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Unintended Consequences? Experts Debate Vaping Flavor Ban

— Most supportive, but one warns black market would fill the void

MedpageToday

WASHINGTON -- Advocates, physicians, and health policy experts debated the potential benefits and harms of banning all flavored tobacco products as part of a new bill that aims to curb the use of e-cigarettes in kids and adolescents.

Lawmakers and federal agencies were caught "flat-footed" by the popularity of e-cigarettes among young people, and now the country is beset by an outbreak of vaping-related lung illnesses, said Rep. Anna Eshoo (D-Calif.), chairwoman of the House Committee on Energy & Commerce Subcommittee on Health, at the start of a hearing on Tuesday.

, nearly 1,500 people across the U.S. have been affected by these illnesses and 33 have died.

Over one-third of the patients are under age 20, Eshoo said.

President Trump last month announced that the FDA would develop a plan to ban nearly all flavored e-cigarettes, but to date no such plan has been released.

The would extend FDA regulations on the sale, marketing, and flavor restrictions and fees on combustible tobacco products to also include e-cigarettes. It would also raise the minimum age to buy tobacco products to 21 and would ban all non-face-to-face sales of tobacco products, including e-cigarettes.

Ranking member for the subcommittee Michael Burgess, MD (R-Texas), stressed that lawmakers and federal agencies need to understand the core problem in order to provide the appropriate response to the current outbreak of lung illnesses.

Most patients impacted by these new lung illnesses had a history of THC use, he said, which confirms that the THC "has played a role in the outbreak."

"As more information becomes known and understood about e-cigarettes, we should ensure that our legislative solutions tackle the true underlying cause of the issue," he said.

While Burgess acknowledged that nicotine in e-cigarettes is highly addictive, e-cigarettes are also important as an alternative pathway for adult smokers trying to quit, he said.

It's "traditional" cigarettes that are the "leading cause of preventable death," he said.

Experts Weigh In

All of the invited witnesses supported the provisions of the bill around raising the age to buy tobacco to 21, extending the same marketing rules that apply to cigarettes to e-cigarettes, and prohibiting non-face-to-face sales of these products, but the question of flavors incited debate.

The use of sweet flavors, youth-friendly marketing, and easy access have led to "skyrocketing" levels of youth e-cigarette use, said Matthew Myers, president of the Campaign for Tobacco-Free Kids, a witness at the hearing, who supports the new bill.

More than one in four high school students (27.5%) used e-cigarettes in 2019, a doubling of the percentage that used them in 2017, according to the 2019 National Youth Tobacco Survey, he noted.

What's more, Myers said, the argument for maintaining access to e-cigarettes so that adults can use them to get help quitting smoking is spurious. The evidence behind e-cigarettes as smoking cessation tools is "vastly overstated," he said.

A third witness, Phillip Gardiner, DrPH, of the University of California Berkeley and co-chair of the African American Tobacco Control Leadership Council, said that while a study in the New England Journal of Medicine showed e-cigarettes could help people quit smoking, around 27 others suggested e-cigarettes weren't effective for smoking cessation.

"There are more people getting on the on-ramp, than are getting off the off-ramp," Gardiner said.

Susanne Tanski, MD, MPH, a pediatrician and tobacco control expert representing the American Academy of Pediatrics, which supports the bill, explained that adolescents are biologically more susceptible to nicotine addiction.

As "pleasure centers become mature before the inhibitory centers become mature," adolescents "don't have the brakes to stop their own behavior," Tanski said.

She added that young individuals can show symptoms of dependence after only days or weeks of occasional use and said some of her patients wake up in the middle of the night to vape -- "a sign of intense nicotine addiction."

Tanski called the provision of the bill banning all flavored tobacco products "the single most important policy that Congress can pass to address the youth tobacco epidemic."

Flavors help attract young users and "hook kids"; they "help mask the harsh taste of nicotine, making repeated use more likely, and thereby increasing the likelihood of developing addiction," she said.

Unintended Consequences

While all of the witnesses supported most parts of the bill, one took exception to the ban on flavors.

Michael Siegel, MD, MPH, of the Department of Community Health Sciences at Boston University School of Public Health, who spoke on his own behalf, estimated that if the bill passed with a flavor ban, approximately 16,000 small businesses would close and 2 million ex-smokers who had already quit smoking would return to combustible cigarettes, or to a new black market that would likely emerge after the bill's passage.

"It's not the flavors that are causing the harm. It's the high levels of nicotine and the special nicotine formulations," Siegel said in his opening statement.

Before Juul, only 4% of youth vapers reported using e-cigarettes every day, but by 2018, the number of youth e-cigarette users who were addicted tripled, rising to 12%. This is because companies like Juul, Suorin, and Phix use a different nicotine formulation than all other companies, a nicotine salt at a high concentration, he said.

On Thursday, Juul announced it had stopped sales of its mango-, crème-, fruit-, and cucumber-flavored e-cigarettes and was "reviewing whether to suspend sales of mint and menthol flavors," according to the .

Regulating nicotine formulations and the level allowable in e-liquids, therefore, is "the single most effective step you can take to help reverse the youth e-cigarette epidemic," Siegel said.

He recommended setting a maximum nicotine level for all e-cigarettes with a lower allowable level, about half, for nicotine salt formulations.

As for the outbreak of lung illnesses, Siegel said the "most likely cause" is the "tainted THC cartridges ... laced with vitamin E acetate" -- a new thickening agent.

If the government eliminates flavored e-cigarettes, more young people would turn to THC products, Siegel predicted, because those would be the only products they could still buy.

"You are actually increasing the risk of more cases of this outbreak," he said.

Tanski in her opening statement noted that the link between THC and lung illnesses isn't airtight. The CDC reported nicotine use in nearly 60% of cases and "exclusive nicotine" use in 13%, she said.

The Case for Banning Flavors, Menthol

Gardiner said he considered the ban on menthol especially important as an issue of social justice. "Eighty-five percent of African-American adults and 94% of black youth who smoke are using menthol products," he said. In part, the high use of menthol products among African Americans is due to "predatory marketing" in African American communities and to the products being cheaper.

Gardiner also said that flavors make it easier to develop a dependency.

"Menthol is the ultimate candy flavor," he said. "It helps the poison to go down easier ... it activates more nicotinic receptors ... it produces more dopamine expression in the body -- meaning they're more pleasurable, you like them more -- that's why it's harder to quit."

As for the other potential consequences of banning flavors that Siegel described, Gardiner noted that in the 26 cities where laws banning menthol were passed, no black market emerged, and a study completed in Minneapolis found "not one person went out of business."