Today is the final day to submit comments on recently-announced proposed rules by the U.S. Food & Drug Administration (FDA) that seek to ban the sale of all flavored cigars, including large flavored cigars such as ACID and Java, as well as ban the sale of menthol cigarettes.
The proposed rule regarding flavored cigars stems from data in the 2020 National Youth Tobacco Survey which indicated that 5 percent of high schoolers surveyed indicated they had smoked a cigar in the past 30 days. Of that, 58.3 percent of the 5 percent—or 2.9 percent of those surveyed—said it was a flavored cigar.
FDA has also cited the success of local bans on flavored tobacco products in reducing youth access to and usage of such products.
The proposal has been opposed by the Premium Cigar Association (PCA) which submitted its comments on July 29, with the organization saying it had several objections:
- PCA raised specific concern over the proposed rule’s impact on an advertiser’s or retailer’s ability to describe the flavor profile of any cigar.
- FDA failed to clearly define “characterizing flavor,” and instead identified non-binding factors that, if present, would indicate the presence of a characterizing flavor. PCA said these non-binding factors “appear so vague and subjective in nature so as to render the rule, at worst, unconstitutionally vague and, at best, exceedingly difficult for industry to implement and for FDA to enforce consistently.”
- FDA failed to adequately conduct an economic impact assessment on minority-owned small businesses.
- FDA failed to consider the broad international impact that the product standard would have on commerce, immigration, and economic stability for U.S. allies in tobacco- and cigar-producing countries.
“FDA has a mechanism to prevent youth access to tobacco,” said Scott Pearce, executive director of the Premium Cigar Association, via a press release. “Yet, instead of working to fulfill the statutory requirements of T-21, the agency is speeding recklessly toward product bans with questionable legal authority.”
Drew Estate has also publicly issued its opposition to the proposal, saying it restricts consumer choice and removes adult products from the market without scientific basis for doing so. It called on FDA to suspend action until further study is done on the manner of use of various types of cigars and its implications.
The proposed rule about banning flavored cigars will not have a direct effect on non-flavored large cigars, as FDA has stated that non-flavored “premium cigars” are not subject to premarket review orders currently. Those “premium cigars” are also awaiting a federal court decision that could result in “premium cigars” being deregulated.
Once the comment period closes today, FDA will have to formulate replies to those comments, a process likely to take at least one year, after which point it can reveal a final rule. That would put such a ban in place in 2024 at the earliest. That timeline does not account for any legal challenges that may lead a court to delay implementation of the new rules.
Any person or entity is able to submit comments in favor or opposition to the proposed bans via this portal.
Update (Aug. 3, 2022) — Both the Cigar Association of America (CAA) and Cigar Rights of America (CRA) have issued press releases that they have filed comments opposing the proposed ban.
The CAA’s opposition centered around the fact that FDA’s data shows underage usage of flavored cigars is at historic lows, and since this underage usage has been called the main rationale for the proposal, the agency is “proposing a solution in search of a problem.” The CAA also says that there is no scientific evidence for the ban, but implantation of it would cause devastating economic consequences to many small businesses both domestically and in cigar-producing countries.
The CAA’s full letter can be found here.
In its comments, Cigar Rights of America said that it remained concerned that “certain subjective factors identified by FDA as being relevant to determining whether a cigar has a characterizing flavor could inadvertently sweep in premium cigars that contain no flavor additives.” The CRA says that should the proposed rule be finalized, “FDA should clarify that the existence of a characterizing flavor will be determined based only on objective factors, such as the product’s labeling and advertising and the existence of flavor additives.” CRA said doing so would be consistent with congressional intent, as well as with how FDA currently enforces the characterizing flavor ban for cigarettes.