Lethal miscommunication: FDA fails to explain the relative risks of tobacco products

The US Food and Drug Administration published a page on the relative risks of tobacco products. It fails in that mission. But did it even try?

“The great enemy of clear language is insincerity. When there is a gap between one’s real and one’s declared aims, one turns, as it were, instinctively to long words and exhausted idioms, like a cuttlefish squirting out ink.”
― George Orwell, Politics and the English Language

On 16th April 2024, the US Food and Drug Administration (FDA) published a new risk communication page, The Relative Risks of Tobacco Products.

In this blog, I will review the contents of this page, quoting the relevant text, providing a critique, and drawing out a few broader issues at the end. The headings and table of contents below follow the FDA’s structure and five headings.

See: FDA website, accessed 18 April 2024

FDA’s page on relative risks of tobacco products

Author’s note: from this point on, the text in blockquotes and the next five headings follow the wording of the FDA’s page of relative risks.

Significant progress has been made in reducing cigarette smoking in the United States through comprehensive, population-level strategies. However, more than 30 million U.S. adults still smoke cigarettes, and smoking remains the leading cause of premature disease and death nationwide.

FDA, April 2024

There is no reflection here on why the demand for cigarettes is so persistent despite the widely known harms and several decades of anti-tobacco campaigns and policies. The common response would be “addiction”. But it is plausible that people use nicotine for at least three reasons: (1) hedonistic – its use is pleasurable; (2) functional – it may help with stress and anxiety or improve cognitive performance in some people; (3) therapeutic – some people may be self-medicating with nicotine.

Understanding the demand is a prerequisite for addressing the harms. If the underlying demand for nicotine is much more robust and resilient than any particular way of taking it, then harm reduction strategies will become more important because they address the harm without requiring the user to stop using nicotine. Until the FDA can grasp the reasons for the demand for nicotine, it will be flying blind both as a regulator and risk communicator.

FDA’s Center for Tobacco Products (CTP) is committed to protecting the health of all people in the United States through a comprehensive approach to reduce the burden of tobacco use. This includes timely and evidence-based public health education that complements the agency’s regulatory actions.

FDA, April 2024

The burden of tobacco use arises overwhelmingly from smoking. The tendency to conflate all tobacco products (including nicotine products that do not contain tobacco) using a legalistic definition is a form of risk miscommunication. The risks of the full range of tobacco and nicotine products likely extend over three orders of magnitude.

In addition to preventing youth initiation and promoting cessation among people who use tobacco products, CTP is working to educate adults who smoke about the relative risks of tobacco products.

FDA, April 2024

The first two of these strategy components are described as forms of behaviour change with intended outcomes (prevention, cessation). Why doesn’t the FDA say something similar for the third option, harm reduction? For that, the FDA is just “working to educate adults who smoke”, not to save actual lives. Why can’t it just assertively recommend switching? For example, why not say: “For people who cannot or do not wish to quit nicotine use, CTP supports the switch to exclusive use of significantly lower-risk tobacco products.”

Also, why do they not want to educate everyone, not just adults who smoke, about relative risks? An agency can’t ethically sustain different versions of the truth for different populations according to its preferences for their behaviour.

What is Meant by the “Relative Risks” of Tobacco Products?

No tobacco product is safe. However, the health risks for different tobacco products exist on a spectrum, which is sometimes referred to as a “continuum of risk.” Combusted, or smoked, tobacco products – such as cigarettes – are the most harmful type of tobacco product. Non-combusted products – such as e-cigarettes and other smokeless tobacco products – generally have lower health risks than cigarettes and other combustible tobacco products.

FDA, April 2024

The problem here is that it is possible to be literally correct but still misleading by omission. In practice, there is a major discontinuity of risk between products that involve inhaling the smoke from burning tobacco leaves and products that do not. This is the most important distinction in nicotine-related public health: between combustible and non-combustible, and it is obscured in this communication. The phrase “generally have lower health risks” is a poor characterisation of the very large differences in risk between combustible and non-combustible products.

Before introducing a new tobacco product to the U.S. market, a company must submit a marketing application to the FDA and receive authorization. New tobacco product applications are evaluated by FDA scientists who determine if the application shows the new tobacco product meets the applicable statutory standards. Tobacco products that may be legally marketed in the United States are listed in FDA’s Searchable Tobacco Products Database.

FDA, April 2024

In this, the FDA is implying that the only products that qualify as lower risk are those it has authorised – otherwise, this text would be extraneous in a section devoted to the “relative risks of tobacco products”. Yet, this is clearly not the case. The relative risks are determined by physics, chemistry and biology, not by bureaucratic affirmation. There are many reasons why much safer products than cigarettes have not been approved by the FDA – principally, the FDA has erected insurmountable, opaque and shifting barriers to entry that exhaust the resources of all but the largest tobacco companies.

Additionally and bizarrely, the FDA has authorised a cigarette product, the 22nd Century VLN, which it inexplicably found to be “appropriate for the protection of public health”. I would like to advise all Americans not to use this cigarette, whatever the FDA says.

Additionally, to market a tobacco product as a modified risk tobacco product (MRTP), an MRTP application must be submitted to the FDA. An order permitting the sale of an MRTP refers to specific products, not an entire class of tobacco products. An MRTP application generally must demonstrate that the product will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

FDA, April 2024

FDA inadvertently highlights a significant problem with its own risk communication regime – the MRTP system. This is an authorisation system for making risk-related claims. However, the communication of risks by this method is contingent on corporate interest, not the public interest. Before a company applies for an MRTP, it has to believe it is worthwhile commercially to spend the money and time to undertake an MRTP application. Two companies with identical products and identical risks may view the case very differently (for example, it may not be worth the application cost for a company with a lower market share or new products on the way). The result is that public communication of risks is shaped by arbitrary commercial considerations and will tend to favour larger companies with greater market share, and simple unchanging product designs.

Are E-Cigarettes a Lower-Risk Alternative to Cigarettes?

While e-cigarettes can generally be a lower-risk alternative for adults who smoke cigarettes, the use of e-cigarettes is not risk-free. These products deliver harmful chemicals and contain nicotine, which is highly addictive. Moreover, given the harmful chemicals found in e-cigarettes, further high-quality research on both short- and long-term health outcomes is needed.

FDA, April 2024

FDA is unwilling to give a straight answer here, where a straight answer is what is most needed. “Yes” would be correct. Or better still, “Yes, much lower risk”. But for some reason, the FDA does not wish to challenge the cigarette trade in this way. So, its communication has the effect of protecting the cigarette trade through doubt and equivocation about the much safer alternative.

This statement is the core risk communication on the whole page, yet two-thirds of it is made up of caveats, doubts and equivocation. What is a person who smokes or a healthcare practitioner advising them supposed to make of this melange of ambiguity and evasion? Should they carry on smoking until the FDA has answers on short- and long-term health outcomes? Are the uncertainties such that vapes might be as dangerous or more dangerous than cigarettes? Or are we talking about uncertainties about the precise point on the polar opposite end of a risk spectrum?

It is impossible to tell.

Let’s unpack the language further:

  • “While…” sets up the sentence to mean “not really” – an introductory caution to wait for the caveats and doubts that will follow.
  • “can generally be” implies that lower risk depends on something unstated, and these products may not be lower risk in certain specific cases. But we cannot gauge how likely there are to be exceptions to the general rule. The right answer is approximately nil exceptions.
  • “lower risk alternative” does not convey any sort of magnitude, without which it is meaningless. Is it 2% lower risk, 20% lower, 95% lower or 99.8% lower? Unless the reader can get a feel for how much lower, the statement conveys nothing of value, nothing actionable.
  • “for adults”—the reduced risk applies to young people, too, and is likely a significant public health gain if young people are diverted from smoking initiation or uptake during their teenage years. FDA insists on ignoring this huge potential benefit arising from youth vaping, but it has no ethical basis or even a legal basis under the Tobacco Control Act to ignore benefits to youth.
  • “The use of e-cigarettes is not risk-free”—again, magnitude matters. Very little in life is completely risk-free. The question is whether the risks involved are outside the normal risk appetites we have for personal consumption or other lifestyle choices. Society runs on a “tolerability of risk” basis, not an aspiration to be “risk-free.” This applies particularly when the risks fall primarily on the user rather than on bystanders.
  • “harmful chemicals” is an implicit misrepresentation of the toxicology involved. Whether the chemicals in question cause harm depends on the extent and duration of exposure to them, not their presence at extremely low but detectable levels in the aerosol. We should be aware that even with smoking, people who smoke for 25 years and quit by age 40 avoid almost all the smoking-related mortality penalty.
  • “contain nicotine” plays into massive misperceptions about the health risks of nicotine, which most Americans incorrectly believe to be the cause of smoking-related disease – see the latest HINTS data (2019): only 21.4% disagreed with the statement that “the nicotine in cigarettes is the substance that causes most of the cancer caused by smoking“. So, the FDA has done nothing here to dispel this misconception but has added its observation about nicotine to a section on whether e-cigarettes pose a lower risk than smoking. It could have included a useful statement from a previous FDA Commissioner and CTP Director, Gottlieb & Zeller 2017, “Nicotine, though not benign, is not directly responsible for the tobacco-caused cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.”
  • “contain nicotine which is highly addictive” – whether nicotine is addictive depends on how it is delivered (its pharmacokinetics) and how “addiction” is defined. In many definitions of addiction, there is a requirement for “serious net harm” or similar, for example, the AddictO ontology uses this definition: “Addiction: A mental disposition towards repeated episodes of abnormally high levels of motivation to engage in a behaviour, acquired as a result of engaging in the behaviour, where the behaviour results in risk or occurrence of serious net harm.” If there is minimal harm. nicotine use would not meet this definition of addiction, even with strong reinforcement.
  • “Moreover, given the harmful chemicals found in e-cigarettes” – the ‘moreover’ provides further cautionary emphasis to a statement that is made without reference to cigarettes, even though the comparison between e-cigarettes and cigarettes is the purpose of this section. Suppose it had used this point to draw on the extensive biomarker and emissions toxicity literature to say, “Given the much lower levels of harmful chemicals…” wouldn’t that have been more useful?
  • “further high-quality research on both short- and long-term health outcomes is needed” – this statement essentially says to the ordinary reader that we just don’t know. Yet, it avoids any reference to what is known, which is a great deal. The word “needed” begs the question, needed for what? Is it needed before we know enough to suggest switching from smoking to vaping, or needed so we can know just how large the health benefits will be from doing that? And if this additional high-quality research is “needed”, when do we expect to have it, or have it sufficiently not to use the absence of evidence to induce doubt using this sort of formulation? The answer to that is probably never if it means measuring long-term health outcomes. This is a pure merchant-of-doubt play. We can always welcome further research, but we are obliged to form judgements with what we have. This is not unusual – for example, it’s done for climate change, intelligence and security assessments, natural hazard management, and a wide range of public health challenges.

Statements of this nature are basically useless as risk communications and have nothing to do with informing the people at risk about their options. They are constructed defensively to protect the entity making the statement from criticism. In effect, they transfer the problem of residual uncertainty to nicotine users while exaggerating unknowns and doing nothing to provide context that would reduce uncertainty.

By way of comparison, how about this for actionable candour from the UK’s national healthcare provider?

Source: National Health Service (England): Using e-cigarettes to stop smoking (extract)

Given that there is no safe tobacco product, youth and adults who do not use tobacco products should not start using e-cigarettes.

FDA, April 2024

This is standard FDA rhetoric and a widely used formulation among governments, regulators and public health agencies worldwide. So, it is not at all surprising to see it here. Yet, it is also unmoored from reality. What purpose does this language serve? It is a solemn but faintly ridiculous incantation of official preferences for youth behaviours. Imagine if we could have the full list of things that the FDA, or adults more generally, disapproved of… It would be very long, but would it make them disappear?

Young people considering whether to use nicotine do not generally make their decision contingent on the advice of the FDA or any other adult authority. To approach this from a public health perspective, we should assume that there is a demand for nicotine as there is with alcohol, caffeine, cannabinoids, and other substances and other risk behaviours and do what we can to contain and reduce harm. That’s not to endorse use but to face the challenge of risk mitigation more honestly.

And what’s that about adults? We certainly should not get into the absurd mess of believing that the only people who should use safer nicotine products are those who have used the more dangerous ones first. We should, however, assume that there are people who will use nicotine whether we like it or not and that, to the extent possible, they should be encouraged and nudged towards the safest ways to use it – and without having to use the most dangerous forms first.

For adults who smoke, switching completely from cigarettes to e-cigarettes may reduce exposure to many harmful chemicals present in cigarettes. However, it is important that they switch completely from cigarettes to e-cigarettes to get the full health benefit. Long periods of dual use of cigarettes and e-cigarettes can result in harms to health similar to, or in addition to, the harms from exclusive use of cigarettes.

FDA, April 2024

Here, FDA links to the National Academies of Science, Engineering and Medicine (NASEM) report on e-cigarettes, 2018. FDA could have reproduced the relevant summary page from the NASEM launch presentation, but chose not to use such plain language.

Instead, it uses equivocating language to add unnecessary distracting doubt. Take the statement “may reduce exposure to many harmful chemicals”; are there any examples of e-cigarettes that do not reduce exposure to many harmful chemicals? No, not one. So why say “may”? And it isn’t “many”; it is almost all. NASEM is willing to infer “likely to be far less harmful” from the available evidence; why not the FDA when it quotes the same report?

Note here that NASEM uses probabilistic language (“likely to be”) and a qualitative sense of magnitude (“far less harmful”) to convey its judgement about what the evidence and uncertainties mean for the intended audience. That is the right and proper approach, completely absent from FDA’s communication.

The encouragement to move to exclusive use is welcome. However, the statements about dual use are incomplete and misleading. Dual use is always an improvement on exclusive smoking, and it would never be appropriate to pretend otherwise. To do so may deter the most dependent smokers from beginning a longer-term migration of their nicotine use to non-combustible products. For many smokers, dual use will form part of a transition pathway to exclusive or near-exclusive vaping. That is something to encourage, not suppress, with risk communications. Dual use is a pretty silly concept anyway, as it varies from almost exclusive smoking to almost exclusive vaping. The aim should be to use risk communications to migrate users towards exclusive or near-exclusive vaping.

To date, FDA has authorized 23 e-cigarette products and devices. These products have undergone rigorous scientific review, including toxicologic assessments, and have been found by FDA to meet the statutory public health standard.

FDA, April 2024

This is one of the most egregious weaknesses in this communication. It implies that the FDA somehow has a grip on the market and that the 23 products it has authorised are those deemed acceptably safe and, by implication, all others are not. These 23 products and devices amount to six tobacco-flavoured product variants accounting for less than 3% of the market and all made by tobacco companies. FDA presents the outcomes of its dysfunctional authorisation system as if it has somehow provided a useful list of acceptably safe vaping products for use by Americans who smoke.

It has done nothing of the sort. FDA has blocked thousands of perfectly reasonable products from the market by using near-insurmountable bureaucratic barriers to entry, insatiable, opaque and shifting evidence demands, and an inappropriate interpretation of the “appropriate for the protection of public health” standard. The authorised products are purely an artefact of the way the FDA’s bureaucratic obstacle course creates selection pressure that favours the tobacco industry’s vape products. For comparison, the European Commission reports that 300,000 vaping products are registered for lawful sale in the European Union. Against all odds, Europeans seem to be fine.

What Options Are Available to Adults Who Smoke Cigarettes and Are Looking to Quit?

For adults who currently smoke cigarettes, fully quitting the use of all forms of tobacco products would most benefit their health. Evidence-based, FDA-approved medications – including nicotine replacement therapy (NRT), bupropion, and varenicline – have been proven to be safe and effective. These approved medications, along with behavioral counseling, should be the first line of therapeutic treatment for adults seeking to quit smoking. Behavioral counseling and medication are independently effective and combining them increases the likelihood of cessation.

FDA, April 2024

This is a very misleading section of the communication

Firstly, let us address the use of the word “safe.” This one word has two distinct and incompatible meanings in this communication. It depends on what it refers to – see these two cases:

  1. No tobacco product is safe.
  2. Evidence-based, FDA-approved medications – including nicotine replacement therapy (NRT), bupropion, and varenicline – have been proven to be safe and effective.

In the case of tobacco products (1), the FDA uses “safe” in the sense of zero or negligible risk of harm. But in the case of medications (2), “safe” does not literally mean zero or negligible risk. In another context, FDA itself explains:

The company must show that the drug is safe and effective for its intended uses. “Safe” does not mean that the drug has no side effects. Instead, it means the FDA has determined the benefits of using the drug for a particular use outweigh the potential risks. FDA, February 2018

When FDA says “safe and effective” in the context of smoking cessation medications, it does not literally mean “safe” in the same way it applies this word to tobacco or nicotine products on the same web page. It means that FDA judges that, on average, the risks of using this drug are outweighed by the benefits when the drug is used for the intended purpose and in the way specified based on the results of trials (not real world experience). In other words, smoking is so seriously harmful, that the FDA believes the risks, including the unknowns, justify the health benefits.

If you really want to know what “safe” means here, take a look at the side effects of these drugs (via MedlinePlus). A greatly abridged list includes potential harms like seizures, hallucinations, uncontrollable shaking, rapid, pounding, or irregular heartbeat (Bupropion) or swollen, red, peeling, or blistering skin, pain; squeezing, or pressure in the chest; back, joint, or muscle pain; sudden weakness or numbness of an arm or leg, especially on one side of the body (Varenicline).

Nor are these risks certain and fully explained. There are also known unknowns. For example, there are warnings about reported neuropsychiatric effects for which the causality is uncertain but with sufficient concern to justify raising it. For example, see Medline, Bupropion: precautions [and Varenicline” precautions carry an almost identical warning]:

….you should know that some people have reported symptoms such as changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts (thinking about harming or killing oneself or planning or trying to do so) while taking bupropion to stop smoking. The role of bupropion in causing these mood changes is unclear since people who quit smoking with or without medication may experience changes in their mental health due to nicotine withdrawal.

By the way, I’m not saying these risks aren’t worth taking. But if we apply the same sort of risk-benefit calculation and take an informed view of uncertainties, then vapes, pouches, and smokeless and heated tobacco would look very attractive based on what we know. We might even call them “safe and effective.” I am objecting to the misleading double standard used for the word “safe”.

As part of its efforts to encourage quitting among adults, CTP has developed cessation education materials for a wide range of audiences. CTP also partners with the National Cancer Institute’s smokefree.gov, which provides quitting support to people who use tobacco products.

FDA, April 2024

Though the theme of this whole page is supposed to be the relative risks of tobacco products, this section digresses to resources that do not address these risks and do not provide useful insights on whether it makes sense to use low-risk tobacco products to quit smoking if the user is inclined to continue nicotine use. This section directs users to a “quit or die” information and support pathway.

The first thing a user sees when opening the resources in the cessation education materials linked here is a youth-orientated “Vaping Prevention and Education” page and anti-vaping materials. Smokefree.gov is worse. Not only does it provide no insights into relative risks, it does not even countenance quitting smoking by switching to lower-risk products. However, it does offer vaping cessation resources, which simply reheats the smoking cessation playbook but for vapes.

For adults who smoke who choose to use e-cigarettes, it is important that they switch completely from cigarettes to e-cigarettes to get the full health benefit. Since there is no safe tobacco product, eventual abstinence from all tobacco products should be the end goal.

FDA, April 2024

The first sentence is good advice. But it is good advice only because of what the FDA has failed to articulate clearly in this communication: that e-cigarettes are much less risky than cigarettes. So, the agency implicitly accepts the premise it is unable to articulate clearly for the public.

The second part about abstinence is very questionable, even if it will appear self-evident to many. Two main things are wrong: first, some people might like vaping, especially if the risks are low. Second, no one lives life with an aspiration to zero risk. Few would ever say something like this about alcohol. There are good reasons for some people not to have complete cessation as the end goal; for example, if they enjoy nicotine use or gain something from it and have reduced most of the health and welfare detriments by switching, or they would experience a prolonged sense of loss or craving, or it would increase risk of relapse to smoking.

Why Is It Important for Adults Who Smoke to Understand the Relative Risks of Tobacco Products?

Many people who use tobacco products have misperceptions about nicotine and the risks of various tobacco products. Despite science that shows that e-cigarettes generally have lower levels of harmful ingredients than cigarettes, many adults believe that e-cigarettes are just as harmful or more harmful than cigarettes.

Research has found that some adults who perceive e-cigarettes to be as or more harmful than cigarettes are less likely to switch from cigarette smoking to exclusive e-cigarette use.

FDA, April 2024

The weakness here is that FDA cites a study highlighting risk misperceptions but then doesn’t say what it thinks the appropriate risk perception should be.

FDA links to a study abstract (Bandi et al. 2022), though there is a paywall for the full study (why choose a paywalled study?). That study illustrates the high and rising share of adults who perceive vaping to be more harmful than smoking – a worrying trend. It would be better to go to the publicly accessible HINTS surveys used in the paywalled studies, which have data from 2022 and show the absolutely dire state of risk perceptions, dominated by wrongness (just as or more harmful) and confusion (don’t know).

National Cancer Institute, HINTS survey 2022

But the simple constructive action here would be for the FDA to give its own answer to the HINTS survey question; Compared to smoking cigarettes, would you say that using e-cigarettes that contain nicotine is…? If the public is asked this question, why shouldn’t the FDA or CDC also be asked for an answer? The only appropriate answer is “Much less harmful“. Why not give it?

I suppose the FDA could say, “I don’t know,” and decline to provide any public leadership. But that would leave Americans wondering why Congress allows the agency to collect $712 million per year – about $8 billion so far – for its tobacco activities and still can’t answer an important basic question.

Somehow, the FDA ignores the culpability of federal government entities, notably the FDA itself, the CDC and the Surgeon General, for causing these risk perceptions to be so wildly misaligned with science and informed expert opinion. But as I have written elsewhere, the US e-cigarette risk communications environment is an American Crime Scene.

Notably, this misinformation includes the false attribution of EVALI to nicotine vaping, which was not and could not have been involved. The Federal government has never done anything to correct the often gleeful but profoundly misleading statements it made at the time. It has declined to change the name EVALI (E-cigarette and Vaping product-Associated Lung Injury) to be something less inherently misleading, despite pressure to do this; see Pesko M. et al. United States public health officials need to correct e-cigarette health misinformation, Addiction, 2022. Given FDA makes the case above that risk misperceptions may be deterring switching and sustaining smoking, it should lead the federal government in identifying and addressing all the ways in which agencies have contributed to misleading the public about these risks. It has so far refused to do so.

What Is CTP Doing to Educate Adults Who Smoke About the Relative Risks of Tobacco Products?

The concept of relative risk is complex, and it is important to ensure efforts to educate adults who smoke on this topic are evidence-based and likely to achieve desired outcomes, while also minimizing impact on unintended audiences, including youth.

FDA, April 2024

Many things in life are complex. The role of expert agencies is to distil and communicate important and actionable information from the complexity while remaining truthful, ethical and respectful of citizens and their autonomy. In this formulation, there is a suggestion that different information about risk should be presented to different audiences – youth and adults. This sounds like code for misleading young people about the comparative risks of smoking and vaping and not allowing the needs of adults to get in the way of frightening young people with falsehoods.

CTP is continuing to build scientific knowledge through research to inform the development of educational strategies and approaches, including potential messaging. A priority of this research is identifying effective ways to reach intended audiences while minimizing the impact of any potential consequences on unintended audiences.

FDA, April 2024

Much FDA-funded research does not build reliable scientific knowledge. Some does, of course. The challenge for the public, press and politicians is to know the difference.

Studies are planned on messages related to the relative risks of tobacco products that include participation by adults who smoke, as well as research among health care providers in primary care settings who may play a key role in the delivery of potential messaging. For example, on August 2, 2023, the National Institutes of Health, in coordination with FDA, published a Notice of Funding Opportunity for “Public Health Communication Messaging about the Continuum of Risk for Tobacco Products.”

FDA, April 2024

It seems extraordinary to me that the FDA cannot tell some simple truths about the risks of different tobacco products without needing a lengthy research program. It has had jurisdiction over e-cigarettes for almost eight years and was preparing for years before that.

This funding opportunity repeats the disturbing ethical issues mentioned above:

Applications should consider effects on audiences for whom the messaging could potentially be useful (i.e., adults who use combustible products) and on those for whom the messaging could have negative consequences (e.g., youth).

Why should truthful risk information be offered to adults but withheld from adolescents? Firstly, there is the ethical issue of misleading deliberately or by omission. Secondly, there are young people for whom relative risk information is important (adolescent smokers or would-be smokers). Third, what if adults receive one message from official sources but another from their kids? Fourth, there are potentially harmful spillover effects arising from trying to tell one story to one audience while concealing it or telling a different story to another audience. Modern connectivity and media simply do not allow for that. Fifth, what about the effects on young people who grow up to be adults with risk misperceptions developed as adolescents?

Broader issues

Clarity and communication. This is not a sincere attempt to communicate the relative risks of tobacco products to any of the relevant audiences (public, practitioners, politicians, media). It is a series of grudging acknowledgements of reality, laden with caveats and evasions that leave the reader unable to judge the magnitude of the difference in risks arising from the use of different tobacco products or the extent of the residual uncertainties involved. Without those elements, no one can make any realistic, actionable judgments. As a risk communication, the page is worthless and worse than merely useless as it implies we know much less than we do. Examples from NASEM and the UK NHS give a better showing of what is required to do this competently.

Explaining better. If the FDA was really trying to communicate relative risks, it would give the reader a descriptive account as to why the risks are likely to be so different. This would be a brief account of how combustion creates thousands of new products in the high-temperature reactions in the burning tip of the cigarette and how these tar particles and hot toxic gases are drawn into the lungs. It would explain why that doesn’t happen with non-combustible products and why the chemical mix inhaled from the products should be simpler and less toxic. Yet there is nothing that backs up the FDA’s defensive and impenetrable statements with a description of why the risks would be much lower. It could have used prior FDA statements to clarify the role of nicotine.

Not safe. It misrepresents pharmaceutical products as “safe and effective” as if they are risk-free and urges smokers to give these products priority. However, they can have numerous side effects, and there are significant residual uncertainties about their adverse neuropsychiatric effects. The “safe and effective” rubric for pharmaceuticals should not be used in the same communication that claims “no tobacco product is safe”. They are different meanings of the word “safe”. If consistent definitional standards are applied, it is possible to make a good case that pharmaceutical treatments for smoking cessation are neither safe nor effective or that some tobacco products are “safe and effective” alternatives to smoking.

Tobacco products other than e-cigarettes. The page purports to be about the relative risks of “tobacco products.” Yet, next to nothing is said about smokeless tobacco and heated tobacco. FDA has designated a heated tobacco product, the iQOS, as “appropriate for the protection of public health” and presumably, therefore, it is content for people to use it instead of smoking. Substantial evidence going back 30 years shows that smokeless tobacco use is much safer than smoking. See Rodu & Cole, Tobacco-related mortality, Nature, 1994 extracted and annotated below:

The chart shows a mortality penalty emerging for smokers from age 50 onwards. No equivalent emerges for smokeless tobacco use. Why can’t FDA show this?

Decades of epidemiological evidence on the risks of modern smokeless tobacco use suggest minimal long-term excess mortality [e.g. see Fisher M. et al 2019]. Yet, risk perceptions for smokeless tobacco are also wildly inaccurate. When asked, “Do you believe that some smokeless tobacco products, such as chewing tobacco and snuff, are less harmful than cigarettes?“, 71% of Americans incorrectly answered “no” (HINTS, 2017). There is nothing here to correct those wildly inaccurate risk perceptions.

No discussion of nicotine pouches. Nor does the FDA have much to say about oral nicotine pouches, which it also classifies as tobacco products. Why? These products are likely to be even safer than smokeless tobacco and safer than vaping as they are not heated and do not involve inhalation. Isn’t that relevant information? Or is the FDA so paralysed by doubt and fear of recrimination that it cannot say anything useful at all?

The muddle over communicating to adults and youth. The FDA’s relative risks page looks as though communicating relative risk to adults is, at best, an afterthought and must be subordinate to communication targeted at youth aiming to frighten them away from using safer alternatives to cigarettes. FDA treats this as a practical challenge: how to prevent messaging for one audience – adults- from contaminating the messaging intended for another – youth – in order to support its youth anti-vaping campaigns. However, the real problem there is ethical, and the likely practical consequence will be the erosion of trust in public institutions. The relative risks of these products are characteristics of the products. If there are age-specific risks, then those should be part of a consistent message to all audiences.

In conclusion, Americans are badly let down by the Food and Drug Administration. The costs are carried by ordinary people in avoidable deaths and diseases that arise from confusion and misleading risk perceptions about much safer alternatives to smoking.

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