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Federal Food, Drug, and Cosmetic Act

Index Federal 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. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. [1]

98 relations: Act of Congress, Advertising, Allura Red AC, Amalgam (dentistry), Artificial heart, Automated external defibrillator, Biologics Control Act, Bioterrorism, Blue, Bottled water, Brilliant Blue FCF, Center for Food Safety and Applied Nutrition, Cherry, Chewing gum, Citrus Red 2, Clinical trial, Commerce Clause, Controlled Substances Act, Cosmetics, Criminal law, Democratic Party (United States), Dental floss, Diana Zuckerman, Dietary supplement, Dietary Supplement Health and Education Act of 1994, Diethylene glycol, Drug, Drug Efficacy Study Implementation, Drug Price Competition and Patent Term Restoration Act, Drugs in the United States, Durham-Humphrey Amendment, Electroconvulsive therapy, Elixir sulfanilamide, Erythrosine, Fair Packaging and Labeling Act, Fast Green FCF, FDA Food Safety Modernization Act, Federal Advisory Committee Act, Federal Meat Inspection Act, Federal Trade Commission, Federal Trade Commission Act of 1914, Food additive, Food and Drug Administration, Food and Drug Administration Amendments Act of 2007, Food and Drug Administration Modernization Act of 1997, Food and Drug Administration Revitalization Act, Food coloring, Food Quality Protection Act, Food safety, Form FDA 483, ..., Franklin D. Roosevelt, Generally recognized as safe, Government in the Sunshine Act, Homeopathy, Indigo carmine, Kefauver Harris Amendment, Lanham Act, Lemon (color), List of food additives, Mammography Quality Standards Act, Medical device, Medical Device Regulation Act, Mineral water, National Academy of Sciences, National Center for Health Research, National Environmental Policy Act, New Drug Application, New York (state), Nutrition Labeling and Education Act of 1990, Office of Criminal Investigations, Orange (colour), Orange B, Orphan Drug Act of 1983, Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, Poultry Products Inspection Act of 1957, Prescription Drug Marketing Act, Prescription Drug User Fee Act, Private law, Project Bioshield Act, Public Health Security and Bioterrorism Preparedness and Response Act, Public Health Service Act, Pure Food and Drug Act, Red, Regulation of therapeutic goods, Royal blue, Royal S. Copeland, Safe Medical Device Amendments of 1990, Shades of green, Strict liability, Sulfanilamide, Sunset Yellow FCF, Supreme Court of the United States, Tartrazine, Title 21 of the United States Code, United States Congress, United States v. Carolene Products Co., Wheeler–Lea Act, 100,000,000 Guinea Pigs. Expand index (48 more) »

Act of Congress

An Act of Congress is a statute enacted by the United States Congress.

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Advertising

Advertising is an audio or visual form of marketing communication that employs an openly sponsored, non-personal message to promote or sell a product, service or idea.

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Allura Red AC

Allura Red AC is a red azo dye that goes by several names.

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Amalgam (dentistry)

Dental amalgam is a liquid mercury and metal alloy mixture used in dentistry to fill cavities caused by tooth decay.

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Artificial heart

An artificial heart is a device that replaces the heart.

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Automated external defibrillator

An automated external defibrillator (AED) is a portable electronic device that automatically diagnoses the life-threatening cardiac arrhythmias of ventricular fibrillation and pulseless ventricular tachycardia, and is able to treat them through defibrillation, the application of electricity which stops the arrhythmia, allowing the heart to reestablish an effective rhythm.

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Biologics Control Act

The Biologics Control Act of 1902, also known as the Virus-Toxin Law, was the first law that implemented federal regulations of biological products such as vaccines in the United States.

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Bioterrorism

Bioterrorism is terrorism involving the intentional release or dissemination of biological agents.

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Blue

Blue is one of the three primary colours of pigments in painting and traditional colour theory, as well as in the RGB colour model.

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Bottled water

Bottled water is drinking water (e.g., well water, distilled water, mineral water, or spring water) packaged in PET Bottle or Glass Water Bottles.

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Brilliant Blue FCF

Brilliant Blue FCF (Blue 1) is an organic compound classified as a triarylmethane dye and a blue azo dye, reflecting its chemical structure.

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Center for Food Safety and Applied Nutrition

The Center for Food Safety and Applied Nutrition (CFSAN, pronounced sif'-san) is the branch of the United States Food and Drug Administration (FDA) that regulates food, dietary supplements, and cosmetics.

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Cherry

A cherry is the fruit of many plants of the genus Prunus, and is a fleshy drupe (stone fruit).

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Chewing gum

Chewing gum is a soft, cohesive substance designed to be chewed without being swallowed.

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Citrus Red 2

Citrus Red 2, Citrus Red No.

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Clinical trial

Clinical trials are experiments or observations done in clinical research.

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Commerce Clause

The Commerce Clause describes an enumerated power listed in the United States Constitution (Article I, Section 8, Clause 3).

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Controlled Substances Act

The Controlled Substances Act (CSA) is the statute establishing federal U.S. drug policy under which the manufacture, importation, possession, use, and distribution of certain substances is regulated.

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Cosmetics

Cosmetics are substances or products used to enhance or alter the appearance of the face or fragrance and texture of the body.

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Criminal law

Criminal law is the body of law that relates to crime.

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Democratic Party (United States)

The Democratic Party is one of the two major contemporary political parties in the United States, along with the Republican Party (nicknamed the GOP for Grand Old Party).

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Dental floss

Dental floss is a cord of thin filaments used to remove food and dental plaque from between teeth in areas a toothbrush is unable to reach.

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Diana Zuckerman

Diana M. Zuckerman (born 16 June 1950) is an American health policy analyst who focuses on the implications of policies for public health and patients’ health.

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Dietary supplement

A dietary supplement is a manufactured product intended to supplement the diet when taken by mouth as a pill, capsule, tablet, or liquid.

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Dietary Supplement Health and Education Act of 1994

The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of United States Federal legislation which defines and regulates dietary supplements.

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Diethylene glycol

Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O.

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Drug

A drug is any substance (other than food that provides nutritional support) that, when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a temporary physiological (and often psychological) change in the body.

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Drug Efficacy Study Implementation

Drug Efficacy Study Implementation (DESI) was a program begun by the Food and Drug Administration (FDA) in the 1960s after the requirement (in the Kefauver-Harris Drug Control Act) that all drugs be efficacious as well as safe, was made part of US law.

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Drug Price Competition and Patent Term Restoration Act

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.

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Drugs in the United States

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." Consistent with that definition, the U.S. separately defines narcotic drugs and controlled substances, which may include non-drugs, and explicitly excludes tobacco, caffeine and alcoholic beverages.

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Durham-Humphrey Amendment

The Durham-Humphrey Amendment explicitly defined two specific categories for medications, legend (prescription) and over-the-counter (OTC).

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Electroconvulsive therapy

Electroconvulsive therapy (ECT), formerly known as electroshock therapy, and often referred to as shock treatment, is a psychiatric treatment in which seizures are electrically induced in patients to provide relief from mental disorders.

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Elixir sulfanilamide

Elixir sulfanilamide was an improperly prepared sulfanilamide medicine that caused mass poisoning in the United States in 1937.

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Erythrosine

Erythrosine, also known as Red No.

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Fair Packaging and Labeling Act

The Fair Packaging and Labeling Act is a U.S. law that applies to labels on many consumer products.

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Fast Green FCF

Fast Green FCF, also called Food green 3, FD&C Green No.

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FDA Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama on January 4, 2011.

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Federal Advisory Committee Act

The Federal Advisory Committee Act (FACA), is a United States federal law which governs the behavior of federal advisory committees.

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Federal Meat Inspection Act

The Federal Meat Inspection Act of 1906 (FMIA) is an American law that makes it a crime to adulterate or misbrand meat and meat products being sold as food, and ensures that meat and meat products are slaughtered and processed under sanitary conditions.

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Federal Trade Commission

The Federal Trade Commission (FTC) is an independent agency of the United States government, established in 1914 by the Federal Trade Commission Act.

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Federal Trade Commission Act of 1914

The Federal Trade Commission Act of 1914 established the Federal Trade Commission.

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Food additive

Food additives are substances added to food to preserve flavor or enhance its taste, appearance, or other qualities.

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Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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Food and Drug Administration Amendments Act of 2007

President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007.

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Food and Drug Administration Modernization Act of 1997

The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act.

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Food and Drug Administration Revitalization Act

The Food and Drug Administration Revitalization Act was introduced by the 101st Congress of the United States.

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Food coloring

Food coloring, or color additive, is any dye, pigment or substance that imparts color when it is added to food or drink.

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Food Quality Protection Act

The Food Quality Protection Act (FQPA), or H.R.1627, was passed unanimously by Congress in 1996 and was signed into law by President Bill Clinton on August 3, 1996.

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Food safety

Food safety is a scientific discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness.

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Form FDA 483

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

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Franklin D. Roosevelt

Franklin Delano Roosevelt Sr. (January 30, 1882 – April 12, 1945), often referred to by his initials FDR, was an American statesman and political leader who served as the 32nd President of the United States from 1933 until his death in 1945.

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Generally recognized as safe

Generally recognized as safe (GRAS) is an American 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.

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Government in the Sunshine Act

The Government in the Sunshine Act is a U.S. law passed in 1976 that affects the operations of the federal government, Congress, federal commissions, and other legally constituted federal bodies.

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Homeopathy

Homeopathy or homœopathy is a system of alternative medicine developed in 1796 by Samuel Hahnemann, based on his doctrine of like cures like (similia similibus curentur), a claim that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people.

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Indigo carmine

Indigo carmine, or 5,5′-indigodisulfonic acid sodium salt, is an organic salt derived from indigo by sulfonation, which renders the compound soluble in water.

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Kefauver Harris Amendment

The U.S. Kefauver Harris Amendment or "Drug Efficacy Amendment" is a 1962 amendment to the Federal Food, Drug, and Cosmetic Act.

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Lanham Act

The Lanham (Trademark) Act (codified at et seq.) is the primary federal trademark statute of law in the United States.

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Lemon (color)

Lemon or lemon-color is a pale yellow color, the color of the lemon fruit.

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List of food additives

;Acids: Food acids are added to make flavors "sharper", and also act as preservatives and antioxidants.

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Mammography Quality Standards Act

The Mammography Quality Standards Act (MQSA) was enacted by the United States Congress to regulate the quality of care in mammography.

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Medical device

A medical device is any apparatus, appliance, software, material, or other article—whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application—intended by the manufacturer to be used for human beings for the purpose of.

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Medical Device Regulation Act

The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States.

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Mineral water

Mineral water is water from a mineral spring that contains various minerals, such as salts and sulfur compounds.

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National Academy of Sciences

The National Academy of Sciences (NAS) is a United States nonprofit, non-governmental organization.

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National Center for Health Research

The National Center for Health Research (formerly the National Research Center for Women & Families) is a Washington, D.C.-based non-profit organization founded in 1999.

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National Environmental Policy Act

The National Environmental Policy Act (NEPA) is a United States environmental law that promotes the enhancement of the environment and established the President's Council on Environmental Quality (CEQ).

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New Drug Application

The Food and Drug Administration's New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing.

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New York (state)

New York is a state in the northeastern United States.

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Nutrition Labeling and Education Act of 1990

The Nutrition Labeling and Education Act (NLEA) (Public Law 101-535) is a 1990 United States Federal law.

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Office of Criminal Investigations

The Office of Criminal Investigations (OCI) was established to provide the US Food and Drug Administration (FDA) with a specific Office to conduct and coordinate Criminal investigations.

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Orange (colour)

Orange is the colour between yellow and red on the spectrum of visible light.

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Orange B

Orange B is a food dye from the azo dye group.

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Orphan Drug Act of 1983

The Orphan Drug Act of 1983 is a law passed in the United States to facilitate development of orphan drugs — drugs for rare diseases such as Huntington's Disease, myoclonus, ALS, Tourette syndrome and muscular dystrophy which affect small numbers of individuals residing in the United States.

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Pandemic and All-Hazards Preparedness Reauthorization Act of 2013

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 is a law enacted by the 113th United States Congress.

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Poultry Products Inspection Act of 1957

The Poultry Products Inspection Act of 1957 (P.L. 85-172, as amended) requires the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) to inspect all domesticated birds when slaughtered and processed into products for human consumption.

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Prescription Drug Marketing Act

The Prescription Drug Marketing Act (PDMA) of 1987 (P.L. 100-293, 102 Stat. 95) is a law of the United States federal government.

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Prescription Drug User Fee Act

The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.

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Private law

Private law is that part of a civil law legal system which is part of the jus commune that involves relationships between individuals, such as the law of contracts or torts (as it is called in the common law), and the law of obligations (as it is called in civil legal systems).

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Project Bioshield Act

The Project Bioshield Act was an act passed by the United States Congress in 2004 calling for $5 billion for purchasing vaccines that would be used in the event of a bioterrorist attack.

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Public Health Security and Bioterrorism Preparedness and Response Act

Signed into effect on 12 June 2002, the Public Health Security and Bioterrorism Preparedness and Response Act, (PHSBPRA) was signed by the President, the Department of Health and Human Services (DHHS) and the U.S. Department of Agriculture (USDA).

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Public Health Service Act

The Public Health Service Act is a United States federal law enacted in 1944.

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Pure Food and Drug Act

The Pure Food and Drug Act of 1906 was the first of a series of significant consumer protection laws which was enacted by Congress in the 20th century and led to the creation of the Food and Drug Administration.

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Red

Red is the color at the end of the visible spectrum of light, next to orange and opposite violet.

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Regulation of therapeutic goods

The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction.

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Royal blue

Royal blue is both a bright shade and a dark shade of azure blue.

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Royal S. Copeland

Royal Samuel Copeland (November 7, 1868June 17, 1938), a United States Senator from New York from 1923 until 1938, was an academic, homeopathic physician, and politician.

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Safe Medical Device Amendments of 1990

Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act.

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Shades of green

Varieties of the color green may differ in hue, chroma (also called saturation or intensity) or lightness (or value, tone, or brightness), or in two or three of these qualities.

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Strict liability

In criminal and civil law, strict liability is a standard of liability under which a person is legally responsible for the consequences flowing from an activity even in the absence of fault or criminal intent on the part of the defendant.

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Sulfanilamide

Sulfanilamide (also spelled sulphanilamide) is a sulfonamide antibacterial.

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Sunset Yellow FCF

Sunset Yellow FCF (also known as Orange Yellow S, or C.I. 15985) is a petroleum-derived orange azo dye with a pH dependent maximum absorption at about 480 nm at pH 1 and 443 nm at pH 13 with a shoulder at 500 nm.

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Supreme Court of the United States

The Supreme Court of the United States (sometimes colloquially referred to by the acronym SCOTUS) is the highest federal court of the United States.

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Tartrazine

Tartrazine is a synthetic lemon yellow azo dye primarily used as a food coloring.

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Title 21 of the United States Code

Title 21 of the United States Code governs Food and Drugs in the United States Code (U.S.C.).

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United States Congress

The United States Congress is the bicameral legislature of the Federal government of the United States.

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United States v. Carolene Products Co.

United States v. Carolene Products Company,, was an April 25, 1938 decision by the United States Supreme Court.

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Wheeler–Lea Act

The Wheeler–Lea Act of 1938 is a United States federal law that amended Section 5 of the Federal Trade Commission Act to proscribe “unfair or deceptive acts or practices” as well as “unfair methods of competition.” http://ftc.gov/ftc/turns100/index.shtm It provided civil penalties for violations of Section 5 orders.

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100,000,000 Guinea Pigs

100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics is a book written by Arthur Kallet and F.J. Schlink first released in 1933 by the Vanguard Press and manufactured in the United States of America.

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Redirects here:

510(k), 510K, 510k, FD&C, FD&C Act, FDA (510k) filing, FFDCA, Federal Food Drug and Cosmetic Act, Federal Food, Drug and Cosmetic Act, Federal Food, Drugs, and Cosmetics Act, Food, Drug and Cosmetic Act, Food, Drug, and Cosmetic Act, PMA (FDA), Pre-market approval, Premarket Notification, Premarket approval, Premarket notification.

References

[1] https://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act

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