Traditional menthol cigarettes could rise to the top of the Food and Drug Administration’s proposals for banned or substantially restricted sales by the time the agency’s commissioner provides his regulatory recommendations next week.
Multiple media outlets, first reported by The Washington Post, said such action could be touted by Commissioner Dr. Scott Gottlieb as one strategy for curtailing what he calls ”an epidemic” of flavored electronic-cigarette use by youths.
Gottlieb has noted a 77 percent increase in high school students’ use of e-cigs based on a small sample size nationally.
Gottlieb said when he unveiled a regulatory “road map” in July 2017 that the agency believes menthol in traditional cigarettes, and candy and fruit flavorings in cigars and e-cigs, are used to entice underage youth to tobacco products.
The strategy could have a major impact on Reynolds American Inc., particularly its Tobaccoville manufacturing plant that produces Newport, the menthol brand that is the nation’s No. 2 traditional cigarette with a 14 percent market share. The majority of Reynolds’ estimated 3,000 local employees work in the 2-million-square-foot plant.
Reynolds spokesman Michael Shannon said “we are not commenting until there is an official statement from the FDA.”
Menthol styles, which are mint-flavored, have proven controversial for decades because they are considered a smoother way to smoke traditional cigarettes, and because manufacturers have been accused of specifically marketing them to minority consumers.
In 2009, a Democratic-controlled Congress exempted menthol from banned flavorings in traditional cigarettes in the federal Tobacco Control Act.
Any action to curtail or ban traditional menthol cigarettes would have to come from Congress. Such a move would likely find support within a Democratic-controlled House in 2019, but opposition from a Republican-controlled Senate and manufacturers.
Anti-tobacco advocates have long argued that without menthol, many smokers would choose not to smoke a tobacco-flavored product and quit, a potential major public-health victory.
Newport’s importance to traditional cigarettes was evident in Reynolds American Inc.’s $29.25 billion purchase of Lorillard Inc in June 2015, essentially to acquire Newport. BAT spent $54.5 billion in July 2017 to acquire the 57.8 percent of Reynolds it didn’t already own.
Calling for a ban on traditional menthol cigarettes “might be more for optics than a definitive plan,” said David Sweanor, an adjunct law professor at the University of Ottawa in Canada and author of several e-cig and health studies.
“The apparently forthcoming attack on vaping products raises questions about why the agency has been so focused on hurting the low-risk alternatives to cigarettes.
“An announced attack on a category of cigarettes gives cover for what might be a bigger and more immediate attack on the products that can replace cigarettes,” Sweanor said.
Interestingly, Wells Fargo Securities analyst Bonnie Herzog said the FDA may consider exempting menthol from the flavored e-cigs ban.
“This makes sense to us, as menthol is too important to adult smoker conversion (from traditional cigarettes), and fraught with potential ‘unintended consequences’ to be removed.”
The FDA appears set to follow through on recommendations for eliminating most flavored e-cigs and significantly limiting where the products can be purchased.
That’s even though a FDA-sponsored study released in March 2017 determined that the driving factor for youth smoking e-cigs is avoiding or reducing harm from smoking traditional cigarettes, rather than the attraction of candy and fruit flavorings.
Gottlieb said in his Oct. 19 appearance on cable news channel CNBC that he would tighten retail marketing and sale restrictions on e-cigs, with top-selling Juul drawing the main focus since it holds 74.5 percent of the e-cig market share.
The expected actions also likely include limiting the sale of cartridge-styled e-cigs to vape shops and removing the products from convenience stores, as well as tightening age verification for online sales.
It does not appear to affect open-pod e-cig products that Gottlieb said “aren’t generally used by kids.”
Juul Labs Inc. entered the mainstream retail marketplace in January 2015. Juul is sold in the form of a pen or a USB flash drive that’s easy to use — and hide — because the vapor typically does not have a smell and quickly dissipates.
That product model and non-tobacco flavorings have drawn scrutiny from the FDA and public-health groups, along with intense criticism from anti-tobacco advocates because they say the model and flavorings appeal to teenagers.
The timing of the agency’s latest regulatory moves comes at the end of 60-day period that Gottlieb gave the top-five e-cig manufacturers to provide their plans for reducing youth consumption of their products.
Vuse is made by R.J. Reynolds Vapor Co., MarkTen XL by Altria Group Inc. subsidiary NuMark LLC, blu eCigs by Imperial Brands Plc subsidiary Fontem Ventures; and Logic, affiliated with Japan Tobacco.
Gottlieb said Oct. 31 that he had “constructive meetings” with the manufacturers as the FDA prepares “to forcefully address youth use” of the products.
After those conversations, both Altria and Reynolds said they had revised their respective sales policies to support raising the minimum age for all tobacco products to 21. Altria also said it was halting sales of its cartridge-styled e-cigs.
On Thursday, N.Y. Gov. Andrew Cuomo’s administration said it planned to ban flavored e-cig sales in 2019.
Convenience stores push back
Anti-smoking advocates say the flavors are a pivotal element in helping adults switch from combustible traditional cigarettes.
Gottlieb has cited e-cigs’ potential to serve as a reduced-risk product for adult smokers.
However, he has made it clear in recent months that the FDA will limit the availability of flavored e-cigs if necessary to curtail teenage consumption.
“This starts with the actions we’re taking … to crack down on retail sales of e-cigarettes to minors,” Gottlieb told CNBC. “A lot of the sales we’ve seen to minors are happening in the brick-and-mortar stores, the convenience stores.”
The proposal is particularly sensitive to convenience stores since traditional cigarette sales represent 28.5 percent of all in-store sales, while other tobacco products, such as e-cigs and moist snuff, are 5.6 percent.
On Sept. 12, the FDA announced it had sent more than 1,300 warning letters and civil fines to retailers who illegally sold the top-five selling e-cigs.
Lyle Beckwith, senior vice president of government relations for the National Association of Convenience Stores, said Gottlieb’s comments unfairly targeted convenience-store operators without providing data to back up his assertions.
“That convenience stores have been singled out causes us grave concern since we are selling legal products in our stores,” Beckwith said.
Meanwhile, several public-health advocacy groups said Friday that “there is nothing to prevent the number of vape shops from rapidly expanding, and there is no solid evidence that vape shops do a good job of preventing illegal underage sales.”