• May 17, 2018

    AAP urges FDA to protect youths from Juuling, other tobacco products

    Devin MillerWashington Correspondent
    • Washington Report

    “Schools fret as teens take to vaping, even in classrooms”— Associated Press

    “Schools and parents fight a JUUL e-cigarette epidemic” — Wall Street Journal

    “Health groups, lawmakers sound alarm on JUUL e-cigarettes” — Medpage Today

    Recent headlines offer a snapshot of how e-cigarettes are increasingly finding their way into the daily lives of children and teenagers.

    The alarming rise in popularity of JUUL e-cigarettes, which resemble a USB flash drive and come in flavors such as mango and fruit medley, has added to the recent uptick in the conversation surrounding the products.

    Earlier this year, a report from the National Academies of Sciences, Engineering, and Medicine found that young people who use e-cigarettes are at increased risk for using traditional cigarettes. In 2016, the U.S. surgeon general concluded that e-cigarettes are addictive and harmful to developing brains. The Academy has long been speaking out about the dangers of these products and advocating for policies to protect children and adolescents.

    “Once the brain is addicted to nicotine, it is extremely hard to go back to a nicotine-free state,” said Jonathan P. Winickoff, M.D., M.P.H., FAAP, a member of the AAP Tobacco Consortium and professor of pediatrics at MassGeneral Hospital for Children. “Children’s brains are being changed in a permanent fashion to be nicotine-hungry, and that has lifelong implications for public health.”

    While the Food and Drug Administration (FDA) recently announced some limited enforcement measures to address e-cigarette use among young people and JUUL in particular, the Academy is urging the agency to do more to stop the introduction of child-friendly tobacco products in the first place.

    In May, AAP CEO/Executive Vice President Karen Remley, M.D., M.B.A., M.P.H., FAAP, and leaders from other partner organizations met with FDA Commissioner Scott Gottlieb, M.D., to discuss tobacco control and how the agency can use its authority to protect children.

    Regulatory advocacy is a critical aspect of the Academy’s work in the nation’s capital. The AAP’s multipronged approach to urge the FDA to keep children safe from e-cigarettes and other tobacco products is one timely example of how this works in practice.

    Here is a closer look at the ways in which the Academy is pushing for strong, immediate regulatory action and reacting to new FDA announcements.

    Pursuing litigation

    One overarching part of this strategy is the Academy’s advocacy urging the FDA to move ahead with reviews of e-cigarettes and the dangers they pose to minors before they come on the market.

    In 2016, the FDA issued a rule to extend its regulatory authority to e-cigarettes, cigars and other tobacco products that previously were unregulated. Under the rule, e-cigarette manufacturers were required to submit information about their products by August 2018. The FDA would use this information to review the product and its public health impact, including its appeal to children.

    Last summer, the FDA announced a delay to this provision, giving e-cigarette manufacturers until August 2022 and cigar manufacturers until August 2021 to comply. This means these products would stay on the market at least until then, unregulated.

    In late March, the Academy and the AAP Maryland Chapter joined with five other public health and medical groups as well as several individual pediatricians to file a lawsuit challenging the delay.

    The lawsuit asserts that the decision leaves tobacco products on the market that appeal to children deprives the FDA and the public of important health information and unfairly relieves manufacturers of the burden to produce scientific evidence that their products have a public health benefit.

    Raising alarm on JUUL 

    In conjunction with its work to urge the FDA to exercise its authority over all e-cigarettes, the Academy is drawing attention to the dangers of JUUL e-cigarettes, which increasingly are being found in schools and classrooms.

    JUUL e-cigarettes are more compact than traditional e-cigarettes. Discrete JUUL pods contain high concentrations of nicotine and are available in youth-appealing flavors and sleek design. In fact, JUUL users often report a rush or “high” when using the product due to the high amount of nicotine it contains.

    “There is a rampant misperception that electronic cigarettes deliver harmless water vapor. Nothing could be further from the truth,” Dr. Winickoff said.

    In late April, the Academy and other health and medical groups sent a letter to the FDA urging immediate action to address the dramatic rise in adolescent use of JUUL. The same day, 11 U.S. senators also sent a letter to the agency demanding action.

    The following week, the FDA announced preliminary steps to address the rise in youth use of JUUL e-cigarettes, including enforcement action against retailers who sell JUUL to minors. The FDA also sent a letter to JUUL Labs, the manufacturer of JUUL, requiring the company to submit documents so the agency could better understand the high rates of youth use and the appeal of JUUL to children and adolescents, including research on youth initiation.

    Most recently, the FDA and Federal Trade Commission issued 13 warning letters to manufacturers, distributors and retailers that are marketing e-cigarette liquids to resemble products such as juice boxes and candy.

    While these are positive steps, the Academy is urging the FDA to prevent the introduction of tobacco products that appeal to children by exercising the premarket review authority the agency chose to defer, rather than taking action after they become popular.

    Future advocacy opportunities 

    Looking ahead, there are several opportunities for the Academy to continue pursuing policies that protect young people from tobacco products.

    The FDA announced earlier this year that it intends to propose rules and seek comments on two topics: reducing nicotine levels in cigarettes to non- or minimally-addictive levels and regulating flavors in tobacco products. Both of these issues highlight potential progress to keep children safe from tobacco and will offer opportunities for the Academy to provide the child health perspective.

    In addition, the Academy continues to urge the FDA to issue a new rule on graphic warning labels for cigarettes. The Academy joined a lawsuit on the issue in October 2016, and a ruling is expected in the months ahead.

    Individual pediatricians also will continue to educate federal leaders, the public and their patients about the harms of tobacco products, especially e-cigarettes.

    “We are some of the frontline providers when kids are asking what is safe to do and what is not,” said Karen M. Wilson, M.D., M.P.H, FAAP, chair of the AAP Tobacco Consortium. “We have the ability to talk to kids about this proactively and to parents about the need to make sure that they are keeping their eyes open for whether their kids are using these products.”

    Copyright © 2018 American Academy of Pediatrics