Vitamin E Acetate and the EVALI Outbreak of 2019 – A Recap

Anyone following the news during the Summer and latter half of 2019, particularly in the electronic cigarette (Electronic Nicotine Delivery Systems or “ENDS”) and/or THC (Tetrahydrocannabinol, the psychoactive ingredient in marijuana) vaping world, would likely have heard stories about a nationwide outbreak of a mysterious vaping related lung illness, afflicting thousands of patients in all 50 states, and even in some limited instances, resulting in some deaths. Eventually, the illness was given a name, EVALI, and potential causes were identified, most prominently, vitamin E acetate, a commonly used synthetic substance, previously believed by almost everyone to be completely safe. This article will provide a brief recap and explanation of the outbreak as well as an update on some of the developments that have taken place since last Summer.

EVALI

In August 2019, the Centers for Disease Control and Prevention (“CDC”) recognized the outbreak of a mysterious vaping related lung illness and officially labeled it “Electronic Cigarette and Vaping Associated Lung Injury” (EVALI). Patients all shared on thing in common – the use of an electronic cigarette or THC vape product prior to reporting symptoms. Symptoms include shortness of breath, coughing, chest pain, lung scarring, and others. Today, the specific cause of EVALI is still somewhat hazy and there is no single test for diagnosing the disease. In fact, EVALI is a diagnosis of exclusion which means it is diagnosed by process of elimination, i.e., ruling out other potential diseases carrying similar symptoms. EVALI diagnoses generally follow this criteria: 1) Patients report use of an electronic cigarette or vaping device during the 90 day period prior to reporting symptoms; 2) chest X-Rays or CT scans show opacities in the lungs; and 3) no other lung infection is detected, meaning tests for viruses and bacterial infections come back negative. By November 2019, about 2,000 cases of EVALI were reported, and by December 2019, the number had increased to over 2,500 cases, reported across all 50 states, Washington DC, and the US Caribbean territories.

Vitamin E Acetate

In November 2019 the CDC announced that it had made a breakthrough, announcing that it had identified vitamin E acetate as a “potential toxin of concern.” The CDC had tested Bronchoalveolar Lavage Fluid (BAL) samples from EVALI patients submitted from ten different states and found that vitamin E acetate was present in 100% of samples tested.

What is Vitamin E Acetate?

Also known as tocopheryl acetate, vitamin E acetate is simply synthesized vitamin E. It is actually found in many foods and cosmetic products, and has been safely consumed through ingestion and applied topically for years without incident. The difference is that until recently it had never been aerosolized and inhaled.

Why is it Related to Vaping and Where is it Found?

Vitamin E acetate has mostly been associated with THC devices as opposed to electronic nicotine delivery systems. Vitamin E acetate has the same viscosity and look as pure THC oil and can be used by illicit sellers of THC containing vaping oil cartridges to dilute or “cut” real THC oil. It is important to recognize that the vitamin E issue has almost exclusively been associated with illegal THC cartridges and not those manufactured and sold by legal and properly licensed manufacturers and sellers. The CDC and other state agencies have found the same in their own investigations, and a report commissioned in late 2019 found that none of the legal THC vaping cartridges tested had any trace of vitamin E acetate.

A Short-Lived Issue?

Electronic cigarette and THC vaping use has been around since the early to mid-2000s yet, the EVALI outbreak and identification of vitamin E acetate as a potential toxin of concern did not come about until mid-2019. The CDC has reported that incidents of EVALI peaked in September 2019 and have been on a sharp decline since then, although it is important to note that states still do regularly report patients presenting with EVALI symptoms. While we are unable to pinpoint the exact time frame for the use of vitamin E acetate with THC products, there are some indications that it appears likely that they were used mostly during the 2019 period. As an example, a law enforcement team in Minnesota seized illicit THC vape products in 2018 and reported that none of the products tested positive for vitamin E acetate. That same group seized illicit THC vape products in 2019 and reported that all of those products tested positive for vitamin E acetate. Although reports seem to indicate a decline in reports of vitamin E acetate and EVALI, the research on both topics is still ongoing and the future remains unclear.

Potential Litigation Issues

Manufacturers, distributors, and sellers of THC products in states where recreational and medical cannabis are permitted, as well as manufacturers, distributors, and sellers of ENDS products should be mindful of these developments and consider what defenses might come into play in the event they find themselves in the unfortunate position of having to defend a lawsuit involving allegations of EVALI and/or vitamin E acetate:

• Product Identification: As noted above, thus far, vitamin E acetate appears to be associated almost exclusively with illegally manufactured and sold THC vape products. Studies conducted on legal products have so far failed to yield any findings of vitamin E acetate. Manufacturers or sellers faced with a products liability lawsuit based on allegations of vitamin E acetate content will want to ensure their chain of production and custody and vigorously argue that when their product was manufactured, Vitamin E acetate was not used.
• Misuse of the Product: Additionally, manufacturers or sellers must be mindful that often end users will manipulate the product, saving the THC or ENDS cartridge and adding their own e-juice, obtained from sources other than the original manufacturer. Manufacturers and sellers of the original product generally will have warned against misuse of their products and should ensure that the e-juice at issue and alleged to have caused a claimant’s ailments is not an illegal replacement product manufactured illegally.
• Medical Defense: Remember, EVALI is a diagnosis of exclusion. It is diagnosed by ruling out other diseases and causes. EVALI carries similar symptoms to other diseases. Make sure the disease at issue is actually EVALI and not a misdiagnosis. For example, compare EVALI and vitamin E acetate to mesothelioma, a well-known disease, almost exclusively associated with exposure to asbestos. A mesothelioma diagnosis is likely to be a strong indicator of prior asbestos exposure as it asbestos is one of the only known causes of that diseased. EVALI on the other hand, carries symptoms with many potential causes. Simple prior use of a vaping device is not necessarily good epidemiology or evidence of causation.