WASHINGTON — With so many critical moves on flavored e-cigarettes happening on the federal and state level, convenience-store retailers are reeling from what seem to be daily headlines.
Everything from state bans to veiled tweets from President Donald Trump himself have put the future of the emerging nicotine-delivery category in peril. One of the latest revelations has been a federal probe into the vaping supply chain, with officials from the investigative branch of the U.S. Food and Drug Administration (FDA) actively looking into the causes of possible illnesses and deaths tied to e-cigarette use.
Here are several recent key developments churning the flavored e-cigarette debate …
Much of the recent publicity over flavored e-cigarettes started when the Centers for Disease Control and Prevention (CDC), Atlanta, made statements about the deaths and illnesses possibly linked to vaping.
On Sept. 6, the CDC announced three deaths that it tied to vaping. At a Sept. 6 press conference, CDC officials gathered medical authorities from three states to discuss initial findings and continuing research into the deaths and related cases of pulmonary and respiratory illnesses allegedly stemming from e-cigarettes and vaping.
“While we don’t have all the answers yet, we are getting clearer about the things we should be looking at to understand the situation,” said Ileana Arias, senior scientific adviser and acting deputy director for noninfectious diseases for the CDC. “The focus of our investigation is narrowing, and that is great news, but we are still faced with complex questions in this outbreak that will take time to answer.”
Dana Delman, the CDC’s incidence response manager, said the agency is working with multiple state health departments on the matter. “Many of these patients reported recent use of THC-containing products, and some reported using both THC- and nicotine-containing products. A smaller group reported using only nicotine products,” Delman said, referring to tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis. “No specific e-cigarette device or substance has been linked to all cases, and e-cigarette include a variety of chemical and additives; consumers may not know what these products contain. Particularly, [for] products obtained from social sources or off the street, it is difficult to know what is contained in these e-cigarette products.”
In discussing some of the investigations, another ingredient, vitamin E, emerged. But “at this time, no one device, product or substance has been linked to all cases,” Delman reiterated.
Ultimately, Delman said the CDC, states and other partners are actively investigating, but so far, no definitive cause has been established.
Preliminary data on youth use emerges
Feeding much of the public comment were preliminary results from annual surveys conducted or supported by federal agencies. Two national surveys figured prominently in officials’ statements, with both reporting a significant rise in young people vaping.
In a study of high school students, more than 1 in 9 seniors reported vaping nicotine on a “near daily basis,” according to the Monitoring the Future Survey, which is supported by the National Institute on Drug Abuse. The New England Journal of Medicine published preliminary results from the survey in mid-September, saying the share of teens who said they vaped nicotine in the preceding 30 days more than doubled for each age group surveyed.
The Washington Post reported on the article and comments from authors of the survey, saying the description of “near daily” suggests nicotine addiction.
Almost a quarter of seniors said they vaped within the previous month, an increase from closer to 1 in 5 the previous year. About 20% of 10th graders and 9% of eighth graders also said they vaped during the same period.
Those results echo what Alex Azar, U.S. Department of Health and Human Services secreary, said were preliminary results from the CDC’s National Youth Tobacco Survey, which showed a continued rise in e-cigarette use. More than a quarter of high school seniors used e-cigarettes in the past 30 days in 2019, with a majority of them saying they used fruit, mint or menthol flavors.
The information bolsters recent efforts to crack down on flavored e-cigarettes and vaping in general. The latest of these developments includes tweeted reactions from President Trump, as well as the governors of Michigan and New York deciding in September to ban flavored e-cigarettes through executive order.
Trump, state reactions
President Trump took up the subject of vaping on Sept. 11, suggesting his administration “may very well have to do something very, very strong about it.” The statement led some to believe he may take action to ban the sale of flavored vaping products.
Trump made the remarks following a meeting with Azar, according to a Bloomberg report. Azar said a new guidance may soon emerge that allows the FDA to remove flavored vaping products believed to appeal to children.
Five million children are using e-cigarette products, Azar said, calling it an “alarming” trend.
“Not only is it a problem overall, but really specifically with respect for children,” Trump told reporters at the White House, according to Bloomberg. “We may very well have to do something very, very strong about it.”
The FDA’s next step
In determining the next phase of the e-cigarette saga, convenience-retailing associations and analysts have focused on the latest, much-anticipated version of the FDA’s guidance document on vaping devices. That version could reveal how the FDA will focus enforcement actions and, more specifically, how flavored nicotine and tobacco products—which could include mint and menthol—will fare in the months to come.
Azar also said the guidance would say how the FDA will handle e-cigarettes currently on the market. All manufacturers introducing new tobacco products to the United States must file a premarket tobacco application (PMTA) with the FDA, the agency said, but prior to the actual PMTA deadlines, they were able to place their products on store shelves. However, because the FDA itself has publicly changed the deadlines for manufacturers to turn in PMTAs on at least five occasions, just about every vaping device on the market today falls in this legal limbo.
Federal officials said in September that at least 530 people in 38 states have become sickened by a mysterious vaping-related lung illness, part of a growing national outbreak, according to The Washington Post. As a result, the enforcement arm of the FDA has been conducting a probe in parallel with the public health investigation led by the CDC, officials said. They still do not know the cause of the lung injuries that are making people sick.
FDA officials said investigators from its Office of Criminal Investigations have been pursuing this investigation since shortly after the illnesses were first reported this summer. That office conducts criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible and bringing them before the U.S. Department of Justice for prosecution.
Alexandria, Va.-based Society of Independent Gasoline Marketers Association (SIGMA) said the good news out of all the recent e-cigarette discussion is that the FDA’s proposals don’t target c-stores or restrict the sale of product to a particular class of trade, such as tobacco shops or 21-and-over retail locations.
Still, Brian Hannasch, CEO of Alimentation Couche-Tard Inc., the Laval, Quebec-based parent of the Circle K chain, said those making policies against e-cigarettes could create an illicit black market, Bloomberg reported. “If there’s just outright bans and you’ve got clear consumer demand, gray and dark markets are going to dominate,” Hannasch said after a September shareholder meeting. “Then you lose control over the quality of the supply chain.”