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,
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.
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:
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.