April 27, 2018

FDA's 5-step plan to cut cigarette use among children, teens

Daily Briefing

    FDA Commissioner Scott Gottlieb this week announced that FDA since March has issued 40 warning letters to retailers over violations involving the illegal sales of electronic cigarettes manufactured by JUUL Labs to minors.

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    The enforcement action is part of a new Youth Tobacco Prevention Plan Gottlieb unveiled this week that aims to prevent the use of tobacco products—particularly e-cigarettes—among children and teenagers.

    Background

    E-cigarettes have been sold in the United States for at least a decade. Federal law prohibits retailers from selling e-cigarettes to anyone under age 18, and some e-cigarette companies, such as JUUL, have imposed 21-year old age limits for online purchases.

    Despite the restrictions, e-cigarette use—or vaping—among school-age children has become more common. According to the 2017 Monitoring the Future survey, 11% of 12th graders, 8.5% of 10th graders, and 3.5% of 8th graders said they had vaped within the past 30 days. Of those 12th graders, 24% said they vaped daily, according to Richard Miech, lead author on the report and a professor at the Institute for Social Research at the University of Michigan.

    Public school officials say a new generation of devices that resemble flash drives and other everyday items began making their way into public school systems last fall, and, according to the Wall Street Journal, have come to serve as a "teen status symbol."

    These newer versions come in a wide variety of flavors—such as mango and crème brulee—that public health experts say appeal to youth, and are smaller and easier to conceal. For instance, JUUL makes an e-cigarette that is small and can be plugged in to a computer's USB port to charge.

    Ashley Gould, chief administrative officer for JUUL, has said the company's products are not intended for children but rather for adults who want to quit smoking. "Our product is not only not for kids, it's not for non-nicotine users," she said.

    According to the Washington Post's "To Your Health," lawmakers and health care organizations last week urged FDA to take aggressive steps to discourage the use of e-cigarettes among minors.

    Gottlieb announces FDA efforts to prevent tobacco use among children, teens

    Gottlieb in the statement Tuesday said, "FDA must—and will—move quickly to reverse these disturbing trends, and, in particular, address the surging youth uptake of JUUL and other products," such as those by myblu, and KandyPens. He outlined five ways FDA is looking to address the issue under the new Youth Tobacco and Prevention Plan.

    1) National covert operation: Gottlieb said the agency since April 6 has been conducting a large-scale, undercover operation across the United States to identify retail stores and online websites illegally selling e-cigarettes, specifically JUUL products, to minors. Gottlieb said FDA since March has identified 40 violations involving the illegal sales of JUUL products to minors and has issued 40 warning letters to retailers over the violations.

    2) Work with eBay to eliminate sales: Gottlieb said FDA recently contacted eBay to discuss the agency's concerns over listings on eBay's website for JUUL products. Gottlieb said eBay took "swift action to remove the listings and voluntarily implement new measures to prevent new listings from being posted to the web retailer's site."

    3) Hold e-cigarette manufacturers accountable: Gottlieb said FDA is taking additional steps to directly reach out to manufacturers and hold them accountable for the illegal sales of e-cigarettes to minors. For example, FDA asked JUUL to submit documents to help FDA "better understand the reportedly high rates of youth use and the particular youth appeal of these product." Specifically, FDA requested:

    • Consumer complaints associated with JUUL products;
    • Documents on product marketing;
    • Information about whether certain product features, ingredients, or specifications appeal to specific age groups;
    • Reports of youth-related adverse events; and
    • Research on the behavioral, health, physiologic, and toxicological effects of JUUL products, including use and initiation among youth.

    Gottlieb said FDA plans to issue other letters to manufacturers requesting such information. Manufacturers that do not comply with the request will be in violation of the law and will be subject to enforcement action, Gottlieb said.

    4) Enforcement actions for misleading marketing tactics: Gottlieb said FDA is planning to take enforcement actions against companies that FDA thinks misleadingly market e-cigarettes to children. Gottlieb said these represent the first "in a series of efforts [FDA is] pursuing as part of [its] newly formed Youth Tobacco Prevention Plan." He said FDA "will announce additional steps in the coming weeks and months."

    5) Youth e-cigarette prevention campaigns: Gottlieb said FDA will continue to invest in science-based campaigns designed to educate youth about the health risks associated with smoking.

    Comments

    Several anti-tobacco and health organizations praised FDA for taking steps to prevent tobacco use among youth, but expressed concerns that the efforts did not go far enough, "To Your Health" reports. 

    Truth Initiative COO Dave Dobbins said, "FDA needs to accelerate its actions when it comes to regulating e-cigarettes like JUUL and remove flavors known to entice youth." Dobbins said, "Keeping e-cigarettes on the market without first evaluating them is putting an entire generation of young people at risk of addiction."

    Matthew Myers, president of the Campaign for Tobacco-Free Kids, applauded FDA's actions, but said "FDA must do more by taking off the market JUUL flavors like mango and cool cucumber that clearly appeal to kids, preventing the introduction of look-alike products and subjecting e-cigarettes to FDA review of their public health impact, as required by law."

    JUUL said the company agrees "with the FDA that illegal sales of [its] product[s] to minors is unacceptable." The company said it "already [has] in place programs to identify and act upon these violations at retail and online marketplaces, and [it] will have more aggressive plans to announce in the coming days." The company added that it is "working with … FDA, lawmakers, parents, and community leaders to combat underage use, and [it] will continue working with all interested parties to keep our product away from youth."

    KandyPens said it does not sell products that are intended to be used exclusively with nicotine. KandyPens CEO Graham Gibson said, "All of our products are sold empty," adding, "We can't control what people put in our products."

    A subsidiary of Imperial Brands that sells myblu devices said its products are for adults and the company supports efforts to crack down on the sales of such products to minors (Zernike, New York Times, 4/24; Boyles, MedPage Today, 4/24; Reuters, 4/24; Chaudhuri/Chaker, Wall Street Journal, 4/24; McGinley, "To Your Health," Washington Post, 4/24; Gottlieb statement, 4/24).

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