There are eight rules that address the tobacco industry, and three have “notable changes” from the spring 2022 plan, according to Jain Gaurav, a Barclays analyst. These include: Rules on a menthol ban in cigarettes and flavored cigars have moved to the “final rule stage” versus the “proposed rule stage”; rules to ban characterizing flavors in cigars have also progressed to the final rule stage; and the nicotine cap proposed standard development has been moved from May to October.
“We continue to believe the Food and Drug Administration’s focus is going to revolve around the evaluation of premarket tobacco [product] applications of deemed products, notably e-cigarettes, in the next few months,” Gaurav said.
“The FDA intends to publish a final (menthol) rule by August 2023. We expect a two-[year] to three-year cycle from the day FDA passes any rule to the time such rule survives the inevitable court challenges.
“We don’t expect a menthol cigarette ban from the FDA implemented (if it were to pass) at least until 2026.”
A cigarette menthol ban could have negative impacts on tobacco stocks with a significant U.S. presence, according to Gaurav and other tobacco industry analysts. Menthol cigarettes account for 35 percent of cigarettes sold in the U.S.
“While there is some risk, a federal ban on menthol cigarettes could reduce smoker initiation and potentially be a catalyst that prompts a number of smokers to quit, thereby having some negative impact on cig volumes,” said Bonnie Herzog, Goldman Sachs analyst, “we continue to believe a more likely scenario is for menthol cig users to convert to nonmenthol cig products or to reduced-risk products that have a menthol variant, such as e-vapor.”
It is expected that the FDA will face lawsuits from tobacco manufacturers and anti-smoking groups if the ban goes through because Congress exempted menthol from banned flavorings in traditional cigarettes in the federal Tobacco Control Act in 2009.
In June, the FDA issued its proposal to reduce nicotine content in traditional cigarettes to minimal and potentially nonaddictive levels as early as May 2023.
“We think it will take a decade or longer for the FDA to introduce nicotine caps due to the long nine-step process at the FDA, the inevitable litigation and then the one year given to retailers to get rid of the excess inventory,” Gaurav said.
Interested parties can now register for the Jan. 12 U.S. Food and Drug Administration seminar covering the ban of menthol flavors in tobacco products. “The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars” is the first FDA tobacco-related seminar of the year.
The presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process the FDA utilized for review of the highly influential scientific assessments for these proposed rules.
Bridget Ambrose, director of the Division of Population Health Science in the Office of Science at the FDA’s Center for Tobacco Products, will be the speaker. Ambrose has over 20 years of experience in tobacco control and regulatory science, with specialized experience in longitudinal analyses of tobacco use.
The U.S. Food and Drug Administration should extend the ban on menthol cigarettes to other products, like pipe tobacco and cigarette tubes, according to researchers at the Rutgers Center for Tobacco Studies and Ohio State University, reports EurekAlert!.
“Tobacco companies have rebranded their roll-your-own cigarette tobacco as pipe tobacco to avoid taxes and rebranded flavored cigarettes as flavored cigars to skirt a federal ban,” said Andrea Villanti, deputy director of the Rutgers Center for Tobacco Studies and co-principal investigator of a study published in Tobacco Control discussing the addiction potential of menthol cigarette alternatives. “We have already seen companies advertising pipe tobacco and cigarette tubes alongside cigarettes and filtered cigars. The products we tested in our study are likely to be products that tobacco companies will promote following a ban on menthol cigarettes.”
Research showed that mentholated pipe tobacco and tubes in a roll-your-own cigarette were the most appealing substitutes for menthol cigarettes and resulted in the highest number of indicators for future nicotine addiction. The proposed menthol ban does not include these products, however.
“The present findings suggest that components of menthol roll-your-own products, including menthol rolling papers, cigarette tubes and pipe tobacco, should be included in the menthol cigarette and flavored cigar product standards,” said Theodore Wagener, director of the Center for Tobacco Research at the Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and corresponding author of the study. “Their absence from this restriction will result in a critical loophole that is already being exploited by the tobacco industry and has the potential to lessen the potential public health benefits of the proposed menthol ban.”
The U.S. Food and Drug Administration’s proposal to a menthol flavored cigarettes will improve public health only if there are viable menthol and flavored vapor products on the market, according to the Vapor Technology Association (VTA).
In April, the FDA announced a plan to ban the sale mentholated cigarettes, which account for about one-third of the U.S. market. The public was invited to share its thoughts on the measures and the official comment period ended Aug. 2.
In its official comment submission to the agency’s proposed product standards, the VTA urges the FDA to continue to build an “offramp” to menthol and flavored vaping products for smokers to access effective smoking alternatives.
“The menthol cigarette rule “has the potential to dramatically reducing cigarette smoking—the leading cause of death and disease of Americans—but only if the agency heeds the warning of scientists that menthol smokers must have access to less harmful vaping and other alternative nicotine products,” the VTA wrote in a statement.
“These limitations threaten to take what should be a public health victory and turn it into a half measure that, in the absence of other decisive action from the FDA, will fall far short of the benefits the agency claims.”
“FDA’s own proffered scientific experts acknowledge that at least 50 percent, and in some cases a larger percentage, of smokers will continue to smoke cigarettes or other combustible products after the menthol cigarette rule is put into effect unless provided access to effective alternatives.
“To fulfill its own harm reduction mission, the agency must use its PMTA process to ensure a rational, regulated legal marketplace with suitable less harmful non-combustible alternatives,” the VTA wrote.
The ban on menthol cigarettes is closer to becoming a reality. After years of discussion, the U.S. Food and Drug Administration has instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. Whether the menthol ban will also cover next-generation tobacco products, such as e-cigarettes, has not yet been clarified.
“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said FDA Commissioner Robert M. Califf. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”
When finalized, the FDA states that the proposed menthol product standard will:
reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.
According to the FDA, the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of the products. Many organizations were quick to condemn the regulatory agency for proposing the rule that is opposed by all major law enforcement, civil rights and criminal justice reform organizations. Opponents of the menthol ban say that banning menthol products will do nothing to reduce combustible cigarette smoking rates but will lead to an increase in people purchasing products on the black market.
“This misguided proposal will have disastrous impacts on public health and public safety. It will do nothing to reduce smoking rates and instead make the United States less safe.” said Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR). “It is unfortunate that as violent crime rates rise across the country, the FDA chooses to divert valuable police resources to pursue an unnecessary ban on menthol products.”
Andrews argues that a menthol ban exposes “vulnerable members of minority communities to conflict with law enforcement, and their purchases could also fund sophisticated international criminal syndicates.” According to the U.S. Department of State, illicit tobacco’s links to funding terrorist organizations already present a “serious threat” to national security. “This policy would worsen the problem while also depriving state governments of excise revenue, putting state government programs at risk,” says Andrews.
Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says that in many markets, such as Asia, companies are creating products to make mentholated cigarettes, because those types of products are not covered by the rule.
“They flavor packets you just slide into a pack of cigarettes. You buy your cigarettes, you put that in there and by the time you get home, the whole pack is mentholated. They also have these– it’s like a little Tic Tac box with a round, small, little mint … but what it does is you put it into the filter, shake, crush and now it’s a menthol cigarette,” said Marianos. “Are we eventually going to be asking border protection to now start looking for minty flavor packets or Tic Tac boxes when they have to concentrate on biological and nuclear threats? When you overlook public safety surrounding this matter, you’re creating an unhealthy situation, not just for smokers, but anybody who’s out there.”
Marianos says that a menthol ban will create a greater level of diversion and criminal activity with high-value targets overseas, it’ll bring more organized crime into the United States. It’ll also create a greater market for border countries to begin manufacturing menthol and bring it into the United States.
“There was one investigation in particular, I remember, where the individual said on a wire that once they banned menthol cigarettes in the United States, you can pave the roads in gold because of the boost in sales of black market and DIY menthol cigarettes,” he said. “Prohibition doesn’t work. Your quality of police work goes down; they can’t concentrate on violent crime as much and it creates a greater wedge between themselves and the community.”
Guy Bentley
Guy Bentley, director of Consumer Freedom Research for the Reason Foundation, said that similar bans have had minimal effects on tobacco consumption in other countries such as Canada and the U.K., adding that a menthol ban is likely to lead to more policing in minority communities, more incarceration, boost black market sales and undermine criminal justice reforms in the U.S.
Bentley explained that a recent study funded by the Norwegian Cancer Society in partnership with the Polish Health Ministry found that in Poland – the EU state with the largest pre-ban menthol share – found “mixed evidence” that the ban is working as intended.
Bentley argues the FDA and Biden administration should apply a harm reduction model, educating the public about safer alternatives to conventional cigarettes and the latest smoking cessation options. Andrews concurs with Bentley, adding that the proposed rulemaking will inevitably lead to further growth of illicit markets, put members of minority communities in danger and divert law enforcement resources away from real crime.
“It ignores best practice expert recommendations on how to reduce smoking rates through proven harm reduction technologies, is a disaster for public health, and will make all Americans less safe,” Andrews said. “If the Biden Administration truly cared about the American people, they would junk this anti-science and genuinely harmful proposal immediately.”
Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities.
The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.
The FDA also states that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If the proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who violate the rules.
