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E-Cigarettes: A Bold New Strategy

CLEAR AND PRESENT DANGER

The rising use of e-cigarettes by America’s youth has reached epidemic proportions, according to FDA Commissioner Scott Gottlieb. A recent report by the Centers for Disease Control backs Gottlieb up: teen use of e-cigarettes has surged 900% from 2011-2015. More than 2 million middle and high school students were current users of e-cigarettes in 2017. In a press release announcing new enforcement action, Gottlieb stated that “[the FDA] must adjust certain aspects of [its] comprehensive strategy to stem this clear and present danger.” Youth use is particularly worrisome because the adolescent brain is especially vulnerable to nicotine addiction.

Yet just last summer the FDA decided to delay regulating e-cigarettes until 2022. A group of public health and consumer advocacy organizations sued the FDA for this decision, criticizing the delay as arbitrary and capricious. On September 12, 2018, Gottlieb announced a new enforcement strategy targeting the manufacturers that market e-cigarettes to minors. The strategy focuses on the makers of 5 products: Vuse, Blu, Juul, MarkTenXL, and Logic. These 5 brands comprise 97% of the U.S. market of e-cigarettes, and make up a vast majority of the products illegally sold to minors. The agency is asking each company to submit to FDA within 60 days plans describing how they will address the widespread youth access and use of their products. If they fail to do so, or if the plans do not appropriately address this issue, the FDA will consider whether it would be appropriate to revisit the current policy that results in these products remaining on the market without a marketing order from the agency. This could mean requiring these brands to remove from the market some or all of their flavored products that may be contributing to the rise in youth use until they receive premarket authorization and otherwise meet all of their obligations under the law.

With respect to flavors such as bubble gum or mango that are often cited as contributing to the epidemic of youth use, FDA Commissioner Gottlieb spoke about this phenomenon specifically when he stated that in his belief, “certain flavors are one of the principal drivers of the youth appeal of these products.” Gottlieb declared that the FDA remains supportive of the role of e-cigarettes in helping adult smokers move away from combustible cigarettes, but that role cannot come at the expense of kids. “We cannot allow a whole new generation to become addicted to nicotine.” In emphasizing this balance, Gottlieb stated again that “in enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers, we won’t allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products.”

UNINTENDED CONSEQUENCES

In embracing e-cigarettes as an alternative to combustible cigarettes, and heralding them as a way to either quit smoking altogether or to engage in a less dangerous form of smoking, the law of unintended consequences took hold. Teens who would never consider smoking traditional, combustible cigarettes experimented with e-cigarettes and their great flavors, not always realizing that those mango and bubble gum vapes have nicotine in them. But of course they do, and teens got addicted. Perhaps these consequences were not so unintended. After all, Juul is designed to look like a USB flash drive, which can be concealed in a pocket. As noted above, multiple candy and juice flavors appeal to minors, and there has been little effort to educate youth on the fact that vapes contain nicotine—a highly addictive substance.

Whether intended or not, the consequences of not regulating e-cigarettes are an estimated 3.6 billion dollar industry in 2018 and an emerging generation of youth addicted to nicotine. While the growth of an industry and individual companies is good (the startup company Juul was valued at 16 billion for 2018), the explosive popularity of e-cigarettes has caught scientists, regulators, educators and parents unprepared. Teen smoking was finally in decline in the U.S., but vaping not only replaced traditional cigarettes, it became a popular alternative because so many kids—and parents—were led to believe that it was safe. Maybe it is time to at least regulate the industry’s marketing and sales which promote access to minors, and to instead promote education and awareness of the dangers of the nicotine in e-cigarettes.

CONTACT YOUR ATTORNEY

If you are concerned about your child’s use of e-cigarettes and believe that the e-cigarettes are fraudulently or otherwise illegally being marketed and sold to minors, contact Dave Thomas at The Thomas Law Firm for a free consultation regarding your legal rights.

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