Smokers need a medically-licensed vape as an aid to smoking cessation and as a safer alternative to cigarettes for those who are dependent on nicotine.

What is meant by a “medically-licensed vape”?

A vaping device or e-cigarette that meets the same standards as recognized medical devices such as an epinephrine auto-injector (“EpiPen”), an asthma inhaler or a naloxone nasal spray. These devices can all be prescribed by physicians, sold by pharmacies, and be covered by government or private health insurance plans. Currently, in countries where vaping products are legal, they are considered to be a consumer product, held to a lower safety standard than medical equipment and are not allowed to claim to have any health benefits.

Vaping can fulfil two different and distinct roles. It can be a smoking cessation product, used for a short time to allow a smoker to transition from smoking to not using nicotine in any form. This is analogous to the use of conventional nicotine replacement therapy (NRT) such as patches and gum. It can also be used as a long-term safer source of nicotine for users who are unable to quit, analogous to the use of methadone for opioid addicts. Ideally, a medical vape should be licensed for both purposes, but given a small degree of uncertainty about the long-term effects of vaping, the first option may be a more achievable goal for the short term.

What would be the advantages of a medical quality vape?

Physicians are unlikely to recommend vaping to their patients while vaping devices are only available as a consumer good that is sold by a retailer with no medical knowledge or training.

A recent Canadian government report ( Evaluation of the Health Portfolio Tobacco and Vaping Activities) confirms that there are no vaping products licensed as cessation aids. “Some of Health Canada’s statements in relation to vaping products appear to be consistent with a therapeutic claim even though no such vaping products are licensed as a cessation aid in Canada“. Health Canada has stated that a medically-licensed vape would be exempted from any nicotine cap or flavour ban that may be imposed on consumer vapes.

Many discussions of the risks and benefits of vaping end with the statement that no vaping products are licensed for smoking cessation. This gives the impression that they are unsafe or ineffective, when in fact multiple controlled trials show that they are more effective than traditional NRT. In many cases, health care providers are forbidden to recommend vaping for smoking cessation as it is not licensed for this purpose. A single example of a licensed vape would legitimize the whole concept of vaping as a way to quit smoking, allow health care providers to recommend vaping, and encourage more smokers to try switching to vaping.

Even in England, which leads the world in supporting vaping as a safer alternative to smoking, people who work in Stop Smoking Services are reluctant to recommend e-cigarettes to their clients because they are unlicensed. In a survey, 55.8% said that they never recommended e-cigarettes to anyone. However, over 65% of them agreed that “if an e-cigarette was a licensed medication, I would definitely recommend them to clients”. (Views from the Coalface: What Do English Stop Smoking Service Personnel Think about E-Cigarettes? Rosemary Hiscock et.al. Int. J. Environ. Res. Public Health 2015, 12, 16157–16167; doi:10.3390/ijerph121215048).

Australian guidelines are similarly hesitant about nicotine vaping products (NVPs):

“Recommendation 15 – For people who have tried to achieve smoking cessation with first-line therapy (combination of behavioural support and TGA-approved pharmacotherapy) but failed and are still motivated to quit smoking, NVPs may be a reasonable intervention ……this needs to be preceded by an evidence-informed shared-decision making process, whereby the patient is aware of the following caveats:

NVPs are not registered therapeutic goods in Australia and therefore their safety, efficacy and quality have not been established.

There is a lack of uniformity in vaping devices and NVPs, which increases the uncertainties associated with their use.

https://www.racgp.org.au/clinical-resources/clinical-guidelines/key-racgp-guidelines/view-all-racgp-guidelines/supporting-smoking-cessation/pharmacotherapy-for-smoking-cessation

In England, commercial vapes are seen as a smoking cessation aid and sold in pharmacies, but in many other countries they are considered a “tobacco product” (even though they do not contain any actual tobacco) and are banned from pharmacy shelves. A medically-licensed vape would belong in a pharmacy, alongside traditional forms of NRT.

Smokers may be deterred from using vaping as a way to quit smoking by the high initial cost of a vaping device and a starter pack of vaping liquid. If these items were medically licensed, then they could be reimbursed through insurance or be considered as a tax-deductible medical expense.

There is a great deal of research that needs to be done on the health effects of vaping, and on the best ways to use vaping to reduce the toll of combustible tobacco products. However, many researchers have difficulty getting ethical approval for vaping studies as there are no licensed vapes that they can use. Research would be aided by the availability of a recognized, licensed, standard vape, just as there are currently standard brands of tobacco for research use. For example, Dr. Peter Selby, a Senior Medical Consultant at the Centre for Mental Health and Addiction (Canada’s largest mental health teaching hospital), is actively seeking a vaping device that can be used for research:  “I am looking for a manufacturer (ideally pod-based non-refillable) willing to go through the regulatory hurdles to allow us to conduct a proper study. This is hard and I feel this is a major regulatory hurdle in Canada.” (Dr. Peter Selby, personal communication, June 2022.)

Role of a medically-licensed vape

A medically-licensed vape would be an addition, rather than an alternative, to the consumer model for selling vape. Many smokers feel that nicotine use is a consumer choice, not a disease, and that they should be able to purchase their preferred source of nicotine in a retail marketplace.

Other smokers may prefer, or be directed towards, a medical model for smoking cessation. Smokers who wish to quit should be offered vaping as an option whether they go to a doctor, to a hospital, a stop smoking clinic, a pharmacist or a vape store. This will only be possible if at least one model of vape is medically licensed.

There should be no “wrong way” of quitting smoking. 

Design requirements

One crucial aspect of vaping that must not be lost in the process of developing a medically licensed vape is the ability of vapers to choose how long each puff lasts for and therefore how much nicotine they inhale with each puff. This ability to self-titrate nicotine absorption to match the nicotine requirements seems to be an essential part of the effectiveness and acceptability of vaping. Some form of metered-dose inhaler for flavoured nicotine might be easier to get approved, but would miss the point. A vape should not cut off the nicotine supply just because a certain number of milligrams of nicotine has been delivered. 

The system should probably be a compact, high nicotine concentration, small volume pod style vape, using nicotine salts, similar to JUUL. Disposable pods would be preferred as they are more tamper-proof and more convenient for people with impaired vision or reduced manual dexterity. They must be available in a wide range of nicotine concentrations from 0 to at least 50 mg/ml. They should be available in a range of flavours including at least one fruit, one dessert, and one citrus or minty option.

Colour and style should reflect the medical nature of the product, perhaps by including the caduceus symbol or by using a shade of blue associated with hospitals such as UK National Health Service Blue (Pantone300).

Process

In Canada, a vaping product that makes any therapeutic claim (i.e., this product can help you quit smoking) would need to be authorized under the Food and Drugs Act. An overview of how vaping products are regulated, which also lists additional information regarding therapeutic claims is available at: https://www.canada.ca/en/health-canada/services/smoking-tobacco/vaping/product-safety-regulation.html

Who should develop this [product?

The development of a medical-quality vaping device would take time and involve significant expense. Ideally this should be undertaken by a company with no association with the tobacco industry, but in practice, the only businesses that have the resources to undertake the necessary product development and research, and deal with the administrative and legal processes, are tobacco companies. There are several tobacco companies that profess an interest in moving to reduced-risk products:

PMI

Of all the global tobacco companies, PMI is the most serious about diversifying into multiple non-combustible tobacco products. It already gets 28% of its revenue from non-combustible tobacco products such as iQOS, the heat not burn device that has captured 19% of the Japanese tobacco market. It now has a new vape, and is in the process of acquiring Swedish Match, with its profound knowledge and experience of oral nicotine products. It aims to become a majority smoke-free business by 2025.  PMI’s CEO, Jacek Olczak says that cigarettes should be treated like internal combustion cars, which will be outlawed from 2030 in the UK. Through organizations such as the Foundation for a Smoke-Free World and projects such as Unsmoke Canada, PMI is playing a leading role in the transformation of “Big Tobacco”. A medically-licensed vape would be a useful additional tool that can assist in achieving this worthy goal.

BAT

BAT state that: “It is widely acknowledged that most of the harm associated with conventional cigarettes is caused by the toxicants in the smoke produced by the burning of tobacco. That is why we are dedicated to the development and commercialization of alternative tobacco and nicotine products that don’t burn tobacco to deliver nicotine to the user and offer smokers an enjoyable, reduced-risk alternative. We’re setting ourselves ambitious targets: we aim to grow our annual revenue from new categories to £5 billion by 2025 and to have 50 million consumers using our non-combustible products by 2030.” A medically-licensed vape could help them meet this target.

Altria

Altria recognizes that the future of the tobacco industry is about innovation, harm reduction and informed consumer choice. They are focusing their tremendous resources and talented people on reducing the risk of tobacco products, while expanding choices for adult consumers. They plan to deliver a portfolio of innovative, authorized smoke-free products and equitably transition adult smokers to them. To achieve this goal in Canada and like-minded countries such as the UK and New Zealand, they should include a medically-licensed vape in their portfolio of products. This will help them to “Move beyond smoking” and fulfill their vision of responsibly leading the transition of adult smokers to a smoke-free future.

JUUL

JUUL was originally an independent vaping company but was later bought by Altia. JUUL brand e-cigarettes have been called the most successful anti-smoking product ever invented. JUUL states that “Our mission is to transition the millions of Canadian adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products” Developing a medically-licensed vape, and marketing it through medical organizations, stop smoking clinics and pharmacies would be a significant way to demonstrate that JUUL is serious about being a smoking cessation tool for adult smokers.

Health Canada and Canadian Universities?

Any product developed by a tobacco or vaping company will be viewed with suspicion by some people. As an example, some organizations are planning to boycott Medicago’s safe and effective Covifenz ® COVID-19 Vaccine simply because the development was funded in part by a tobacco company. However, Canadian Universities have a great deal of expertise in engineering, design and technology, and are capable of inventing new products and spinning off successful businesses. Health Canada should sponsor a design competition for the safest possible vape and provide seed money so that the winning designs can be brought to market. This would benefit the Universities, Health Canada, and most importantly, Canadians who smoke. However, at present, Health Canada only looks at vaping as a threat to non-smoking teenagers and is not promoting vaping as a smoking cessation tool or as a safer alternative for smokers who are dependent o nicotine.

CONCLUSION

In many countries, including Canada, the UK and Australia, a medically-licensed vape would create consumer confidence in the concept of vaping as a safer alternative to smoking. It would make it easier for physicians and other health care providers to recommend or prescribe vaping, encourage the sale of vaping products in pharmacies (in addition to vape stores), and allow vaping products to be covered by health insurance plans, like other forms of nicotine replacement therapy.

Unfortunately, the legislative burden that many governments impose means that, without government support, only companies funded by the tobacco industry have the scientific, administrative and legal resources needed to develop a medically-censed vape. While many tobacco companies talk about investing in reduced-risk products, it remains to be seen how far they are actually willing to go in transforming the tobacco market and saving the lives of cigarette smokers, and if the medical community would accept a health product manufactured by the tobacco industry.

The best approach to getting a medically-licensed vape into the Canadian market might be a collaboration between Health Canada and some of Canada’s leading universities, but this seems unlikely.

A medically-licensed vape would make it more likely that smokers would try vaping, it would help some of them to quit, and provide a reduced-risk alternative for those who continue to need nicotine, but neither market forces nor government intervention seems likely to create such a product.