FDA’s New Vision for Tobacco Harm Reduction

U.S. Food and Drug Administration Commissioner Scott Gottlieb on July 28 fully endorsed tobacco harm reduction. In a speech (here), he clearly defined the problem: “[I]t’s cigarettes that are the primary cause of tobacco-related disease and death.” 

Dr. Gottlieb cited facts about nicotine, emphasizing its addictive qualities and the need to keep children away from all tobacco products. He also made one critical distinction:

“[T]he nicotine in cigarettes is not directly responsible for the cancer, lung disease, and heart disease that kill hundreds of thousands of Americans each year.  Yes, it got them all addicted and kept them addicted for the long term.  And it got most of them addicted when they were still teenagers.  But it’s the other chemical compounds in tobacco, and in the smoke created by setting tobacco on fire, that directly and primarily cause the illness and death, not the nicotine.”

This has been one of my principle themes for over two decades.

Dr. Gottlieb called for reduction of nicotine in cigarettes to non-addictive levels, an idea that I criticized in my 1995 book, For Smokers Only (updated version here) and more recently in my blog (here and here).  However, I was critical because advocates of nicotine fadeout were deluded in thinking it would work in the absence of viable tobacco substitutes.  Unlike them, Dr. Gottlieb embraces the harm reduction component: “…we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels.  And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them…”

The new commissioner underscored the value of less harmful products: “I also hope that we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, of products capable of delivering nicotine without having to set tobacco on fire.  The prospective benefit may be even greater for the subset of current cigarette smokers who find themselves unable or unwilling to quit.”

Note two key phrases above: (1) “less harmful forms [of tobacco], efficiently delivering satisfying levels of nicotine, are available for adults who need or want them;” and (2) “…current cigarette smokers who find themselves unable or unwilling to quit.”

I used the latter words in 1994 to describe my vision for a new approach to smoking control:

“In a review of the avoidable causes of cancer, Doll and Peto observed that ‘No single measure is known that would have as great an impact on the number of deaths attributable to cancer as a reduction in the use of tobacco or a change to the use of tobacco in a less dangerous way.’  Unfortunately, the second part of this observation has not received attention.  Because smokeless tobacco causes far fewer and considerably less serious health effects than does smoking, it should be promulgated as an alternative to cigarettes for smokers unable or unwilling to overcome their nicotine addiction.” (article here, emphasis added)

Dr. Gottlieb’s use of “unable or unwilling” acknowledges the effectiveness of tobacco harm reduction, without judging smokers. 

This theme is repeated in Dr. Gottlieb’s closing: “A renewed focus on nicotine can help us to achieve a world where cigarettes no longer addict future generations of our kids; and where adults who still need or want nicotine can get it from alternative and less harmful sources.  FDA stands ready to do its share.”

Many of the commissioner’s talking points are virtually identical to the policies I have researched and advocated for two decades.  Dr. Gottlieb notes the rancor in this field, saying, “…there’s the ongoing divisive debate around the pros and cons of e-cigarettes.  Precious little progress has been made as competing camps dig in on the benefits and risks of a harm reductionist approach to this new technology.  Both sides are convinced that they’re right, but we’ve seen little progress, and virtually no common ground.”  He encouraged “…participants from all sectors in the ongoing harm reduction debate…to take a step back and work together to reach greater common ground.”

I applaud Dr. Gottlieb’s leadership on this issue and offer my support in turning his vision into reality.

Government’s Abstinence from Smokeless Truth Detailed by Wall Street Journal

The Wall Street Journal on July 21 reported what readers of this blog already know: “Many scientists agree that…smokeless tobacco, including chewing and dipping tobacco, is significantly less harmful than cigarettes.  But rather than encouraging the country’s 37 million smokers to switch to less-risky products, U.S. health officials have so far stuck with an abstinence-only message to the public.”

Journalist Jennifer Maloney underscored the government’s withholding of relative risk information about smokeless tobacco: “Online fact sheets published by the Centers for Disease Control, the Food and Drug Administration and the National Cancer Institute list multiple health risks associated with smokeless tobacco…but give no indication it is less harmful than cigarettes. ‘There is no safe form of tobacco,’ the cancer institute says on its website.”

Scientific research says otherwise.  Although it is impossible to prove absolute safety, dozens of epidemiologic studies over three decades have documented that health risks among American chewers and dippers are not significantly elevated.  Last year, a government study failed to find any mouth cancer risk among men who chew or dip (here). 

The CDC claims that it is unable to provide risk estimates for smokeless users (here, here and here).  Yet researchers from Altria produced them from CDC data; these are seen in the chart above (source here).  Smokeless users’ risks were comparable to those of nonusers of tobacco, whereas smokers had twice the risk of dying.

That Altria was able produce these dramatic results from CDC’s data underscores the government’s refusal to acknowledge the scientific truth about smokeless tobacco’s reduced harm profile. That is irresponsible and contrary to public health interests.

Federal health officials told Maloney, “more research needs to be done on the potential population-level consequences of broadcasting the fact that some tobacco products are safer than cigarettes.” 

Such facts should not be withheld from the American public.  Here is the consequence of public health officials’ persistent obfuscation and mendacity:

There were 8.1 million smokeless users in 2014, according to the National Survey on Drug Use and Health (NSDUH) (here), and 41% of them were also smokers.  This means that 3.36 million Americans are equally comfortable and satisfied using nearly harmless chew or dip, and smoking, which is deadly.  Government data shows that smokers have no idea that they are needlessly putting their lives at risk (here).  Federal agency leaders are aware of the differential risks, but choose not to push that potentially life-saving information to the public. 

The Wall Street Journal is to be applauded for helping to expose this transgression.

United Kingdom Doubles Down on Support for Tobacco Harm Reduction

The United Kingdom Department of Health’s new position statement (here), “Towards a Smokefree Generation,” is, as Clive Bates wrote (here), “probably the first significant government policy paper anywhere that recognises and pursues the opportunities of tobacco harm reduction, rather than defining these technologies as a threat to be suppressed.  For that, the Department of Health and its allies deserve considerable credit.”

Indeed.

British health authorities have been telling smokers the truth about vaping since 2011 (as I have noted here, here, here and here), and British smokers have listened – the UK’s vaping population has ballooned to 2.9 million (here), while smoking has significantly declined.  In fact, a Public Health England official recently reported (here) that the UK smoking rate is now the second lowest in the European Union, after SWEDEN!

Meanwhile, the U.S. persists in advocating for a “tobacco-free society” and a “tobacco endgame,” demonizing smoke-free products with untruths and giving continuing life to urban anti-vaping myths.  The UK paper underscores this stark contrast.

“Towards a Smokefree Generation” sets forth the facts about e-cigarettes’ relative safety:

“… the evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco.”

The UK Department of Health promises to help smokers make the switch:

“The government will seek to support consumers in stopping smoking and adopting the use of less harmful nicotine products. Public Health England has produced guidance for employers and organisations looking to introduce policies around e-cigarettes and vaping in public and recommend such policies to be evidence-based.”

The paper dismisses the unfounded claim that second-hand vapor is a health threat:

“Public Health England recommends that e-cigarette use is not covered by smokefree legislation and should not routinely be included in the requirements of an organisation’s smokefree policy.”

Additionally, the document invites the introduction of new tobacco harm reduction products, an apparent reference to products like Philip Morris International’s heat-not-burn iQOS:

“… there has been the development and very recent introduction of novel tobacco products that claim to reduce the harm of smoking. We welcome innovation that will reduce the harms caused by smoking and will evaluate whether products such as novel tobacco products have a role to play in reducing the risk of harm to smokers.”

Concluding, the UK pledges:

“Public Health England will continue to provide smokers and the public with clear, evidence based and accurate information on the relative harm of nicotine, e-cigarettes, other nicotine delivery systems and smoked tobacco, to enable informed decision-making.”

American health authorities, are you listening?