Oral Nicotine Products – an underused option for people wanting to quit smoking?
This post uses the term “oral nicotine products” to refer both to traditional tobacco-based nicotine pouches like Swedish snus and to “modern oral” nicotine pouches that are tobacco-free. It excludes nicotine gum and lozenges.
These products are designed to be placed inside the user’s mouth, between the upper lip and the gum. Nicotine is rapidly absorbed through the oral mucosa and enters the general circulation without being metabolized. After about 20 – 60 minutes, when the effect and flavour have worn off, the user removes the pouch and discards it, often into a special container built into the lid of the package that the pouch was sold in.
Oral tobacco products have a bad reputation, based on chewing tobacco and traditional oral products (such as paan and gutkha) used in countries like India and Iran that contain many toxic compounds and can cause oral cancer. Modern snus and nicotine pouches are much cleaner and have health risks similar to medical nicotine replacement therapy
Swedish snus
Swedish snus is made from tobacco that is cleaned and purified to reduce toxicity. The pH and moisture content is carefully controlled for maximum benefit at the lowest possible risk. As a result, in October 2019, eight Swedish Match “General” brand name snus were authorized for marketing in the USA through the FDA’s modified risk tobacco product (MRTP) pathway. This means that the manufacturer can market these specific products with the claim “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
Snus is very popular in Sweden. The Swedish smoking rate is very low, but so many people use snus that the overall prevalence of nicotine use is one of the highest in Europe. This is associated with the lowest rate of tobacco-related diseases in Europe and a low rate of oral and pancreatic cancers, that were associated with older forms of oral tobacco.
Despite the apparent health benefits in Sweden, snus is banned in the rest of the EU. After Brexit, the UK could have reversed the ban on snus, but this has not happened. In the “Khan Report” on smoking cessation in the UK, Javed Khan did not recommend oral nicotine pouches. He told me that they are safe and effective, but he did not feel that they were needed in the UK, given the success of vaping at reducing smoking in the UK. n Canada, snus is considered a “tobacco product” and can be sold wherever cigarettes are sold, with the same age limits and ban on advertising.
Tobacco-free nicotine pouches
Modern oral products were test-marketed in 2014 and have been widely sold in the USA since 2016. The US market is now estimated to be worth about $US 500 m. As of March 202, five major tobacco companies offered 12 brands and 42 private companies sold at least 57 brands of nicotine pouches (Dr. O’Leary, personal communication).
They are typically 12 – 18 mm wide and 25-35 mm long. They most commonly contain 8 to 20 mg/g of nicotine, but the level can be as low as 3 mg/g or as high as 65mg/g. Most major manufacturers use nicotine from tobacco, but a few minor producers use synthetic nicotine. The pouches are about 80-90% cellulose. They usually contain an acidity regulator such as sodium carbonate to increase pH and promote the absorption of nicotine. Many contain salt or saline, and most include a sweetener. Some include humectants for moisture and sodium alginate as a thickener. They also contain food-grade flavour additives. Common flavours are citrus, fruit, berry mint and “cool”. Less popular flavours include coffee and tobacco. (Dr. O’Leary, personal communication.)
Personal taste test
I tried samples of “General Classic Portion” snus and Zyn “Cool Mint #4”. I am not a tobacco user or a regular user of any nicotine product, so I am not the target consumer for either product.
The snus looks like a very small used tea bag, with a distinctive taste that is difficult to describe. It is more like damp cardboard than tobacco. Once in place, within a few minutes, there was a slight tingling sensation, a rather weird taste, and a moderate nicotine “hit”. It seemed to me that it would be an acquired taste, perhaps like English bitter beer. If I was craving nicotine it would have helped me, but it seemed more like medicine than something I personally would enjoy.
The Zyn looks clean, modern, and pristine white. There is a slight minty odour. Within seconds there was a very strong nicotine hit. (I was using the strongest of four strengths, with 11mg/g of nicotine). After a couple of minutes, I felt dizzy and nauseous and had to discard the product. I was impressed by how much nicotine it delivered so quickly, and I think even a two-pack-a-day smoker would have been satisfied.
Efficacy for delivering nicotine
Nicotine pouches deliver nicotine as quickly and in a similar concentration to other snus. Their efficacy in reducing withdrawal symptoms and helping smokers reduce or stop combustible tobacco use should be similar to or better than NRT products.
Research does show that nicotine pouches release nicotine more slowly than cigarettes, but if an 8 – 10 mg nicotine pouch is left in the mouth for an hour the peak level is about twice that achieved by smoking and lasts longer than a single cigarette.
Safety
Oral nicotine pouches are the safest consumer nicotine product. They are very close to, or may even exceed, the safety of medical products such as nicotine patches and gum. Because nothing is being inhaled, they are safer than vape or heat-not-burn products. This might be a particular advantage to people with respiratory disease, and to people who are worried by the negative publicity surrounding vaping.
In a study, Lyft nicotine pouches had lower levels of ten potentially harmful chemicals than snus and generally, no difference could be seen between nicotine replacement therapy (NRT) products and Lyft nicotine pouches.
Where do snus and oral nicotine products fit in the spectrum of safer nicotine products?
Smokers who want to switch to a safer nicotine product have several choices. Vaping is the commonest option because it is the most widely available and most discussed. It provides a cigarette-like physical experience with a range of nicotine concentrations and flavours and is very much less harmful than cigarette smoking. Heat not burn products provide a much better tobacco taste and flavour than vape, but they are less safe than vaping, although still many times safer than smoking.
Snus is made from real tobacco and is recognized by the FDA as being safer than smoking. Non-tobacco nicotine pouches are safer than vape, and may be safer than conventional nicotine replacement therapy. At present, many people are put off vaping by the massive media coverage of rare or even non-existent complications of vaping. This group may feel more comfortable with oral nicotine products. Oral nicotine products have no up-front equipment cost, nothing to learn to change, charge or refill, and can be a “grab and go” alternative to cigarettes.
Oral nicotine pouches are unauthorized in Canada
Health Canada calls tobacco-free oral nicotine pouches “nicotine buccal pouches”.Despite the scientific evidence that nicotine pouches are even safer than snus, they are unauthorized in Canada. In fact, Health Canada has published a public advisory: “Unauthorized nicotine buccal pouches may pose serious health risks“. This states that “Nicotine is a highly toxic and addictive substance. Excessive amounts of nicotine can cause acute poisoning, resulting in respiratory failure and death.”, It goes on to say:
The article then explains the legal situation of oral nicotine pouches:
A nicotine buccal pouch is classified under the Food and Drugs Act. Depending on the amount of nicotine the pouch delivers, a nicotine buccal pouch would be considered a prescription drug (if it delivers more than 4mg of nicotine/dose) and require a Drug Identification Number, or a natural health product (if it delivers 4mg or less of nicotine/dose) and require a Natural Product Numer. All nicotine buccal pouches need market authorization from Health Canada to be legally sold in Canada.
At present no oral nicotine pouches have either a Drug Identification Number or a Natural Product Number, so they cannot be sold legally either as a prescription drug or as a natural health product. Furthermore, the division of these products into two categories will make marketing very difficult for manufacturers, and purchasing difficult for consumers. Nicotine pouches come in a wide variety of nicotine concentrations so that users can gradually decrease their nicotine consumption over time. It would be very inconvenient if some concentrations were available only from a medical smoking cessation service and others only from a convenience store.
Despite this, they are available mail-order from companies such as Snus Direct. Common brands such as Zyn, On! and Velo cost $4.29 a package and are available in 1.5 to 4mg strengths and in a variety of minty, fruity and berry flavours, but there is a substantial post and packaging charge.
What are the pros and cons of oral nicotine products for smoking cessation?
So far I have been unable to find any research on using tobacco-free nicotine pouches for smoking cessation except for a non-peer-reviewed observational report performed by a tobacco company. In this study, at the end of 6 weeks, 27% of adult smokers provided free access to nicotine pouches in a variety of strengths and flavours reported no use of cigarettes and 39% reduced their daily consumption of cigarettes.
There are many observational studies that seem to associate snus use with lower smoking rates, but randomized controlled trials have been inconclusive. (See: Snus: a compelling harm reduction alternative to cigarettes.)
As a nicotine delivery system, oral products would have a slower onset than vaping but would last longer. It should be relatively easy for someone who is dependent on nicotine to maintain the desired nicotine level using pouches throughout the day. They may be less effective at managing cravings, although anecdotally some people say that they get a nicotine hit from an oral pouch within a few minutes.
Oral products are very different from cigarettes or vaping, which creates both disadvantages and benefits. They do not provide people who are used to smoking the opportunity to fidget with a cigarette or the repetitive hand-to-mouth movements or the ability to make a cloud of vapour. Like vape, they come in a range of flavours and nicotine concentrations.
Perhaps their benefit is that they can be used in places where smoking and vaping are either forbidden or considered anti-social. Oral products can be used discretely in offices, theatres and restaurants, in planes, trains cars or elevators. It would be logical for a nicotine consumer to use vape when outdoors or with friends who also vape and oral products in an indoor environment or with friends who would not like to be exposed to vape.
At a minimum, oral tobacco products are another choice for consumers. They may not be for everyone, or for use at all the times that someone would otherwise like to smoke. However, given their high level of safety compared to cigarettes, and even to other safer sources of nicotine, they should be available for smokers who want them, while preventing access for non-smoking teenagers.
Where should oral nicotine pouches be sold?
A simple and logical answer is that safer nicotine products such as oral ouches should be available everywhere that combustible cigarettes are sold. As there is public concern about non-smoking teens accessing safer nicotine products the rules and penalties for selling nicotine pouches to underage customers should be similar to the penalties for selling tobacco.
Ideally, all nicotine products, including cigarettes, should only be sold in an adult-only store by licensed retailers who would lose their licence to sell any age-restricted product (nicotine, tobacco, cannabis or alcohol) if they are repeatedly sold to youth.
CONCLUSION
Oral nicotine products are very safe sources of nicotine, with tobacco-free nicotine pouches being even safer than snus. People who smoke and who are dependent on nicotine should be encouraged to use oral nicotine pouches, especially if they have been scared away from vaping by adverse media coverage, or need to consume nicotine in areas where vaping is banned.
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