Nevcore Innovations Inc. has recently announced that its Premarket Tobacco Product Application (PMTA) for CLEW, a lesser known oral nicotine pouches (NP) brand, has been accepted by the U.S. Food and Drug Administration (FDA). The start of this review process will place CLEW among the leading brands in the industry, offering another smoke-free alternative for adult nicotine consumers.

There are of course a number of other NP brands which have submitted their PMTAs and are currently undergoing the rigorous review process. These include ZYN: produced by Swedish Match USA Inc., ON!: Manufactured by Helix Innovations LLC, a subsidiary of Altria Group Inc., and VELO: a product of R.J. Reynolds Vapor Company.

Meanwhile across the border, several flavoured nicotine pouches have been recalled due to a lack of authorization for sale. Health Canada issued recalls for eight types of Zyn nicotine pouches, which include flavours such as apple mint, bellini, black cherry, citrus, cool mint, espresso, original, and spearmint, each containing either 1.5 or 3 milligrams of nicotine. Additionally, eight types of nicotine pouches sold by XQS, containing 4 and 6 milligrams of nicotine, were also taken off the shelves.

Health Canada emphasized that these products were sold without market authorization and urged consumers to check for recalled products and consult a healthcare provider before discontinuing use due to health concerns. Philip Morris International (PMI), the manufacturer of Zyn products (who does not sell in Canada) spoke in support of Health Canada’s actions against unauthorized sales, while it’s Canadian affiliate Rothmans Benson & Hedges, stated that they are working with law enforcement to combat illicit trade. Currently, the only authorized nicotine pouch available in Canada is Zonnic from Imperial Tobacco, which received approval from Health Canada in October 2023.

Meanwhile, in response to reports of an increase in NP use among minors, earlier this year Canada’s Health Minister Mark Holland announced that he was seeking authority to restrict nicotine pouch sales solely for smoking cessation purposes. On the same day, Health Canada issued a public advisory stating that nicotine pouches should be used only by adults aged 18 and above as a method to quit smoking, not recreationally by non-smokers.

A new wave of panic about NP uptake by minors may be overshadowing the products’ benefits

A systematic review published in Nicotine and Tobacco Research, concluded that while NPs have fewer and lower levels of harmful chemicals compared to cigarettes, the level of harmful chemicals varies by product, possibly due to different flavourings.

The review took also into account the increasing use among youth, and noted that 35% to 42% of U.S. youth are aware of these pouches, and 9% to 21% of non-nicotine users are open to trying them. As public awareness and marketing of these products grow, there is a rising demand for information about their effects from smokers, non-smokers, and policymakers.

The paper acknowledged that if nicotine pouches were to completely replace smoking, they could bring substantial health benefits to smokers and those around them. However, given the concerns about their rising popularity among adolescents, the review recommends further research and careful regulation in order to understand and manage their health impacts effectively.

Why are nicotine pouches appealing? And to whom?

Meanwhile, a recent study published in The American Journal on Addictions by renowned Professor of Medicine at the University of Louisville, Brad Rodu D.D.S. and his peers, examined the consumer appeal of ZYN. A blog by Rodu explained that nicotine pouches were initially test-marketed in Colorado six years ago, expanded to 11 western U.S. states in 2016, and became available nationwide in April 2019. Despite limited marketing efforts, ZYN achieved significant sales success as reported by various press outlets.

“The market for pouches is booming, mainly because they deliver nicotine efficiently like traditional smokeless products, with appealing flavours but without the aesthetic and social stigma. Their popularity will surely speed the demise of the cigarette market.”Dr. Brad Rodu, Professor of Medicine at the University of Louisville, Endowed Chair in tobacco harm reduction research, and member of the James Graham Brown Cancer Center at U of L.

In 2018, Swedish Match commissioned two marketing surveys to understand consumer perceptions and usage patterns of ZYN. In 2023, alongside Rodu, researchers Drs. Karl Fagerström, John Hughes, Nantaporn Plurphanswat, set out to analyze this survey data independently. Their study aimed to assess adult appeal and interest in ZYN, as well as user characteristics and usage patterns.

Key findings revealed that one-third of current smokers, over half of smokeless tobacco (ST) users, and two-thirds of dual cigarette-ST users showed interest. While nearly 90% of never and former tobacco users did not find ZYN appealing, with only 3% and 2% of these respectively, expressing interest in purchasing ZYN. The study highlighted that exclusive ST users were most likely to purchase ZYN, than cigarette or dual users, possibly due to the similarity in usage methods—placing the pouch between the lip and gum.

The majority of ZYN users were white men, aligning with typical ST user demographics. About 90% used the pouches daily, with most preferring the 6 mg nicotine version over the 3 mg option. Over a third of users had been using ZYN for about 3-6 months. Users cited reasons such as “less harmful,” “discreet use,” and “avoiding spitting” as major factors for choosing ZYN. Among current smokers, top reasons included “less harmful than cigarettes” and “no smoke smell.”

The importance of higher nicotine levels in NPs for smoking cessation

Rodu mentioned the fact ZYN’s market entry was soon followed by similar products like DRYFT and On!, which also offer tobacco-free nicotine pouches at varying strengths. The popularity of these products may be attributed to higher nicotine doses compared to medicinal nicotine gum and lozenges, which are capped at 4 mg by the FDA. In fact studies have consistently shown that higher nicotine doses make it easier for smokers to switch from cigarettes to safer nicotine alternatives.

Vaping Post asked Professor Rodu whether in his opinion there is a possibility that in the future the FDA decides to impose the same 4mg nicotine limit currently on medicinal nicotine products, onto NPs. He explained that while it’s difficult to predict what actions the FDA’s Center for Tobacco Products (CTP) may take, he hopes the 4 mg “limit” on nicotine medications won’t apply to NPs since these are intended for consumers and fall under the CTP’s jurisdiction, not the Center for Drug Evaluation (CDE).

The professor highlighted how the success of NPs would contribute greatly to decreasing smoking rates. “The market for pouches is booming, mainly because they deliver nicotine efficiently like traditional smokeless products, with appealing flavours but without the aesthetic and social stigma. Their popularity will surely speed the demise of the cigarette market,” Rodu told Vaping Post.

The Recent Bad Press Surrounding Zyn NPs Has Culminated in a Lawsuit. Is This The Begining of the End?

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