Current FDA oversight of vaping industry likely to have minimal impact
It’s failing to target key players and products most popular with young people
Peer-Reviewed PublicationCurrent Food and Drug Administration (FDA) oversight of the vaping industry in the US is likely to have minimal impact, suggests an analysis of the regulator’s warning letters for marketing violations, published online in the journal Tobacco Control.
The regulator is failing to target the key players or the products most popular with young people, the analysis suggests, with over 90% of warnings sent to small online retailers rather than leading tobacco companies, and a focus on refillable devices.
While the prevalence of vaping among US adults remains low, at just under 4% in 2020, it is four times higher among young people.
In 2016 the FDA announced plans to regulate the vaping industry, including a requirement for the manufacturers of e-cigarettes to obtain pre-market approval (PMTA) to ensure that their products protect public health.
In 2017, the regulator began sending warning letters to manufacturers, retailers, and distributors for potential violations, such as advertising to young people, selling to minors, packaging or labelling that contravened regulations, and failure to apply for a PMTA.
But little is known about who received these letters, the types of product they concerned, or details of the violations and their consequences.
To try and find out, the authors from non-profit tobacco control organisation, Truth Initiative, assessed the content and recipients of publicly available FDA warning letters issued in 2020 and 2021. In total, the FDA issued 303 warnings:126 in 2020 and 177 up to 9 September 2021.
The analysis revealed that in 2021, over 98% of all the targeted companies fulfilled all three roles (manufacturer, distributor and retailer).
But nearly all the letters (97%) were sent to small online retailers, none of which was a large company with measurable market share, as evidenced by sales data.
Companies were cited for between one and three infractions. Most involved failure to obtain a PMTA. In 2020 and 2021, respectively, 56% and 99%+ of the infractions concerned a PMTA violation.
And more than 90% of the products cited–880 different ones in total–were flavoured refillable e-cigarette liquids, rather than the disposable vaping devices (‘pod mods’) which the evidence indicates are most popular with young people.
Penalties ranged in severity from product detention to product seizure and fines. But loss of tobacco distributor licence and criminal charges appeared less frequently in both years than these other consequences.
At the time of the review, most (72%) of the websites cited for 2020 infractions were still operating, as were 29% of websites cited for 2021 infractions.
And as the authors note, it was impossible to find out how the targeted companies responded, and whether the FDA followed through with the consequences cited in the warning letters, because that information isn’t publicly available.
“While current research estimates that online sales comprise around one-third of the marketplace, data tell us that most young people get their products from friends (32.3%), buy them from another person (21.5%), or purchase from a vape shop (22.2%),” note the authors.
“Prioritising the products most accessed by youth which are made available from a variety of sources will be important to curb youth use,” they add.
And they emphasise:“Strong, impactful and transparent consequences need to be in place to prevent the sale of products that violate regulations necessary in protecting the health of adult users of e-cigarettes and preventing youth use alike.”
“The FDA should use its enforcement powers to target the manufacturing, distribution, and sellers of the tobacco products that have the greatest impact on youth and products that provide no public health benefit,” they conclude.
JOURNAL
Tobacco Control
METHOD OF RESEARCH
Data/statistical analysis
SUBJECT OF RESEARCH
Not applicable
ARTICLE TITLE
Analysis of e-cigarette warning letters issued by the Food and Drug Administration in 2020 and 2021
New research shows e-cigarettes cause cardiac arrhythmias
Some cardiac effects of e-cigarette ingredients are similar to or worse than conventional cigarettes
Peer-Reviewed PublicationIMAGE: ALEX CARLL, ASSISTANT PROFESSOR IN THE UOFL DEPARTMENT OF PHYSIOLOGY, FRONT, WITH MATTHEW NYSTORIAK, ASSOCIATE PROFESSOR OF MEDICINE. view more
CREDIT: UNIVERSITY OF LOUISVILLE PHOTO
A new study from University of Louisville researchers in the Christina Lee Brown Envirome Institute has found that exposure to e-cigarette aerosols can cause heart arrhythmias in animal models — both in the form of premature and skipped heart beats. The study findings, published Oct. 25 in Nature Communications, suggest exposure to specific chemicals within e-cigarette liquids (e-liquids) promote arrhythmias and cardiac electrical dysfunction.
“Our findings demonstrate that short-term exposure to e-cigarettes can destabilize heart rhythm through specific chemicals within e-liquids,” said Alex Carll, assistant professor in the UofL Department of Physiology who led the study. “These findings suggest that e-cigarette use involving certain flavors or solvent vehicles may disrupt the heart’s electrical conduction and provoke arrhythmias. These effects could increase the risk for atrial or ventricular fibrillation and sudden cardiac arrest.”
The researchers tested the cardiac impacts of inhaled e-cigarette aerosols solely from the main two ingredients in e-liquids (nicotine-free propylene glycol and vegetable glycerin) or from flavored retail e-liquids containing nicotine. They found that for all e-cigarette aerosols, the animals’ heart rate slowed during puff exposures and sped up afterwards as heart rate variability declined, indicating fight-or-flight stress responses. In addition, e-cigarette puffs from a menthol-flavored e-liquid or from propylene glycol alone caused ventricular arrhythmias and other conduction irregularities in the heart.
Conducted in collaboration with Daniel Conklin and Aruni Bhatnagar, professors in the UofL Division of Environmental Medicine, this work adds to a growing body of research on the potential toxicity and health impacts of e-cigarettes reported by the American Heart Association Tobacco Regulation and Addiction Center, for which UofL serves as the flagship institute.
"The findings of this study are important because they provide fresh evidence that the use of e-cigarettes could interfere with normal heart rhythms -- something we did not know before," Bhatnagar said. "This is highly concerning given the rapid growth of e-cigarette use, particularly among young people."
As e-cigarette use has grown nationwide, the potential advantages and harms of vaping have been debated. Since vaping does not involve combustion, it exposes users and bystanders to little if any carbon monoxide, tar or cancer-causing nitrosamines compared with conventional cigarettes. However, e-cigarettes can deliver aldehydes, particles and nicotine at levels comparable to combustible cigarettes. Vaping might help smokers quit combustible cigarettes, but the appeal and addictiveness of e-cigarettes may encourage youth to vape amidst unknown long-term risks or take up smoking. More than 25% of high schoolers and 10% of middle schoolers in the U.S. reported using e-cigarettes before the pandemic.
Additional research by Carll and Matthew Nystoriak, an associate professor of medicine at UofL, to determine the effects of vape flavorings on the heart recently received $3.6 million in research funding from the National Institutes of Health.
“Our team’s findings that specific ingredients in e-cigarette liquids promote arrhythmias indicates there is an urgent need for more research into the cardiac effects of these components in both animals and humans,” Carll said.
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DOI: 10.1038/s41467-022-33203-1
Research reported in this publication was supported by the National Heart, Lung, And Blood Institute (NHLBI) of the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) under Award Number R01HL147353 (A.P.C.), R01HL163818 (A.P.C. and M.A.N.), U54HL120163 (A.B.), and R01HL122676 (D.J.C.), the National Institute of General Medical Sciences of the NIH under Award Number P30GM127607 (A.B.), the Jewish Heritage Fund for Excellence (M.A.N. and A.P.C.), a Fellowship from the American Heart Association (AHA) Tobacco Regulation and Addiction Center (AHA FX-ATRAC-UL1-05; A.P.C.), and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES) Scholarship - Process no {88881.131525/2016-01} (C.A. and R.S.). Research reported in this publication was supported by NHLBI and FDA Center for Tobacco Products (CTP). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH, the FDA, or the AHA.
JOURNAL
Nature Communications
METHOD OF RESEARCH
Experimental study
SUBJECT OF RESEARCH
Animals
ARTICLE TITLE
E-cigarettes and Their Lone Constituents Induce Cardiac Arrhythmia and Conduction Defects in Mice
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