Partner Letter to FDA on Tobacco Product Applications for JUUL
As you are aware, the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) is reviewing Premarket Tobacco Product Applications (PMTAs) for e-cigarettes and other new tobacco products on the market as of the effective date of the deeming rule (August 8, 2016). In his “Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline,” (FDA Progress Report), issued February 16, 2021, CTP Director Mitch Zeller makes it clear that the products accounting for the greatest market share will receive “first review.” According to the FDA Progress Report, this expedited treatment is justified because “[t]he continued marketing of these products has the potential to have the greatest public health impact – either positively or negatively – as they hold the largest overall market share and therefore likely used by the largest number of people.”
Because JUUL’s products continue to have the largest share of the e-cigarette market, and therefore presumably are undergoing expedited review, we write at this time to express our conclusion that based on all of the publicly available evidence, no JUUL product currently on the market can meet the statutory public health standard. Therefore, they should not receive a marketing order.