Federal Food, Drug, and Cosmetic Act

Food, Drug, and Cosmetic ActFood, Drug and Cosmetic ActFederal Food, Drug and Cosmetic ActFD&CFDCA510(k)510(k) clearancede novo pathwayFood, Drugs, and Cosmetic Act of 19381938 Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S.wikipedia
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Food and Drug Administration

FDAU.S. Food and Drug AdministrationUnited States Food and Drug Administration
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs.

Elixir sulfanilamide

Elixir Sulfanilamide disasterElixir sulfanilamide incidentElixir of Sulfanilamide
The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form (see elixir sulfanilamide disaster).
The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act.

Form FDA 483

FDA 483Form 483483
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec.

Tartrazine

Yellow 5E102Yellow #5
It is also known as E number E102, C.I. 19140, FD&C Yellow 5, Acid Yellow 23, Food Yellow 4, and trisodium 1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-5-pyrazolone-3-carboxylate).

Medical device

medical devicesmedical equipmentmedical instrument
On May 28, 1976, the FD&C Act was amended to include regulation for medical devices.

Generally recognized as safe

GRASgenerally recognized as safe (GRAS)safe
Some food colorings are generally recognized as safe (GRAS) by the FDA and do not require certification.
Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts, and so is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive tolerance requirements.

Royal S. Copeland

Royal CopelandCopelandAmerican Institute of Homeopathy
A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from New York.
Copeland served as primary author and sponsor of the Federal Food, Drug, and Cosmetic Act of 1938 which entrenched special protections for pseudoscientific homeopaths.

Sunset Yellow FCF

sunset yellowYellow 6E110
When added to foods sold in the United States it is known as FD&C Yellow 6; when sold in Europe, it is denoted by E Number E110.

Drug Efficacy Study Implementation

DESIDrug Efficacy Study Implementation (DESI)
Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs.

Diethylene glycol

DEGdi-diethylene glycol poisonings
The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form (see elixir sulfanilamide disaster).
This episode was the impetus for the Federal Food, Drug, and Cosmetic Act of 1938.

Medical Device Regulation Act

Medical Device AmendmentsamendmentMedical Device Amendments of 1976
The amendment required that all medical devices be classified into one of three classes:
The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt.

Food coloring

food dyefood colouringartificial color
The FD&C is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as "FD&C Yellow No. 6." The Act made the certification of some food color additives mandatory.
In the United States, FD&C numbers (which indicate that the FDA has approved the colorant for use in foods, drugs and cosmetics) are given to approved synthetic food dyes that do not exist in nature, while in the European Union, E numbers are used for all additives, both synthetic and natural, that are approved in food applications.

Dietary supplement

dietary supplementsnutritional supplementnutritional supplements
Pursuant to the Federal Food, Drug, and Cosmetic Act ("the Act") and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.

Food additive

food additivesadditivesadditive
The FD&C is perhaps best known by the consumer because of its use in the naming of food coloring additives, such as "FD&C Yellow No. 6." The Act made the certification of some food color additives mandatory.
In the United States, this led to the adoption of the Delaney clause, an amendment to the Federal Food, Drug, and Cosmetic Act of 1938, stating that no carcinogenic substances may be used as food additives.

Sulfanilamide

sulphanilamideSulfanilimideAVC
The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form (see elixir sulfanilamide disaster).
In 1938, the Food, Drug and Cosmetic Act was passed.

Federal Meat Inspection Act

Meat Inspection ActFederal Meat Inspection Act of 1906federal meat inspector
The Food, Drug, and Cosmetic Act authorizes the FDA to provide inspection services for all livestock and poultry species not listed in the FMIA or PPIA, including venison and buffalo.

Drug Price Competition and Patent Term Restoration Act

Hatch-Waxman ActDrug Price Competition and Patent Term Restoration Act of 1984Drug Price and Competition Act
Although the Federal Food, Drug, and Cosmetic Act made it possible for generic companies to get regulatory approval for drugs by filing an Abbreviated New Drug Application (ANDA), in the early 1980s it became clear that very few generics were coming to market.

Orange B

Orange B was first listed as an approved food dye by the FDA in 1966.

Controlled Substances Act

Schedule ISchedule IISchedule III
Others were the Federal Food, Drug, and Cosmetic Act (1938), and the Kefauver Harris Amendment of 1962.

Biologics Control Act

Biologics Control Act of 1902
This law paved the way for further regulation of drug products under the Pure Food and Drug Act of 1906 and the Federal Food, Drug, and Cosmetic Act of 1938.

Homeopathy

homeopathichomeopathhomoeopathy
Homeopathic preparations are regulated and protected under Sections 201(g) and 201(j), provided that such medications are formulated from substances listed in the Homeopathic Pharmacopoeia of the United States, which the Act recognizes as an official drug compendium.
In the April 1997 edition of FDA Consumer, William T. Jarvis, the President of the National Council Against Health Fraud, said "Homeopathy is a fraud perpetrated on the public with the government's blessing, thanks to the abuse of political power of Sen. Royal S. Copeland [chief sponsor of the 1938 Food, Drug, and Cosmetic Act]."

Pure Food and Drug Act

Pure Food and Drug Act of 1906Pure Food and Drugs ActFood and Drugs Act of 1906
It replaced the earlier Pure Food and Drug Act of 1906.
Deficiencies in this original statute, which had become noticeable by the 1920s, led to the replacement of the 1906 statute with the Federal Food, Drug, and Cosmetic Act which was enacted in 1938 and signed by President Franklin Roosevelt.

Drugs in the United States

drugsdecriminalization of certain drugsdrug addiction
In the United States, the Federal Food, Drug, and Cosmetic Act defined the word "drug" as an "article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and those "(other than food) intended to affect the structure or any function of the body of man or other animals."