What’s Behind the Vaping Ban?

By Ron Benvenisti. The CDC, FDA, and state health authorities have made progress in identifying substances of concern in EVALI, and in characterizing the outbreak. The identification of EVALI as a new clinical syndrome highlights a need for further studies. Understanding the long-term health consequences of EVALI will require long-term patient follow-up. It is not known whether additives other than vitamin E acetate in e-cigarette, or vaping, products might cause similar lung injury. In addition, ongoing surveillance for lung injury associated with e-cigarette, or vaping, product use needs to continue to detect possible increases in lung injury if new additives (e.g., a harmful diluent other than vitamin E acetate) are added to these products in the future. Syndromic surveillance helped demonstrate that EVALI was a new clinical syndrome, with ED visits sharply increasing in August 2019 and declining after peaking in September 2019

THC and Vitamin E Acetate

Nationwide, 82% of patients hospitalized with e-cigarette or vaping, product use–associated lung injury (EVALI) reported tetrahydrocannabinol (THC)-containing product use. Vitamin E acetate, an additive to THC-containing e-cigarette, or vaping, products, is strongly linked to the EVALI outbreak. THC is component of Marijuana products that gets you high. 

The number of EVALI cases reported to CDC peaked during the week of September 15, 2019; the weekly number of hospitalized patients has since steadily declined. This is likely to the widespread publicity regarding the recorded negative reactions and fatalities.

CDC recommends that persons not use THC-containing e-cigarette, or vaping, products, especially those acquired from informal sources such as friends, family members, or from in-person or online dealers. Vitamin E acetate is strongly linked to the EVALI outbreak and should not be added to any e-cigarette, or vaping, products, however, evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases.

Clinicians and public health practitioners should remain vigilant for EVALI cases. CDC recommends that persons not use THC-containing e-cigarette, or vaping, products, particularly from informal sources. Evidence is not sufficient to rule out the contribution of other chemicals of concern, including chemicals in either THC- or non-THC–containing products, in some reported EVALI cases.

Pulegone

Pulegone, a potential carcinogen banned as a food additive, is present in high levels in some e-cigarette liquids and smokeless tobacco products, according to a new study.

Pulegone (pronounced pju-leh-goan) is in menthol and mint flavored e-cigarettes and smokeless tobacco products. Because of its carcinogenic properties, the US Food and Drug Administration banned pulegone as a food additive last year in response to petitions from consumer groups.

Yet the agency does not regulate the chemical’s presence in e-cigarettes and smokeless tobacco, which companies promote as safer alternatives to regular cigarettes.

“Our findings suggest that the FDA should implement measures to mitigate pulegone-related health risks before suggesting mint- and menthol-flavored e-cigarettes and smokeless tobacco products as alternatives for people who use combustible tobacco products,” says lead author Sven-Eric Jordt, a professor of the anesthesiology department at Duke University.

Jordt and research partner Sairam V. Jabba became interested in the topic because the US Centers for Disease Control and Prevention published studies showing that mint- and menthol-flavored e-cigarette liquids and smokeless tobacco products marketed in the US contain substantial amounts of pulegone.

The two researchers analyzed whether several top brands of regular menthol cigarettes, three e-cigarette brands, and one smokeless tobacco brand contain enough pulegone to be a cause for concern. They compared the CDC-reported amounts of pulegone with the FDA’s exposure risk data—the levels at which exposure-related tumors were reported in animal studies.

Their analysis found that the levels in the e-cigarettes and smokeless tobacco exceeded the thresholds of concern. Regular menthol cigarettes contained levels below the thresholds.

“Our analysis suggests that users of mint- and menthol-flavored e-cigarettes and smokeless tobacco are exposed to pulegone levels higher than the FDA considers acceptable for intake in food, and higher than in smokers of combustible menthol cigarettes,” Jordt says.

“The tobacco industry has long known about the dangers of pulegone and has continuously tried to minimize its levels in menthol cigarette flavorings, so the levels are much lower in menthol cigarettes than in electronic cigarettes,” Jordt says. E-cigarette manufacturers may be less familiar with the dangers and use cheaper ingredients to lower costs.

One limitation of the study is that the FDA’s exposure risk calculations are based on oral exposure in animal studies. These risks may apply to the oral exposure through smokeless tobacco but may differ from inhalation exposure through e-cigarette vapor. There is no toxicity data available on exposure via inhalation. This is concerning because toxicologists consider the lung to be more sensitive to toxic chemicals than the digestive tract.

The study appears in JAMA Internal Medicine.

The National Institute of Environmental Health Sciences of the National Institutes of Health supported the research. The findings are the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.

Source: Duke University

Original Study DOI: 10.1001/jamainternmed.2019.3649

Other references sourced for this article include:

https://www.cdc.gov/tobacco/basic_information/e-cigarettes/assets/2019-Lung-Injury-Surveillance-Case-Definition-508.pdfpdf icon.

https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease/healthcare-providers/pdfs/National-Case-Report-Form-v01.pdfpdf icon.

NSSP records free-text comments about the reason for ED visit, discharge diagnosis codes, and patient demographic characteristics from approximately 70% of ED visits nationwide.

https://www.detroitnews.com/story/news/local/michigan/2019/12/17/michigan-recalls-marijuana-vaping-products-vitamin-e-acetate/2679157001/external icon.

https://www.cnn.com/2019/12/24/health/black-market-vapes/index.htmlexternal icon.

https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html.

https://www.cdc.gov/tobacco/campaign/tips/quit-smoking/index.html?s_cid.

Studies

  1. Moritz ED, Zapata LB, Lekiachvili A, et al.; Lung Injury Response Epidemiology/Surveillance Group. Update: characteristics of patients in a national outbreak of e-cigarette, or vaping, product use–associated lung injuries—United States, October 2019. MMWR Morb Mortal Wkly Rep 2019;68:985–9. https://www.cdc.gov/mmwr/volumes/68/wr/mm6843e1.htm?s_cid=mm6843e1_w
  2. Blount BC, Karwowski MP, Shields PG, et al.; Lung Injury Response Laboratory Working Group. Vitamin E acetate in bronchoalveolar-lavage fluid associated with EVALI. N Engl J Med 2019;NEJMoa1916433. CrossRefexternal icon
  3. CDC. National Syndromic Surveillance Program (NSSP): what is syndromic surveillance? Atlanta, GA: US Department of Health and Human Services, CDC; 2019. https://www.cdc.gov/nssp/overview.html
  4. Hartnett KP, Kite-Powell A, Patel MT, et al. Syndromic surveillance for e-cigarette, or vaping, product use–associated lung injury. N Engl J Med 2019. https://www.nejm.org/doi/10.1056/NEJMsr1915313external icon
  5. Ellington S, Salvatore PP, Ko J, et al.; Lung Injury Response Epidemiology/Surveillance Task Force. Update: product, substance-use, and demographic characteristics of hospitalized patients in a nationwide outbreak of e-cigarette, or vaping, product use–associated lung injury—United States, August 2019–January 2020. MMWR Morb Mortal Wkly Rep 2020;68. https://www.dx.doi.org/10.15585/mmwr.mm6902e2external icon CrossRefexternal icon PubMedexternal icon
  6. Chatham-Stephens K, Roguski K, Jang Y, et al.; Lung Injury Response Epidemiology/Surveillance Task Force; Lung Injury Response Clinical Task Force. Characteristics of hospitalized and nonhospitalized patients in a nationwide outbreak of e-cigarette, or vaping, product use–associated lung injury—United States, November 2019. MMWR Morb Mortal Wkly Rep 2019;68:1076–80. CrossRefexternal icon PubMedexternal icon
  7. Ghinai I, Navon L, Gunn JKL, et al. Characteristics of persons who report using only nicotine-containing products among interviewed patients with e-cigarette, or vaping, product use–associated lung injury —Illinois, August–December 2019. MMWR Morb Mortal Wkly Rep 2020;69. https://www.dx.doi.org/10.15585/mmwr.mm6903e1external icon
  8. Taylor J, Wiens T, Peterson J, et al. Characteristics of e-cigarette, or vaping, products used by patients with associated lung injury and products seized by law enforcement—Minnesota, 2018 and 2019. MMWR Morb Mortal Wkly Rep 2019;68:1096–1100.
  9. Food and Drug Administration. Lung illnesses associated with use of vaping products. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2019. https://www.fda.gov/news-events/public-health-focus/lung-illnesses-associated-use-vaping-productsexternal icon
  10. Food and Drug Administration. FDA, DEA seize 44 websites advertising sale of illicit THC vaping cartridges to US consumers as part of Operation Vapor Lock. Silver Spring, MD: US Department of Health and Human services, Food and Drug Administration; 2019. https://www.fda.gov/news-events/press-announcements/fda-dea-seize-44-websites-advertising-sale-illicit-thc-vaping-cartridges-us-consumers-part-operationexternal icon

 

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