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The Dietary Supplement Health And Education Act Of 1994
The Dietary Supplement Health and Education Act of 1994 ("DSHEA"), is a 1994 statute of List of United States federal legislation, United States Federal legislation which defines and regulates dietary supplements. Under the act, supplements are regulated by the Food and Drug Administration, FDA for Good Manufacturing Practices under Title 21 of the Code of Federal Regulations, 21 CFR Part 111. The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing of their health and medical claims. Background In the late 1980s and early 1990s, the American Congress was evaluating several bills which would have increased the powers of the FDA. One of these acts, the ''Nutrition Advertising Coordination Act of 1991'' would have tightened the regulations regarding supplement labeling. In response to the proposed bill, many health food companies began lobbying the government to vote down ...
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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 the United States 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. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. 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. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol ...
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United States Department Of Health And Human Services
The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America". Before the separate federal Department of Education was created in 1979, it was called the Department of Health, Education, and Welfare (HEW). HHS is administered by the Secretary of Health and Human Services, who is appointed by the president with the advice and consent of the United States Senate. The position is currently held by Xavier Becerra. The United States Public Health Service Commissioned Corps, the uniformed service of the PHS, is led by the Surgeon General who is responsible for addressing matters concerning public health as authorized by the secretary or by the assistant secretary for Health in addition to his or her primary mission of administering the Comm ...
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Food Safety In The United States
Food safety in the United States relates to the processing, packaging, and storage of food in a way that prevents food-borne illness within the United States. The beginning of regulation on food safety in the United States started in the early 1900s, when several outbreaks sparked the need for litigation managing food in the food industry. Over the next few decades, the United States created several government agencies in an effort to better understand contaminants in food and to regulate these impurities. Many laws regarding food safety in the United States have been created and amended since the beginning of the 1900s. The United States has recently taken food safety into consideration again after several deadly outbreaks occurred in the early 2000s. Incidents such as the E.coli contaminated spinach in 2006 bring attention to the regulation surrounding the food industry and food quality control. Many outbreaks have occurred because of loose enforcement of regulation and lack ...
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Food Law
{{Commons category, Food law Law Law is a set of rules that are created and are enforceable by social or governmental institutions to regulate behavior,Robertson, ''Crimes against humanity'', 90. with its precise definition a matter of longstanding debate. It has been vario ... Law by issue Food politics ...
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103rd United States Congress
The 103rd United States Congress was a meeting of the legislative branch of the United States federal government, composed of the United States Senate and the United States House of Representatives. It met in Washington, D.C. from January 3, 1993, to January 3, 1995, during the final weeks of George H. W. Bush's presidency and the first two years of Bill Clinton's presidency. The apportionment of seats in the House of Representatives was based on the Twenty-first Census of the United States in 1990. This is the most recent Congress to have a Democratic senator from Texas, Bob Krueger, who lost election to finish Lloyd Bentsen's term in 1993. Three Democratic senators from the state of Maine, George J. Mitchell, and the state of Tennessee, Jim Sasser and Harlan Mathews, only Sasser lost re-election and the other two retired in 1994, respectively. In addition, a Democratic senator from the state of Oklahoma, David Boren, resigned in the final weeks of the Congress. Both chamb ...
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Dietary Supplement
A dietary supplement is a manufactured product intended to supplement one's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources or that are synthetic in order to increase the quantity of their consumption. The class of nutrient compounds includes vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled. Creating an industry estimated to have a 2020 value of ...
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Regulation Of Food And Dietary Supplements By The U
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and society, but the term has slightly different meanings according to context. For example: * in biology, gene regulation and metabolic regulation allow living organisms to adapt to their environment and maintain homeostasis; * in government, typically regulation means stipulations of the delegated legislation which is drafted by subject-matter experts to enforce primary legislation; * in business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set and enforce rules with less government involvement; and, * in psychology, self-regulation theory is the study of how individuals regulate their thoughts and behaviors to reach goals. Social Regulation in the social, political, psychological, and economic domains can take many forms: legal restri ...
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David Aaron Kessler
David Aaron Kessler (born May 13, 1951) is an American pediatrician, attorney, author, and administrator (both academic and governmental) serving as Chief Science Officer of the White House COVID-19 Response Team since 2021. Kessler was the commissioner of the Food and Drug Administration (FDA) from November 8, 1990, to February 28, 1997. He co-chaired the Biden-Harris transition’s COVID-19 Advisory Board from November 2020 to January 2021 and was the head of Operation Warp Speed, the U.S. government program to accelerate the development of COVID-19 vaccines and other treatments, from January to February 2021. Background After graduation from Amherst College in 1973, Kessler studied medicine at Harvard University, obtaining an M.D. degree in 1979. While at Harvard, Kessler obtained a J.D. degree in 1977 from the University of Chicago Law School. While serving his residency in pediatrics at Johns Hopkins Hospital in Baltimore, he worked as a consultant to Republican senator ...
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Steven Novella
Steven Paul Novella (born July 29, 1964) is an American clinical neurologist and associate professor at Yale University School of Medicine. Novella is best known for his involvement in the skeptical movement as a host of '' The Skeptics' Guide to the Universe'' podcast and as the president of the New England Skeptical Society. He is a fellow of the Committee for Skeptical Inquiry (CSI). Early life and education Novella was born July 29, 1964 to Joseph Novella and Patricia Novella née Danbury. He was raised in New Fairfield, Connecticut and has four siblings. Novella considered becoming a lawyer prior to attending college but decided to go into medicine as a teenager. As an undergraduate, he pursued premed and science. In 1991, Novella earned a medical degree from Georgetown University School of Medicine. He spent the first year of residency at Georgetown University Hospital/Washington Hospital Center in internal medicine. He completed his residency in neurology at Yale� ...
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Adverse Events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. AEs in patients participating in clinical trials must be reported to the study sponsor and if required could be reported to the local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening, results in persistent or significant incapacity, a congenital anomaly, birth defect or medically important condition) must be reported to the regulatory authorities immediately, whereas non-serious adverse events are ...
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Calcium
Calcium is a chemical element with the symbol Ca and atomic number 20. As an alkaline earth metal, calcium is a reactive metal that forms a dark oxide-nitride layer when exposed to air. Its physical and chemical properties are most similar to its heavier homologues strontium and barium. It is the fifth most abundant element in Earth's crust, and the third most abundant metal, after iron and aluminium. The most common calcium compound on Earth is calcium carbonate, found in limestone and the fossilised remnants of early sea life; gypsum, anhydrite, fluorite, and apatite are also sources of calcium. The name derives from Latin ''calx'' "lime", which was obtained from heating limestone. Some calcium compounds were known to the ancients, though their chemistry was unknown until the seventeenth century. Pure calcium was isolated in 1808 via electrolysis of its oxide by Humphry Davy, who named the element. Calcium compounds are widely used in many industries: in foods and ph ...
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