FDA's Proposed Menthol & Flavored Cigar Bans Face Multistep Journey

SILVER SPRING, Md. — It came as little surprise that the Food and Drug Administration (FDA) announced its proposals to ban not only menthol cigarettes but all flavored cigars, excluding tobacco. What comes next is the question.

The agency will open up the two proposed product standard rules for public comment beginning May, and it will also hold two public listening sessions on June 13 and 15. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards. 

However, any final decision by the agency is sure to face legal challenges, which could delay any implementation. "Ultimately, it is a complex and lengthy process that, based on precedent, could likely take several years to be successfully implemented, if at all," said Bonnie Herzog, managing director at Goldman Sachs.

As she noted, menthol represents approximately 33 to 34 percent of total cigarette category volume in the United States.

According to Herzog, any menthol ban could reduce smoker initiation and push some current smokers to quit, which would negatively impact cigarette volumes; however, "a more likely scenario is for menthol cigarette users to convert to non-menthol cigarette products or to reduced-risk products that have a menthol variant such as e-vapor."

Tobacco Companies React

As Kingsley Wheaton, chief marketing officer at British American Tobacco (BAT), echoed that the FDA's rulemaking process is a multiyear, multistep process and the company plans to work with the agency throughout the process.

"Our corporate purpose is clear: to build A Better Tomorrow by reducing the health impact of our business. We are transforming BAT and are committed to tobacco harm reduction," Wheaton said. "We believe our portfolio of scientifically substantiated reduced-risk products can play a critical role in its delivery. We will continue to work with FDA to support access and choice for adult consumers."

BAT is reviewing the details of the proposed regulations and will continue to participate in the rulemaking process by submitting science-based comments to FDA, Wheaton added

"We strongly believe that there are more effective routes to deliver tobacco harm reduction than banning menthol in cigarettes. Evidence from other markets, including Canada and the EU where similar bans have been imposed, demonstrates little impact on overall cigarette consumption," Wheaton said, adding the company does not believe the published science supports regulating menthol cigarettes differently from non-menthol cigarettes.

London-based BAT's combustible brands include Kent, Lucky Strike and Pall Mall. Its U.S.-specific combustible brands are Camel, Natural American Spirit and Newport. Reynolds American Inc. is an indirect, wholly owned subsidiary of the BAT Group.

In its earnings call on April 28, which took place hours before the FDA's announcement, Richmond, Va.-based Altria Group Inc.'s CEO Billy Gifford pointed out that underage smoking is at the lowest level in a generation and moves to prohibit the sale of legal products to adults — like alcohol and cannabis — have failed.

"Prohibition pushes products into illegal markets that lack regulatory oversight and lack underage prevention. We believe equitable harmed option is a better public policy approach to reducing smoking and improving public health," he said. "This means manufacturers must develop, and the FDA authorize, an array of potentially reduced harm alternatives that can appeal to and transition smokers across all backgrounds and demographic routes. We expect to be actively engaged in providing our perspective to the FDA throughout the process."

He added Altria remains optimistic about the future of harm-reduction in the U.S.

While much of the focus has been on the FDA's action against menthol, Jacksonville, Fla.-based Swisher raised concerns with the agency's plan to remove flavors from the cigar category.

The company, which includes the Swisher Sweets Cigars Co. among its brands, said it will continue business as usual as the product standard process plays out.

"The [FDA] is moving forward with a proposed product standard regarding characterizing flavors in cigars despite a near-vacuum of scientific evidence to support this decision," Swisher said in a company statement.

"The evidence that does exist shows moderate consumption by a small cohort of adults and historically low youth usage. Based on the government's own studies, youth usage of cigars has been declining for years and is at an all-time low," the company added. "Furthermore, insufficient time has passed to determine whether raising the minimum age of purchase to 21, which was promoted as a tool to further impact and mitigate youth usage of all tobacco products, will effectively reduce these already low numbers."

According to Swisher, the FDA's action restricts consumer choices and removes adult products from the market without scientific basis.

"FDA should suspend action on a flavor standard for cigars until further study is done on the manner of use of various types of cigars and its implications," it said. "Adult cigar consumers should be empowered to weigh the evidence and risk as that information emerges and make fully educated choices."

Swisher plans to oppose this measure with meaningful scientific and economic data.

Support for the Proposals

Federal lawmakers have been urging the FDA to act on menthol for several years. In 2017, a group of legislators sent a letter to then-FDA Commissioner Scott Gottlieb to move forward with a ban.

"For years, Big Tobacco has added menthol flavor to mask the harshness of cigarettes, and targeted these addictive, deadly products particularly to Black smokers. Prohibiting menthol in cigarettes and banning flavored cigars will save lives, reduce disparities and improve health," Sen. Dick Durbin (D-Ill.) said on April 28. "Today's announcement is a long-overdue step forward, and I will continue to push the FDA to protect our kids from Big Tobacco's predatory tactics by prohibiting any menthol-flavored e-cigarettes."  

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids called the FDA's proposal to ban menthol cigarettes and flavored cigars an "historic and long-overdue action to protect our nation's kids, advance health equity and save lives, especially among Black Americans and other populations that have been targeted by the tobacco industry and suffered enormous harm from the predatory marketing of these products."

The proposals will have "a profound and certain impact" on reducing health disparities in the United States, Myers added.