4 Tobacco and Vapor Products at Risk Post-‘Deeming’

Melissa Vonder Haar, Freelance Writer

Mitch Zeller

Not surprisingly, much of the talk surrounding the U.S. Food and Drug Administration’s (FDA) recently announced “deeming” regulations has been about the newly deemed products: cigars, electronic cigarettes, pipe tobacco and hookah tobacco. Obviously, these segments stand to be most immediately affected by the new FDA rules.

That said, the deeming regulations—and the way FDA Center for Tobacco Products (CTP) director Mitch Zeller talked about future tobacco regulations—could have a ripple effect on other tobacco and vapor products down the line. Here are four products that may be at risk for strict regulations (or outright bans) in the post-deeming era.

Flavored cigars

flavored cigars

Current status: In 2015, Nielsen reported that flavored cigars accounted for 24.8% of c-store cigar volumes and 19.3% of cigar dollar sales. If you count “sweet” as a flavor, those percentages go up to a 51.4% volume share and a 41.1% dollar share.

Potential risks: Though the FDA did not address flavors in the deeming rule, the agency announced intentions to propose a rule that would extend the ban on “characterizing flavors” in cigarettes to include cigars. As with deeming, those regulations will take years to propose, revise and finalize—but Zeller indicated the FDA might not wait long to start clamping down.

“On an application-by-application basis, the industry is likely going to have to address the impact of initiation of products based on the presence of particular flavors,” Zeller said in a media briefing. “That’s something that we would factor in to our overall assessment of whether marketing authorization for that new product is warranted.”

Click here for more information in cigar sales in 2016.




Current status: In June, 2014, Swedish Match submitted an application to market its General Snus products as less harmful than cigarettes, becoming the first modified-risk tobacco product (MRTP) application to be accepted for FDA review. While a Tobacco Products Scientific Advisory Committee (TPSAC) panel ruled against the application last April, the FDA has yet to make an official ruling.

Potential risks: Swedish Match has expressed optimism that the FDA will rule in favor of at least some aspects of its application (such as granting modified-risk status, but not allowing the company to change warning labels on tooth lost and gum disease). To be clear, the deeming regulations are a completely separate issue from Swedish Match’s MRTP application—but many public-health advocates have linked the two decisions in terms of the FDA’s thinking on the potential of tobacco harm reduction.

“The FDA has a chance to demonstrate to American tobacco users that it is supportive of tobacco harm reduction when it makes these decisions,” Brad Rodu, a professor of medicine and holder of the endowed chair in tobacco harm-reduction research at the University of Louisville in Kentucky, told CSP back in April.

Based on the FDA’s refusal to acknowledge e-vapor as a potential reduced-harm option in the deeming regs—repeatedly describing cessation claims as “anecdotal” and citing concerns about youth usage and exploding batteries—the harm-reduction community is concerned about the future of modified risk.

Click here for more on Swedish Match’s MRTP application.

Heat-not-burn products


Current status: Not yet available in the United States, Philip Morris International’s (PMI) heat-not-burn technology (named iQOS) already has the industry talking based off successful test markets in Europe and Asia. Wells Fargo analyst Bonnie Herzog has described iQOS—which vaporizes actual tobacco, vs. liquid nicotine (like e-cigarettes)—as approaching a “gold standard of cessation,” predicting the product could displace as much as 30% of the worldwide combustible-cigarette market by 2025. Reynolds American Inc. is also testing its own heat-not-burn product (named Core) internationally.

Potential risks: At the March 2016 Society for Research on Nicotine and Tobacco conference, PMI indicated it would submit MRTP and premarket tobacco product applications (PMTAs) for iQOS by the end of the year. While the company (which has a technology-sharing agreement with U.S.-based Altria Group Inc.) can certainly afford the steep cost of these FDA applications, it’s unlikely that iQOS will be on the market before the Aug. 8, 2016, date that the deeming regs go into effect. That means the company will not be able to sell iQOS in the United States until the FDA rules on these applications. With the FDA estimating up to a one-year turnaround on PMTA decisions, we’re likely in for a long wait to see this heat-not-burn tech stateside.

Click here for more about PMI's iQos.

“Alternative” vaporizers


Current status: Vaporizers: not just for tobacco! When New York passed its medical marijuana law, it stipulated that only noncombustible marijuana would be allowed (specifically marijuana oils to be used with a vaporizer or inhaler). With more states legalizing marijuana for medical and recreational use, there are several products aimed at vaporizing just marijuana, not tobacco or e-liquids.

Potential risks: There stands be a lot of confusion over FDA authority over such vaporizer devices, because the deeming regulations stipulate that they apply to any product meant to be used with tobacco, even if that product does not actually contain tobacco (e.g., vaporizers, tanks and mods). The problem is, there are a lot of products that could be used with tobacco or marijuana.

“It will all come down to whether any product in question meets the statutory definition of a tobacco product or if it’s something that could be used in conjunction with something that meets the statutory definition of a tobacco product,” Zeller said in his media briefing when asked about marijuana vaporizers. “We can’t go beyond that in answering what is a very fair question.”

In other words, the FDA might also require marijuana vaporizers to submit the expensive $1 million PMTA if this legal gray area isn’t cleared up.

Click here for more on marijuana and vaping.