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Premarket Tobacco Application
A premarket tobacco application (PMTA) is an application that must be reviewed and approved by the Food and Drug Administration before a new tobacco product can be legally marketed in the United States. The first PMTA, and only to date, was approved by US FDA on November 10, 2015, when the FDA authorized the marketing of eight Swedish Match North America Inc. snus smokeless tobacco products (to be marketed under the brand name "General"). New tobacco product A new tobacco product is either a product commercially marketed in the United States after February 15, 2007, or any modification to a tobacco product commercially marketed after February 15, 2007. If a predicate product existed prior to February 15, 2007, applicants can apply via the Substantial Equivalence (SE) regulatory pathway. FDA deeming regulation On May 10, 2016, the US FDA finalized its "deeming" rule, subjecting additional products to scrutiny under the Federal Food, Drug and Cosmetic Act as amended by the Family Sm ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, 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 drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but 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 d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Tobacco Products
Tobacco is the agricultural product of the leaves of plants in the genus ''Nicotiana'', commonly termed ''tobacco plants''. All species of ''Nicotiana'' contain the addictive drug nicotine—a psychostimulant alkaloid found in all parts of the plants except the seeds, and most heavily-concentrated in the leaves—which occurs in varying amounts depending on the species of ''Nicotiana'' grown; the breed, type, or variety of tobacco cultivated and produced; and the method used to cure and process tobacco leaves once they have been harvested. This article provides a list of tobacco preparations and products. This list includes both tobacco products meant for consumption and those intended for other uses. Under the heading of consumable tobacco products, several categories of tobacco product are described in this list. Of these four basic categories, the first two include what are most often traditional types of tobacco products and preparations, relegated to the broad sub-categ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Swedish Match
Swedish Match AB is a Swedish multinational tobacco company headquartered in Stockholm. The company manufactures snus, nicotine pouches, moist snuff, tobacco- and nicotine-free pouch products, chewing tobacco, chew bags, tobacco bits, cigars, matches, and lighters, with operations in Sweden, Denmark, the United States, the Dominican Republic, Brazil, the Netherlands, and the Philippines. The company's origins can be traced back to 1868, and Ivar Kreuger. Swedish Match has played an important part in Sweden's industrial development. History The operations of Swedish Match originate from two companies: Svenska Tobaksmonopolet, a tobacco monopoly owned by the Swedish state and founded in 1915, and Svenska Tändsticks Aktiebolaget (STAB), a match manufacturing company founded in 1917 by Ivar Kreuger (also known as the ”Match King”) in connection with the acquisition of Jönköpings Tändsticksfabrik. In 1992, the tobacco and lights operations were joined in the Procordia ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Snus
Snus ( , ) is a tobacco product, originating from a variant of dry snuff in early 18th-century Sweden. It is placed between the upper lip and gum for extended periods, as a form of sublabial administration. Snus is not fermented. Although used similarly to American dipping tobacco, snus does not typically result in the need for spitting and, unlike naswar, snus is steam-pasteurized. The sale of snus is illegal in all the European Union countries except for Sweden. It is the most common type of tobacco product in Norway (which is not in the EU), and is available in Switzerland as well. Some EU countries like Estonia allow the sale of nicotine pouches, snus-like products that contain nicotine but no tobacco. Snus is also available in the United States. Canada makes it difficult to obtain snus through its high taxes on imported tobacco products. Snus has been seen as an alternative to smoking, vaping, chewing, dipping, and dissolvable and snuff tobacco products. Snus usually con ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Brand Name
A brand is a name, term, design, symbol or any other feature that distinguishes one seller's good or service from those of other sellers. Brands are used in business, marketing, and advertising for recognition and, importantly, to create and store value as brand equity for the object identified, to the benefit of the brand's customers, its owners and shareholders. Brand names are sometimes distinguished from Generic brand, generic or store brands. The practice of branding - in the original literal sense of marking by burning - is thought to have begun with the ancient Egyptians, who are known to have engaged in livestock branding as early as 2,700 BCE. Branding was used to differentiate one person's cattle from another's by means of a distinctive symbol burned into the animal's skin with a hot branding iron. If a person stole any of the cattle, anyone else who saw the symbol could deduce the actual owner. The term has been extended to mean a strategic personality for a produ ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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 was us ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Family Smoking Prevention And Tobacco Control Act
Family (from la, familia) is a group of people related either by consanguinity (by recognized birth) or affinity (by marriage or other relationship). The purpose of the family is to maintain the well-being of its members and of society. Ideally, families offer predictability, structure, and safety as members mature and learn to participate in the community. Historically, most human societies use family as the primary locus of attachment, nurturance, and socialization. Anthropologists classify most family organizations as matrifocal (a mother and her children), patrifocal (a father and his children), conjugal (a wife, her husband, and children, also called the nuclear family), avuncular (a man, his sister, and her children), or extended (in addition to parents and children, may include grandparents, aunts, uncles, or cousins). The field of genealogy aims to trace family lineages through history. The family is also an important economic unit studied in family economics. The w ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
E-cigarette
An electronic cigarette is an electronic device that simulates tobacco smoking. It consists of an atomizer, a power source such as a battery, and a container such as a cartridge or tank. Instead of smoke, the user inhales vapor. As such, using an e-cigarette is often called "vaping". The atomizer is a heating element that vaporizes a liquid solution called e-liquid, which quickly cools into an aerosol of tiny droplets, vapor and air. E-cigarettes are activated by taking a puff or pressing a button. Some look like traditional cigarettes, and most kinds are reusable. The vapor mainly comprises propylene glycol and/or glycerin, usually with nicotine and flavoring. Its exact composition varies, and depends on several things including user behavior. Vaping is likely much less harmful than smoking. E-cigarette vapor contains fewer toxins than cigarette smoke. It contains traces of harmful substances not found in cigarette smoke. Nicotine is highly addictive. Users beco ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cigar
A cigar is a rolled bundle of dried and fermented tobacco leaves made to be smoked. Cigars are produced in a variety of sizes and shapes. Since the 20th century, almost all cigars are made of three distinct components: the filler, the binder leaf which holds the filler together, and a wrapper leaf, which is often the highest quality leaf used. Often there will be a cigar band printed with the cigar manufacturer's logo. Modern cigars often come with two bands, especially Cuban cigar bands, showing Limited Edition (''Edición Limitada'') bands displaying the year of production. Cigar tobacco is grown in significant quantities primarily in Central America and the islands of the Caribbean, including Cuba, the Dominican Republic, Haiti, Honduras, Mexico, Ecuador, Nicaragua, Guatemala, Costa Rica, Panama, and Puerto Rico; it is also produced in the Eastern United States, Brazil and in the Mediterranean countries of Italy and Spain (in the Canary Islands), and in Indonesia and the P ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Vape Pen
An electronic cigarette is an electronic device that simulates tobacco smoking. It consists of an atomizer, a power source such as a battery, and a container such as a cartridge or tank. Instead of smoke, the user inhales vapor. As such, using an e-cigarette is often called "vaping". The atomizer is a heating element that vaporizes a liquid solution called e-liquid, which quickly cools into an aerosol of tiny droplets, vapor and air. E-cigarettes are activated by taking a puff or pressing a button. Some look like traditional cigarettes, and most kinds are reusable. The vapor mainly comprises propylene glycol and/or glycerin, usually with nicotine and flavoring. Its exact composition varies, and depends on several things including user behavior. Vaping is likely much less harmful than smoking. E-cigarette vapor contains fewer toxins than cigarette smoke. It contains traces of harmful substances not found in cigarette smoke. Nicotine is highly addictive. Users ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Modified Risk Tobacco Product
A modified risk tobacco product (MRTP) is a legal designation in the United States for a tobacco product that poses lower health risks to individual users and the population as a whole when compared to existing products on the market such as cigarettes (see health effects of tobacco). The Family Smoking Prevention and Tobacco Control Act of 2009 gives the US Food and Drug Administration (FDA) broad authority to regulate tobacco products; the FDA's power extends to approving or rejecting MRTP applications. Without approval from the FDA's Center for Tobacco Products, a tobacco company may not legally make reduced risk claims or change warning label statements. General Snus from Swedish Match became the first FDA-approved MRTP in October 2019; the designation is valid for five years. In December 2021, the U.S. Food and Drug Administration (FDA) authorized the marketing of 22nd Century Group Inc.'s "VLN King" and "VLN Menthol King" combusted, filtered cigarettes as modified risk to ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Regulation Of Tobacco 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 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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