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.
POM Wonderful, LLC is a private company which sells an eponymous brand of beverages and fruit extracts. It was founded in 2002 by the billionaire industrial agriculture couple Stewart and Lynda Rae Resnick. Through The Wonderful Company, their holding company, they are also affiliated with Teleflora, FIJI Water, pesticide manufacturer Suterra, and Paramount Agribusiness.
Heckler v. Chaney, 470 U.S. 821 (1985), is a decision of the Supreme Court of the United States which held that a federal agency's decision to not take an enforcement action is presumptively unreviewable by the courts under section 701(a)(2) of the Administrative Procedure Act (APA). The case arose out of a group of death row inmates' petition to the Food and Drug Administration (FDA), seeking to have the agency thwart the state governments' plans to execute the inmates by lethal injection. The FDA declined to interfere, a decision the inmates appealed unsuccessfully to the District Court for the District of Columbia. On further review, the D.C. Circuit Court of Appeals held that the FDA's action was reviewable and that its denial was "arbitrary and capricious". The Supreme Court unanimously reversed the appeals court and declared in an 8–1 decision that agency nonenforcement decisions were presumptively unreviewable.
Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress.
An electronic cigarette (e-cigarette), or vape, is a vaporizer 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. 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.
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 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. A 2023 report by the World Health Organization (WHO) found that 34 countries had banned the sale of e-cigarettes.
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.
Blu is an electronic cigarette brand, produced by Fontem Ventures and owned by Imperial Brands. The brand Blu sells various types of rechargeable and disposable e-cigarettes with a wide selection of flavored and unflavored liquids. Its products are available in many countries and each market offers different types of products suited to public demand and opportunities. The global headquarters of Blu is located in Amsterdam. Local offices are active around the world to service all markets which sell the brand.
The health effects of electronic cigarettes (e-cigarettes) include a range of potential risks such as exposure to toxic chemicals, the possibility of increased likelihood of respiratory and cardiovascular diseases, and concerns about their possible role in cancer development. Upon their introduction, there were marketing claims that they were a safer alternative to traditional tobacco products.
An electronic cigarette is a handheld battery-powered vaporizer that simulates smoking, but without tobacco combustion. E-cigarette components include a mouthpiece, a cartridge, a heating element/atomizer, a microprocessor, a battery, and some of them have an LED light on the end. An atomizer consists of a small heating element, or coil, that vaporizes e-liquid and a wicking material that draws liquid onto the coil. When the user inhales a flow sensor activates the heating element that atomizes the liquid solution; most devices are manually activated by a push-button. The e-liquid reaches a temperature of roughly 100–250 °C (212–482 °F) within a chamber to create an aerosolized vapor. The user inhales an aerosol, which is commonly but inaccurately called vapor, rather than cigarette smoke. Vaping is different from smoking, but there are some similarities, including the hand-to-mouth action of smoking and an aerosol that looks like cigarette smoke. The aerosol provides a flavor and feel similar to tobacco smoking. There is a learning curve to use e-cigarettes properly. E-cigarettes are cigarette-shaped, and there are many other variations. E-cigarettes that resemble pens or USB memory sticks are also sold that may be used unobtrusively.
A vape shop is a retail outlet specializing in the selling of vaping products, though shops selling derived psychoactive cannabis products have increased in the United States since the passage of the 2018 Farm Bill. There are also online vape shops. A vape shop offers a range of vaping products. The majority of vape shops do not sell vaping 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 vaping products in one US state took place in vape shops. Big Tobacco believes the independent vape market is a threat to their interests.
Juul Labs, Inc. is an American electronic cigarette company that spun off from Pax Labs in 2017. The Juul electronic cigarette atomizes nicotine salts derived from tobacco supplied by one-time use cartridges.
Vuse is an electronic cigarette produced by R. J. Reynolds Vapor Company, a subsidiary of the Reynolds American tobacco company. In 2015, it was the most popular e-cigarette in the United States with 33% market share in Nielsen-tracked channels. However, Vuse lost its top position in 2017, when Juul overtook it to become the most popular e-cigarette in the US. As of August 2018, Vuse controlled 10% percent of the American e-cigarette market, compared to Juul's 72% market share. By September 2023, however, Vuse's market share stood at 41.5% versus Juul's 24.7% market share.
NJOY, LLC is an 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. On June 1, 2023, the company was acquired by Altria Group.
Scott Gottlieb is an American physician, investor, and author who served as the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA), a member of the board of directors of drug maker Pfizer, Inc and gene sequencing company Illumina, Inc., and a contributor to the cable financial news network CNBC and the CBS News program Face the Nation. An elected member of the National Academy of Medicine, Gottlieb is the author of The New York Times best selling book Uncontrolled Spread on the COVID-19 pandemic and the national security vulnerabilities that it revealed. His forthcoming book, The Miracle Century: Making Sense of the Cell Therapy Revolution, traces the scientific achievements that propelled progress in cell therapies.
An outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) started in 2019 among users of illegal, unregulated cannabis vaping products, almost exclusively in the United States. The first cases of this particular outbreak were identified in Illinois and Wisconsin in April 2019; as of 18 February 2020, a total of 2,807 hospitalized cases, including 68 deaths, have been confirmed. According to the U.S. Centers for Disease Control (CDC), "Vitamin E acetate is strongly linked to the EVALI outbreak...Evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC or non-THC products, in some of the reported EVALI cases".
Vaping-associated pulmonary injury (VAPI), also known as vaping-associated lung injury (VALI) or e-cigarette, or vaping, product use associated lung injury (E/VALI), is an umbrella term, used to describe lung diseases associated with the use of vaping products that can be severe and life-threatening. Symptoms can initially mimic common pulmonary diagnoses, such as pneumonia, but sufferers typically do not respond to antibiotic therapy. Differential diagnoses have overlapping features with VAPI, including COVID-19. According to a systematic review article, "Initial case reports of vaping-related lung injury date back to 2012, but the ongoing outbreak of EVALI began in the summer of 2019." According to an article in the Radiological Society of North America news published in March 2022, EVALI cases continue to be diagnosed. “EVALI has by no means disappeared,” Dr. Kligerman said. “We continue to see numerous cases, even during the pandemic, many of which are initially misdiagnosed as COVID-19.”
Electronic cigarettes are marketed to smoking and non-smoking men, women, and children as being safer than cigarettes. In the 2010s, large tobacco businesses accelerated their marketing spending on vape products, similar to the strategies traditional cigarette companies used in the 1950s and 1960s.
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 2022.
