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, 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 United States Federal Food, Drug, and Cosmetic Act 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.
Y1 is a strain of tobacco that was cross-bred by Brown & Williamson to obtain an unusually high nicotine content. It became controversial in the 1990s when the United States Food and Drug Administration (FDA) used it as evidence that tobacco companies were intentionally manipulating the nicotine content of cigarettes. Y1 has also been investigated by the Pan American Health Organization (PAHO).
A menthol cigarette is a cigarette flavored with the compound menthol.
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.
Wyeth v. Levine, 555 U.S. 555 (2009), is a United States Supreme Court case holding that Federal regulatory approval of a medication does not shield the manufacturer from liability under state law.
Tobacco politics refers to the politics surrounding the use and distribution of tobacco.
The Family Smoking Prevention and Tobacco Control Act, is a federal statute in the United States that was signed into law by President Barack Obama on June 22, 2009. The Act gives the Food and Drug Administration the power to regulate the tobacco industry. A signature element of the law imposes new warnings and labels on tobacco packaging and their advertisements, with the goal of discouraging minors and young adults from smoking. The Act also bans flavored cigarettes, places limits on the advertising of tobacco products to minors and requires tobacco companies to seek FDA approval for new tobacco products.
Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress. With this statute, the Food and Drug Administration (FDA) was given the ability to regulate tobacco products.
There are smoking cessation policy initiatives by the United States government at federal, state and local levels.
Regulation of electronic cigarettes varies across countries and states, ranging from no regulation to banning them entirely. As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.
POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102 (2014), was a United States Supreme Court case that held that a statutory private right of action under the Lanham Act is not precluded by regulatory provisions of the Food, Drug, and Cosmetic Act.
The scientific community in United States and Europe are primarily concerned with the possible effect of electronic cigarette use on public health. There is concern among public health experts that e-cigarettes could renormalize smoking, weaken measures to control tobacco, and serve as a gateway for smoking among youth. The public health community is divided over whether to support e-cigarettes, because their safety and efficacy for quitting smoking is unclear. Many in the public health community acknowledge the potential for their quitting smoking and decreasing harm benefits, but there remains a concern over their long-term safety and potential for a new era of users to get addicted to nicotine and then tobacco. There is concern among tobacco control academics and advocates that prevalent universal vaping "will bring its own distinct but as yet unknown health risks in the same way tobacco smoking did, as a result of chronic exposure", among other things.
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. 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.
A vape shop is a retail outlet specializing in the selling of electronic cigarette products, though shops selling derived psychoactive cannabis products have increased since the passage of the 2018 Farm Bill. There are also online vape shops. A vape shop offers a range of e-cigarette products. The majority of vape shops do not sell e-cigarette products that are from "Big Tobacco" companies. In 2013, online search engine searches on vape shops surpassed searches on e-cigarettes. Around a third of all sales of e-cigarette products take place in vape shops. Big Tobacco believes the independent e-cigarette market is a threat to their interests.
NJOY is an independent American company that manufactures and distributes electronic cigarettes and vaping products. In 2017, NJOY acquired the assets of NJOY, Inc., one of the first companies to sell e-cigarettes.
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.
The major questions doctrine is a principle of statutory interpretation in United States administrative law which states that courts will presume that Congress does not delegate to executive agencies issues of major political or economic significance.
The Vaporized Nicotine and Non-Nicotine Products Regulation Act, officially recorded as Republic Act No. 11900, is a law in the Philippines which aims to regulate the "importation, sale, packaging, distribution, use and communication of vaporized nicotine and non-nicotine products and novel tobacco products", such as electronic cigarettes and heated tobacco products. It lapsed into law on July 25, 2022. As a proposed measure, the law was known as the Vape Regulation Bill.
Brian King is an American Epidemiologist who currently serves as the Director of the Food and Drug Administration’s Center for Tobacco Products (CTP). He was appointed to his role in July of 2022.
