In a complex lawsuit that has lasted for several years, the cigar industry has sought to prevent the U.S. Food and Drug Administration (FDA) from regulating premium cigars. On August 9, 2023, the District Court of the District of Columbia gave the cigar industry a win and struck a blow to the FDA’s ability to regulate tobacco products. Because of the court’s ruling, the FDA no longer has authority to regulate premium cigars. This decision will have negative implications for public health.
In 2016, the FDA issued its final rule deeming all existing and future tobacco products subject to the agency’s jurisdiction, including premium cigars. As a result, the agency had authority to impose health warning labels and premarket review requirements on premium cigars, as it does with other tobacco products. Several cigar industry trade associations, retailers, and manufacturers sued to challenge the FDA’s rule. Among other claims, the industry argued that the FDA’s choice to regulate all cigar products was “arbitrary and capricious,” in violation of the Administrative Procedure Act, and that the agency failed to consider data that would support exempting premium cigars from the rule, such as differences in patterns of use of certain cigars and possible differences in disease risk. For an overview of the case, view our litigation tracker entry here.
In 2022, after years of litigation, the D.C. Circuit ruled in favor of the cigar industry, finding that the FDA had indeed acted arbitrarily and capriciously in deciding not to exempt premium cigars. The court then sent the case back to the district court to determine the appropriate remedy. As a remedy, the cigar industry requested that the district court vacate or invalidate the FDA’s rule that brought premium cigars under its regulatory authority. The FDA in turn requested that the court not invalidate the rule.
In August of 2023, the district court vacated the FDA’s rule as applied to premium cigars. The court noted that leaving the rule in place was only warranted in “exceptional circumstances” and that these circumstances were not present. This decision means that, unless the FDA appeals or crafts a new rule specific to premium cigars, premium cigars (unlike all other tobacco products) remain entirely unregulated by the FDA.
What are possible next steps? Although this may be unlikely, the FDA could appeal the district court’s decision. The agency could challenge the court’s determination that exceptional circumstances do not exist. It could review the premium cigar-related evidence that it had failed to consider adequately on remand, and attempt to address any deficiencies with the rule. It could also argue that leaving premium cigars unregulated by the FDA could have significantly disruptive consequences by, for example, giving consumers the false and misleading impression that premium cigars are safer than other tobacco products – an impression the industry would be likely to exploit.
A more promising but time-consuming route would be for the FDA to create an entirely new rule specific to premium cigars. Because the courts determined that the FDA had not adequately considered data that might support treating premium cigars differently than other tobacco products, the FDA could thoroughly review this evidence base while conducting an explicit rulemaking process with rationale and regulations specific to this product.
What’s key to keep in mind is that premium cigars contain the same carcinogens and nicotine as cigarettes and other similar tobacco products. The use of premium cigars not only harms the health of consumers but produces secondhand smoke that can harm bystanders. Regardless of the regulatory route it takes, the FDA should weigh all relevant cigar-related evidence and, as it has with other tobacco products, implement regulations for premium cigars to ensure the health and safety of the public.
Luke I. Haqq, Staff Attorney
September 11, 2023