Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) sent oversight letters to the four dominant e-cigarette manufacturers today requesting information on each of the companies’ research into the public health impacts of their products, their marketing practices, and their role in the promotion of e-cigarette use by adolescents. The letters were sent to JUUL Labs, Inc., Fontem Ventures, Japan Tobacco International, USA, Inc., and Reynolds American Inc., which collectively represent most of the current e-cigarette market.
In his letters, Pallone cites the mysterious vaping-related lung illnesses recently reported by the Centers for Disease Control and Prevention (CDC) and raises concern with the heightened popularity of electronic nicotine delivery systems (ENDS), including e-cigarettes among young people. According to the 2018 National Youth Tobacco Survey, youth usage of e-cigarette products increased by nearly 80 percent among high school students and nearly 50 percent among middle school students in the prior year while the Food and Drug Administration (FDA) and CDC reported that 1.5 million more students used e-cigarettes in 2018 than in 2017.
“I am concerned that ENDS products, like JUUL, are continuing to be disseminated, marketed, and used while consumers lack adequate information to evaluate the health implications of using these products," Chairman Pallone wrote in his letter to JUUL’s CEO Kevin Burns. “In fact, [CDC] and state health officials are currently investigating 94 possible cases of ‘pulmonary illnesses linked to e-cigarette use’ among young people reported in recent weeks across 14 states."
Last month, a U.S. District Court judge ordered e-cigarette manufacturers with products currently on the market to file premarket tobacco applications (PMTAs) with FDA by May 2020. FDA followed up on the court’s ruling stating that the agency “stands ready to accelerate the review of e-cigarettes and other new tobacco products," and indicated that manufacturers do not need to wait till May 2020 to submit PMTAs.
Pallone also noted his interest in reports that some of the manufacturers may be conducting clinical research into the so-called positive health effects of e-cigarette products.
“It has come to my attention that JUUL has begun conducting clinical research to examine ‘the potential positive impact of vapor products,’" Pallone continued in his letter to JUUL. “Given the health concerns outlined above, as well as the prevalence of use of these products by young people, I am interested in JUUL’s research agenda, as well as how JUUL plans to utilize this research in the future."
As part of his inquiry, Pallone is requesting documents and answers to a series of questions posed to each of the e-cigarette manufacturers by Sept. 20, 2019, including:
* Any research or studies conducted or financed by the four companies on the health impacts of their products on adolescents and adults;
* Reports on any adverse experiences by users of the companies’ products, including health effects like seizures as well as product-related defects that could cause harm;
* Information on whether any of the companies indicate in their ads and packaging that their products have not been approved by FDA for use in smoking cessation, or that their products have not been reviewed and found to be safe or effective for that purpose;
* Sales information for all the companies’ products since January 2016, including a breakdown by store-front retail type and online sales of each product;
* Details on promotional and marketing research, including how much each of the companies has spent on marketing and promotion of its products each year since their launch;
* A list of all social media influencers the companies have paid to market their products and any handles and usernames for social media bots that the companies use to market their products;
* An overview of the companies’ strategies to prevent the sale of e-cigarettes to young people online and in retail stores; and
* Information on whether each of the companies intend to submit PMTAs for their products to FDA prior to the May 2020 deadline.
Earlier this year, Chairman Pallone and Rep. Donna Shalala (D-FL) introduced the Reversing the Youth Tobacco Epidemic Act of 2019. The legislation aims to address the sharp rise in use of tobacco and e-cigarette products among young people, and among other things would prohibit all characterizing flavors of tobacco products and make it unlawful to market, advertise, or promote any e-cigarette products to individuals under the age of 21.
To read each of Pallone’s letters, click below:
Letter to Fontem Ventures
Letter to Japan Tobacco International, USA, Inc.
Letter to JUUL Labs, Inc.
Letter to Reynolds American Inc.
UPDATE: Chairman Pallone sent a fifth letter to e-cigarette manufacturer NJOY on Aug. 23, 2019. Pallone's letter to NJOY is available below:
Letter to NJOY, LLC
