDA to order apparatus product recalls and other activities.

1991

Regulations published to Accelerate the Overview of Medication for life-threatening diseases. This rule issue requirements for researchers that obtain and document informed consent secures special security for children, women, and prisoners elaborate on required processes for institutional review boards, also ensures that research institutions comply with the regulations.

1992

Prescription Drug User Fee Act requires drug and biologics manufacturers to cover fees for product applications and nutritional supplements, along with other services. The action also requires FDA to use these funds to hire more reviewers to evaluate the software.

Mammography Quality Standards Act requires all mammography facilities in the United States to be licensed and federally certified as meeting quality standards effective Oct. 1, 1994. After initial certification, centers must pass annual inspections by national or state inspectors.

Nutrition facts, basic per-serving nutritional info, are required on meals under the Nutrition Labeling and Education Act of 1990. Based on the most recent general health recommendations, FDA and the Food Safety and Inspection Service of the Department of Agriculture recreate the food label to list the most important nutrition in an easy-to-follow arrangement.

1993

Consolidation of numerous adverse reaction reporting systems is launched as MedWatch, created for voluntary coverage of issues related to medical products to be registered with FDA by caregivers.

Companies are encouraged to include patients of both genders in their investigations of medication and also to analyze any gender-specific phenomena.

1994

Dietary Supplement Health and Education Act determines specific labeling requirements, provides a regulatory framework, and authorizes FDA to promulgate good manufacturing practice regulations for dietary supplements. This action defines"dietary supplements" and"dietary ingredients" and classifies them as food.

Animal Medicinal Drug Use Clarification Act allows veterinarians to prescribe extra-label utilization of veterinary drugs for animals under certain circumstances. Also, the legislation permits accredited veterinarians to prescribe human drugs for use in animals under certain conditions.

1995

FDA declares cigarettes to be"drug delivery devices." Restrictions are suggested on marketing and sales to decrease smoking by young people.

A streak of proposed reforms to reduce the regulatory burden on pharmaceutical makers is announced, such as a growth of allowable promotional material on accepted applications of drugs that companies can distribute to health professionals, streamlining certain components the documentation of investigational drug research, and also a reduction in both ecological impact filings and pre-approval conditions in capsule fabrication.