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The United States Food and Drug Administration is a Federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) rather than final products. By regulating APIs instead of specific drug formulations, governments allow manufacturers the freedom to formulate ingredients, or combinations of ingredients, into proprietary mixtures.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, physical hazards and more recently radiological hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
Cannabidiol (CBD) is a phytocannabinoid discovered in 1940. It is one of 113 identified cannabinoids in cannabis plants and accounts for up to 40% of the plant's extract. As of 2019, clinical research on CBD included studies of anxiety, cognition, movement disorders, and pain, but there is insufficient high-quality evidence that it is effective for these conditions.
The United States Federal Food, Drug, and Cosmetic Act, 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. 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 butterfly kingfish is an ocean-dwelling ray-finned bony fish in the mackerel family, Scombridae – a family which it shares with the tunas, mackerels, Spanish mackerels, and bonitos. Unlike the 50 species from those four tribes, however, this species is unique in that it is the only scombrid to be classified apart from the rest, into the subfamily Gasterochismatinae and genus Gasterochisma.
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Dr. Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
The escolar, Lepidocybium flavobrunneum, a species of fish in the family Gempylidae, is found in deep tropical and temperate waters around the world. It is also known as snake mackerel, walu walu, and is sometimes sold as "butterfish" or "white tuna", a matter aggravated by potential health problems related to consumption of escolar, also giving rise to the mocking name ex-lax fish.
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
The Food Safety and Inspection Service (FSIS), an agency of the United States Department of Agriculture (USDA), is the public health regulatory agency responsible for ensuring that United States' commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. The FSIS draws its authority from the Federal Meat Inspection Act of 1906, the Poultry Products Inspection Act of 1957 and the Egg Products Inspection Act of 1970. The FSIS also acts as a national health department and is responsible for the safety of public food-related establishments as well as business investigation.
Applied Food Technologies, Inc. (AFT) is a privately held corporation in Alachua, Florida that develops diagnostics needed in the seafood industry and runs fee-for-service species identification and verification programs. The DNA-based species identification diagnostics developed by AFT are used in-house and are also packaged in a kit format and sold to federal, state and private laboratories in the US, Europe and Asia. AFT has established an extensive library of taxonomically verified fish species and has developed DNA standards for these fish.
This article is about the history of the United States Food and Drug Administration.
Dennis' Horseradish is a regional food item that is grown near Delhi, Ontario, Canada. The business has been in operation since 1969; selling their products at chain supermarkets in Ontario. Western Canada has been seen as a "target" market for Dennis' Horseradish. Currently, Dennis' Horseradish has been sold as far north as Lindsay, Ontario where it is a featured item at their farmers' market.
Shrimp and prawn are important types of seafood that are consumed worldwide. Although shrimp and prawns belong to different suborders of Decapoda, they are very similar in appearance and the terms are often used interchangeably in commercial farming and wild fisheries. A distinction is drawn in recent aquaculture literature, which increasingly uses the term "prawn" only for the freshwater forms of palaemonids and "shrimp" for the marine penaeids.
Seafood species can be mislabelled in misleading ways. This article examines the history and types of mislabelling, and looks at the current state of the law in different locations.
Antimicrobials destroy bacteria, viruses, fungi, algae, and other microbes. The cells of bacteria (prokaryotes), such as salmonella, differ from those of higher-level organisms (eukaryotes), such as fish. Antibiotics are chemicals designed to either kill or inhibit the growth of pathogenic bacteria while exploiting the differences between prokaryotes and eukaryotes in order to make them relatively harmless in higher-level organisms. Antibiotics are constructed to act in one of three ways: by disrupting cell membranes of bacteria, by impeding DNA or protein synthesis, or by hampering the activity of certain enzymes unique to bacteria.
Fisheries law is an emerging and specialized area of law. Fisheries law is the study and analysis of different fisheries management approaches such as catch shares e.g. Individual Transferable Quotas; TURFs; and others. The study of fisheries law is important in order to craft policy guidelines that maximize sustainability and legal enforcement. This specific legal area is rarely taught at law schools around the world, which leaves a vacuum of advocacy and research. Fisheries law also takes into account international treaties and industry norms in order to analyze fisheries management regulations. In addition, fisheries law includes access to justice for small-scale fisheries and coastal and aboriginal communities and labor issues such as child labor laws, employment law, and family law.
Taro Pharmaceutical Industries is an Israeli research-based pharmaceutical manufacturer publicly listed in the New York Stock Exchange. The company has more than 180 of its own drugs sold all over the world, reaching the markets of over 25 countries. The company's products are mainly sold in the United States, Canada and Israel. The symbol of the company in NYSE is "TARO". Taro Pharmaceutical Industries is reported to be on steady growth since 2008.
Lusutrombopag, sold under the brand name Mulpleta among others, is a medication that has been developed for certain conditions that lead to thrombocytopenia such as thrombocytopenia associated with chronic liver disease in patients prior to elective invasive procedures. It is being manufactured and marketed in Japan by Shionogi. It was approved by the U.S. Food and Drug Administration (FDA) in July 2018, and NICE in January 2020.
References
- Guidance for Industry: The Seafood List - FDA's Guide to Acceptable Market Names for Seafood Sold in Interstate Commerce https://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/Seafood/ucm113260.htm
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