The Food and Drug Administration confirmed Thursday the launch of a pilot program to streamline and fast-track the application review process for nicotine pouches.
The announcement comes about two weeks after the posting of several media reports on the FDA’s plans for nicotine pouches, which have surged in popularity among tobacco consumers over the past two years.
FDA has authorized 20 nicotine pouch products to date, all from Philip Morris International’s top-selling Zyn brand.
Among pending premarket tobacco product applications are for Zyn, R.J. Reynolds Vapor Co.’s Velo Plus, Altria Group Inc.’s on! Plus, Imperial Brands Plc’s Zone, and Alp. Those products are currently available at retail during the FDA review process.
Velo Plus nicotine pouches are available in ice berries, lemon, lime, punchy lime, mango, peppermint, spearmint and watermelon flavors.
“For adults who smoke and want to switch to a nicotine pouch product, this pilot will potentially result in a wider variety of authorized nicotine pouches from which to choose,” FDA said in its news release.
“The pilot will feature increased real-time communication between FDA and applicants with the goal of providing more frequent feedback and shorter review timeframes … with the hope to address issues sooner, or at least limit the number and severity of issues included in a deficiency letter at the conclusion of the evaluation.”
The FDA’s decision to authorize or reject smokeless tobacco products comes mostly through “continuum of risk” standards.
Those standards measure whether — and by how effective — smokeless tobacco and nicotine products have a reduced-risk public health benefit compared with traditional cigarettes. The benefit is measured for regular tobacco and nicotine users, non-users and the population as a whole.
“There is evidence that nicotine pouches can help some adults switch away from more harmful tobacco products,” the FDA said.
“Adults who significantly reduce their cigarette use, or fully switch from smoking cigarettes to using a lower-risk alternative tobacco product, could generally reduce their health risks and exposure to toxic and cancer-causing chemicals.
‘Increased innovation’
Barclays analyst Gaurav Jain said fast-tracking FDA review of nicotine pouches “is going to lead to increased innovation.”
“We think this accelerated review by the FDA will help address PMI’s long-term competitive issues (in the U.S.) and close the product gap in pouches by launching Zyn Ultra.”
Jain said he envisions Zyn, with the Ultra version in the market, sustaining a market-share lead of 45% to 50% — similar to the 48% to 50% traditional cigarette market share held for years by Philip Morris USA’s Marlboro.
Jain projects Velo brands peaking in the 25% range and on? Plus in the low double-digit range.
The latest four-week smokeless tobacco and nicotine product analysis by Goldman Sachs analyst Bonnie Herzog has Zyn with a 66.8% market share for nicotine pouches of Sept. 6.
Meanwhile, on! is at 11.9%, with Velo Plus at 10.7% and all Velo-branded nicotine pouches at a combined 11.9%
“Ultimately, all the players are focused on profitability, which is based on prices of cigarettes and traditional smokeless tobacco,” Jain said.
The FDA announcement “looks like an improvement over the hugely bureaucratic system that has to date ignored the legislatively mandated time limit and prevented legal access to life saving alternatives to lethal cigarettes,” said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cigarette and health studies.
“But more details are needed, as well as evidence that the new system actually works.
“A big test is whether the FDA will start rapid approvals of products that are not from the large cigarette companies.”
Responses
Philip Morris International said in a statement that “a project of this nature could be a step in the right direction.”
“The FDA’s review process for smoke-free products requires urgent reform, as we have conveyed to administration officials,” PMI said.
“We encourage efforts toward a workable and timely review for products that are a better choice for legal-age adults that would otherwise use traditional tobacco products, including combustible cigarettes.”
Altria said in a statement that “this approach by the FDA is encouraging and would be a positive development for harm reduction.”
Although Reynolds has not commented on the FDA reviewing of nicotine pouches, it has said the products fit into “the BAT Group’s mission to build a smokeless world by providing adult nicotine consumers with high-quality, innovative, alternative nicotine products.”
The Campaign for Tobacco-Free Kids said that “any effort to gain efficiency — including this pilot program — must not jeopardize the scientific integrity of the review process required by Congress before new tobacco products can be introduced.”
The anti-tobacco advocacy group cautioned that nicotine pouches’ growing popularity also is reflected in increased usage among those under age 21.
“These products share many features that fueled (early) youth use of e-cigarettes, the campaign said.
“They’re sold in appealing flavors, easy to hide and heavily promoted on social media. These products expose kids to high levels of nicotine, which is extremely addictive and can harm the developing adolescent brain, impacting memory, attention and learning.
“The FDA must ensure the law is applied as intended to protect kids and public health, not the interests of the tobacco industry.”
rcraver@wsjournal.com
336-727-7376; @rcraverWSJ
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