Regulation Of Food And Dietary Supplements By The U.S. Food And Drug Administration
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Regulation Of Food And Dietary Supplements By The U.S. Food And Drug Administration
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). 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 Packaging and labeling, labeling about both the composition and the health benefits of foods. Substances which the FDA regulates as food are subdivided into various categories, including foods, food additives, added substances (man-made substances which are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements. The specific standards which the FDA exercises differ from one category to the next. Furthermore, the FDA has been granted a variety of means by which it can address violations of the ...
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Food And Drug Administration Logo
Food is any substance consumed by an organism for Nutrient, nutritional support. Food is usually of plant, animal, or Fungus, fungal origin, and contains essential nutrients, such as carbohydrates, fats, protein (nutrient), proteins, vitamins, or Mineral (nutrient), minerals. The substance is Ingestion, ingested by an organism and assimilated by the organism's Cell (biology), cells to provide energy, maintain life, or stimulate growth. Different species of animals have different List of feeding behaviours, feeding behaviours that satisfy the needs of their unique metabolisms, often evolved to fill a specific ecological niche within specific geographical contexts. Omnivore, Omnivorous humans are highly adaptable and have adapted to obtain food in many different ecosystems. The majority of the food energy required is supplied by the industrial food industry, which produces food with Intensive farming, intensive agriculture and distributes it through complex food processing and f ...
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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. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective, ineffective, or needing further study.Pharmacy Today. August 2008.FDA aims to remove unapproved drugs from market: Risk-based enforcement program focuses on removing potentially harmful products/ref> The Drug Efficacy Study Implementation (DESI) evaluated over 3,000 separate products and over 16,000 therapeutic claims. By 1984, final action had been completed on 3,443 products; of these, 2,225 were found to be effective, 1,051 were found not effective, and 167 were pending. One of the early effects of the DESI study was the development of the Abbreviated New Drug Application (ANDA). See also * Estes Kefauver * Federal ...
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Kidney Beans
The kidney bean is a variety of the common bean ('' Phaseolus vulgaris''). It resembles a human kidney and thus is named after such. Red kidney beans should not be confused with other red beans, such as adzuki beans. Classification There are different classifications of kidney beans, such as: *Red kidney bean (also known as: common kidney bean, rajma in India, surkh (red) lobia in Pakistan). *Light speckled kidney bean (and long shape light speckled kidney bean). *Red speckled kidney bean (and long shape light speckled kidney bean). *White kidney bean (also known as cannellini in Italy, lobia in India, or safaid (white) lobia in Pakistan). Nutrition Kidney beans, cooked by boiling, are 67% water, 23% carbohydrates, 9% protein, and contain negligible fat (table). In a 100-gram reference amount, cooked kidney beans provide of food energy, and are a rich source (20% or more of the Daily Value, DV) of protein, folate (33% DV), iron (22% DV), and phosphorus (20% DV), with modera ...
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Starch
Starch or amylum is a polymeric carbohydrate consisting of numerous glucose units joined by glycosidic bonds. This polysaccharide is produced by most green plants for energy storage. Worldwide, it is the most common carbohydrate in human diets, and is contained in large amounts in staple foods such as wheat, potatoes, maize (corn), rice, and cassava (manioc). Pure starch is a white, tasteless and odorless powder that is insoluble in cold water or alcohol. It consists of two types of molecules: the linear and helical amylose and the branched amylopectin. Depending on the plant, starch generally contains 20 to 25% amylose and 75 to 80% amylopectin by weight. Glycogen, the energy reserve of animals, is a more highly branched version of amylopectin. In industry, starch is often converted into sugars, for example by malting. These sugars may be fermented to produce ethanol in the manufacture of beer, whisky and biofuel. In addition, sugars produced from processed starch are used ...
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United States Court Of Appeals For The Seventh Circuit
The United States Court of Appeals for the Seventh Circuit (in case citations, 7th Cir.) is the U.S. federal court with appellate jurisdiction over the courts in the following districts: * Central District of Illinois * Northern District of Illinois * Southern District of Illinois * Northern District of Indiana * Southern District of Indiana * Eastern District of Wisconsin * Western District of Wisconsin The court is based at the Dirksen Federal Building in Chicago and is composed of eleven appellate judges. It is one of 13 United States courts of appeals. The court offers a relatively unique internet presence that includes wiki and RSS feeds of opinions and oral arguments. It is also notable for having one of the most prominent law and economics scholars, Judge Frank H. Easterbrook, on its court. Richard Posner, another prominent law and economics scholar, also served on this court until his retirement in 2017. Three judges from the Seventh Circuit, Sherman Minton, John Pau ...
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Self-reference
Self-reference occurs in natural or formal languages when a sentence, idea or formula refers to itself. The reference may be expressed either directly—through some intermediate sentence or formula—or by means of some encoding. In philosophy, it also refers to the ability of a subject to speak of or refer to itself, that is, to have the kind of thought expressed by the first person nominative singular pronoun "I" in English. Self-reference is studied and has applications in mathematics, philosophy, computer programming, second-order cybernetics, and linguistics, as well as in humor. Self-referential statements are sometimes paradoxical, and can also be considered recursive. In logic, mathematics and computing In classical philosophy, paradoxes were created by self-referential concepts such as the omnipotence paradox of asking if it was possible for a being to exist so powerful that it could create a stone that it could not lift. The Epimenides paradox, 'All Cretans are ...
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Chewing Gum
Chewing gum is a soft, cohesive substance designed to be chewed without being swallowed. Modern chewing gum is composed of gum base, sweeteners, softeners/plasticizers, flavors, colors, and, typically, a hard or powdered polyol coating. Its texture is reminiscent of rubber because of the physical-chemical properties of its polymer, plasticizer, and resin components, which contribute to its elastic-plastic, sticky, chewy characteristics. History The cultural tradition of chewing gum seems to have developed through a convergent evolution process, as traces of this habit have arisen separately in many early civilizations. Each early precursor to chewing gum was derived from natural growths local to the region and was chewed purely out of the instinctual desire to masticate. Early chewers did not necessarily desire to derive nutritional benefits from their chewable substances but at times sought taste stimuli and teeth cleaning or breath-freshening capabilities. Chewing gum in ...
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List Of United States Federal Legislation
This is a chronological, but still incomplete, list of United States federal legislation. Congress has enacted approximately 200–600 statutes during each of its 115 biennial terms so that more than 30,000 statutes have been enacted since 1789. At the federal level in the United States, legislation (i.e., "statutes" or "statutory law") consists exclusively of Acts passed by the Congress of the United States and its predecessor, the Continental Congress, that were either signed into law by the President or passed by Congress after a presidential veto. Legislation is not the only source of regulations with the force of law. However, most executive branch and judicial branch regulations must originate in a congressional grant of power. ''See also'': Executive orders issued by the President; ''Code of Federal Regulations'' for rules issued by executive branch departments and administrative agencies; and the Federal Rules of Civil Procedure of the federal courts. Publication of the ...
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Pure Food And Drug Act
The Pure Food and Drug Act of 1906, also known as Dr. Wiley's Law, 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. Its main purpose was to ban foreign and interstate traffic in adulterated or mislabeled food and drug products, and it directed the U.S. Bureau of Chemistry to inspect products and refer offenders to prosecutors. It required that active ingredients be placed on the label of a drug's packaging and that drugs could not fall below purity levels established by the United States Pharmacopeia or the National Formulary. In the late 1800s, the quality of food in the United States decreased significantly as populations moved to cities and the time from farm to market increased. Many food producers turned to using dangerous preservatives, even formaldehyde, to keep food fresh. Simultaneously, the quality of medicine was abysmal. Quack medicine was ...
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Elixir Sulfanilamide Disaster
Elixir sulfanilamide was an improperly prepared sulfonamide (medicine), sulfonamide antibiotic that caused mass poisoning in the United States in 1937. It is believed to have killed more than 100 people. The public outcry caused by this incident and other similar disasters led to the passing of the 1938 Federal Food, Drug, and Cosmetic Act, which significantly increased the Food and Drug Administration's powers to regulate drugs. History Aside from the Pure Food and Drug Act of 1906 and the Harrison Act of 1914 banning the sale of some narcotic drugs, there was no federal regulatory control in the United States of America for drugs until Congress enacted the 1938 Food, Drug, and Cosmetic Act in response to the elixir sulfanilamide poisonings. In 1937, S. E. Massengill Company, a pharmaceutical manufacturer, created an oral preparation of sulfanilamide using diethylene glycol (DEG) as the solvent or excipient, and called the preparation "Elixir Sulfanilamide". DEG is poisonous to ...
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Diethylene Glycol
Diethylene glycol (DEG) is an organic compound with the formula (HOCH2CH2)2O. It is a colorless, practically odorless, and hygroscopic liquid with a sweetish taste. It is a four carbon dimer of ethylene glycol. It is miscible in water, alcohol, ether, acetone, and ethylene glycol. DEG is a widely used solvent.Siegfried Rebsdat and Dieter Mayer "Ethylene Glycol" in Ullmann's Encyclopedia of Industrial Chemistry, 2002, Wiley-VCH, Weinheim.. It can be a contaminant in consumer products; this has resulted in numerous epidemics of poisoning since the early 20th century. Preparation DEG is produced by the partial hydrolysis of ethylene oxide. Depending on the conditions, varying amounts of DEG and related glycols are produced. The resulting product is two ethylene glycol molecules joined by an ether bond. "Diethylene glycol is derived as a co-product with ethylene glycol (MEG) and triethylene glycol. The industry generally operates to maximize MEG production. Ethylene glycol is by f ...
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