FDA Denies Authorization to Market JUUL ENDS Products; Company Intends to Seek Stay of the Marketing Denial Orders
On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs) to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years ago, contained insufficient data for the Agency to assess the potential toxicological risks of using JUUL products. As a result, according to FDA, Juul did not show that permitting the marketing of its products would meet FDA’s “appropriate for the protection of the public health” (APPH) standard.
FDA’s issuance of the MDOs to Juul prohibits the commercial distribution, importation, and retail sales of all JUUL ENDS products, including:
Virginia Tobacco flavored JUULpod (3% nicotine)
Virginia Tobacco flavored JUULpod (5% nicotine)
Menthol flavored JUULpod (3% nicotine)
Menthol flavored JUULpod (5% nicotine)
FDA indicated that although it had not received clinical information to suggest that there is an immediate hazard associated with the use of JUUL products, the Agency determined that the company’s PMTAs lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the APPH threshold standard was met. Specifically, FDA indicated that:
The information and data contained within Juul’s PMTAs precluded FDA from completing a toxicological risk assessment to determine whether the APPH standard had been met;
There was “insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from . . . [Juul’s] e-liquid pods;” and
The Agency is concerned about the potential harm from mixing the use of third-party e-liquid pods with the JUUL device, as well as the use of JUULpods with non-JUUL devices.
FDA’s Acting Director for the Center for Tobacco Products (CTP), Michele Mital, noted that the responsibility of demonstrating that a particular tobacco product meets the relevant standards ultimately falls on the manufacturer and not on FDA, which is tasked with ensuring that the products meet the relevant standards. As such, FDA has, to date, only authorized 23 tobacco-flavored ENDS products under the PMTA pathway.
As a result of the MDOs issued, Juul must remove all of its products from the U.S. commercial market immediately or be subject to enforcement action. FDA has noted that one of its highest enforcement priorities is for unauthorized ENDS products and that its enforcement action is applicable to not only commercial distribution and sales by Juul but also by third-party distributors and retailers of JUUL products.
In a statement posted on its website, Juul maintained that it believes it provided FDA with sufficient information and data based on high quality research and that it “appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being ‘appropriate for the protection of the public health.’” The company further noted that it intends to seek a stay of the MDOs and that it is “exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator.”
The company’s initial PMTA submission included detailed scientific data from over 110 studies totaling over 125,000 pages evaluating the JUUL products’ impact on both current users of tobacco products and nonusers, including those who are underage. Last year, the company had a number of its long-term perception and behavioral studies published in a special edition of the American Journal of Health Behavior. Those studies estimated, among other things, the prevalence of ENDS and JUUL use among young and older adults and documented the 12-month smoking trajectories of adults who purchased a JUUL Starter Kit. Overall, cigarette smoking prevalence was halved, with most smokers switching completely as dual use declined.
FDA has issued MDOs for over 99% of the non-tobacco flavored ENDS products that it has reviewed thus far. As noted above, FDA has issued marketing granted orders (MGOs) for 23 ENDS products, including tobacco-flavored ENDS products from the R.J. Reynolds Vapor Company, Logic Technology Development LLC, and NJOY LLC.