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Pallone to Gottlieb: “JUULing” Threatens Kids’ Health

Mar 8, 2018
Press Release
“There is simply no reason for FDA to not begin reviewing these products immediately”

Washington, D.C. – Stating that tobacco products like JUUL and other e-cigarettes are gaining widespread popularity among America’s youth, Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ) sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb today voicing concerns that the delays to the May 2016 final deeming rule will lead to more kids and teens getting addicted to these products. 

FDA’s decision in July 2017 to delay important compliance deadlines for the final deeming rule will permit some newly deemed products, like JUUL, to stay on the market until 2022 without premarket review by FDA.  Prior to the delay, manufacturers would have been obligated to begin submitting certain categories of applications this year.  This compliance extension means that for over four more years these products will lack needed public health oversight and will risk continued exposure to a new generation of youth. 

“The availability of JUUL and e-cigarettes to youth is extremely troubling, and I am deeply concerned that FDA’s delay of the final deeming rule will lead to more kids and teens using these harmful products and getting addicted to nicotine,” Pallone wrote in his letter to Commissioner Gottlieb.

The need for FDA oversight has become all the more critical as e-cigarette products like JUUL have, according to recent press reports, become widely used by minors.  JUUL’s sleek design (it resembles a USB flash drive and can be charged in a computer) and flavors like “crème brulee,” “fruit medley,” and “cool cucumber” are especially concerning.  Nicotine containing products such as JUUL can be highly addictive.  JUUL itself advertises on its website that the device’s nicotine cartridge contains the same amount of nicotine as a pack of cigarettes.  A study released earlier this week found that adolescents who use e-cigarettes are exposed to at least five different dangerous chemicals and that fruit-flavored products produced significantly higher levels of certain cancer-causing chemicals. 

“It is concerning to me that these products will continue to be disseminated, marketed, and utilized for several more years without FDA having all necessary information to evaluate the health risks and potential health implications for these products,” Pallone continued in his letter to FDA.  “There is simply no reason for FDA to not begin reviewing these products immediately.  FDA must exercise its authority to the fullest extent without delay in order to protect the American public, and most especially American youth, from the harmful effects of tobacco usage.” 

Pallone is urging FDA to reconsider the compliance extensions to the deeming rule and immediately exercise its authority under the Tobacco Control Act to review new tobacco products like JUUL.

According to the Centers for Disease Control (CDC) and the Surgeon General, e-cigarettes are now the most commonly used form of tobacco by youth in the United States, and young people are trying these products based on curiosity, taste, and the belief that e-cigarettes are less harmful than other tobacco products.  According to CDC, 11.3 percent of high school students and 4.3 percent of middle school students were current e-cigarette users in 2016.  However, a recent study identified that a quarter of youth and young adult JUUL users refer to JUUL use as “JUULing” and not “vaping.”  As a result, CDC e-cigarette data may not be fully capturing the extent of JUUL usage.

Today’s letter follows previous inquiries from Pallone to FDA outlining his concerns and seeking more information about the delay of the final deeming rule, including the alarming delay of certain compliance extensions relating to FDA’s expanded authority to regulate all tobacco products, such as e-cigarettes and other electronic nicotine delivery systems. 

Pallone’s letter is available HERE.