Closing the loopholes on a flavored cigar ban: Anticipated challenges and solutions

Abstract

For the first time since Congress authorized the U.S. Food and Drug Administration (FDA) to regulate tobacco in 2009, FDA proposed two tobacco product standards on May 4, 2022. After a period of public comment and agency review, if the product standards are finalized in their current form, they will ban menthol cigarettes (U.S. Food and Drug Administration, 2022b), which comprised 37% of the U.S. cigarette market in 2019 and 2020 (Federal Trade Commission, 2021), and flavored cigars (U.S. Food and Drug Administration, 2022a), which have exceeded 50% of cigar sales since 2012 (Delnevo et al., 2021b). This commentary examines potential challenges to banning flavored cigars and highlights issues FDA and Congress should consider.

1. Introduction

Trade sources estimate that machine-manufactured, mass-merchandise cigars constitute nearly 92% of today’s cigar market (Delnevo et al., 2021b; U.S. Government Accountability Office, 2012). Historically, cigars have taken advantage of relatively lax regulations and lower taxes, compared to cigarettes (Delnevo et al., 2017b; Delnevo et al., 2021b). That pattern continued after the Family Smoking Prevention and Tobacco Control Act (TCA) granted FDA regulatory authority over tobacco products in 2009 (Pub. L. No. 111–31, 2009). The TCA banned flavored cigarettes, except menthol, and menthol’s share of the U.S. cigarette market grew to 37% by 2019 (Federal Trade Commission, 2021). But the TCA did not restrict flavors for cigars or other types of tobacco products. Unfettered by the TCA, manufacturers of mass-merchandise cigars seized the opportunity to feature product flavorings and small pack sizes to maintain strong sales: between 2009 and 2020, cigar sales increased 32%, driven by increases in flavored cigar sales, while nonflavored cigar sales remained stable (Delnevo et al., 2021b). Every year since 2012, flavored cigars have comprised more than 50% of cigar sales (Delnevo et al., 2021b). This is a critically important public health issue because flavored cigars can influence initiation and progression to regular use (Villanti et al., 2019). After FDA announced a plan to ban menthol cigarettes in 2018 (U.S. Food and Drug Administration, 2018b), we described why FDA is likely to prevail in a tobacco industry lawsuit (Schroth et al., 2019). Our 2019 commentary addresses challenges that a ban on menthol cigarettes may face. We stand by that 2019 comentary in light of the FDA’s recent proposed rule to ban menthol cigarettes(U.S. Food and Drug Administration, 2022b). This commentary complements our menthol paper by examining potential challenges to FDA’s proposed ban on flavored cigars (U.S. Food and Drug Administration, 2022a) and highlights issues FDA should consider. As explained below, Congressional action is also needed to complement FDA’s enforcement efforts.

2. FDA should prepare to regulate concept flavors, descriptors, or package colors

FDA’s proposed rule, if implemented, would prohibit the use of characterizing flavors (other than tobacco) in cigars. The proposed rule explains that a cigar must not contain as a constituent, artificial or natural flavors (other than tobacco), and it lists a non-exhaustive list of flavors and categories of flavors, including menthol, followed by the phrase “that is a characterizing flavor of the tobacco product or tobacco smoke” (U.S. Food and Drug Administration, 2022a). It provides additional relevant factors in determining whether a cigar has a characterizing flavor, including:

• The presence and amount of artificial or natural flavor additives;

• Multisensory experiences, including “cooling,” in the mouth and throat;

• “flavor representations (including descriptors), either explicit or implicit, in or on the labeling (including packaging) or advertising of a tobacco product….” (U.S. Food and Drug Administration, 2022a)

FDA also requests comments regarding “potential alternatives to prohibiting characterizing flavors,” like “prohibiting all flavor additives….” (U.S. Food and Drug Administration, 2022a). This clearly implies that the proposed rule would not prohibit low levels of flavor additives that do not rise to the level of imparting a characterizing flavor. It appears that FDA’s proposed rule was designed to provide a measure of specificity for the regulated industry, while also preserving “critical flexibility and enforceability to achieve the public health goals of the rule.”

Market scanner data point to an increasing number of flavored cigars with ambiguous names like Jazz, known as “concept flavors,” which lack a flavor descriptor (e.g., grape) (Andersen-Rodgers et al., 2021; Delnevo et al., 2017a; Delnevo et al., 2021b; Gammon et al., 2019). This practice of using ambiguous names frustrates efforts to identify flavored cigars. Between 2009 and 2020, concept-flavored cigars increased from 2.2% to 21% of the flavored cigar market (Delnevo et al., 2021b). These include Jazz, a Black & Mild brand cigar with an ambiguous name manufactured by John Middleton Cigar Co., which is owned by Altria.

Courts have upheld the power of states and local governments to ban the sale of flavored tobacco products, including flavored cigars (Schroth, 2021). In 2017, a convenience store in Yarmouth, Massachusetts was cited for selling flavored cigars (Black & Mild Jazz) despite a municipal regulation that had banned the sale of flavored tobacco products. The convenience store, Cumberland Farms, filed a lawsuit challenging the conclusion that Jazz has a characterizing flavor. A protracted lawsuit came to a conclusion in 2020, when a Massachusetts appellate court approved a finding that Jazz cigars have a fruity, citrus flavor (Cumberland Farms Inc. v. Board of Health Yarmouth, 97 Mass. App. Ct. 1111 (2020)).

At roughly the same time, in a completely separate legal forum, John Middleton Co. applied for FDA authorization to continue selling Jazz cigars through a substantial equivalence (SE) order. Under the FDA’s regulatory authority, any new tobacco product, including any cigar first introduced to U.S. markets after February 15, 2007, must receive FDA authorization to stay on the market after September 9, 2021. To obtain an SE order, the applicant cigar must demonstrate that the new product has the same characteristics as a predicate product, which could be a pre-February 15, 2007 cigar or another cigar with an existing SE order from FDA; if the cigar has different characteristics from a predicate product, the SE application must show that the cigar features do not raise different questions of public health (Pub. L. No. 111–154, 2010). This is FDA’s mechanism for acting as a gatekeeper for U.S. tobacco markets and preventing the introduction of new products that are potentially more hazardous than existing products. In the Jazz application for substantial equivalence, John Middleton Co. identified Jazz as unflavored with a Wine flavored predicate cigar as its substantial equivalent. FDA granted Jazz’s application, and in a footnote, FDA states that it did not confirm if Jazz has a characterizing flavor:

The applicant uses the term “identifying flavor” to indicate whether it identifies the cigar product by use of a flavor identifier. For the new product, the applicant states that the identifying flavor is “none.” Properties to uniquely identify the new tobacco product were provided by the applicant, and not confirmed by FDA. In this case, FDA determined that no additional information regarding characterizing flavor was necessary to compare the new and predicate tobacco products.

(U.S. Food and Drug Administration, 2019).

Focusing on the toxicity of both cigars, FDA did not report on the role of flavor in initiation and progression to regular smoking (Cullen et al., 2019; Villanti et al., 2019) in its review. Considering that Jazz has been found to have a fruity, citrus flavor, it seems that the FDA could have questioned whether Jazz has greater consumer appeal than Black & Mild Wine – a question that could raise different questions of public health and, therefore, have regulatory significance.

Given the policy priorities outlined in FDA’s proposed rule to ban flavored cigars, FDA may consider ascribing greater weight to characterizing flavors when it assesses SE applications for cigars prospectively. In Jazz’s SE application, Middleton embraced a predicate cigar with an explicitly named characterizing flavor, Wine, as Jazz’s substantial equivalent. Assuming Wine has a characterizing flavor, it should be banned by the product standard, and it should not be eligible to serve as a predicate for any cigar, including one that claims to be unflavored. Based on a common sense understanding of what “flavored” and “equivalent” mean, it seems reasonable to infer that if a predicate cigar is flavored, the substantially equivalent applicant is probably also flavored. But Middleton defied common sense by asserting that – even though they are substantially equivalent – Wine is flavored, and Jazz is not. FDA declined to comment on those inconsistent positions, stating, in the footnote referenced above, that no determination “regarding characterizing flavor was necessary.” Clearly, these legal and regulatory forums call for the use of precise terms of art, and there is a difference between equivalent and substantially equivalent. Nevertheless, the FDA builds credibility when its rules are interpreted with common sense, and in light of its overarching objective of advancing public health. Moreover, Jazz’ application was decided before the proposed rule was issued. The issuance of that rule, which reflects FDA’s current thinking regarding characterizing flavors and cigars, should influence its assessment of SE applications prospectively.

FDA’s proposed rule provides significant flexibility in determining whether a cigar is prohibited (U.S. Food and Drug Administration, 2022a). The term “characterizing flavor” allows FDA to consider whether a cigar contains as a constituent, artificial or natural flavors (other than tobacco). The key question is whether the cigar imparts a characterizing flavor. The FDA expressly provides itself with a wide range of factors to consider in making an assessment, including additives, sensory effects, or representations that could be explicit or implicit. While the FDA leaves open the possibility of revising the rule to prohibit all flavor additives, the rule should follow the scientific evidence, and much of the evidence deals with characterizing flavors, rather than the existence of trace levels of flavor additives. One study that found flavor-related chemicals in 14 out of 16 cigars recommended setting a maximum level of 0.1 mg/g of added flavor-related chemicals. (Farley et al., 2018). This idea provides an appealing level of clarity. Setting a conservative baseline as a floor – which could be adjusted based on emerging data – may prevent cigar manufacturers from continually trying to stretch the limits of what constitutes a characterizing flavor. This benchmark could serve as a supplement to, rather than a replacement for, the proposed rule’s characterizing flavor factors.

It is notable that the FDA has the flexibility to consider flavor representations (including descriptors), either explicit or implicit, on labeling, packaging or advertising. This is important because cigar manufacturers are adept at attracting customers with pack colors and descriptors that imply flavors without explicitly listing them (Delnevo et al., 2021a). Previous studies demonstrated that when certain descriptors on packaging (e.g., “light”) were banned, cigarette package colors communicated product type information, undermining those restrictions (Alpert et al., 2018; Borland et al., 2019; Yong et al., 2016). The proposed rule is not clear on how the FDA would address the use of colors on packaging as an implicit message that a product is flavored. For example, green packaging is closely associated with menthol, and blue is associated with frost or cooling flavors (Borland et al., 2019). However, identifying flavored products based on the color of the packaging may raise the risk of a lawsuit based on the First Amendment. The Tobacco Control Act’s requirement that tobacco advertising and labeling must have black lettering on a white background was struck down based on a similar rationale (Discount Tobacco City and Lottery v. United States 674 F.3d 509 (6th Cir. 2012)). However, a narrowly tailored rule that restricts the deceptive or misleading use of colors associated with flavorings may be worth considering.

3. Preventing the emergence of flavoring components

Restricting combustible flavored tobacco products creates a risk that consumers will modify their products with flavor enhancers (Chaiton et al., 2020). In jurisdictions that banned menthol cigarettes, “flavor cards” for cigarettes emerged (Chaiton et al., 2021). It is conceivable that similar products like blunt wraps could be used for, or designed to be used for, cigars. The deeming rule empowers FDA to regulate “components and parts,” which are defined to include “materials intended or reasonably expected” to “alter” a tobacco product’s “performance or characteristics” (U.S. Food and Drug Administration, 2016). The proposed rule incorporates and uses this language, showing the FDA is apparently planning to take advantage of these provisions to proactively regulate or prohibit products like blunt wraps, flavor cards or liquids that could be used with cigars.

4. Countering the demand for contraband

In issuing a product standard, FDA is required to consider potential countervailing effects, including the creation of a significant demand for contraband. The illicit trade of cigarettes, driven largely by geographic tax and price differentials, has been studied extensively, and several laws are designed to minimize it (Chaloupka et al., 2015). When the Prevent All Cigarette Trafficking (“PACT”) Act prohibited the shipment of cigarettes through U.S. mail (Pub. L. No. 111–154, 2010), internet cigarette retailers moved operations overseas (Williams et al., 2017). If the proposed rule prohibiting flavored cigars goes into effect, domestic production of flavored cigars may grind to a halt. Although some cigar manufacturers are based in the U.S., an increasing number of cigars have been manufactured abroad in recent years (Soneji et al., 2021). In fact, a recent study regarding the most commonly sold cigars in U.S. convenience stores contains an image showing that virtually all of the cigars bear statements indicating they were made in the Dominican Republic (Giovenco et al., 2022). Shifts in manufacturing or distribution overseas in response to a flavored cigar ban may result in attempts to ship these products into the U.S. to maintain sales.

The FDA’s proposed rule highlights studies on illicit trade in the event of a tobacco product standard, including the 2015 IOM report, which found that the demand for nonconforming products is likely to be modest (National Research Council, 2015; U.S. Food and Drug Administration, 2018a). The proposed rule also notes that when Canada banned menthol cigarettes, one tax authority found the prevalence of illicit tobacco actually decreased (Stoklosa, 2019). Moreover, the FDA would be able to respond to illicit trade through enforcement, as outlined in the proposed rule.

To supplement its enforcement capabilities, the TCA mandated that the FDA “shall promulgate regulations” to combat the illicit trade of tobacco products by creating a track and trace program (Pub. L. No. 111–31, 2009, codified as § 920 (b)(1); 21 U.S.C. § 387 t). The FDA has declined to act on this Congressional mandate, despite being petitioned to do so in 2013 (Campaign for Tobacco-Free Kids, 2013). A track and trace system would enable government agencies to monitor the movement of tobacco products and support investigations regarding illicit trade. In this sense, the creation of product standards offers the FDA a specific impetus to fulfill a statutory requirement and, at the same time, create a new tool to help counter the illicit trade of tobacco products.

One potential tool to combat the illicit trade of flavored cigars requires Congressional action. The U.S. Postal Service (USPS) and law enforcement have already struggled to reign in illicit cigarettes, and illicit cigars could pose similar challenges. A report from the USPS Inspector General highlighted deficient processes related to USPS’s enforcement of the PACT Act, frequently allowing prohibited cigarette shipments – often shipped directly to consumers – to reach their destination (Office of Inspector General, 2017). The report explained that rather than seizing and destroying prohibited shipments, USPS, which lacked sufficient funding for enforcement, devised a “Return to Sender Program” to save money. This provided overseas shippers with a second chance to bypass USPS enforcement. New York City, California, Connecticut, Illinois and Pennsylvania sued USPS to compel it to enforce the PACT Act more effectively (City of New York v. U.S. Postal Service, 519 F. Supp 3d 111 (E.D.N.Y 2021)). In a recent settlement, USPS agreed to implement significant improvements to stop the flow of illicit cigarettes from overseas sources through facilities under its control (NYC Settlement with USPS, 2022).

To combat a potential influx of illicit menthol cigarettes delivered through the mail, USPS needs adequate funding from Congress to fulfill its existing, and potentially expanding, enforcement duties under the PACT Act. To combat a potential market for illicit cigars, the PACT Act would have to be amended to provide USPS with jurisdiction to deal with illicit flavored cigars. These tasks related to the PACT Act require Congressional action.

5. Prioritizing cigar surveillance

The 1998 National Cancer Institute Monograph on cigars issued a call to action, to improve population surveillance of cigars (National Cancer Institute, 1998). Despite the call to action, cigar measurement in most national surveys is sparse and infrequent (Delnevo and Bauer, 2009). Notably, coinciding with the 1998 Cigar Monograph, the FTC released its first and only federal data on cigar marketing and sales. This stands in contrast to the biennial release of FTC data on cigarette and smokeless tobacco marketing and sales. Data like these are critical for identifying unintended consequences, including product substitution, suboptimal compliance, patterns of use among specific segments of the population, and emerging illicit markets (Berman et al., 2015). The National Academies of Science, Engineering and Medicine recently recommended a federal surveillance and evaluation infrastructure to monitor different cigar types and called on the US Department of Health and Human Services to ensure its implementation (National Academies of Sciences, 2022).

6. Conclusion

To maximize the public health benefit of FDA’s proposed product standard on flavored cigars, FDA should consider the following five ideas, and Congress should be pressed to consider a sixth idea. First, the FDA should take advantage of the flexibility in the proposed rule to prevent manufacturers from selling cigars with flavoring levels above an objective standard that can serve as a floor and supplement the factors FDA may rely on in making characterizing flavor assessments. For example, FDA could mandate that the maximum level of added flavor-related chemicals cannot exceed 0.1 mg/g. Second, FDA should proceed with its proposal to ban components that impart flavors to tobacco products and prevent them from gaining a foothold in U.S. markets. Third, FDA should consider increasing the weight it ascribes to the role that characterizing flavors play when it assesses SE applications for cigars. Fourth, to deal with the threat of illicit trade, in addition to using its enforcement powers, the FDA should comply with Congress’ mandate to implement a track and trace program, which would help the FDA to enforce against the illicit trade of tobacco products. Fifth, FDA should also require cigar manufacturers to pay for a federal surveillance and evaluation infrastructure to monitor different cigar types. Sixth, Congress should amend the PACT Act to prohibit the shipment of illicit flavored cigars and fund USPS adequately to improve enforcement.

Data availability

No data was used for the research described in the article.