Saturday 29 April 2023

Sesh+: Another nicotine product hits convenience store shelves

Almost a generation of Canadian children have grown up without ever seeing a display of cigarettes in corner stores. Almost three years have passed since corner stores across Canada were required to take down promotional displays of electronic nicotine products. 

And yet self-service displays of nicotine products are once again beside the cash registers across Canada. Since January, Circle K, Shell and other retailers have supported the national launch of a modernized nicotine gum sold under the brand Sesh+.

Sesh+ display at Shell
Station

The federal law which governs these products does not include restrictions on paid promotional displays.  

Sesh+: not your father's NRT

Sesh+ distinguishes itself from the more staid NRT manufactured by established consumer pharmaceutical companies. 

  • it is sold in convenience stores, not pharmacies
  • it is packaged to resemble ordinary chewing gum
  • the outer-labelling does not indicate that it is intended for therapeutic use
  • it is sold in more exotic flavours (i.e. pomegranate)
  • it is sold in smaller packages with a lower price (SRP $8.99)

Sesh+: A Canadian start-up with an American footprint. 

Sesh products is owned and operated out of Vancouver, B.C. It was incorporated in Canada in November 2020 and a year later in the United States. In September 2021, the company applied to trademark its brand for both nicotine gum and pouches. 

Sesh+ nicotine gum are reported to have first appeared in stores in April 2022. Sesh+ nicotine pouches are sold on-line to Canada from the United States, but are not legal for sale in stores. Sesh Products does not manufacture either Sesh+ gum or pouches, but sells gum made in the United States and pouches made in Sweden.

From the registration on Health Canada's Licensed Natural Health Products Database, it is evident that Sesh+ gum is the same as the nicotine gum sold in the United States under the Lucy brand name. They share the same Natural Product Number (NPN 80108821). The same NPN number is used on Luy Brand Spearmint, Citrus Berry and Red Mango (available online only), and on Sesh+ branded flavours  cinnamon, wintergreen and pomegranate.

Sesh+ and Lucy are the same product sold in Canada different flavours
under different names. They share a Natural Products number. 

Sesh+:  Marketing hype or new nicotine formulations?

The Sesh+/Lucy nicotine gum is promoted as being different (and better) than Nicorette and other established brands. These marketing claims are considerably more subtle in Canada than in the U.S. 

In Canada, the product is promoted by Mr. Cunningham as a product which overcomes the "negative stigma around trying to overcome addiction, the toll on mental health, and asking for support ... Sesh+ was my way of providing people with something that I knew worked, was accessible, delicious, and not something you needed to hide.”

The Canadian web-site for the product says little about the ingredients. (The Health Canada registration identifies 23 non-medicinal ingredients, which are collectively described here as "food-grade ingredients").  The formulation of the nicotine in Seth+ that is reported to Health Canada is 2-Propenoic acid, 2-methyl-, polymer with diethenylbenzene, compd. with 3-((2S)-1-methyl-2-pyrrolinidinyl)pyridine. 

By contrast, American consumers are given more information on the product by the distributors of Lucy. The website for Lucy claims that the gum differs from others in part because the nicotine has been altered to provide a quicker nicotine hit.
 
pH Adjusters. We use a customized buffering system which interacts with the nicotine as it is released from the resinate and gum matrix in order to maximize buccal absorption. Absorption of nicotine across the buccal membrane depends on the amount of nicotine present in the unionized “free base” form. In an acidic (low) pH, nicotine is ionized and does not cross biological membranes, whereas in an alkaline (high) pH environment, nicotine is un-ionized and readily absorbed. We invested a lot of effort into ensuring that our buffering system maximizes the amount of free base nicotine while avoiding the acrid taste of standard buffer systems.

Sesh+: an offshoot from the tobacco industry 

The founder and owner, Max Cunningham, is not new to the nicotine market, having once worked to promote products for Imperial Tobacco. He identifies on his LinkedIn profile that prior to working full time on Sesh+ in September 2021 he worked for Market Recon where he "created and executed marketing and sales strategies on behalf of one of the world's largest tobacco company's for their next generation product category."  (Market Recon supplies retail promotions and brand activation for Imperial Tobacco).

Mr. Cunningham says his motivation for entering the business was his own addiction to vaping“Like many young adults around the world, when vaping first hit the market, I thought it caused no real harm to my health. But shortly after I started, I felt my physical health decline specifically in my lungs and shortness of breath. Once I noticed the negative effects on my body I knew I had to quit, but after a couple of failed tries I realized it wasn’t that simple.”  

Sesh+ gum: Good or bad for public Health?

Some may see the sale of Sesh+ in corner stores as a health benefit, in the expectation that selling smoking cessation medications in the same locations as tobacco products can make it easier for smokers to make a quit attempt. They may also consider attractive flavourings and accelerated nicotine delivery as helpful to sustaining quit attempts. From this perspective, the appearance of Sesh+ on convenience store counters could benefit public health.

On the other hand, there are reasons to be concerned that the way this product is marketed could produce harms that exceed any benefits. These include the likelihood that the benefits will be small, as the evidence to date suggests that nicotine gum when sold over the counter does not increase quitting rates.(1) Because most of the customers in corner stores are not smokers or vapers, the risk that impulse tries will be by non-smokers and the product may recruit non-smokers to nicotine use cannot be discounted. Contributing to this risk is the generally appealing design of the packaging, the noticeability of the counter-top promotions, the attractive product flavourings and the affordability of a trial pack. Although the package carries a caution that the product should not be used by anyone but daily smokers, it is in very very small print and is unlikely to be seen until after purchase.

In article published last year, U.S. researchers raised concerns about the public health risks presented by Lucy (Seth+) gum (2), "We believe that Lucy’s packaging similarities to chewing gum, lack of warning information, and noted dissimilarities to other smokeless tobacco products may attract youth and non-nicotine-users to initiate nicotine use."

Sesh+:  Exposing the cracks in Canada's nicotine policy

The launch of this product is a stark reminder that the era of "good/therapeutic nicotine" (produced by big pharmaceutical companies and sold mostly in pharmacies) and "bad/harmful nicotine" (produced by big tobacco companies and sold mostly in convenience stores) is over. Manufacturers and governments have deliberately blurred this line. 

Tobacco companies have blurred the line by presenting vaping products, heated tobacco and modern oral nicotine as though they have health benefits, although the products have not been authorized for sale as pharmaceutical, natural health products or medical devices. The major companies are also expanding into the area of authorized medications. Eighteen months ago, for example,  Philip Morris International purchased Fertin Pharma, which specialized in gum-and other oral delivery systems for drugs and which has research and manufacturing facilities in Canada.

Canada's federal government has blurred the line through its heterogenous nicotine policies. The right hand of Health Canada's Health Products and Food branch regulates nicotine gum and pouches as natural health products (and requires market authorization before sales are legal). Nicotine gum or pouches are legal for sale without prescription in Canada provided  that they contain less than 4 mg of nicotine, and also that they are registered with Health Canada as a Natural Health Product. To date, market authorization has not been granted to any nicotine pouch applications. The department has already forced recall of nicotine pouches after attempts to sell them in Canada (including Seth).  Meanwhile, the left hand of the Controlled Substances and Cannabis Branch permits any vaping or tobacco product to be offered for sale without pre-approval. 

Although the law forbids promotional claims that vaping products are safer than cigarettes, the companies have been permitted to promote their products as being reduced risk.




An integrated nicotine policy is not yet in place

Health Canada has not yet established an integrated nicotine regulatory framework to address the expanding range of nicotine formulations which are neither short-term medications nor combustible tobacco. In the absence of such a framework, we can expect to see more innovations like Sesh+ exploit the in-between market for nicotine. 

In the meantime, provincial governments can help by banning self-serve displays of nicotine products sold outside of pharmacies and by reviewing the appropriateness of addictive products like nicotine being sold in convenience stores. The Netherlands provides an example of how this can be approached: it has adopted a staged approach that has already reduced the outlets that can sell tobacco and which will place them in adult-only specialty shops in 2032. (3)


References

(1) Walsh RA. Over-the-counter nicotine replacement therapy: a methodological review of the evidence supporting its effectiveness. Drug Alcohol Rev. 2008 Sep;27(5):529-47. doi: 10.1080/09595230802245527. PMID: 18696300.

(2) Unger JB, Barker J, Cruz TB, Leventhal AM, Pentz MA. Lucy-Novel Flavored Nicotine Gum, Lozenges, and Pouches: Are They Misleading Consumers? Subst Use Misuse. 2022;57(8):1328-1331. doi: 10.1080/10826084.2022.2076881. Epub 2022 May 19. PMID: 35586938; PMCID: PMC9451008.

(3) Nagelhout GE, Poole NL, Metze M, Willemsen MC, Vermeulen W, van den Brand FA. Reducing the number and types of tobacco retail outlets in the Netherlands: Study protocol for a comprehensive mixedmethods policy evaluation. Tobacco Prevention & Cessation. 2023;9(March):8. doi:10.18332/tpc/161825.

 Thank you to a colleague who drew our attention to this product.