Zonnic: best-in-class nicotine replacement therapy or big tobacco’s latest ploy?

Zonnic nicotine pouches only started being sold in mid-October, but they’re already controversial. The pouches come in brightly coloured containers that look similar to gum and in three flavours: Tropic Breeze, Chill Mint and Berry Frost. Users tuck a pouch under their lip for up to an hour, slowly releasing the 4 mg of nicotine in each pouch. They’re being sold in convenience stores, gas stations and pharmacies. Imperial Tobacco Canada, which makes Zonnic, created it as nicotine replacement therapy (NRT) for smokers. In July, Health Canada approved them for sale under Natural Health Product Regulations, since they contain nicotine but not tobacco. A study in Nature found that oral nicotine pouches compared favourably to other nicotine replacement products, saying the users reported had fewer minor adverse events and greater satisfaction with them than nicotine lozenges or gum. Read: Cytisinicline shows promise for smoking cessation in large U.S. studyHowever, shortly after Zonnic hit shelves this fall, six national health organizations called on Ottawa to change the rules that let Zonnic be sold this way. They’re saying the approval was a mistake, as the product is legally allowed to be sold to minors of any age, and that can be promoted on billboards, through advertising and through free samples. Health Canada said in an emailed response to questions that it had had discussions with the manufacturer “to underscore the importance of preventing youth access to the product and to work with them to make changes to the current labelling and advertising to make it clearer that these products are only for use by adults over 18 years who are trying to quit smoking.”It also said that "The Department is assessing regulatory and policy options to further prevent youth access should additional measures be deemed necessary." Youth access debatedThe health groups—Action on Smoking and Health, Canadian Cancer Society, Canadian Lung Association, Coalition québécoise pour le contrôle du tabac, Heart & Stroke, and Physicians for a Smoke-Free Canada—asked the Health Ministers to reclassify Zonnic as a prescription product or ban its sale. They’re also asking for a temporary stop on approvals for other nicotine pouches or other new categories of nicotine products. “Right now, it is legal to sell this product to kids of any age,” says Rob Cunningham, senior policy analyst at the Canadian Cancer Society. “That’s unbelievable, and it’s the first time in more than 100 years in Canada that a nicotine product from a tobacco company can be sold to minors. And that shouldn’t be happening.” “These products are attractive to youth. They come in appealing flavours. They come in containers that could well hold candy. Of course, youth are going to be interested in them,” Cunningham continued.Read: FIP releases new supports for pharmacists to help patients quit smokingImperial Tobacco Canada says they’re being unfairly attacked for a product that’s squarely aimed at adults. “We’ve actually self-regulated on this: We have made agreements with all of our retail partners. It is part of our conditions that this product will be sold behind the counter, and in order to buy it, you need proof of age,” says Eric Gagnon, vice president of legal and external affairs for Imperial Tobacco Canada, adding that retailers who don’t comply will not be able to sell any Imperial Tobacco products, including cigarettes. The health groups counter that even though this isn’t allowed under the terms of sale, it’s still legal, and there aren’t fines or other legal penalties to retailers who sell it to children. “It may say on the label that the product is only intended for those over age 18, but this is useless,” Cunningham said. “A retailer that sells to minors will face no offence, no charges and no fines.”In Quebec, the rules are different, and nicotine pouches can only be sold in pharmacies. The Association québécoise des pharmaciens propriétaires recently told its members it was up to them whether or not they should stock the product, and whether it should be sold behind the counter or with other NRT products. Read: Ontario to add provincial tax to vaping products; meant to discourage youth uptakeAdvertising argumentCBC News raised these concerns with federal Health Minister Mark Holland, who said, “There are very serious questions about what the tobacco industry is doing here and what their intention is. And it would seem that their intention is to addict new young people to nicotine, which is disgusting...We want to shut down this loophole.”“The way that this was presented is that it was for the purposes of cessation. In their marketing and their approach, it exists in a completely different way. We were duped,” Holland said.Gagnon countered this to the CBC, saying, “There’s no loophole. We’ve been through a process. We have answered many questions around the product. We’ve demonstrated the efficacy and the safety of Zonnic to help people quit smoking, and that’s exactly why we’ve put this product on the market.”“We don’t target kids.”Read: Feds must enforce vaping penalties to protect kids: advocatesHealth Canada has specific requirements around NRTs. “Heath Canada expects that labels and advertisements prominently display information indicating that the products are intended only for smoking cessation in adults aged 18 years and older who are regular smokers,” it said. Cunningham says the ads for Zonnic emphasize lifestyle, are in locations like convenience stores and on social media where they’re likely to reach children, and only have “nicotine replacement therapy” in small print. In many ways, they look like cigarette ads from decades ago, he continues. “They contain the classic lifestyle advertising that was used for cigarettes. You have young people in a social setting, having a good time; there’s a couple, suggesting romance; there’s an association with sports or physical activity. They’re showing repeated places where you can’t smoke, such as a subway, a restaurant, a bar or taxi, so they’re not marketing this as an alternative to not smoking,” he says. Gagnon says that the flavours target what adults like, the advertisements show adults using the products, and the company has told retailers to sell them only to adults. If the “usual anti-tobacco lobby groups” want Canada to reduce smoking rates to less than 5% by 2035, its stated goal, they need to “embrace these less risky alternatives,” he added. Zonnic isn’t being promoted in a different way than any other nicotine replacement products, he says, arguing that nicotine gums and other NRTs also use lifestyle advertising and that they are also sold in convenience stores. “We fundamentally believe that Zonnic is not marketed any different than all the other NRT products in Canada,” Gagnon said to Pharmacy Practice + Business. “It is marketed the same way as other NRTs, it blends really well in the NRT space, and the only reason we’re being singled out is because it’s [from] Imperial Tobacco Canada.” Read: Tobacco harm reduction and vaping cessation: New opportunities for pharmacist skillsThe new vaping? Cunningham compares nicotine pouches to vaping, which was not very regulated for the first years of its existence. Flavours were part of the reason for the rapid growth in youth vaping, which grew rapidly. Another was the government playing catchup with regulations, says Cunningham, noting that in the beginning, there were no restrictions on the location of sale of vapes, and they were advertised on television and billboards that youth saw. “We’ve learned so many lessons from tobacco, and more recently from vaping, that shouldn’t have to be starting all over again,” says Cuningham, who wants to see Zonnic be prescription only or there to be a temporary suspension until a federal and provincial regulatory framework is created. Canada has some of the highest teen vaping rates in the world, with 17% of high schoolers saying they had vaped in the last month, according to a Health Canada survey. Gagnon says this is an entirely different product than vaping, and it’s incorrect to compare the two. “It’s a consumer product in Canada, not a cessation product,” he says. Cuningham is worried other, similar products could also follow. “[The health groups] want a moratorium on any new products, since we could have another company put its own product through. There are other products, like nicotine toothpicks or nicotine pearls, that are starting to be sold in Europe. There need to be regulations around this: it can’t just be the Wild West.”Read: Vaping and smoking linked to increased risk for severe COVID in young adults

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