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85-605: The word clove , first used in English in the 15th century , derives via Middle English clow of gilofer , Anglo-French clowes de gilofre and Old French clou de girofle , from the Latin word clavus "nail". The related English word gillyflower , originally meaning "clove", derives via said Old French girofle and Latin caryophyllon , from the Greek karyophyllon "clove", literally "nut leaf". The clove tree

170-663: A boron -based wood preservative. Cloves can be used to make a fragrant pomander when combined with an orange. When given as a gift in Victorian England, such a pomander indicated warmth of feeling. The use of clove for any medicinal purpose has not been approved by the US Food and Drug Administration , and its use may cause adverse effects if taken orally by people with liver disease , blood clotting and immune system disorders, or food allergies . Cloves are used in traditional medicine as an essential oil , which

255-743: A medical practitioner 's supervision like ibuprofen . In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program , but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016. During

340-460: A "FDA Compliant" or "FDA Acceptable". Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by

425-425: A REMS program called iPLEDGE . Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in

510-767: A case. The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of

595-586: A common element in spice blends (as part of the Malay rempah empat beradik –"four sibling spices"– besides cinnamon, cardamom and star anise for example), including pumpkin pie spice and speculaas spices. In Mexican cuisine , cloves are best known as clavos de olor , and often accompany cumin and cinnamon . They are also used in Peruvian cuisine, in a wide variety of dishes such as carapulcra and arroz con leche . A major component of clove's taste

680-527: A company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether

765-426: A complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh . When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within

850-432: A long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if

935-782: A mechanical movable type began the printing press . These two events played key roles in the development of the Renaissance . The Roman papacy was split in two parts in Europe for decades (the so-called Western Schism ), until the Council of Constance . The division of the Catholic Church and the unrest associated with the Hussite movement would become factors in the rise of the Protestant Reformation in

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1020-560: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in

1105-651: A number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of

1190-498: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed

1275-523: A satisfied requirement. The FDA does not approve applied coatings used in the food processing industry . There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not and cannot be considered as FDA Approved, but rather, they are

1360-504: A small central ball. Clove stalks are slender stems of the inflorescence axis that show opposite decussate branching. Externally, they are brownish, rough, and irregularly wrinkled longitudinally with short fracture and dry, woody texture. Mother cloves (anthophylli) are the ripe fruits of cloves that are ovoid, brown berries, unilocular and one-seeded. Blown cloves are expanded flowers from which both corollae and stamens have been detached. Exhausted cloves have most or all

1445-440: A substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.) The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and

1530-561: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play

1615-610: 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, caffeine 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 . The FDA's primary focus

1700-401: Is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by

1785-651: Is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in

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1870-457: Is an evergreen that grows up to 8–12 metres (26–39 ft) tall, with large leaves and crimson flowers grouped in terminal clusters. The flower buds initially have a pale hue, gradually turn green, then transition to a bright red when ready for harvest. Cloves are harvested at 1.5–2 centimetres ( 5 ⁄ 8 – 3 ⁄ 4  in) long, and consist of a long calyx that terminates in four spreading sepals , and four unopened petals that form

1955-458: Is cultivated in three separate ways, a monoculture , agricultural parklands, and agroforestry systems. Archaeologist Giorgio Buccellati found cloves in Terqa , Syria, in a burned-down house which was dated to 1720 BC during the kingdom of Khana . This was the first evidence of cloves being used in the west before Roman times. The discovery was first reported in 1978. They reached Rome by

2040-564: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in

2125-484: Is imparted by the chemical eugenol , and the quantity of the spice required is typically small. It pairs well with cinnamon, allspice , vanilla , red wine , basil , onion , citrus peel , star anise , and peppercorns . It is often added to betel quids to enhance aroma while chewing. The spice is used in a type of cigarette called kretek in Indonesia. Clove cigarettes were smoked throughout Europe, Asia, and

2210-745: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands , and Puerto Rico . In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. FDA headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,

2295-402: Is often present in a root canal treatment failure. Studies to determine its effectiveness for fever reduction, as a mosquito repellent, and to prevent premature ejaculation have been inconclusive. It remains unproven whether blood sugar levels are reduced by cloves or clove oil. The essential oil may be used in aromatherapy . Until the colonial era , cloves only grew on a few islands in

2380-449: Is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs. The original authority for government regulation of biological products

2465-741: Is the branch of the FDA responsible for the premarket approval of all medical devices , as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&;C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators . CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation . Examples of CDRH-regulated devices include cellular phones , airport baggage screening equipment , television receivers , microwave ovens , tanning booths , and laser products . CDRH regulatory powers include

2550-406: Is used as an anodyne ( analgesic ) mainly for dental emergencies and other disorders. There is evidence that clove oil containing eugenol is effective for toothache pain and other types of pain, and one review reported the efficacy of eugenol combined with zinc oxide as an analgesic for alveolar osteitis . Clove essential oil may prevent the growth of Enterococcus faecalis bacteria which

2635-702: Is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities : drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status

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2720-451: Is voluntary. While this remains the primary tool of post-market safety surveillance , FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials , called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that

2805-701: The Battle of Bosworth Field , establishing the Tudor dynasty in the later part of the century. Constantinople , known as the capital of the world and the capital of the Byzantine Empire , fell to the emerging Muslim Ottoman Turks , marking the end of the tremendously influential Byzantine Empire and, for some historians, the end of the Middle Ages. This led to the migration of Greek scholars and texts to Italy, while Johannes Gutenberg 's invention of

2890-685: The Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved

2975-725: The Delhi Sultanate . Under the rule of the Yongle Emperor , who built the Forbidden City and commanded Zheng He to explore the world overseas , the Ming dynasty 's territory reached its pinnacle. In Africa , the spread of Islam led to the destruction of the Christian kingdoms of Nubia , by the end of the century, leaving only Alodia (which was to collapse in 1504). The formerly vast Mali Empire teetered on

3060-689: The Julian calendar dates from 1 January 1401 (represented by the Roman numerals MCDI) to 31 December 1500 (MD). In Europe , the 15th century includes parts of the Late Middle Ages , the Early Renaissance , and the early modern period . Many technological, social and cultural developments of the 15th century can in retrospect be seen as heralding the " European miracle " of the following centuries. The architectural perspective , and

3145-730: The Moluccas (historically called the Spice Islands ), including Bacan , Makian , Moti , Ternate , and Tidore . Cloves were first traded by the Austronesian peoples in the Austronesian maritime trade network (which began around 1500 BC, later becoming the Maritime Silk Road and part of the Spice Trade ). The first notable example of modern clove farming developed on the east coast of Madagascar , and

3230-898: The Yuan dynasty (1271 to 1368 AD) Chinese merchants began sending ships directly to the Moluccas to trade for cloves, and other spices. In the Western Classical literature cloves are mentioned by Pliny the Elders' Natural History . Dioscorides mentions cloves in his book De materia medica . The Liber Pontifcalis records an endowment made by Passinopolis under Pope Sylvester I . This endowment included an Egyptian estate, its annual revenues, 150 libra (around 50 kg or 108 lb) of cloves, and other amounts of spices and papyrus. Cosmas Indicopleustis in his book Topographia Christiana outlined his travels to Sri Lanka, and recounted that

3315-643: The coronavirus pandemic , FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. The Center for Biologics Evaluation and Research

3400-424: The flavonoids eugenin , kaempferol , rhamnetin , and eugenitin , tri terpenoids such as oleanolic acid , stigmasterol , and campesterol and several sesquiterpenes . Although eugenol has not been classified for its potential toxicity , it was shown to be toxic to test organisms in concentrations of 50, 75, and 100 mg per liter. 15th century The 15th century was the century which spans

3485-606: The '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc. The Center for Veterinary Medicine (CVM)

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3570-406: The 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an Abbreviated New Drug Application (ANDA). 80% of prescription drugs sold in

3655-511: The FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation , Assistant Attorney General , and even Interpol . OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of

3740-633: The FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating

3825-724: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,

3910-713: The FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018,

3995-594: The FDA's drug review budget Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic. The programs for safety regulation vary widely by the type of product, its potential risks, and

4080-881: The Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic 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 of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives , added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements . Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids , and enzymes . Specific standards

4165-770: The Indians said that cloves, among other products, came in from unspecified places along sea trade routes. Cloves were also present in records in China , Sri Lanka , Southern India , Persia , and Oman by around the third century to second century BC. These mentions of "cloves" reported in China, South Asia, and the Middle East come from before the establishment of Southeast Asian maritime trade. But all of these are misidentifications that referred to other plants (like cassia buds, cinnamon , or nutmeg ); or are imports from Maritime Southeast Asia mistakenly identified as being natively produced in these regions. Archaeologists recovered

4250-647: The Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA), 

4335-459: The Moluccas, and the trade in cloves was beyond the limited policing powers of the corporation". One clove tree named Afo that experts believe is the oldest in the world on Ternate may be 350–400 years old. Tourists are told that seedlings from this very tree were stolen by a Frenchman named Pierre Poivre in 1770, transferred to the Isle de France ( Mauritius ), and then later to Zanzibar , which

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4420-681: The Officialdom of the Han Dynasty, dating to around 200 BC). The book states a rule that ministers should suck cloves to sweeten their breath before speaking to the emperor. From Chinese records during the Song Dynasty (960 to 1279 AD) cloves were primarily imported by private ventures, called Merchant Shipping Offices, who bought goods from middlemen in the Austronesian polities of Java , Srivijaya , Champa , and Butuan . During

4505-488: The United States are generic brands. In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from

4590-498: The United States. Clove cigarettes are currently classified in the United States as cigars , the result of a ban on flavored cigarettes in September 2009. Clove essential oil may be used to inhibit mold growth on various types of foods. In addition to these non-culinary uses of clove, it can be used to protect wood in a system for cultural heritage conservation, and showed the efficacy of clove essential oil to be higher than

4675-784: The agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture , the Drug Enforcement Administration , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by

4760-468: The authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing. Clearance requests are required for medical devices that prove they are "substantially equivalent" to

4845-764: The brink of collapse, under pressure from the rising Songhai Empire . In the Americas , both the Aztec Empire and the Inca Empire reached the peak of their influence, but the voyages of Christopher Columbus and other European voyages of discovery in the Americas, beginning the European colonization of the Americas , changed the course of modern history. Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA )

4930-625: The burial practices of Europeans from the late middle ages into the early modern period. During renovations on the Grote Kerk of Breda a tomb was rediscovered that was used between 1475 and 1526 AD by eight members of the house of Nassau . These burials had to be moved, but before being re-interred these burials were studied for botanical remains. The burial of Cimberga van Baden contained pollen from cloves. The Dutch Physician Pieter Van Foreest wrote down multiple recipes for embalming some of which included cloves. One of these recipes he wrote down

5015-478: The case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and

5100-511: The contexts varying from household pets to human sperm donated for use in assisted reproduction . The FDA is led by the commissioner of Food and Drugs , appointed by the President with the advice and consent of the Senate . The commissioner reports to the secretary of health and human services . Robert Califf is the current commissioner as of February 17, 2022. The FDA's headquarters

5185-420: The drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising COVID-19 vaccines during

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5270-416: The drug is used safely. For example, thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs. The drug isotretinoin has

5355-431: The earliest known example of macro-botanical cloves in northwest Europe from the wreck of the Danish-Norwegian flagship, Gribshunden . The ship sank near Ronneby , Sweden in June 1495 while King Hans was sailing to political summit at Kalmar, Sweden. Exotic luxuries including cloves, ginger, peppercorns, and saffron would have impressed the noblemen and high church officials at the summit. Cloves have been documented in

5440-553: The early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without

5525-648: The federal agency resulted in racketeering and in violations of antitrust law . "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ( Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it

5610-436: The federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs. The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients,

5695-401: The first century AD. Other archeological finds of cloves include: At the Batujaya site a single clove was found in a waterlogged layer dating to between the 100s BC to 200s BC corresponding to the Buni culture phase of this site. A study at the site of Óc Eo in the Mekong Delta of Vietnam found starch grains of cloves on stone implements used in food processing. This site was occupied from

5780-424: The first to eighth century BC, and was a trading center for the kingdom of Funnan . Two cloves were found during archaeological excavations at the Sri Lankan city of Mantai dated to around 900–1100 AD. Cloves are mentioned in the Ramayana . Cloves are also mentioned in the Charaka Samhita . One of the earliest examples of literary evidence of cloves in China is from the book the Han Guan Yi (Etiquettes of

5865-421: The following century. Islamic Spain became dissolved through the Christian Reconquista , followed by the forced conversions and the Muslim rebellion , ending over seven centuries of Islamic rule and returning southern Spain to Christian rulers. The spices, wines and precious metals of the Bengal Sultanate had attracted European traders to trade with Bengal, but the trade was subsequently lower, due to

5950-587: The island of Sulawesi produced over 40% collectively. Eugenol comprises 72–90% of the essential oil extracted from cloves, and is the compound most responsible for clove aroma. Complete extraction occurs at 80 minutes in pressurized water at 125 °C (257 °F). Ultrasound-assisted and microwave-assisted extraction methods provide more rapid extraction rates with lower energy costs. Other phytochemicals of clove oil include acetyl eugenol, beta- caryophyllene , vanillin , crategolic acid , tannins , such as bicornin , gallotannic acid , methyl salicylate ,

6035-479: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)

6120-685: The modern fields which are known today as banking and accounting were founded in Italy . The Hundred Years' War ended with a decisive French victory over the English in the Battle of Castillon . Financial troubles in England following the conflict resulted in the Wars of the Roses , a series of dynastic wars for the throne of England. The conflicts ended with the defeat of Richard III by Henry VII at

6205-521: The oil removed by distillation. They yield no oil and are darker in color. Cloves are used in the cuisine of Asian , African , Mediterranean , and the Near and Middle East countries, lending flavor to meats (such as baked ham ), curries , and marinades , as well as fruit (such as apples, pears, and rhubarb ). Cloves may be used to give aromatic and flavor qualities to hot beverages, often combined with other ingredients such as lemon and sugar. They are

6290-533: The period in which they had only been approved under Emergency Use Authorization . After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals

6375-422: The predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed. Cosmetics are regulated by the Center for Food Safety and Applied Nutrition ,

6460-580: The regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of

6545-470: The regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483 . In June 2018,

6630-689: The rise of the Ottoman Empire, which introduced new taxes and tariffs against European traders. This had led to explorers like Christopher Columbus finding a route to reach India, which eventually reached the Americas. Explorers like Vasco da Gama , a Portuguese traveller, also found a route to reach to India from the African coast. In Asia , the Timurid Empire collapsed and the Afghan Pashtun Lodi dynasty took control of

6715-448: The safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having

6800-458: The same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical ). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear

6885-488: Was buried in 1737 AD contained whole cloves. During the colonial era, cloves were traded like oil, with an enforced limit on exportation. As the Dutch East India Company consolidated its control of the spice trade in the 17th century, they sought to gain a monopoly in cloves as they had in nutmeg. However, "unlike nutmeg and mace , which were limited to the minute Bandas , clove trees grew all over

6970-533: Was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide , a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In

7055-543: Was established by the 1902 Biologics Control Act , with additional authority established by the 1944 Public Health Service Act . Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health ; this authority was transferred to the FDA in 1972. The Center for Devices and Radiological Health (CDRH)

7140-489: Was once the world's largest producer of cloves. Current leaders in clove production are Indonesia , Madagascar , Tanzania , Sri Lanka , and Comoros . Indonesia is the largest clove producer, but only about 10-15% of its cloves production is exported, and domestic shortfalls must sometimes be filled with imports from Madagascar. The modern province of Maluku remains the largest source of cloves in Indonesia with around 15% of national production, although provinces comprising

7225-489: Was that used by his fellow physicians Spierinck and Goethals. An embalming jar associated with Vittoria della Rovere also contained clove pollen. This probably came from her ingestion of clove oil as a medicine in her final days. When burials needed to be moved from the church of Saint Germain in Flers , France they were also studied for botanical remains. The body and coffin of Philippe René de la Motte Ango, count of Flers who

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