With 55% Market Share and the Creation of a New Verb (“JUULing”), JUUL is Now at the Center of a Firestorm (Vaporstorm?) of Attention

By Stacy Ehrlich

On April 24, 2018, FDA announced a number of new actions relating to youth access to and use of JUUL products and other electronic nicotine delivery systems (ENDS) products (e.g., e-cigarettes).  For example,

  • On April 6, 2018, FDA initiated a large-scale, undercover nationwide “blitz” to crack down on the sale of e-cigarettes – specifically JUUL products – to minors at both brick-and-mortar and online retailers, which will continue to the end of April.
  • Based on April 2018 compliance checks to date, FDA has already issued 40 warning letters for illegal sales of JUUL products to minors.
  • FDA contacted eBay to raise concerns over several listings for JUUL products on its website.  eBay removed the listings and indicated that it would voluntarily implement measures to prevent new listings from being posted.
  • Pursuant to its authority under Section 904(b) of the Federal Food, Drug, and Cosmetic Act, FDA sent an official request for information directly to JUUL Labs requesting that the company submit documents relating to marketing practices and research on the following general topics:
    • Product marketing;
    • Product design;
    • Public health impacts involving youth; and
    • Adverse experiences and complaints involving youth.

The letter includes specific categories of information within these general topics, such as information on “nicotine formulation, (e.g., nicotine salt formula) and nicotine concentration/content.”  The letter requests a response by June 19, 2018.

  • FDA also indicated that it plans to issue document requests to other manufacturers of products “that raise similar concerns about youth use.”
  • The Agency is planning additional enforcement actions focused on companies that it believes are “marketing products in ways that are misleading to kids.”  FDA plans to release more information on this effort “in the coming weeks.”
  • FDA has established a Youth Tobacco Prevention Plan.  The above efforts are apparently the first in a series of actions FDA will take under this plan, and additional steps will be announced “in the coming weeks and months.”
  • FDA plans to launch in September 2018 a full-scale “youth e-cigarette prevention campaign” under its “The Real Cost” brand umbrella.
  • FDA intends to pursue product standards and other regulations for electronic nicotine delivery systems, such as e-cigarettes, to address known hazards and concerns, including exploding batteries and accidental ingestion of e-liquids.

Importantly, however, in his  statement announcing these actions, FDA Commissioner Dr. Scott Gottlieb also acknowledged the potentially positive role that ENDS products can play as part of FDA’s comprehensive nicotine plan, announced on July 28, 2017, as follows:

  • Make no mistake. We see the possibility for ENDS products like e-cigarettes and other novel forms of nicotine-delivery to provide a potentially less harmful alternative for currently addicted individual adult smokers who still want to get access to satisfying levels of nicotine without many of the harmful effects that come with the combustion of tobacco. But we’ve got to step in to protect our kids.
  • As the FDA considers regulating nicotine levels in cigarettes to render combustible cigarettes minimally or non-addictive, products such as e-cigarettes may offer a potentially lower risk alternative for individual adult smokers. These ENDS products will still need to be put through an appropriate series of regulatory gates by the FDA. But the viability of these products is severely undermined if those products entice youth to start using tobacco and nicotine.

One can reasonably view FDA’s announcement as directly responsive to a March 8, 2018, letter from the House Committee on Energy and Commerce, and an April 18, 2018, letter from a number of public health groups, including the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics.  The House Commerce Energy and Commerce Committee letter, signed by Frank Pallone (D-NJ), requested that FDA reconsider the “lengthy compliance extensions to the deeming rule that will leave potentially risky products on the market for several more years.”  In addition to including a similar request to reverse these extensions, the health organizations’ letter asked that FDA implement other actions, including: (1) the removal from the market of JUUL flavors, and other similar products, that were allegedly introduced after the August 8, 2016, cutoff date for introducing so-called deemed “new tobacco products” without prior FDA authorization; (2) the suspension of internet sales of JUUL until FDA promulgates rules on age verification; and (3) a ban on merchandise using the JUUL name or trademark.

JUUL Labs also received an April 18, 2018, letter directly from  a group of Democratic Senators that “urg[ed] JUUL Labs, Inc., to immediately take action to reduce youth use of your dangerous and addictive device.”  In particular, the letter included, among others, inquiries about the company’s support for raising the federal minimum purchase age to 21, whether the company will agree to stop selling products containing certain flavors that “clearly appeal to children and young people,” the legal status of company products that appear to have entered the market after August 8, 2016, and the company’s use of nicotine salts rather than free-base nicotine.

In its April 24th release, FDA acknowledged that JUUL Labs had expressed recognition of the youth access problem and contacted FDA and other stakeholders to discuss these concerns.  On April 25, 2018, JUUL Labs announced a “comprehensive strategy to combat underage use.”  This strategy will include actively supporting state and federal initiatives to raise the minimum age to purchase tobacco products to 21 and an investment of $30 million over the next three years to support research, education, and community engagement efforts.  JUUL Labs also announced that it will work with Tom Miller, Attorney General of Iowa and a public supporter of making ENDS products available to adult smokers, to assemble a group of public officials and tobacco control advocates to work on youth access initiatives.

Some public health groups remain skeptical.  In an April 25, 2018, statement, Matt Myers, President of the Campaign for Tobacco-Free Kids, stated: “The voluntary steps announced today by Juul Labs are not a substitute for effective FDA regulation of Juul e-cigarettes and all tobacco products. History has shown over and over again that voluntary action by tobacco manufacturers doesn’t work.”  In the coming weeks, we will see what other actions FDA might have in store for JUUL and the rest of the industry.