This is the second post from Radhika Dhingra, PhD and Meghan E. Rebuli, PhD on the topic of vaping. Their first post can be found here: Introduction to E-Cigarettes. This post covers EVALI (e-cigarette or vaping associated lung injury).
In 2019 and 2020, an alarming number of otherwise healthy young people were diagnosed with serious lung damage. Over 2,800 cases of this new illness, now known as E-cigarette or Vaping Associated Lung Injury (EVALI), were diagnosed in the US during that time period. The majority of these occurred in people under the age of 30. The diagnoses were geographically widespread, with documented cases in all 50 states, as well as Washington DC, and two US territories (US Virgin Islands and Puerto Rico).
EVALI cases peaked in September 2019 and have been declining since—the shift was so dramatic that CDC ended its surveillance of EVALI cases in February 2020—yet that doesn’t mean we should stop paying attention to the e-cigarette industry. The sudden outbreak and subsequent decline of EVALI serve as a stark example of the consequences of the lack of regulation in the e-cigarette industry and the dangers ahead if e-cigarettes are not proactively regulated.
Why did EVALI decline?
There are many reasons EVALI cases have declined, including the removal of vitamin E acetate from vape liquids, increased public awareness about the dangers of vaping and e-cigarettes, and law enforcement actions related to black market vaping products. In the absence of federal regulation of e-cigarettes and vaping devices, scientists, public health advocates, and states took action to fill the gap and protect the public.
Through careful epidemiological study, scientists identified the suspected additive. In addition, many states temporarily banned the sale of flavored vape products that were associated with EVALI, with Massachusetts banning the sale of all flavored tobacco products in December 2019. Collectively, these actions halted the outbreak. However, federal regulation of these products would have considerably shortened the outbreak or even prevented it entirely. While the FDA has had the authority to regulate e-cigarettes since 2016, the FDA has only just begun the process of reviewing these products now in 2021.
What is EVALI?
EVALI, which stands for e-cigarette and vaping associated lung injury, is a severe, primarily respiratory illness related to e-cigarette use. You may have seen EVALI referred to as VAPI, VALI, EVAPI, or e-cigarette related lung illness. These terms all refer to the same thing. The CDC first defined this disease in August 2019, after health officials across the country noticed alarming cases of severe lung injury in otherwise healthy young people.
When patients develop EVALI, their lungs cease to function well enough to transfer sufficient oxygen to the blood, with many patients requiring a ventilator. The main symptoms of EVALI include cough, shortness of breath, chest pain, fever, chills, gastrointestinal symptoms like stomach pain, nausea, vomiting or diarrhea, rapid heartbeat, and rapid breathing. In extreme cases, EVALI patients require extracorporeal membrane oxygenation (ECMO), a treatment where a patient’s oxygen-starved blood is pumped outside of the body to a heart-lung machine to remove carbon dioxide and send oxygen-filled blood into the body. (You may have heard about ECMO as a treatment for severe COVID-19.)
Unfortunately, there is no simple diagnostic test to confirm an EVALI diagnosis. EVALI is diagnosed by ruling out other causes of illness like lung bacterial or viral infections, by confirming e-cigarette use, and by the appearance of spots known as “opacities” on a X-ray or CT scan.
What causes EVALI?
While it was initially apparent that EVALI was related to vaping in early 2019, pinpointing vitamin E acetate as the likely culprit required quick epidemiologic detective work that was complicated by the lack of information provided by the unregulated e-cigarette industry. The lack of regulatory oversight meant that manufacturers did not have to provide a list of chemical components in e-cigarettes, and that severely hindered researchers’ efforts to identify the chemical culprit.
Scientists first suspected THC-containing e-cigarette products because many EVALI patients indicated that they were using vaping fluid that contained THC. However, many manufacturers were using the same branding and packaging from Dank Vapes for their own products, which complicated the identification of the manufacturers and ingredients responsible for EVALI. Despite this lack of transparency, researchers identified vitamin E acetate as a common ingredient in the cannabis-containing vape liquid that was linked to EVALI cases. In addition, laboratory studies found vitamin E acetate in the lungs of patients. While these findings strongly link vitamin E acetate to EVALI, it remains unclear if vitamin E acetate is the sole culprit of EVALI, or if other compounds may be involved.
Because of the strong association of EVALI with THC-containing products, the CDC specifically recommends avoiding vaping or using e-cigarettes that contain THC, especially from informal sources whose production processes may not be known or tested. Because of the variable legal status of marijuana across states in the US, THC is often sold as an “at home” additive to manufacture DIY vape liquid. Thus, the potential for unknown and dangerous quantities of toxic chemicals or additives, like vitamin E acetate, is higher in DIY formulations. For those reasons, the CDC recommends staying away from all THC-containing vaping products, but especially vaping products purchased from informal sources.
What is Vitamin E Acetate?
Vitamin E acetate was frequently added to vape liquid containing THC to thicken the vape liquid and to dilute THC concentration; these lower amounts of THC made the e-liquids cheaper to manufacture. Vitamin E acetate is a common component in food, skin, beauty products and is considered safe to put on your skin and to eat. However, there is very little research on its effects and safety when inhaled. Just like there are products that are safe to put on our skin but not to eat, like disinfectants and hand sanitizer, there are many substances that are safe to eat, but not inhale, like water.
Is Vitamin E acetate still used in vape liquid?
Because these products remain unregulated, we do not know with certainty if vitamin E acetate has been removed from all e-cigarette products. However, we have seen a precipitous drop in EVALI cases in late 2019 and early 2020, which could mean that fewer vaping products on the market now contain vitamin E acetate. Manufacturers may have voluntarily removed vitamin E acetate from their products, and the crackdown on black market vape liquid may have also helped to remove products that contain Vitamin E acetate from the market.
Why was Vitamin E acetate allowed in vaping products?
The FDA has been slow to regulate e-cigarettes. The agency has had the authority to regulate e-cigarettes since 2016, when it expanded its regulation of tobacco products to include e-cigarettes and other vaping products. However, the FDA did not act on this in a timely manner. They delayed the initial product review application deadline by several years to August of 2022. Last year, a federal judge moved that deadline to May 2020 in response to a lawsuit filed by seven public health and medical groups, including the American Academy of Pediatrics. The judge ruled that the FDA had acted illegally by allowing e-cigarettes to remain on the market for so long without an application for FDA authorization. However, the beginning of the product review process to determine potential consumer safety was then delayed by four months due to the COVID-19 pandemic, pushing the deadline to September 9, 2020.
While this means that the process of regulation has now finally begun, little has changed for consumers. All e-cigarette products on the market today remain unregulated. An application for FDA authorization allows a product to stay on the market for one year, essentially unregulated, while FDA completes its review. In the meantime, a patchwork of state-level regulations has tried to step into the hole left by the slow-moving federal government (see your state’s laws here), but these state efforts are not as robust as federal action.
Without stronger federal regulation, the potential remains for e-cigarette manufacturers to introduce untested additives with little oversight or disclosure. In the absence of regulatory changes that require companies to disclose and demonstrate the safety of their ingredients prior to selling them, the only way we will find out if another e-cigarette ingredient is harmful is for many people to get sick and for doctors or scientists to then make the connection between the cases, as we saw with EVALI. Even though EVALI cases are no longer on the rise, there are many other health risks associated with vaping that warrant regulation and oversight. Stronger regulatory action is necessary to force transparency from the e-cigarette industry and protect public health.
- Quick Facts on the Risks of E-cigarettes for Young People (CDC)
- CDC EVALI outbreak information page
- Information and recommendations for parents from CDC and the Surgeon General
- Tips for parents on talking to teens about e-cigarettes from the Surgeon General
- CDC electronic cigarette info page
- DrugFacts: Electronic Cigarettes (National Institute on Drug Abuse)
- Know the Risks: E-cigarettes and Young People (Surgeon General)
Smoking cessation programs
There are also new e-cigarette specific tools via the Truth Initiative, including the text-based service, This is Quitting, (text “DITCHJUUL” to 88709) and a comprehensive program through the Mayo Clinic: BecomeAnEx ®.
About the authors
Meghan E. Rebuli, PhD is an Assistant Professor in the Department of Pediatrics, the Center for Environmental Medicine, Asthma and Lung Biology, and the Curriculum in Toxicology & Environmental Medicine in the School of Medicine at the University of North Carolina at Chapel Hill. Dr. Rebuli is actively engaged in clinical research on the effects of e-cigarettes on respiratory toxicology and has several related publications.
Radhika Dhingra, PhD is an Assistant Professor in the Department of Environmental Sciences and Engineering in the Gillings School of Public Health at the University of North Carolina at Chapel Hill. Dr. Dhingra is interested in the public health implications of e-cigarette use and is collaborating on several e-cigarette research projects.