In May of 2016, the U.S. Food and Drug Administration published its “deeming” rule through which the agency extended its regulatory authority from cigarettes, smokeless tobacco and roll-your-own tobacco, to all types of commercial tobacco products, including e-cigarettes, cigars, shisha, pipe tobacco, and novelties such as dissolvables and gels. All of these tobacco products are subject to existing FDA regulations, however FDA granted the 2016 deemed products an enforcement grace period for some requirements and restrictions. One notable area paused for later deemed products is the requirement that products are not sold or distributed without FDA authorization. FDA issues this authorization, or marketing order, only to products shown (through its manufacturer’s application to FDA) to meet the public health standard. This process is referred to as pre-market review.
Predictably, tobacco manufacturers and their trade groups filed challenges in federal courts across the country alleging that FDA’s application of agency rules to specific products exceeded its authority, violated the rulemaking process, and restricted rights protected by the U.S. Constitution. Our colleagues at the Public Health Law Center summarize many of the lawsuits brought by tobacco product manufacturers on the “Commercial Tobacco Control Litigation” section of their website.
Separately, in 2016 health groups challenged the authority of FDA’s decision to delay enforcement of pre-market review for deemed products. These groups sought to vacate the agency’s 2017 Guidance extending pre-market review deadlines for some 2016 deemed products (namely, e-cigarette and cigars). That case is summarized here:
American Academy of Pediatrics, et al., v. Food and Drug Administration, et al., 8:18-cv-00883-PWG (D.Md. 2019)
In a May 2019 decision, U.S. District Judge Paul W. Grimm vacated FDA’s 2017 Guidance that indefinitely allowed e-cigarettes on the market without FDA pre-approval. In a win for the plaintiff public health groups, the court concluded that the terms of the Guidance exceeded FDA’s authority under the Tobacco Control Act, and that the Guidance was akin to a rule and therefore must be promulgated through administrative notice and comment procedures. After subsequent input from parties on the application and review timeline, the judge ordered a deadline of May 12, 2020 for manufacturers to submit Pre-market Tobacco Product Applications to FDA. (In separate litigation, cigar manufacturers challenge the applicability of the new court-ordered timeline to submissions for marketing orders sought through Substantial Equivalence review, a likely pathway to market for many cigars.)
The decision results from the March 2018 lawsuit brought by six public health groups and four individual doctors challenging the FDA’s decision to indefinitely delay regulation of e-cigarettes, despite having deemed these tobacco products subject to FDA regulatory authority. To legally market a new tobacco product in the United States, a manufacturer must receive a written marketing order from FDA. Upon deeming e-cigarettes tobacco products in 2016, FDA set a 2018 deadline for manufacturers to submit applications for a marketing order, meanwhile allowing existing brands to remain available on the market. However, via 2017 Guidance, the agency extended this application deadline to August 8, 2022—essentially providing a “five-year compliance safe-harbor,” as characterized by Judge Grimm. Further, FDA did not set a deadline for the agency to complete review of applications, thus indefinitely extending the period of “safe-harbor” during which unevaluated tobacco products are marketed and used.
Through their lawsuit, health groups argued that the FDA’s 2017 Guidance extending the compliance deadline violates the Administrative Procedure Act (APA) in three ways: It exceeded the agency’s authority under the Tobacco Control Act; its issuance failed to comply with notice and comment rule-making requirements; and it is “arbitrary and capricious” because the agency did not offer sufficient rationale for reversing its course on its initial timeline for requiring e-cigarette manufacturers to submit applications to market new tobacco products.
Judge Grimm concurred, finding that FDA was “abdicating its statutory duty to review new tobacco products in the prompt fashion dictated by Congress.” In vacating the 2017 Guidance, the court concluded FDA’s action does not fall within the agency’s enforcement discretion, but rather “is inconsistent with the Tobacco Control Act and in excess of its statutory authority, and it cannot stand.” The court further found the Guidance tantamount to a legislative act and therefore subject to APA notice and comment requirements.
The court expressed the dramatic consequences of FDA’s impermissible action, noting: “Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that are approved – results entirely contrary to the express purpose of the Tobacco Control Act.”
Finally, a coalition of state and national vapor trade associations, including the New York State Vapor Association, sought and were ultimately granted intervener status, allowing them to participate in the litigation. Both FDA and Interveners have filed motions to appeal the District Court of Maryland’s decision to shorten the deadline for pre-market review submissions to May 12, 2020. This summary will be updated as the case progresses.
In another case brought before federal courts in the Kentucky district, the Vapor Technology Association and one of its member vapor businesses are seeking relief from enforcement of Judge Grimm’s order requiring e-cigarette pre-market applications by May 2020. In this case, the plaintiff vapor product companies argue that before setting a pre-market application deadline, FDA must first finalize a rule regarding the submission process and contents of application. Prior to publishing a final rule, vapor companies claim, the agency must defer enforcement against any companies that have not formally sought a marketing order.