Outrage of the Month: FDA Inaction Spurred Epidemic of Teen Nicotine Addiction Via E-Cigarette Use
Health Letter, November 2019
By Michael Carome, M.D.
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Alarming new findings from a study published online on Sept. 18, 2019, in the New England Journal of Medicine reveal that the proportion of adolescents who admit to using electronic cigarettes (commonly called vaping) continued to increase substantially in 2019, with reported use in the past 30 days more than doubling since 2017.
On Sept. 25 — exactly one week after the release of this new evidence of the exploding epidemic of teenage nicotine addiction linked to e-cigarettes — Dr. Norman Sharpless, the Acting Commissioner of the Food and Drug Administration (FDA), admitted before a hearing of the Subcommittee on Oversight and Investigations of the U.S. House of Representatives’ Energy and Commerce Committee what had been obvious to many: his agency “should have acted sooner” to rein in e-cigarette manufacturers.
E-cigarettes, which were first marketed in the U.S. in 2007, are handheld, battery-powered devices that deliver nicotine, combined with flavorings and other additives, in the form of an aerosol. Nicotine, a drug found naturally in tobacco, is very addictive. In fact, according to the Centers for Disease Control and Prevention, more people in the U.S. are addicted to nicotine than to any other drug. Studies have shown that nicotine may be as addictive as heroin, cocaine and alcohol.
Adolescents appear to have an enhanced sensitivity to nicotine’s addictive properties. Even more troubling, nicotine exposure can impair brain development and increase the risk of developing psychiatric disorders and cognitive impairment later in life.
The new study on adolescent e-cigarette use, which was funded by the National Institute on Drug Abuse, involved annual surveys of a nationally representative sample of students in 12th, 10th and 8th grades in 2017, 2018 and 2019 that were conducted by the University of Michigan. For each of the three years, surveyed students were asked whether they vaped nicotine ever, during the past 12 months and during the past 30 days. For the 2019 survey, students for the first time also were asked if they vaped daily, which was defined as vaping on at least 20 days during the past 30 days.
The researchers found that the proportion of students who reported vaping nicotine during the past 30 days increased by more than twofold from 2017 to 2019 at each grade level: from 11% to 25% for 12th graders, from 8% to 20% for 10th graders and from 4% to 9% for 8th graders. Likewise, the proportion of students who reported vaping nicotine during the past 12 months nearly doubled at each grade level: from 19% to 35% for 12th graders, from 16% to 31% for 10th graders and from 8% to 16% for 8th graders.
Of particular concern, the researchers found that in 2019 the proportion of students who reported vaping nicotine daily was 12% in 12th graders, 7% in 10th graders and 2% in 8th graders. Such daily vaping likely reflects the development of nicotine addiction. The researchers highlighted the fact that almost all nicotine addiction is established during adolescence.
E-cigarette makers, like Juul, have made their products widely appealing to young people by adding flavors, such as apple, blueberry menthol, grape, lemonade, mango, mint and strawberry milkshake. Bloomberg reported that school districts in New York City, Kansas City, St. Louis and Washington state on Oct. 7 filed separate lawsuits against Juul in federal courts, accusing the company of intentionally marketing its products to teens and creating a public nuisance with the health problems tied to vaping.
Remarkably, as Sharpless stated in his Sept. 25 testimony before Congress, all e-cigarettes currently marketed in the U.S. — including those currently being used by adolescents across the country — are illegal. Under the Family Smoking Prevention and Tobacco Control Act of 2009 (the Tobacco Control Act) and subsequent rules issued by the FDA in 2016, a nicotine vaping product may not be legally marketed unless it has undergone scientific review by the FDA and the agency has determined that marketing the product is appropriate for the protection of human health. No nicotine vaping products have undergone such review. Moreover, Sharpless told Congress that “e-cigarette products are not safe, [and] they are not without harm.”
Nevertheless, the FDA has allowed e-cigarettes to remain on the market in violation of the law under an all too commonly misused policy known as “enforcement discretion.” In August 2017, the FDA issued a policy giving manufacturers of e-cigarettes that were already on the market as of Aug. 8, 2016, until August 2022 to submit the legally required applications to the FDA for scientific review of their products.
Asserting that the FDA’s five-year delay in implementing the requirements of the Tobacco Control Act with respect to e-cigarettes was unlawful and a threat to the health of children and others, seven public health and medical groups — including the American Academy of Pediatrics, American Cancer Society Cancer Action Network and Campaign for Tobacco-Free Kids — and five individual pediatricians sued the FDA in federal court in March 2018.
In May 2019, U.S. District Judge Paul W. Grimm issued a ruling in favor of the public health and medical groups. In July, the judge ordered the FDA to require manufacturers of e-cigarettes (and certain other tobacco products) on the market as of August 2016 to submit applications to the agency for scientific review of their products within 10 months. Manufacturers that fail to submit applications by the May 2020 deadline would then be subject to FDA enforcement action. For manufacturers that do submit applications, the judge imposed a one-year deadline for FDA review.
Commenting on the federal court’s order, Sharpless preposterously stated that the judge’s ruling “validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth.” This statement from the head of the FDA disregards the years of agency foot-dragging that has allowed tens of millions of young people to become addicted to nicotine, thus endangering their health.
 Goriounova NA, Mansvelder HD. Short- and long-term consequences of nicotine exposure during adolescence for prefrontal cortex neuronal network function. Cold Spring Harb Perspect Med. 2012;2(12):a012120.