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Public Health Advocacy Institute

at Northeastern University School of Law

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You are here: Home > Tobacco Control > Tobacco Litigation > FDA Deeming Rule

FDA Deeming Rule

In May of 2016, the U.S. Food and Drug Administration published its “deeming” rule, through which the agency extended its regulatory authority to nearly all types of commercial tobacco products, including e-cigarettes, cigars, shisha, and pipe tobacco. While FDA tobacco product regulations now technically apply to these products, through agency guidance, FDA granted an enforcement grace period, delaying the application of some requirements for products deemed in 2016, if that product was on the market as of August 8, 2016. One notable pause in enforcement for these products is the requirement that tobacco 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.

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 e-cigarette, cigars, and pipe tobacco that were on the market as of August 8, 2016, and allowing these products to remain on the market unchecked. That case is summarized here: 

American Academy of Pediatrics, et al., v. Food and Drug Administration, et al., 379 F. Supp.3d 461 (D.Md. 2019); consolidated with Cigar Association of America v. Food and Drug Administration and appealed (4th Cir. 10/2019) 19-2198. (Challenging FDA guidance allowing e-cigarettes to indefinitely remain on the market without agency review).

In a May 2019 decision, U.S. District Judge Paul W. Grimm vacated FDA’s 2017 guidance that indefinitely allowed e-cigarettes, cigars, and pipe tobacco to remain 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. With input from parties, the judge ordered a May 12, 2020 deadline for manufacturer applications seeking FDA pre-market review of a product that was being sold in the U.S. as of August 8, 2016. (In separate litigation combined with this case upon appeal, cigar manufacturers challenge the applicability of this court-ordered timeline to manufacturer submissions seeking FDA “Substantial Equivalence” review, an alternate pathway to an FDA marketing order.)

The lower court 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.”

Following this decision, 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 appealed the District Court’s order requiring a May 12, 2020 deadline for pre-market tobacco applications. In October 2019, the case was consolidated with a case brought by the Cigar Association of America challenging FDA’s regulatory timeline with respect to cigars.

In April 2020, the court granted FDA’s request for a 120-day extension of the May 12, 2020 deadline, due to disruptions posed by the COVID-19 outbreak. The current deadline for submitting an application for FDA pre-market review of a tobacco product that was sold in the U.S. by August 8, 2016 is September 9, 2020, and FDA’s deadline to act on these applications is September 9, 2021. The FDA may take enforcement action at any time against a product that is deemed especially youth-friendly. We will update this summary of these combined cases throughout the appeals.

Separately, 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. These cases are ongoing, and include:

 Last updated May 5, 2020

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