June 11, 2021
On June 11, 2021, the Office of Information and Regulatory Affairs published the federal government’s Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions. As part of the Spring 2021 agenda, FDA has withdrawn an entry related to premium cigars.
In March 2018, FDA issued an advance notice of proposed rulemaking (ANPRM) for premium cigars. Then in August 2020, FDA stated that “the comments received by the FDA to date — both in favor of and against regulation of premium cigars — have not provided new data sufficient to address questions of whether the characteristics of premium cigars or their patterns of use may result in different health effects than other tobacco products.”1 FDA further stated that it intended to undertake a research effort specific to premium cigars and their health effects, patterns of use, and other factors. FDA also stated that it planned to seek broad public comment on the research plan, which the agency anticipated would include a comprehensive review of existing evidence as well as generate new evidence.
The Fall 2020 Unified Agenda2 included an entry for a request for information (RFI) that would seek such comment. However, since that entry, FDA has contracted with the National Academies of Sciences, Engineering, and Medicine (NASEM) to conduct a comprehensive and systematic assessment and review of the scientific literature and provide a final report of the study results. The review will include analysis of data on both short-term and long-term health effects of “premium” cigars. The NASEM review has begun and is expected to conclude in spring 2022.
Also in August 2020, a court enjoined FDA from enforcing premarket review requirements for premium cigars pending FDA’s consideration of whether premium cigars should have a streamlined substantial equivalence process.
The 2018 ANPRM sought new information that could further inform FDA’s thinking about the regulation of premium cigars, but reiterated FDA’s position in the deeming rule that: “[a]ll cigars pose serious negative health risks; (2) the available evidence does not provide a basis for FDA to conclude that the patterns of premium cigar use sufficiently reduce the health risks to warrant exclusion, and (3) premium cigars are used by youth and young adults.”3 FDA received many comments to the ANPRM, including comments from public health groups noting the known adverse health effects of all cigars, the rise of cigar use among youth and youth use of premium cigars, the evolving tobacco market, and the potential for market manipulation to avoid regulation if FDA were to treat premium cigars more favorably than other tobacco products.
FDA expects that the results of the ongoing NASEM review and assessment will further inform the agency’s regulatory policy. At this time however, based on current information and policy considerations, we do not intend to take further action pursuant to the ANPRM and no longer intend to request information about conducting additional possible studies before reviewing the results of the ongoing NASEM review, as such additional studies may be unnecessary. Accordingly, the agency has withdrawn the Unified Agenda entry pertaining to the premium cigars ANPRM and RFI.
The NASEM review and assessment may identify areas for potential additional research, as well as provide data to inform aspects of FDA’s ongoing regulation of premium cigars. However, current regulatory measures applicable to premium cigars—such as the prohibition of sales to youth—are supported by the existing evidence. Even if there is significant occasional use of premium cigars, some premium cigar smokers have frequent use with significant exposure to harmful constituents that are known to increase the risk of oral, esophageal, laryngeal, and lung cancer (among other negative health consequences) in cigar smokers compared to non-tobacco users. Dual use of premium cigars with other tobacco products is also a significant concern. Premium cigars are combusted tobacco products containing nicotine, an addictive substance. Further, the premarket review requirement that Congress established for new tobacco products – including deemed new tobacco products – benefits the public health, including by ensuring that the products do not raise different questions of public health than predicate products and preventing more harmful or addictive products from reaching the market.
Given high interest in potential future regulations related to premium cigars, FDA is announcing the withdrawal of this entry from the Unified Agenda. We expect to update the public following completion of the NASEM review.
1. Am. Acad. of Pediatrics v. FDA, No. 18-883, ECF No. 188, at 2 (D.Md. Aug. 5, 2020)
2. The Unified Agenda is published twice a year and provides information about regulations that the Federal government is considering or reviewing. It does not create a legal obligation on agencies to adhere to published schedules or to confine their regulatory activities to regulations that appear within the Unified Agenda
3. 83 Fed. Reg. 12901, 12902 (Mar. 26, 2018)