2019–2020 vaping lung illness outbreak

Nicotine-containing products are regulated in the U.S. by the Food and Drug Administration (FDA) which has not approved any e-cigarette product for sale; THC products are illegal under federal law, but allowed by some states. A 2020 review stated "Initial case reports of vaping-related lung injury date back to 2012, but the ongoing outbreak of EVALI began in the summer of 2019..." At least 19 cases of vaping-associated pulmonary injuries had been reported worldwide prior to 2019. Similar cases were reported in the UK and Japan before the outbreak. The first case of e-cigarettes inducing lipid pneumonia was documented in the medical literature in 2012; the causative agent was identified as glycerin. Glycerin was long thought to be a safe e-liquid additive. However, formaldehyde is a known product of propylene glycol and glycerol vapor degradation, and may cause lung inflammation. Lipid pneumonia is known to cause lung inflammation, with exogenous and endogenous factors that cause this disease. EVALI is a diagnosis of exclusion as the symptoms are diffuse and mostly non-specific. Confirmed cases have the following features: • use of e-cigarettes in the 90 days prior to symptom onset; • pulmonary infiltrates on chest CT scans; • absence of pulmonary infection; • no other possible alternative diagnoses. == History ==

Prior to the outbreak, vitamin E acetate was used in concentrations under 20% of the formula in vape cartridges, as a thickening agent. Cases were first identified in Illinois and Wisconsin in April 2019. In September 2019, New York Governor Andrew Cuomo instructed the state health department to issue subpoenas against three sellers of thickening agents used in illicit vaping products. The e-cigarette industry blamed illicit vaping liquids. Juul Labs stated that some news reports state that several cases of lung illness were associated with vaping THC. By September 2019 the CDC and FDA recommended that the public should consider not using vaping products during their investigation, particularly those containing THC from informal sources. As of February 18, 2020, a total of 2,807 hospitalized cases had been reported to CDC, across all 50 states, the District of Columbia, and two US territories (Puerto Rico and US Virgin Islands). Some jurisdictions restricted the sale of products containing vitamin E acetate and other chemicals in response to the outbreak. == Treatment ==

File:Number_of_EVALI_cases_from_February_2019-January_2020.png|thumb|Chart from the CDC in 2020 showing the number of EVALI cases by week of hospital admission from February 2019 - January 2020. Around 95% of patients require hospitalization. Pharmacological management includes antibiotics and potentially antivirals as well as corticosteroids. Of the 2,506 reported cases, information is available in the three months prior to symptom onset for 1,782 of them as of December 3, 2019. The CDC reported that their findings suggest vaping products containing THC are linked to most of the cases and play a major role in the outbreak. == Public health recommendations ==

The CDC recommends that the public should consider not using any vaping products during their investigation, particularly those containing THC from informal sources like friends, family, or in-person or online dealers as of 20 November 2019. The CDC recommends that e-cigarette, or vaping, products should never be used by youths, young adults, or women who are pregnant. Adults who do not currently use tobacco products should not start using e-cigarettes or vaping products, according to the CDC. == United States ==

Cases involved in the outbreak of severe vaping-associated pulmonary injury were first identified in Illinois and Wisconsin in April 2019. As of 3 December 2019, the CDC is only reporting hospitalized vaping-associated lung illness cases and vaping-associated lung illness deaths, regardless of hospitalization status.|alt=Percentage of persons needing intubation and hospitalization among persons with vaping-associated lung injury. Many patients have required medical treatment with supplemental oxygen, including some who required assisted ventilation. As of 5 September 2019, the New York State Department of Health reported 34 cases of severe lung illness in patients who were reportedly using different vaping products. None of the nicotine-based product samples contained vitamin E acetate. In the reports from Illinois and Wisconsin, the onset of respiratory findings appeared to have occurred over several days to several weeks before hospitalization. As of 5 September 2019, the Illinois Department of Public Health reported 42 cases of lung illness, seven that were still being investigated, and one death. Severe lung illness among young adults and youth who used vaping products required hospitalization in 11 cases in Wisconsin, and others were being investigated in August 2019. Deaths have been confirmed as of 18 February 2020 among 27 states and the District of Columbia. As of 18 February 2020, there were a recorded number of 68 deaths. Many of these deaths have been linked to illegal (black market) cannabis vaping products, which have been confirmed in 27 states and the District of Columbia: Alabama, California (4), Connecticut, Delaware, District of Columbia, Florida, Georgia (3), Illinois (5), Indiana (4), Kansas (2), Louisiana, Massachusetts (3), Michigan, Minnesota (3), Mississippi, Missouri (2), Montana, Nebraska, New Jersey, New York (2), Oregon (2), Pennsylvania, Rhode Island, South Carolina, Tennessee (2), Texas, Utah, and Virginia. The median age of deceased persons was 51 years, and ranged from 15 to 75 years, as of 14 January 2020. ==Canada ==

On 18 September 2019, a case of severe lung illness associated with vaping in Canada was reported. His health improved and he was released from the hospital. This case has not been confirmed, as 27 September 2019. and other cases are under investigation in British Columbia. Two probable cases have been reported in New Brunswick as of 16 October 2019. A case in Newfoundland and Labrador was reported as a probable case of a lung illness tied to vaping in January 2020. As of 4 February 2020, 17 cases of lung injuries have been reported to the Public Health Agency of Canada. == Other countries ==

What has occurred in the United States has not occurred in other places where vaping is frequent, such as the UK. == Investigation ==

audio of the telebriefing conference call with reporters.|alt=Sounding the Alarm: The Public Health Threats of E-Cigarettes. (THC)-containing e-cigarette products while speaking to healthcare personnel, or in follow-up interviews by health department staff. On 6 September 2019, The New England Journal of Medicine reported that "Information on product use is based on reports by the patients, and patients may be reluctant to report illicit drug use." On 17 October 2019, the American Journal of Clinical Pathology reported that lung biopsies from eight patients with vaping-associated lung injury show acute lung injury patterns, not exogenous lipoid pneumonia. Of the 2,506 reported cases, information is available in the three months prior to symptom onset for 1,782 of them as of 3 December 2019. No one compound or ingredient has emerged as the cause of these illnesses so far; and it may be that there is more than one cause of this outbreak. A 2020 study found that vaporizing vitamin E acetate produced carcinogenic alkenes and benzene, but also exceptionally toxic ketene gas (also known as ethenone), which may be a contributing factor to the pulmonary injuries. Exposure to concentrated levels of ketene gas causes humans to experience irritation of body parts such as the eye, nose, throat and lungs. Extended toxicity testing on mice, rats, guinea pigs and rabbits showed that ten-minute exposures to concentrations of freshly generated ketene gas as low as 0.2 mg/liter (116 ppm) may produce a high percentage of deaths in small animals. These findings show ketene gas is toxicologically identical to phosgene. == Illicit vaping ==

cannabis cartridges are being sold to users at a reduced cost. Dank Vapes is an illicit brand that uses a cartridge. Dank Vapes appears to be the most prominent in a class of largely counterfeit brands, with common packaging that is easily available online, and that is used by distributors to market THC-containing cartridges with no obvious centralized production or distribution. Some of the vaping products that contained exceedingly high amounts of vitamin E acetate include Chronic Carts and Dank Vapes. As of 27 August 2019, the most frequently used product reported by patients experiencing respiratory, gastrointestinal, and/or constitutional symptoms in Illinois and Wisconsin was the THC product called Dank Vapes. Dank Vapes was the most commonly reported product brand used by patients nationwide, although there are regional differences. While Dank Vapes was most commonly reported in the Northeast and South, TKO and Smart Cart brands were more commonly reported by patients in the West, and Rove was more common in the Midwest. The composition of THC based oils is, to a large extent, unknown. ==Public health recommendations==

The CDC recommends that the public should consider not using any vaping products during their investigation, particularly those containing THC from informal sources like friends, or family, or in-person or online dealers as of 20 November 2019. A lot of speculation has focused on Honey Cut. Honey Cut, used as a diluent thickener, became widely used in Los Angeles' vape pen manufacturing plants in late 2018. After Honey Cut became widely used in THC vape cartridges many other similar products from other companies were introduced into the market in early 2019. Counterfeit products from China that look like Honey Cut products were being sold, which increased the confusion in regard to which products people may have been vaping. The company Floraplex in Michigan has shutdown the buyers page for their Uber Thick brand. The diluent products called Clear Cut were sold by Connoisseur Concentrates from Tigard, Oregon. As of 10 September 2019, Mass Terpenes' Pure Thickener diluent is no longer available on its website. It is estimated that at least 40 companies in the US sold a cutting agent containing vitamin E acetate. Thickening agents were used to water down and bulk up vape oils. Vitamin E acetate dilutes vape oil without making it look like the oil was watered down. Previously, vitamin E was used in low concentrations, or lower than 20% of the formula in vape cartridges. Regulations in legal markets for cannabis use allow the use of many additives such as tocopherols (various forms of vitamin E). As of December 2019, Washington state has now banned vape products containing vitamin E acetate, thought to be linked to illness. == Legal proceedings ==

Subpoenas In September 2019, New York Governor Andrew Cuomo instructed the state health department to issue subpoenas against three sellers of thickening agents used in illicit vaping products. The subpoenas are being served against Honey Cut Labs in Santa Monica, California, for its Honey Cut product; Floraplex Terpenes in Ypsilanti, Michigan, for its Uber Thick product; and Mass Terpenes in Amherst, Massachusetts, for its product. All three firms sell a product used as a thickener in vape liquids. The thickeners from all three firms were found to contain mostly vitamin E acetate, according to test results from the Wadsworth Center. The purportedly candy-themed containers used names such as Sour Patch. when the packaging stated it was just 5 milligrams. Roughly $1.5 million worth of THC products were seized during the raid. 57 mason jars containing THC oil were also seized during the raid. An initial appearance in Kenosha County court was held for both brothers on 16 September 2019. The Huffhines brothers pleaded not guilty on 23 October 2019. On 3 October 2019, Hannah Curty was charged with making THC, as a party to an offense against the law. Courtney Huffhines and Hannah Curty were in court on 11 October 2019. Courtney Huffhines and Hannah Curty pleaded not guilty on 23 October 2019. On 17 October 2019, 22-year-old Jordan Lynam was charged with making THC vape cartridges in relation to the Huffhines's purportedly illicit vaping operation. Daniel Graumenz, Wesley Webb, and Tarail King are facing charges in relation to the illicit vaping operation. Civil lawsuits On 23 September 2019, a product liability lawsuit, Charles Wilcoxson v. Canna Brand Solutions LLC et al., was filed in Superior Court of Pierce County, Washington, against makers of THC vape cartridges. In September 2019, 35-year-old Erin Gilbert from Virgin Islands filed a lawsuit against Just CBD in a Broward County, Florida court, contending that her sickness was the result of a CBD vape oil containing mango flavor that she had purchased from a merchant in Saint Croix. In May 2019, a 21-year-old was hospitalized for more than two weeks due to fluid in his lungs and was in a medically induced coma for 8 days. In October, the patient sued Juul, complaining the company did not disclose the dangers of its pod system and deceptively advertised its products as being safer than combustible cigarettes. In September 2019, a lawsuit was brought on behalf of an 18-year-old from Illinois who had been hospitalized with lung damage from vaping. The plaintiff charged Juul with targeting teens with false marketing of a dangerous product, and a gas station for allowing him to buy vaping products as a minor. On 29 October 2019, the Los Angeles Unified School District, the second largest district in the nation filed a class action suit against Juul for creating an epidemic of youth vaping that it alleged to impede student learning and endanger the health and safety of its students. By January 2020, a total of 10 California school districts had joined a lawsuit against Juul, seeking injunctive relief and abatement remedy to fight against the vaping epidemic in California school districts. On December 8, 2022, a global settlement was reached with Juul resolving claims brought by school districts, municipalities and county governments. == Responses ==

E-cigarette industry The e-cigarette industry is placing the blame on illicit vaping liquids for the lung injuries. "Like any health-related events reportedly associated with the use of vapor products, we are monitoring these reports," Juul Labs stated to Reuters in August 2019. However recent research using commercially sourced JUUL nicotine vape products has documented harms from these devices. A February 2022 research article on vape aerosol from JUUL products showed "Profound pathological changes to upper airway, lung tissue architecture, and cellular structure," of mice exposed for as little as 9 weeks. "This vaping-induced pulmonary injury model demonstrates mechanistic underpinnings of vaping-related pathologic injury." United States The CDC recommends that people should not use e-cigarette, or vaping, products that contain THC, particularly from informal sources like friends, or family, or in-person or online dealers. On 4 October 2019, the US FDA strengthened its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products. "The legal vapes have been actively regulated by FDA since Aug 2017. FDA has conducted thousands of inspections of manufacturers and vape stores, published manufacturing guidance, sought product removals etc. These tragedies point to illegal vapes and THC," former FDA Commissioner Scott Gottlieb tweeted in August 2019. During an interviewed on CNBC's Squawk Box on 9 September 2019, Gottlieb said that "the current belief is the illnesses are linked to illegal vapes containing vitamin E oil." "The e-cigarette-related lung illnesses currently sweeping across the country reaffirm our belief that the use of e-cigarettes and vaping is an urgent public health epidemic that must be addressed. We must not stand by while e-cigarettes continue to go unregulated. We urge the U.S. Food and Drug Administration (FDA) to speed up the regulation of e-cigarettes and remove all unregulated products from the market. We also call on the FDA to immediately ban flavors, as well as marketing practices, that enhance the appeal of e-cigarette products to youth," Patrice A. Harris, the president of the American Medical Association, stated on 9 September 2019. On 19 November 2019, the American Medical Association urged for a complete ban on all types of vaping products that are not approved by the US FDA as quitting smoking aids. Various states have banned vitamin E acetate in vaping products, including Colorado, Ohio, and Washington. The governor of Massachusetts declared a public health emergency on 24 September 2019, and ordered a 4-month moratorium on the sale of all vaping products, both for nicotine and THC. After courts determined it had sole jurisdiction over THC products, the Massachusetts Cannabis Control Commission quarantine all THC vape products until they could be screened for vitamin E acetate and other chemicals. A Massachusetts testing lab offering tests to consumers found vitamin E acetate was widespread in unlicensed products but not in licensed products. The nicotine vaping ban was also challenged and ended early, but prompted the state legislature to ban flavored nicotine products to reduce underage vaping, among other new measures. The federal government has been criticized for instituting bans on flavored products rather than passing caps on nicotine concentrations and establishing accountability measures for negligent marketing. Canada Health Canada, the responsible government agency, responded to the US cases of potentially deadly lung illness by issuing a warning on 4 September 2019. On 11 October 2019, Chief Public Health Officer of Canada recommended to Canadians to consider holding back from vaping. Health Canada started a $766,000 advertisement campaign to curb underage vaping in part in response to the US and Canadian outbreak. Europe "What little we know of recent reports from the U.S. is that the devices used appear to be linked to 'home brews' of illicit drugs and not legitimate vaping products," Martin Dockrell, overseer of tobacco control at Public Health England, stated in September 2019. India Following a string of deaths tied to vaping in the US, India has banned the sales of vaping products in September 2019. World Health Organization Dr. Vinayak Prasad, overseer of tobacco control at World Health Organization, told CNN on 12 September 2019, that WHO was observing the events in the US and abroad and will provide information to governments at the appropriate time. == Hospitalized patients ==

News media featured hospitalized lung vaping illness patients in narratives including the following: • Dehydration from nausea, multifocal pneumonia, sepsis, acute respiratory failure with hypoxemia, and blood clots, necessitating a medically induced coma and removal of fluid from the lungs. • Vomiting, coughing up blood, and lipid pneumonia • Nausea, chest pains, shortness of breath, and acute respiratory distress syndrome necessitating extracorporeal membrane oxygenation (ECMO) • Shoulder and back pain, double lung collapse • Vomiting, fever, sweating, painful coughing, bronchitis, and double pneumonia in a patient who had vaped THC • Severe pain in the side, lung collapse, "black spots" on the lungs in a patient using about half a Juul mint pod a day for about 18 months. • Chest and back pain from recurrent pneumothoraces (air in the chest outside of the lungs) • Trouble breathing, necessitating a ventilator and medically induced coma. The 18-year-old patient says she bought vaping products from a smoke shop that did not ask for her ID card, enabling her to lie and claim that she was 22. • Dizziness, vomiting, abdominal pain, difficulty breathing, necessitating supplemental oxygen. • Breathing problems mistaken for the flu or stomach virus, eventually requiring ECMO • Difficulty breathing, requiring supplemental oxygen and steroids, diagnosed as popcorn lung. • Dizziness and vomiting, problems breathing diagnosed as pneumonitis • Patient discovered unresponsive in bedroom, mucus and blood coming from lungs, cardiac arrest • Double lung transplant for a 17-year-old from Michigan on 15 October 2019, believed to be the first such procedure due to vaping ==Criticism of vaping bans==

Critics of vaping bans state that vaping is a much safer alternative to smoking tobacco products and that vaping bans incentivize people to return to smoking cigarettes. For example, critics cite the British Journal of Family Medicine in August 2015 which stated, "E-cigarettes are 95% safer than traditional smoking." San Francisco's chief economist, Ted Egan, when discussing the San Francisco vaping ban stated the city's ban on e-cigarette sales will increase smoking as vapers switch to combustible cigarettes. Critics of smoking bans stress the absurdity of criminalizing the sale of a safer alternative to tobacco while tobacco continues to be legal. In 2022, after two years of review, the Food and Drug Administration (FDA) denied Juul's application to keep its tobacco and menthol flavored vaping products on the market. Critics of this denial note that research published in Nicotine and Tobacco Research found that smokers who transitioned to Juuls in North America were significantly more likely to switch to vaping than those in the United Kingdom who only had access to lower-strength nicotine products. This happened as the Biden administration was seeking to mandate low-nicotine cigarettes which, critics noted, is not what makes cigarettes dangerous. They note that vaping does not contain many of the components that make smoking dangerous such as the combustion process and certain chemicals that are present in cigarettes that are not present in vape products. In 2022, Brian King, the head of the FDA's Center for Tobacco Products, stated, "We do know that e-cigarettes — as a general class — have markedly less risk than a combustible cigarette product." When asked by Reason whether the FDA is going to commit any resources to correct misperceptions about e-cigarettes, King responded with "I can't commit to any specific actions." == See also ==