Banning most flavors of electronic cigarettes from the retail marketplace — recommended forcefully by President Donald Trump last week — has prompted two main responses from analysts and advocates.
One is cautious celebration that the removal process has gained such high-profile support, particularly since the U.S. Food and Drug Administration was ordered by a federal judge July 12 to accelerate its regulatory oversight over e-cigarettes by May 2020.
Although the removal process could start within months, it likely will take several years for the FDA to work though the expected legal challenges from tobacco manufacturers and advocates.
The other reaction is a concern about “throwing the baby out with-the bathwater,” given that several studies have demonstrated that some flavored e-cigarettes are helping to wean smokers from traditional cigarettes.
The latest FDA proposal to remove all flavors but tobacco is a major change in policy. The agency previously said it would allow mint and menthol flavorings to remain because of their appeal to adult smokers.
“President Trump’s announcement ... is a necessary and long-overdue step to address the epidemic of youth e-cigarette use in the United States,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids.
“But it must be comprehensive, immediate and long-lasting,” Myers said. “This is a public-health crisis and we cannot afford more delays in confronting it.”
At least 80% of youths who use e-cigarettes say they picked the product because it “comes in flavors that I like,” rather than the nicotine they consume, according to government surveys.
“Banning flavors, aside from tobacco, would cut down on youth vaping, but it is less likely to greatly affect adult vaping,” said Dr. John Spangler, a professor of family medicine at Wake Forest Baptist Health.
Gregory Conley, the president of American Vaping Association, said his members “are deeply disappointed in the president’s decision to take direction from anti-vaping activists ... by attempting to ban the sale of nearly every vaping product on the market.”
“A ban will remove life-changing options from the market that have been used by several million American adults to quit smoking,” Conley said.
He noted that prohibition-type efforts have not worked in the U.S.: “It didn’t work with alcohol. It hasn’t worked with marijuana. It won’t work with e-cigarettes.”
That Trump stepped in — at first lady Melania Trump’s urging — was expected.
For weeks, there have been advocacy, public-health and congressional calls to “Do something” about the increasing number of severe illnesses connected primarily to open-pod vaping of liquids with unregulated contents.
North Carolina’s attorney general has filed two separate lawsuits against e-cigarette manufacturers, claiming they target underage youths with flavored products.
None of the e-cigarette defendants — Juul Labs Inc., Beard Vape, Direct eLiquid, Electric Lotus, Electric Tobacconist, Eonsmoke, Juice Man, Tinted Brew and VapeCo. — have operations in North Carolina.
Attorney General Josh Stein said the lawsuits were brought under the N.C. Unfair or Deceptive Trade Practices Act. He is requesting that a judge shut down sales from these companies in the state.
Some critics of Trump’s intervention say the same “Do something” outcries have been made about gun control to little avail with much larger daily life-and-death consequences.
On Thursday, the U.S. Centers for Disease Control and Prevention reduced to 380 the number of confirmed and probable cases of severe lung disease associated with vaping, based on a more precise case definition developed in August. The previous estimate was at least 450.
Cases have been rerported in 36 states, including North Carolina, and the U.S. Virgin Islands.
The CDC said the previous case count was higher because it reported possible cases that were still under investigation. The current number includes only confirmed and probable cases.
No single device, ingredient or additive has been identified by federal health officials as the cause, though many cases involve marijuana vaping liquids.
“We simply have to remove these attractive flavored products from the marketplace until they can secure FDA approval, if they can,” U.S. Secretary of Health Alex Azar said at last week’s joint news conference with the Trumps.
Wake Forest Baptist Medical Center said Thursday that two previously healthy individuals in their 20s were put on life support as they are being treated in intensive care for lung damage related to vaping.
Dr. Peter Miller, the hospital’s assistant professor of critical-care medicine, said the illnesses are likely the result of using e-cigarettes with liquids that contain cannabis products including THC.
“While we do not yet know the long-term effects for these patients, both of them seem to be recovering and are very lucky to be alive,” Miller said.
“People really need to be aware, since we don’t know exactly what is in these products or their origin, especially when they’re bought online or off the street.”
Former FDA Commissioner Dr. Scott Gottlieb told cable business channel CNBC last week that the federal government needs to regulate cannabis products.
“People who are vaping nicotine and having these reactions probably are vaping illegal products that are counterfeit,” Gottlieb said. “We have to have a federal reckoning here.”
2 types of e-cigarettes
There are two main types of e-cigarettes — closed pods and open pods.
Open-pod systems allow smokers to refill the nicotine or non-nicotine liquid manually, while closed-pod systems use ready-filled tanks and screw directly onto the e-cigarette battery.
The major e-cigarette manufacturers, such as Juul Labs Inc., R.J. Reynolds Vapor Co. (Vuse) and Fontem Ventures (blu eCigs), focus on the closed-pod systems with limited flavors.
Open-pod systems tend to be sold by smaller makers of e-cigarette, including vape shops, that offer more flavor options, such as several varieties of fruit, candy and coffee.
Juul pulled four sweet flavors from U.S. retail in November, although it continues to sell them overseas.
The original Vuse version by R.J. Reynolds Vapor is the No. 2 selling e-cigarette. Its current flavors are tobacco, menthol, mint, rich tobacco, chai, crema, fusion, tropical, mixed berry, melon and nectar.
The British American Tobacco Group, R.J. Reynolds Vapor’s parent company, issued a statement in support of robust product-quality standards and the need for measures in the U.S. to deny young people access to e-cigarettes.
Kingsley Wheaton, BAT’s chief marketing officer, said in a statement Thursday that it “welcomes the FDA shining a spotlight on the important issue of preventing youth access to vapour products and consumer safety.”
“We wish to work with governments and regulators worldwide to ensure clear and responsible regulatory frameworks are developed, which take account of all industry stakeholders — including consumers, regulators and the industry,” Wheaton said. “We share the FDA’s concern that the marketing of some flavors could resonate with children.
“At the same time, it is hard to overestimate the role that the responsible marketing of flavors plays in helping adult consumers move on from combustible products to alternative tobacco and nicotine products.”
Wheaton said in the statement that BAT has “invested billions of dollars in the research and development of our potentially reduced-risk products and the ingredients and components used in these products have been scrutinised by our team of 50 toxicologists for their suitability for vaping.”
“Consistent with this, we do not include oils containing THC or Vitamin E acetate.”
Wheaton said BAT expects that planned pre-market tobacco applications for its four Vuse products will be submitted before the FDA’s May deadline.
“If approved, (it) will enable our Reynolds business to continue selling its Vuse-branded vaping products within the new U.S. regulatory framework,” Wheaton said.
Nothing ‘kid friendly’
Reynolds American Inc. spokeswoman Kaelan Hollon said the manufacturer “shares President Trump’s concern that some flavors, such as those resembling ‘kid friendly’ food products, may play a role in increasing youth appeal and that marketing activities should not be directed to youth.
“Of note, we do not market such vapor flavors and in fact, we have supported measures to remove vapor products intended to mimic children’s food products or otherwise designed to target youth, and have procedures in place to ensure our products are only marketed to adult tobacco consumers,” Hollon said.
She said in a statement Reynolds “will continue working with the administration regarding proposed changes moving forward over the coming months, and feel confident in our planned premarket tobacco application submissions to the FDA.”
Fontem has said it will continue selling its sweeter flavors, including honeymoon, neon dream, blue ice and melon time.
The FDA has been under the most pressure to tighten and enhance e-cigarette regulations in response to the meteoric rise in popularity of top-selling Juul, which has about 74% of the U.S. market share.
Under agency standards, only products that represent a positive public-health benefit could be approved — a major reason why the FDA has been methodical with its flavorings review.
“I think the message is actually leaning more toward no one vaping,” said Spangler, the family-medicine professor with Wake Forest Baptist.
“Not only does the medical community not yet understand the short-term effects that are causing death, we absolutely do not know the long-term effects,” he said.
“There is no guarantee that long-term vaping will actually be safer than smoking combustible cigarettes. We used to think that short-term e-cigarette use was safer than short-term smoking, but even that idea has to be abandoned,” Spangler said.
Some free-market advocates say they believe Trump is overreacting to the vaping and lung illness connection.
“Trump needs to know the fact that adult smokers are switching en masse to these new reduced-risk products and they’ve been proven to be 95% less harmful than traditional cigarettes,” said Yaël Ossowski, the deputy director of the Consumer Choice Center.
“These individuals switch in part due to vaping flavors, and that should be kept in mind.
“We should not use isolated cases caused by illegal products to inform public policy on the life-saving capabilities of vaping devices for adults,” Ossowski said. “That is bad science and bad public policy.”
Brad Rodu, a professor of medicine at the University of Louisville and an anti-smoking advocate, said the public needs to keep in mind when advocating for severe cutbacks on e-cigarette availability that smoking of traditional cigarettes is responsible for more than 480,000 deaths a year in the United States.
Rodu and other anti-smoking advocates say the CDC “is being ‘unnecessarily vague’ about describing the injuries as simply vaping-related when many people might have been injured by vaping THC oil.”
“The sudden appearance of these cases and links to THC strongly suggest that contaminated street liquids are at fault, not legitimate retailers’ e-cigarettes or vape products.
“How many thousands of former smokers who currently vape will conclude that the risks aren’t worth it, and return to smoking?” Rodu asked. “How many millions of smokers will never consider this vastly safer smoke-free option?”
Wells Fargo Securities analyst Bonnie Herzog, a leading tobacco-industry expert, said the FDA plan to target mint and menthol e-cigarette flavors “is significant as mint/menthol are hugely popular among adult smokers and critical smoking cessation agents.”
Herzog said that the FDA “has threatened (even) stiffer actions if there’s not a reduction in youth e-cigarette usage ... such as a potential ban on all e-cigs, regardless of flavor.”
“If so, it would effectively wipe out an entire nicotine product category, which we aren’t certain is enforceable under the Tobacco Control Act without congressional approval — a multiyear process and bound to be heavily litigated.”
Herzog said age-21 restriction initiatives should take precedence given it “could be a huge disruptor to kids getting access to e-cigarettes — and tobacco/e-cigarette manufacturers are on board.”
“While we agree kids and e-cigarettes shouldn’t mix, we hope cool heads prevail given potential unintended consequences, such as increased black market activity and a resurgence in combustible cigarette use should smokers move back to the category.”