New FDA Commissioner Saves the Day: Embraces Harm Reduction Strategy for Tobacco Control

On Friday, the new FDA Commissioner – Dr. Scott Gottlieb – saved the day for the public’s health by officially embracing a harm reduction approach to tobacco control. Commissioner Gottlieb announced a new approach to the regulation of tobacco products that, unlike the FDA’s previous strategy, acknowledges the vastly different risks of tobacco cigarettes compared to electronic cigarettes and proposes to regulate each product in alignment with its risk level.

Previously, the FDA had simply lumped e-cigarettes into the exact same category as tobacco cigarettes and in fact, regulated e-cigarettes much more stringently. The FDA previously required e-cigarettes to complete burdensome and expensive pre-market applications just to remain on the market, a process from which all cigarettes were exempted. The old approach would have destroyed about 99% of the existing vaping product market, leading to a major reduction in smoking cessation in the U.S. and with that, an increase in smoking-related morbidity and mortality.

Instead, the FDA will now delay the implementation of the pre-market application requirement for e-cigarettes while seeking ways to ease the expense and burden of the process. At the same time, the FDA will – for the first time – actually set safety standards for e-cigarettes so that the benefits of these products can be realized while minimizing potential harms. And, to top it all off, the agency will consider – also for the first time – actually setting a safety standard for real cigarettes that would require the reduction of nicotine to non-addictive levels if that is found to be technologically and practically feasible.

Commissioner Gottlieb also, for the first time, tied implementation of a harm reduction approach based on vaping products to the idea of making combustible cigarettes less addictive through substantial nicotine reduction, thus reducing the demand for real cigarettes but at the same time, making a viable alternative available to smokers to help ease them through the transition to the tobacco-free, smoke-free cigarettes.

Dr. Gottlieb emphasized that while nicotine is largely responsible for the addictive potential of cigarettes, the nicotine itself is not what kills smokers. As he stated: “the 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.”

Commissioner Gottlieb unveiled his vision of ” 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.”

Specifically, the strategy outlined by Commissioner Gottlieb involves the following:

1. Implementation of the requirement for pre-market applications for electronic cigarettes will be delayed until 2022, giving vaping product manufacturers another four years to remain on the market and to prepare the necessary application materials.

2. New guidance for the pre-market applications will be developed, which will presumably greatly simplify the requirements and reduce the burden and expense of preparing these applications.

3. Safety standards for electronic cigarettes will be developed, addressing issues such as battery safety, e-liquid ingredients, and flavorings.

4. The agency will examine the effectiveness and feasibility of requiring a reduction of nicotine levels in real, tobacco cigarettes to a non-addictive level.

5. Ideally, the reduction of nicotine levels in real cigarettes would be paired with the development and promotion of electronic cigarettes and vaping products as a viable alternative to smoking.

The Rest of the Story

This is truly a great day for public health. For the first time since 2009, when the FDA began regulating tobacco products, we now have a rationale approach to their regulation. This approach explicitly acknowledges the differential in risk between smoking and vaping and proposes to regulate these products according to the level of risk they present. It acknowledges that while nicotine is a critical contributor to the addiction potential of tobacco products, it is not what actually kills smokers. It aims to maximize the benefits of electronic cigarettes while minimizing their harms by both embracing e-cigarettes for harm reduction and easing their ability to stay on the market and setting safety standards to make these products as safe as possible. Finally, it aims to reduce the attractiveness of cigarettes and facilitate a transition from combusted to non-combusted nicotine products by reducing the addictive potential of cigarettes, thus promoting a shift to safer forms of nicotine delivery.

More than anything else, the greatest contribution of this new approach is that it is evidence-based, rather than based on ideology or political concerns. Instead of punishing smokers by depriving them of potentially life-saving alternatives, it embraces the idea of giving them much lower-risk choices that have already been shown to help millions of smokers quit.

The greatest risk to successful implementation of this sensible approach comes from the anti-tobacco groups themselves. Already, the Campaign for Tobacco-Free Kids is complaining about the pre-market tobacco application deadline extension for e-cigarettes. In a statement released Friday by the Campaign, it attacked the agency for attempting to save the e-cigarette industry, arguing that: “it is a serious error for the FDA to significantly delay critical deadlines for complying with the FDA’s 2016 rule establishing oversight of electronic cigarettes, cigars and other previously unregulated tobacco products. This long delay will allow egregious, kid-friendly e-cigarettes and cigars, in flavors like gummy bear, cherry crush and banana smash, to stay on the market with little public health oversight.”

This complaint is complete crap. There is nothing in the deeming regulations that directs the agency to eliminate “kid-friendly” flavors. To do that, the agency would almost certainly have had to formally consider the issue and make a decision regarding the overall public health impact of such a restriction. It would have also had to carefully consider exactly how to define “kid-friendly” flavors. It is almost inconceivable that such a decision would have been made arbitrarily through the process of approving or denying pre-market tobacco applications. Moreover, in the approach outlined by Dr. Gottlieb on Friday, he specifically stated that the agency would examine the issue of “kid-friendly” flavors and make a decision about whether and how to implement such a policy. In contradiction with the Campaign’s false claims, the FDA has full authority and oversight over e-cigarette flavorings and can regulate these flavorings completely independently of the pre-market application process.

It is great to see this major change in the FDA’s approach to the regulation of tobacco products and especially, to see the shift from an ideologically-driven approach to an evidence-based one. It is time for the anti-tobacco groups to make such a change as well. The ideological crap that is coming out of these groups has to end. Frankly, that crap is the greatest threat to the successful implementation of the sensible, evidence-based public health approach to tobacco control that the FDA has now embraced. 

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IN MY VIEW: American Lung Association Guilty of Public Health Malpractice

Yesterday, researchers from the University of California, San Diego published a landmark paper in the BMJ (British Medical Journal) which reported that for the first time in 15 years, the smoking cessation rate among adults in the U.S. has increased. The researchers tie this unprecedented increase in the smoking cessation rate to the availability of electronic cigarettes. The paper reports that the advent of electronic cigarettes was associated with a significant increase in the population smoking cessation rate. It also finds that smokers who use e-cigarettes are more likely to quit smoking than those who do not.

Combined with abundant existing research, the findings of this study make it clear that among adult smokers, electronic cigarettes have had a huge public health benefit. They have increased the number of quit attempts as well as the proportion of successful quit attempts. The reason for this is clear: many smokers have trouble quitting not simply because of nicotine addiction, but because of addiction to the physical, behavioral, and social aspects of smoking. None of these are addressed by existing FDA-approved cessation methods, but they are specifically addressed by e-cigarettes, which replace almost all aspects of the smoking experience other than the tar, smoke, and high levels of 60+ carcinogens and 10,000+ toxins.

It is also clear that smokers who are able to quit using e-cigarettes have greatly improved their health. Even dual users have improved their health, as lung disease risk drops with a decline in cigarette consumption, albeit not as much as quitting entirely. There is also a decline in cancer risk, although again, not as much as quitting altogether. (There is probably not a significant decline in heart disease risk among dual users).

One would think that public health groups would hail this study and, if making recommendations to smokers, advise them to quit any way they are able to, including with the use of e-cigarettes if that works for them. 

But no … that’s not the case with many health groups. One in particular — the American Lung Association — is still urging smokers not to quit using e-cigarettes. Instead, they are urging smokers to only use FDA-approved methods that are clearly not going to work for many smokers. And if you are one of those smokers, the American Lung Association would apparently rather that you continue smoking than try to quit by switching to vaping.

While many public health researchers affirmed the value of electronic cigarettes for many adult smokers, an article on the new study in the San Diego Union-Tribune quoted the American Lung Association as continuing to advise smokers not to try to quit using e-cigarettes. There was no qualifying clause, so the American Lung Association is giving this advice even to those smokers who are unable to quit using FDA-approved drugs.

According to the article: “People who had tried e-cigarettes in the previous 12 months were significantly more likely to have quit smoking traditional cigarettes than in previous years. The quit rate remained virtually the same for those who didn’t try e-cigarettes. … “It’s important to remember that no e-cigarette has yet been found by the FDA to be safe and effective in helping smokers quit,” said Erika Sward, the American Lung Association’s assistant vice president of national advocacy.”

The Rest of the Story

The American Lung Association’s advice is tantamount to a physician telling a smoker who has failed to quit multiple times using FDA-approved drugs and who expresses interest in e-cigarettes that she should not try vaping and instead should stick to the failed methods in which she has no interest. This is precisely the advice that the American Lung Association is giving to America’s smokers. And it is inappropriate and health-damaging advice. I view it as a form of public health malpractice.

Most physicians will advise smokers to quit in whatever way they are able to. Quitting smoking is so difficult, and individuals are so different in what works for them, that physicians should not take any reasonable options off the table. It is one thing for a physician to make recommendations about what methods are most effective based on the evidence. But it is quite another for a physician to tell a patient for whom those methods have failed to continue hitting their head against a wall, rather than trying a new, promising method in which the patient has expressed interest and which has worked successfully for millions of other smokers. This is exactly the medical advice that the American Lung Association is giving.

In my opinion, the American Lung Association should either correct this misinformed and dangerous advice or it should get out of the business of making medical recommendations altogether. With this advice, the American Lung Association is doing far more harm than good. The central principle of medicine and public health is “to do no harm.” The American Lung Association is violating this core principle.

The rest of the story is that the American Lung Association is guilty of public health malpractice because despite clear evidence that e-cigarettes have helped millions of smokers quit, it continues to advise smokers not to use this method to quit. Apparently, the American Lung Association is more concerned that smokers quit “the right way” than that they quit. Smoking is apparently a moral issue, not merely a health issue, and if you quit the wrong way, you apparently haven’t paid the proper penance for your addiction.

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New Jersey bans the sale of low-risk nicotine products to anyone under 21

In a shocking reversal from last year’s veto, New Jersey Governor, Chris Christie signed a Tobacco 21 bill into law on Friday, July 21st. The new law raises the purchase age for all tobacco and vapor products from 19 to 21 and will take effect on November 1, 2017. New Jersey is the third state following Hawaii and California to enact a Tobacco 21 law.

While the list of local governments, and now states, that have adopted or are considering a Tobacco 21 policy is growing, new evidence supporting the claims of proponents is not moving at a similar pace. Proponents still point to a small town in Massachusetts and one study conducted by the Institute of Medicine (IOM) as support. But neither the case of Needham, MA or the IOM report account for the availability of low-risk vapor products and neither compare the effectiveness of raising the age to 21 to adopting a harm reduction strategy. For governments to accept such little evidence as satisfactory support clearly shows a bias and a deference to emotional arguments in favor of prohibition over harm reduction.

Indeed, many of us have experienced the early loss of a loved one due to smoking–including Governor Christie–and by year’s end, millions more will lose someone close to them. But the solution to this problem is not in taking reduced harm options away from people. Tobacco 21 laws are dangerous and have the potential to do more harm than good by prohibiting sales of low-risk, smoke-free products to adult consumers. Governor Christie knows that a one-size-fits-all policy is failing in the area of opioid addiction. He has no reason to believe that relegating smokers to traditional quit methods will have a positive outcome.

The new law in New Jersey is expected to create a $4-$8 million hole in the state’s budget. Any public health gains that might translate to savings will be minimal at best and will not be realized for decades.

Legislatures in Maine and Oregon have also sent Tobacco 21 bills to their governors for signing. Maine’s Governor, Paul LePage, has wisely vetoed the Tobacco 21 legislation.

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Yet Another Group of Anti-Tobacco Researchers Encourage Lying to Kids About Relative Health Effects of Vaping and Smoking

It seems that honesty has disappeared as a core principle in tobacco control. Today, I report that yet another group of tobacco control researchers is bemoaning the fact that many youth understand the relative health effects of vaping and smoking and is encouraging lying to kids instead.

In a paper published in Tobacco Prevention and Cessation, investigators from the University of Louisville examined YouTube videos promoting electronic cigarettes. They found that one of the major selling points for vaping in these videos was the claim that using e-cigarettes is safer than smoking and switching from cigarettes to e-cigarettes can therefore improve health. However, here is how they report this finding and how they describe its implications:

“Our findings extend similar conclusions in related work: that the majority of YouTube videos promoting e-cigarettes demonstrate the social benefit and acceptability of e-cigarettes in part by claiming that using e-cigarettes is safer and healthier than consuming traditional tobacco products. This comparison perpetuates a narrative that e-cigarettes are safe because they are “healthier” or “safer” than other traditional tobacco products. Promoting a product by claiming that it is better than a hazardous substance, like traditional tobacco, only has merit when targeting cigarette users who are considering quitting or cutting back. Given that scientific information about safety is largely inconclusive, claims using words like “safer” to describe e-cigarettes could contribute to confusion about the overall safety of these products, especially among youth. A recent analysis found that 34.2% of youth believe that e-cigarettes are less harmful than traditional cigarettes, and 45% are not sure. Furthermore, e-cigarette use among youth who did not use traditional cigarettes was more likely when they perceived e-cigarettes to be less harmful than traditional cigarettes.”

The paper concludes that: “There is a need for “anti” e-cigarette videos on YouTube, especially ones targeted at youth, to more accurately convey current scientific understanding about the safety of these products.”

The Rest of the Story

To be clear, this paper is suggesting that e-cigarette promotional videos are inaccurately asserting that vaping is safer than smoking. The paper calls for anti-vaping videos that “more accurately” convey scientific understanding about the safety of these products, condemning videos that claim that e-cigarettes are safer than real, tobacco cigarettes.

In other words, the paper is clearly calling for public health practitioners to lie to our nation’s youth by telling them that vaping is no safer than smoking or by hiding the fact that vaping is much safer than smoking.

Ironically, the paper argues that telling kids the truth – that vaping is safer than smoking – is creating “confusion” because a recent analysis showed that one-third of youth believe that e-cigarettes are less harmful than traditional cigarettes. How is that confusion? What the paper calls “confusion” is actually the truth.

The investigators appear to be upset that many youth have a correct understanding of the relative safety of vaping compared to smoking.

A core principle of public health is honesty. Another core principle of public health is transparency. And a key element of health communication is telling the truth. We do not mislead, deceive, or lie to the public in order to promote health behavior change. That is what we have incessantly attacked the tobacco companies for doing. Deceiving people is not a valid or appropriate strategy in public health.

But the rest of the story is that many tobacco control practitioners are encouraging precisely such a strategy. They can’t stand the fact that youth may have a correct understanding of the relative health effects of vaping compared to smoking, and they want youth to be lied to in order to confuse them or even worse, deceive them into thinking that vaping is actually just as hazardous as smoking.

While the overall goal of this dishonesty may be valid – trying to discourage kids from vaping – the means being urged to reach this end are inappropriate. In public health, we do not lie to the public to promote our agenda. That’s what the tobacco companies used to do. And there is no excuse for us to sink to that level.

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CASAA Commentary on FDA’s Battery Safety Efforts

The mission of the Consumer Advocates for Smoke-free Alternatives Association (CASAA) is to ensure that availability, diversity, and truthful information is available to those who seek lower risk alternatives to traditional combusted tobacco.  As a part of this mission we published a battery safety primer for our members, accessible to the general public, and written based on engineering best-practices, failure mode analysis, and information collected from various sources including the National Fire Prevention Association, electronic product standards associations, and federal agencies. Our view is comprehensive, not because vapor products pose a unique risk, but because the proliferation of lithium powered devices in our work, homes, and cars – every aspect of daily life. This essential guide can be reviewed here: Battery Safety – Making Peace With Power.

Recently the FDA held a workshop of its own on battery safety for electronic cigarettes. Ostensibly this workshop was to explore the risks, mitigation of those risks, standards that may be used to protect consumers, and communications to consumers and the general public about battery safety for e-cigarettes. While much of the information presented in our own safety primer was presented at that workshop, along with some solid ideas on how battery risks may be mitigated, there was always an undercurrent of ‘these devices should not exist’. Understand that the selection of the participants in this workshop was entirely at the discretion of the FDA itself. They chose who they would listen to. Just as the messaging FDA and it’s sister organization CDC, misrepresents the risks of non-combustible alternatives in other areas, so too the messaging about e-cigarette batteries falls more in line with a political motive rather than a true concern for consumer safety. Once again, FDA ignores the continuum of risk – notably that cigarettes and other combustible tobacco products are the cause of vastly greater damage to health, and property due to fires. FDA conflates the risks inherent in electronic cigarettes, which have a much lower failure incidence, to be greater than the risks in other consumer electronics that use lithium batteries as their power source, approaching the equivalence of the combustibles they replace.

The reliable truth presented in the workshop was the disclosure to FDA that industry risk assessment and non-governmental standards organizations lead the way in establishing criteria for consumer safety. A key fact that is buried between the lines of the information presented is that these standards and industry best-practices rapidly evolve. How quickly does industry respond when laptops, cell phones, hoverboards, and aerial drones catch fire? Very rapidly indeed! The Institute of Electrical and Electronics Engineers (IEEE) and the Underwriters Laboratories (UL) each have standards that are constantly being improved and expanded to understand, mitigate, and protect the industries they serve from product liability. As any lawyer can tell you, the cheapest way to reduce liability is to ensure your product is safe, and to upgrade it quickly – including recalling products and replacing them with better products, rather than face large class-action lawsuits that can end the life of a company.

The trouble with FDA, as far as its regulations are concerned, is that it moves very, very, slowly. Whether it is regulationing drugs, medical devices, or tobacco products, a lot of paperwork has to be submitted if an approved product is substantially changed even if that change improves the safety of the product. This delays introduction of the improved product to the market. While FDA may force a company to recall its products, the ability to rapidly replace those products with better, safer, products is hampered by the very regulations that are supposed to increase consumer safety. In the drug and medical device world it means that artificial shortages appear in drugs and devices such as antibiotics, pacemakers, Epi-pens, and patient monitors, which drives up the price of the remaining products – effectively adding to the ever spiraling cost of health care. The same is true for tobacco products. Combustible cigarettes that self-extinguish exist, but the cost to bring them to market is too expensive – so we are left with the grandfathered products which burn houses and people. Electronic cigarettes that receive market authorization cannot be “substantially altered” without undergoing another round of pre-market approval, similarly delaying product improvements. If the richest Big Tobacco firm can’t afford to PMTA the self-extinguishing cigarette, how can FDA expect smaller vapor product companies to file on their product improvements? This limits not only the diversity of the market for smoke-free alternatives, but directly affects all tobacco product’s ability to be modified to address safety issues.

A further problem is that FDA often speaks before it understands the issues. In the case of e-cigarette battery safety, the FDA issued this warning infographic on its website before it even held the workshop designed to gather information. Predictably the result is the dissemination of information that is laughably inaccurate to those who do understand the issues – and sets the stage for any correct information to cause confusion in the public.

Original FDA Infographic Updated FDA Infographic

As one can see the lack of expertise results in inconsistent messaging. Indeed throughout the entire history of FDA’s involvement with smoke-free alternatives, be it vapor products, or smokeless tobacco, it has often rushed to publish information that confirms ideology well ahead of the science it purports to base its decisions upon. The problem this creates is that science often catches up with and discredits the dogma that political agencies like FDA produces. When this happens, and every time it happens, the credibility and public trust the agencies need to be able to function effectively is undermined. When the people can no longer trust the agencies of their government to tell them the truth, then public safety is sacrificed. While the subject here is e-cigarettes, it is easy to see this play out in many other areas – drug safety, food safety, dietary recommendations, to name but a few.

CASAA supports reasonable evidence-based best practice engineering in the design, development, production, and warranty of electronic cigarettes. We do not foresee FDA’s involvement in this aspect of the industry as being of any benefit as it is being currently pursued. We call on FDA to cease its attempts to become a regulatory technical authority over devices and defer to those with real expertise and established track records, such as the IEEE or UL and other agencies such as the International Standards Organization (ISO), and the American National Standards Institute (ANSI), all of whom have active working committees engaged on the issues of safety for consumer products and electronic cigarettes. FDA needs to recognize that it is neither knowledgeable enough, or has sufficient resources, to compare to these long established bodies. The end result, should FDA continue its present course, will be to undermine public trust and that has broader implications for public safety beyond regulation of e-cigarettes.

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ECigIntelligence User Survey

In the fall of 2016 CASAA was approached by ECigIntelligence for assistance in conducting a focused survey of e-cigarette users. The integrity of ECigIntelligence was verified as was the purpose and scope of the survey. The survey was conducted with our help by sharing it with our members. The results were tallied into a comprehensive picture of electronic cigarette users. As a part of our diligence to our members CASAA requested the ability to publish the relevant results to educate and advocate for our members.

We are grateful to our members that participated in the survey. Indeed your participation made this survey one of the most comprehensive and meaningful efforts to date.

The demographics of the sample are overwhelmingly male, between 25-54, who have been vaping over 2 years and use variable voltage/variable wattage mods.

94% of our respondents were exclusive vapors who had switched from a pack-a-day or greater use of combustible tobacco.

Here are two key info-graphics. The first shows that the number of dual-users decreases by nearly 50% with time. From 25.5% dual use in the early period (0-6 months) the number drops dramatically to just 3% dual-use at over 2 years. The second graph shows that the innovation in devices has had a positive effect in helping users completely switch from combustible tobacco. One in every seven users of closed system devices (cig-a-likes) were dual users while higher technology devices reduced dual use by almost 5x to 1 in 30.

A key info-graphic in combating the youth use argument. Here we note that the majority of purchases of e-liquid is through online or dedicated brick-and-mortar facilities all who have age-verification requirements by federal law. If youth are obtaining products they must do so outside of the legal channels.

In this survey flavors were a key question. Once again we find confirmation that non-tobacco flavors dominate the user preference with fruit and sweet flavors being the largest preference. Taken together non-tobacco flavors account for 86% of all flavor preferences with menthol and tobacco accounting for a mere 14%. Adults like flavors!

In this info-graphic key motivation for initiation and use were explored. While advertising did have an influence the most prevalent reason given for trying e-cigarettes was positive feedback from family and friends. In simple terms, vapors are the best sales tool to reach those still unaware that there are alternatives to combustible tobacco. The second graphic shows that the internal motivation for continued use is overwhelmingly based on reducing the harm from combustible tobacco use.

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