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Fighting Rising Youth eCigarette Use

Does FDA Have the Tools?

Margaret Egan Auderset
Medical & Regulatory Writer
Cortellis | Clarivate Analytics
Twitter @_meg_egan

hillip Fuhrman took his first hit of an eCigarette as an eighth grader. He coughed some, but liked it. “The thing that I liked most was the minty feel in my throat,” the 15-year-old told an FDA panel at a January 18, 2019, public hearing, Eliminating Youth Electronic Cigarette Use: The Role for Drug Therapies. “The mint tasted like gum, and who didn’t like gum?” Phillip took that first hit from a friend’s device, but got his own a few weeks later; when his mother found and threw it away, he replaced it easily with another bought online. That cycle continued, thanks to the internet and the ease of friends willing to share. Phillip now says he was addicted to nicotine by the end of ninth grade.

The words “crisis” and “epidemic” are commonly attached to the ongoing surge in eCigarette use by US youth. According to the 2018 National Youth Tobacco Survey (NYTS), one in five high school students are users, a 78 percent rise over 2017 (20.8 percent versus 11.7 percent). Among middle school students, current use increased 48 percent (from 3.3 percent to 4.9 percent). FDA Commissioner Dr. Scott Gottlieb has asserted the value of eCigarettes to help adults quit smoking, but also called the rise in youth use “alarming” and said—more than once—that he was unwilling to let eCigarette availability “come at the expense of addicting a generation of kids to nicotine.”


Also called ENDS (electronic nicotine delivery systems) products, eCigarettes come in a variety of styles. Some mimic the look of “regular” combustible cigarettes; others resemble pens, and JUULs—a favorite among US youth—are easy to confuse with flash drives. Whatever their design, most contain a mouthpiece, battery, heating element, and cartridge or reservoir for the eLiquid. Once heated, the liquid vaporizes and is ready to be inhaled or “vaped.” eCigarette aerosol typically contains nicotine, which is highly addictive and harmful to the developing brain according to the US Centers for Disease Control and Prevention; it can also contain chemicals, volatile organic compounds, heavy metals, and ultrafine particles associated with heightened risk for cardiovascular and lung disease.

Manufacturer JUUL Labs dominates the US market, claiming more than 70 percent of cartridge-based eCigarette sales, according to the US Surgeon General. Regardless of their potential to help adult smokers quit, promoting eCigarette use by minors is uniformly condemned both in medical circles and by industry, chiefly due to nicotine. Most eLiquids—and all flavors of JUUL “juice”—contain it. As an example, JUUL manufactures “pods” in two strengths, 3 percent and 5 percent nicotine by weight; a 5 percent pod equates to a pack of cigarettes, the company website says: 20 cigarettes or approximately 200 puffs, with the same amount of nicotine.

“JUULing” is both a social and cultural phenomenon among US youth. JUULs resemble flash drives and can be charged via USB ports, so they blend in with everyday teenage odds and ends. Many efforts to curtail youth eCigarette use target JUUL products; JUUL Labs has also taken steps to promote them as adults-only.

“I think, in a way, JUUL slang has kind of become a universal code amongst teens,” 17-year-old Caleb Mintz told the FDA panel at that January public hearing. “In the way that, if I go to a different town and I say to another kid, do you play basketball? You know it’s making a connection with that kid. I can say things now like, do you have a JUUL pod on you? Or do you JUUL? And it’s kind of like I instantly make a connection with that kid. I think it’s that prevalent.”

FDA Regulation of Tobacco Products

The Surgeon General considers eCigarettes tobacco products because most contain nicotine, which comes from tobacco. In the US, the Family Smoking Prevention and Tobacco Control Act of 2009 assigns the FDA regulatory authority over tobacco products; the Agency decides whether and how they are manufactured, distributed, and marketed. Manufacturers of new tobacco products must gain marketing authorization via the FDA’s premarket tobacco application process, for example, and the FDA can (and does) require warning statements on packaging and in advertisements.

In 2016, the FDA introduced the “Deeming Rule,” extending its regulatory authority beyond combustible cigarettes, cigarette tobacco, “roll-your-own” and smokeless tobacco, to include eCigarettes and eLiquid, cigars, hookah, pipe tobacco, nicotine gels, and dissolvables. Provisions also restrict youth access to “deemed” products: Legally, they may not be sold to people younger than 18 years, nor in vending machines in areas accessible by them. The FDA’s 2018 Youth Tobacco Prevention Plan emphasizes eCigarettes; Agency actions include a “nationwide undercover enforcement effort” targeting offending manufacturers and retailers, warning letters, multiple crackdowns, and public meetings.

Special Rule for Cigarettes

While the Tobacco Control Act contains a “Special Rule for Cigarettes” forbidding flavors—“including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee”—in combustible cigarettes, the Deeming Rule does not ban them from deemed products. But young eCigarette users like flavors; among respondents to the 2016 NYTS, 31 percent of those who used cited “flavors such as mint, candy, fruit, or chocolate” as the reason, the CDC and FDA reported. And the 2018 survey found that roughly 68 percent of high-school-aged users vaped flavors, a 7 percent rise over 2017. A new FDA “policy framework” introduced in November 2018 is, in part, intended to restrict youth access to flavored ENDS products (other than tobacco, mint, and menthol flavors) with steps to limit sales to “age-restricted, in-person locations” and to institute “heightened age verification processes” for online purchases.

In a press release about the new framework, Commissioner Gottlieb stated he was asking FDA officials to “revisit” another policy: In May 2017, the FDA extended premarket review compliance deadlines for deemed products on the market as of August 8, 2016. Spurred by the youth eCigarette crisis, Gottlieb directed officials to reconsider that extension “as it applies to deemed ENDS products that are flavored”—excepting those that taste like mint, menthol, or tobacco because “data suggests” that they “are more popular with adults than with kids.” Four months later, on March 13, 2019, the FDA proposed moving the compliance deadline for “all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored)” up by one year, to August 8, 2021.

The proposal came in a draft FDA guidance document, Modifications to Compliance Policy for Certain Deemed Tobacco Products. In it, the Agency states plans to “prioritize” its enforcement resources, focusing on products that contribute to “the alarming trend of youth use,” including:

  • Flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) sold in ways that make it easier for minors to get them—for example, without independent, third-party verification of a buyer’s age and identity.
  • Flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) sold after August 8, 2021, “without the manufacturer submitting (and FDA receiving) a premarket application.”
  • Any ENDS product targeted to minors or likely to promote use by minors.

The document also notes FDA expectations that industry will “do more to keep their products out of the hands of minors.”

Like previous FDA statements, the draft guidance asserts the potential for eCigarettes to help adult smokers quit. It says the Agency’s exception of tobacco-, mint-, and menthol-flavored ENDS products from the 2021 deadline “reflects a careful balancing of public health considerations,” citing data suggesting that adults like mint and menthol more than “other flavors,” while minors more often choose “other flavors.”

Is FDA Doing Enough?

A diverse group spoke to the FDA panel at that January 18th hearing, including a few critics who questioned labeling youth eCigarette use an “epidemic” and called the NYTS biased and invalid. But the majority said FDA officials should step up Agency efforts to tackle youth eCigarette use, including making better use of existing regulatory authorities.

The Tobacco Control Act gives the FDA several tools to make eCigarettes less attractive and less available to minors, several speakers said. According to attorney Lauren Lempert, who works as a specialist at the University of California-San Francisco’s Center for Tobacco Control Research and Education:

  • The Agency should “fulfill its legal mandate” under Section 910 of the act and remove from market all eCigarettes that have not yet received FDA authorization via premarket review. The new compliance deadline for flavors is not enough, Lempert said via eMail; it “still means that thousands of ENDS products will remain on the market for at least another 2 1/2 years without any FDA review.”
  • For young people, eCigarettes are recreational. Vaping is cool, and tastes good. To minimize the appeal, the FDA should use its authority under Section 907 and initiate a rulemaking to prohibit all eCigarette flavors, including mint and menthol.
  • Section 906(d) gives the FDA “broad authority” over marketing and advertising restrictions. It should initiate a rulemaking to prohibit all internet sales of eCigarettes and ban ads that target youth, including those on social media, Lempert said; “heightened age verification processes” are not enough.
  • Section 911 introduced modified risk tobacco products (MRTPs) intended “to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.” The FDA has processed applications for MRTP status but not yet authorized any; as a result, at present, no manufacturer may legally make modified-risk claims. FDA should respond “aggressively” to unauthorized claims, Lempert said—including testimonials from smokers saying that eCigarettes helped them quit. Similarly, officials must be cautious when discussing the potential merits of eCigarettes. Calling them “tools” suggests that they are less harmful than combustible cigarettes; for teens, the takeaway message is that eCigarettes are safe.

Many organizations work to convince young people not to try tobacco products, but the CDC says eCigarettes have hemorrhaged their progress. Some 4.9 million middle and high school students were “current users” of “some type of tobacco product” in 2018, 1.3 million more than in 2017, the CDC reported in its February 2019 Vital Signs report—and eCigarettes are solely to blame for the increase, as youth use has not increased for any other product.

“As a 17-year-old, I recognize that my generation isn’t the priority,” Caleb Mintz told the FDA panelists in January. “Preventing younger kids from JUULing, to me, is the priority. I can’t help but feel as if my generation is gonna be known as being the generation of damage control.”

References available upon request.