Top Ten Questions

About Smoke Free Products Answered by Experts

Cigarette smoking is one of the leading preventable causes of illness and death. Projections by public health experts using World Health Organization data show that there will be more than one billion smokers around the globe for the foreseeable future. Despite all the regulations and strict policies enforced by governments, people still find a way to smoke. Smoke-Free products offer an alternative. It is based on the idea of harm reduction: we can incentivize smokers to switch from cigarettes to products that reduce the risks of smoking. Public health experts predict that smokers who switch to combustion-free products can substantially reduce smoking and the risk of developing smoking related diseases and eventually overall population harm. As consumers, we have the right to choose products that are less harmful than cigarettes.

  • Nicotine is necessary to ensure that e-cigarettes are acceptable to smokers. Without nicotine, no one will buy a less harmful alternative product. 
  • Royal College of Physicians: The main culprit [for the deaths caused by cigarette smoking] is smoke and, if nicotine can be delivered effectively and acceptably to smokers without smoke, most if not all of the harm of smoking could probably be avoided. 
  • Public Health England: “The principal addictive component of tobacco smoke is nicotine. However, aside from minor and transient adverse effects at the point of absorption, nicotine is not a significant health hazard. Nicotine does not cause serious adverse health effects such as acute cardiac events, coronary heart disease or cerebrovascular disease, and is not carcinogenic.”
  • UK National Institute for Health and Care Excellence: “It is primarily the toxins and carcinogens in tobacco smoke, not the nicotine, that cause illness and death.”
  • UK Royal College of Physicians: “Extensive experience with nicotine replacement therapy in clinical trial and observational study settings demonstrates that medicinal nicotine is a very safe drug and there are no grounds to suspect appreciable long-term adverse effects on health.”
  • US Food and Drug Administration: “We have reviewed the published literature on this longer-term use of Nicotine Replacement Therapy products and have not identified any safety risks associated with such use.”
  • Mitch Zellner, Director of the US FDA Center for Tobacco Products: “Nicotine is the very same compound FDA has approved for over 30 years as a safe and effective medication. People are dying from the tobacco-related diseases from the smoke particles, not the nicotine.”
  • The gateway theory is usually invoked in addiction discourse, suggesting that the use of one drug will lead to the use of another drug. No clear provenance exists and its origin appears to derive from lay, academic, and political models. 
  • A recent analysis of the gateway theory concluded “Although the concept of the gateway theory is often treated as a straightforward scientific theory, its emergence is rather more complicated. In effect, it is a hybrid of popular, academic, and media accounts – a construct retroactively assembled rather than one initially articulated as a coherent theory.”
  • Despite these serious and fatal flaws in the arguments, the use of the term “gateway” is commonplace both in the academic literature and in the lay press, particularly in relation to e-cigarette use and whether it leads to smoking. Public Health England strongly suggested that use of the gateway terminology be abandoned until it is clear how the theory can be tested in real-world conditions.
  • Public Health England observed that since e-cigarettes were introduced to the market, smoking prevalence among adults and youth has declined. Thus, there is no evidence that e-cigarettes are renormalizing smoking. On the contrary, it is very much possible that their presence has contributed to further declines in smoking or denormalization.
  • World Health Organization: In one country (United Kingdom), where tobacco-control measures are very strong and ENDS use is popular and growing, it seems that smoking prevalence, cigarette consumption as well as overall nicotine use continues to decrease gradually… at least for the United Kingdom, renormalization as measured by prevalence of smoking is not occurring currently.  

It is clear that instead of driving people towards cigarettes, e-cigarettes are driving smokers to switch away from cigarettes. As shown in the study by Kozlowski et al., Adolescents and e-cigarettes: Objects of concern may appear larger than they are (May 2017): 

“The proportion of never-smoking youth who try e-cigarettes is small.  With only a fraction of those being induced to try smoking (if the gateway theory does hold), the proportion of never-smokers so induced is much smaller still.  Further, the percentage of youth who try smoking who go on to become dependent smokers is itself minor. So the aggregate risk implied by the prospective studies is very small.  Further – and we consider this very important – the data from large national cross-sectional studies provide no evidence that kids’ use of e-cigarettes is increasing smoking.  If anything, those data suggest the opposite.”

 

A study involving young people’s use of e-cigarettes in the United Kingdom found that there is no evidence of e-cigarettes driving smoking prevalence upwards: 

“Our findings indicate that there is no evidence of e-cigarettes driving smoking prevalence upwards. This is important, and suggests that fears about e-cigarettes as a gateway to more youth becoming smokers are not currently justified, at least in the UK.”

 

Public Health England in a recent review of the evidence also concluded that the increase in the use of e-cigarettes has not led to higher smoking rates which has continued to decline:

[T]he main factor which challenges the ‘vaping leads to smoking’ hypothesis is what is happening with rates of youth tobacco cigarette use in the UK (and indeed in North America where the other studies were conducted). During the period when surveys show that young people are experimenting with [electronic cigarettes], including some non-smokers, tobacco cigarette smoking rates have continued to decline.

If [electronic cigarette] use was causing smoking at the population level, these reductions in youth cigarette smoking would have significantly slowed or indeed reversed in the UK. This is not happening, and suggests that EC are not currently undermining what decades of efforts to prevent youth smoking uptake have achieved. 

Concerns over the initiation of never smokers or former smokers returning to tobacco use as a result of the availability of HTPs is not supported by data from Japan. The same is true in other countries. In the UK, for example, among the more than 3.2 million e-cigarette users, only 100,000 are never smokers.

  • The evidence in the United Kingdom does not support the theory that e-cigarettes are attracting minors. In their 2015 study, Public Health England found that regular e-cigarette use among the youth is rare with around 2% using e-cigarettes at least monthly and some 0.5% using it weekly. Prevalence of use (at least monthly) among never smokers is 0.3% or less. 
  • Public Health England: E-cigarette use is frequently misreported, with experimentation presented as regular use. 
  • Cancer Research UK: “There’s a common perception that the rise we’ve seen in the use of e-cigarettes will lead to a new generation of adults who have never smoked but are dependent on nicotine. This fear is based on the expectation that due to the appeal of the products, children who have never used tobacco will be attracted to e-cigarettes and start to use them regularly. Our survey is in line with others in the different parts of the UK that show this is not happening. Young people are certainly experimenting with e-cigarettes, some of which do contain nicotine. However, our data show that at the moment this experimentation is not translating into regular use.” 
  • Cancer Research UK: “These data on electronic cigarette use in youth suggests that e-cigarettes are not serving as a gateway to tobacco. It’s reassuring that rates of smoking in young people are continuing to fall at a time when e-cigarette use has been rising.”
  • This concern over minors using e-cigarettes is addressed by legislation that will ban the sale and marketing of these products to people below 18 years of age.
  • Actually, we do know what people are inhaling. E-cigarette vapor typically contains propylene glycol or glycerine, water, nicotine, and flavorings. Considering that the initial science shows that it is significantly safer than regular cigarettes, e-cigarettes should be allowed as an option for adult smokers who may think of switching to less harmful alternatives. 
  • Public Health England: “Propylene glycol is an active ingredient of the solutions used to generate the synthetic smoke widely used in the performing arts and nightclubs, and in this context is generally considered to be safe… Studies of repeated inhalation in rats found no evidence of damage to the lungs.”
  • Public Health England: “Two recent worldwide media headlines asserted that e-cigarette use is dangerous. These were based on misrepresented research findings. A high level of formaldehyde was found when e-liquid was over-heated to levels unpalatable to e-cigarette users, but there is no indication that e-cigarette users are exposed to dangerous levels of adelhydes… While vaping may not be 100% safe, most of the chemicals causing smoking-related disease are absent and the chemicals that are present pose limited danger. It had previously been estimated that e-cigarettes are around 95% safer than smoking. This appears to remain a reasonable estimate.”
  • French Office for Prevention of Tobacco: “Despite the uncertainty, it is very likely that the electronic cigarette is much less hazardous than traditional cigarettes and replacing smoking with electronic cigarettes can be beneficial for health.”
  • David Khayat, oncologist and tobacco control advisor to former French President Jacques Chirac (2016): “It has been perfectly demonstrated in the cancer studies field that there is always a relation between the dosage of carcinogenic substances (solar radiation, wine, tobacco, alcohol) and the risk of developing cancer. For this reason, if anyone finds a way to smoke without the same level of carcinogenic substances in tobacco, the risk will certainly be reduced.”
  • Allison Cox, Director of Cancer Prevention at Cancer Research UK: There is growing evidence that e-cigarettes are a much safer alternative to tobacco, and suggests that the long-term effects of these products will be minimal. Understanding and communicating the benefits of nicotine replacements, such as e-cigarettes, is an important step towards reducing the number of tobacco-related deaths in the UK. 
  • UK Medicines and Regulatory Healthcare Agency: “It seems likely the risks [of e-cigarettes] are smaller than from smoking tobacco cigarettes and switching to electronic cigarettes, even temporarily, may yield a health benefit.”
  • E-cigarettes do not emit smoke, what comes out of the device is just vapor. 
  • Public Health England: The constituents of cigarette smoke that harm health – including carcinogens – are either absent in e-cigarette vapor or, if present, they are mostly at levels much below 5% of smoking doses (mostly below 1% and far below safety limits for occupational exposure). 
  • Public Health England found that e-cigarettes release negligible levels of nicotine into ambient air with no identified health risks to bystanders. This is after they surveyed several studies of nicotine in ambient air. E-cigarette exhalations contained eight times less nicotine than cigarette exhalations. The fact that e-cigarettes have no side-stream smoke (smoke that comes out of a cigarette even when a smoker is not puffing) also contributes to this conclusion given that it accounts for some 85% of second hand smoke. At the highest concentration recorded on a surface (550 ug/m2), an infant would need to lick over 30 square meters of exposed surface to obtain 1 mg of nicotine.
  •  Public Health England: “E-cigarettes release negligible levels of nicotine into ambient air with no identified health risks to bystanders.”
  • Public Health England: “Partners of vapers had [nicotine concentrations] about 1,000 times less than the concentrations seen in smokers and similar to levels generated by eating a tomato.”
  • UK Action on Smoking and Health: “We have been unable to find any published scientific evidence of harm from indirect exposure to NCPs [nicotine containing products]. The MHRA [UK medicines regulator] review considered four studies looking at passive harm, or what we would call ‘secondhand exposure’. All these studies found levels of potentially harmful constituents in vapor at levels which are, by many times, lower than tobacco smoke, with one concluding ‘no apparent risk to human health.’”

No. The experts say that so long as people don’t share devices and maintain proper social distancing, then the use of smoke free products will not impact a person’s risk of catching COVID at all. 

 

Dr. Konstantinos Farsalinos (University of Patras) “There is no pathophysiological basis or rationale that only ever but not current use predisposes to positive COVID-19 diagnosis. Finally, the findings are in disagreement with a large number of studies showing that smokers are less likely to be diagnosed or be hospitalized for COVID-19. A recent UK study of 8 million participants, with 19,000 of them being diagnosed with COVID-19, found that smokers were 50-60% less likely to be diagnosed with COVID-19 and 80-90% less likely to be admitted to the ICU for COVID-19, and these findings provide further support for the potential protective role of nicotine in COVID-19, a hypothesis that has been presented since early April.” 

Source: https://www.facebook.com/483339025193530/posts/1610384589155629/?d=n

 

The US FDA even authorized the marketing of IQOS, a heated tobacco product, with reduced exposure information in July of this year, in the middle of the pandemic. The agency stated that scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.

Source:  https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-iqos-tobacco-heating-system-reduced-exposure-information 

 

There is no data or evidence that vaping can increase the risk of COVID-19 transmission. In fact, even the WHO has only identified water pipe smoking (and not cigarette smoking or vaping) as having the potential of increasing the risk of transmission of disease. This is due to the nature of water pipe smoking where a single mouthpiece is shared between users and the apparatus may promote the survival of microorganisms outside the body. This is not the case in vaping where the device is not shared by different users. 

Source: http://www.emro.who.int/tfi/know-the-truth/tobacco-and-waterpipe-users-are-at-increased-risk-of-covid-19-infection.html

 

Sussman (National University of México) and Escrig (Universidad Autónoma de Madrid, Spain): Exhaled vapor as a risk of SARS-CoV-2 contagion does not require more strict protective measures than those contemplated for non-vapers. The associated flow dynamics suggests that keeping the same 1.5 to 2 meters “social separation” distance recommended for non-vapers should prevent any contagion from an infected vaper. Aerosol dynamics tell us that contagion risk from exhaled vapor is not even remotely comparable to the contagion risk from sneezing or coughing.

 

Rosanna O’Connor, director of the Tobacco Alcohol and Drugs of Public Health England stated that there is no evidence of contagion through vapor exhaled by users of e-cigarettes

 

Professor Neil Benowitz of the University of California at San Francisco declared that: It is my understanding that exhaled e-cigarette vapor consists of very small particles of water, propylene glycol and glycerin and flavor chemicals, not droplets of saliva. The vaping aerosol evaporates very quickly, while particles that are emitted when coughing or sneezing are large particles that persist in the air for a relatively long period of time. Thus, I would not think that vapers present any risk of spreading COVID-19, unless they are coughing when they exhale the vapor.

Source: https://athra.org.au/wp-content/uploads/2020/03/Sussman-R-Escrig-C.-A-review-of-vaping-and-COVID19.pdf  

  • Royal College of Physicians: Nicotine regulation should be designed to make these products a more attractive, available, and affordable option for smokers than cigarettes, to prevent, as far as possible, uptake of nicotine use by never-smokers, particularly children, and to make smoked tobacco products as unappealing as possible.
  • Prof. Kevin Fenton, National Director of Health and Well-being at Public Health England: “The evidence is clear that vaping is much less harmful than smoking and that e-cigarettes are helping many smokers to quit… Different approaches will be appropriate in different places, but policies should take account of the evidence and clearly distinguish vaping from smoking.”
  • We need a regulatory regime that will ensure that minors are not allowed to access and to use tobacco or nicotine-containing products. 
  • Clive Bates: Imposing excessively restrictive or burdensome cigarette regulations on non-combustible products, including e-cigarettes and heated tobacco products, provides de facto protection for cigarette sales and will prolong and deepen the smoking epidemic. 
  • Abrams, D., et al., Statement from Specialists in Nicotine Science and Public Health Policy: Policies that are excessively restrictive or burdensome on lower risk products can have the unintended consequence of protecting cigarettes from competition from less hazardous alternatives, and cause harm as a result. 
  • UK Department of Health: The best thing a smoker can do for their health is to quit smoking. However, the evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco. The government will seek to support consumers in stopping smoking and adopting the use of less harmful nicotine products.

EVALI: Fact and Fiction

What is EVALI?

According to the Harvard Medical School, E-cigarette or Vaping Product Use Associated Lung Injury (or EVALI) is an inflammatory response in the lungs (i.e. pneumonia) triggered by inhaled substances, many of them illicit or counterfeit. 

Alleged EVALI case in the Philippines

On Nov. 15, 2019, the Department of Health (DOH) recorded the first claimed case of EVALI in the Philippines, 16-y/o girl from Central Visayas who had been using e-cigarettes (not a heated tobacco product) for six months while also smoking regular cigarettes. She was admitted on Oct. 21 that same year, initially presented with sudden-onset severe shortness of breath, required oxygen supplementation, and ICU admission. She was eventually discharged from the hospital. 

On Nov. 16, 2019, Secretary Francisco Duque III of the DOH cited that findings on the patient were “not conclusive (of EVALI),” noting that the patient needed to undergo more tests to rule out possible infectious diseases that may be caused by a virus or bacteria. The Secretary instructed the Research Institute for Tropical Medicine to look into further evaluation (The results were not shared publicly).

On Jan. 6, 2020, the FDA released a report concerning an early 2020 case of a 17 y/o male from Iloilo, who presented low heart rate and seizures. History showed consumption of “Gluttony Mamon” liquid e-cigarette. A PDEA analysis revealed illegal cannabinol and tetrahydrocannabinol (THC) in the liquid, the principal psychoactive constituent of cannabis.

The FDA subsequently warned the public when purchasing ENDS and ENNDS products with incomplete product declarations as these pose a public health risk (on top of being a violation of the Dangerous Drugs Act). A similar warning was sent to sellers and distributors.

As of today, there is no local case of EVALI that has been officially recorded by the DOH.

EVALI Resolution in the United States

In August 2019, the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) investigated the more than 2,290 alleged EVALI cases in the United States. A proliferation of false news from July to September, pointed to vaping in general as the main culprit of the US’s lung injuries, was markedly observed.

Finally, in late September 2019, the CDC detected that many samples tested contained THC and the presence of Vitamin E acetate. Based on reports, it appears unlikely that these products have been subjected to appropriate safety and quality controls.

A preliminary analysis published  in the New England Journal of Medicine found that 84%  of patients reported using THC in e-cigarettes. 

The CDC and the FDA then re-emphasized the following: 

  1. Not to use THC-containing products (not e-cigs per se but those with illicit additives), especially those with Vitamin E acetate. THC use has also been associated with a wide range of health effects, so it is best to avoid products containing THC.
  2. Adults using a nicotine-containing e-cigarette or vaping products as an alternative to cigarettes should not go back to smoking.
  3. E-cigarette, or vaping, products should never be used by youths, young adults, or women who are pregnant. Adults who do not currently use tobacco products should not start using e-cigarette, or vaping, products.

Due to the subsequent identification of the primary cause of EVALI, the availability of US CDC and US FDA guidelines, and the eventual and considerable decline in EVALI cases, the CDC stopped collecting these data from states as of February 2020.

Regulation to Prevent EVALI 

The EVALI case highlights that a wild west approach to e-cigarette regulation can harm consumers. This learning experience of having black market vaping products in the US shows the importance of a regulatory framework that would allow the following:

  1. Access to these products for one audience: current adults who smoke and would continue to do so. Former and never users of nicotine, especially youth, should not use  any kind of nicotine products.
  2. Channels that provide factual information about smoke-free products should be allowed. In the absence of such information, many adults who have made the switch from cigarettes may, unfortunately, go back to smoking, while those who might switch to better choices will instead continue to smoke.
  3. Better oversight of vapor products in the market, with a clear and distinct differentiation vs. regular/ smoked cigarettes.
  4. Creation and enforcement of product standards will safeguard public safety from substandard devices and illicit ingredients and protect consumer rights.

Heated tobacco products have a similar operating principle as e-cigarettes – providing nicotine without burning tobacco – but a different mode of doing so: they heat tobacco rather than burning it to generate a nicotine-containing vapour instead of smoke. Because they eliminate combustion, a number of public health experts agree that heated tobacco products have a dramatically different risk profile than cigarette smoking and their availability would benefit public health. 

In the context of the first heated tobacco product application to the U.S. FDA for authorization to market a modified risk tobacco product — an advisory committee to the FDA agreed, by a vote of 8-1, that “[s]cientific studies have shown that switching completely from cigarettes to the [tobacco heating system] significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

The US FDA concluded in its MRTP decision that IQOS, as actually used by consumers, is appropriate to promote the public health and is expected to benefit the health of the population as a whole. In summary, the FDA stated that the available evidence to date shows the following: 

  • The IQOS system heats tobacco but does not burn it. 
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals. 

The FDA further mentioned in its conclusion that “the totality of evidence presented suggests that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies.” 

Other independent studies also confirmed that the aerosol from heated tobacco products is less toxic than cigarette smoke. Comparing heated tobacco products with cigarettes, Public Health England (PHE) has found that “heated tobacco products are likely to expose users and bystanders to lower levels of particulate matter and harmful and potentially harmful compounds (HPHC).” The U.K. Committee on Toxicity, an independent advisory committee to the UK Department of Health, independently assessed two heated tobacco products. The Committee determined that “it is likely that there is a reduction in risk, though not to zero, to health for smokers who switch completely to heat-not-burn tobacco products.” Later on, the Science & Technology Committee of the U.K. House of Commons reached a similar conclusion, stating that “‘[h]eat-not-burn’ products contain tobacco which is heated rather than combusted, and [are] therefore likely to be less harmful compared to conventional cigarettes.” Public Health England stated that compared with cigarettes, heated tobacco products are likely to expose users and bystanders to lower levels of particulate matter and harmful and potentially harmful compounds.