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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IN MY VIEW: Campaign for Tobacco-Free Kids is Deliberately Lying to the Public

In a press release issued yesterday lamenting the passage by the House Appropriations Committee of a bill that grandfathers in existing e-cigarettes from the pre-market approval requirements of FDA vaping product regulations, the Campaign for Tobacco-Free Kids claimed that the bill strips the FDA of authority to review the public health impact of e-cigarettes.

Specifically, the Campaign for Tobacco-Free Kids stated that the bill:

“would “grandfather” e-cigarettes and cigars already on the market and exempt them from FDA review of their public health impact, including whether they appeal to kids.” 

The Rest of the Story

The rest of the story is that the Campaign for Tobacco-Free Kids is lying. And I now believe that they are doing so deliberately with the specific intention of deceiving the public.

The truth is that the Bishop-Cole bill would not exempt e-cigarettes from FDA review of their public health impact. All it does is to prevent the FDA from requiring expensive and burdensome pre-market applications in order for e-cigarettes to remain on the market. The bill does nothing to take away the FDA’s ability to review the public health impact of these products and to issue product standards, including restrictions on product flavorings, to protect the public’s health.

For as long as I could, I tried to convince myself that the Campaign was just stretching the truth to protect its political interests and was not deliberately lying. While the Campaign was spreading misinformation, I did not necessarily believe that the Campaign lacked ethical integrity.

However, it is now clear to me that the Campaign for Tobacco-Free Kids is a organization that has neither scientific nor ethical integrity.

How do we know that the Campaign is deliberately lying? Well, later in the press release, the Campaign essentially admits as such. In trying to downplay the significance of a provision in the bill which requires the FDA to promulgate a standard regarding product flavorings within three years, the Campaign emphasizes that the FDA already has the authority to issue product standards, including standards to regulate flavorings. They state: “In one change this year, the House bill gives the FDA three years to develop a product standard addressing “characterizing flavors” in e-cigarettes. The FDA already has the authority under current law to issue such a product standard, so this provision does not provide the FDA with any new authority.”

So any thought that the Campaign’s false statement that the bill strips the FDA of its ability to review the impact of e-cigarettes was just an oversight is clearly laid to rest. The Campaign is fully aware that this is not the case and in fact makes this very argument in response to its opponents.

Furthermore, the Campaign for Tobacco-Free Kids is wrong on this point. The Bishop-Cole bill is significant because it requires the FDA to promulgate standards to regulate vaping product flavorings. The agency has had the authority to do so for 8 years, but has failed to issue a single product standard during that time. Thus, forcing the FDA to act within 3 years is a very significant impact of the Bishop-Cole legislation.

The bottom line is that I now believe the Campaign for Tobacco-Free Kids is intentionally lying, with a deliberate aim of deceiving the public and its constituents. It is no more ethical than many of our public health opponents. However, I view their dishonesty as more troubling because the Campaign has incessantly attacked the tobacco companies for lying to the American people. The Campaign should therefore be beyond reproach in its own statements to the public.

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IN MY VIEW: Position of Australian Medical Association (and Many U.S. Health Groups) on Vaping is Just Plain Evil

In a submission to the Australian government, the Australian Medical Association (AMA) argues that there is no evidence that e-cigarettes can help smokers quit, that e-cigarettes are harmful to health because they simply substitute one addiction for another, and that physicians must fight to prevent vaping from becoming an acceptable alternative to smoking.

According to an article published by the Australian Journal of Pharmacy: “Commenting on its submission to an inquiry into the devices, the AMA says it believes that there is currently no compelling evidence that e-cigarettes are successful in helping people to stop smoking. … AMA President Dr Michael Gannon says that the growth in e-cigarette products internationally has provided sections of the tobacco industry with the opportunity to rebrand themselves as part of the effort to reduce smoking – but there is no evidence that e-cigarettes work as a deterrent. … “E-cigarettes must not be allowed to be marketed with claims that they are a smoking cessation aid,” Dr Gannon says. “There is no such evidence. … “We must not allow e-cigarettes to become a socially acceptable alternative to smoking.””

The Rest of the Story

Up to this point, I have been criticizing many anti-tobacco groups for presenting false information about the relative safety and effectiveness of vaping and for supporting public policy that would harm the public’s health. However, I have refrained from attacking the motives or intentions of these groups, assuming instead that they are simply misguided or uninformed about the scientific evidence.

That all changes today.

After reading the position statement of the Australian Medical Association, it is now clear to me that there is thinking going on in the anti-tobacco movement that is just plain evil.

Specifically, I am now convinced that in order to preserve a certain misguided ideology in tobacco control (the idea that addiction itself is unacceptable under any circumstances), anti-tobacco groups are willing to sacrifice the health and lives of smokers.

In other words, this really isn’t about helping smokers and reducing the morbidity and mortality from smoking-related diseases. This is instead about protecting the world from the scourge of addiction itself, without regard to the impact of these statements and policies on the lives of smokers.

Smokers are literally being sacrificed for what is viewed as the “greater good,” which is protecting the world from nicotine addiction.

To be blunt, the idea that anyone might actually derive enjoyment from, and health benefit from the use of nicotine is so unacceptable to anti-tobacco groups that it must be destroyed, even if that comes at the expense of smokers’ lives.

I apologize, but this is just plain evil. This is not what public health and medicine are supposed to be about.

These groups are now admitting that they would rather not see smokers have a safer alternative that could save their lives. They do not want to see vaping become an alternative to smoking.

Think about that: They would rather smokers continue to smoke than to quit smoking if they are still deriving pleasure from nicotine. This equates to the position that they would rather see smokers die than save their lives but continue to derive pleasure from the use of nicotine.

This is a cruel position to take.

Many readers have inquired as to why the frequency of my posts have decreased recently. Part of that is of course due to the summer season. But a major part of it has been that I have been beset with a sense of utter frustration and disillusionment. I have realized that the ultimate goals of the modern anti-tobacco movement do not align with my goals and I fail to see any change in the movement, no matter how much I point out the incoherence of current tobacco policy. I can’t think of a single anti-smoking groups that has revised or corrected its false statements on the health effects of vaping after being informed about the errors in their communications. It’s not clear that anyone actually cares.

But today marks a turning point from even that level of frustration. Because it is now clear that we are not just dealing with scientific misinterpretation, poor communication, and misguided policy. We are dealing with cruel intent. And that is not something that some posts on a blog are able to change.

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CASAA Submits Comment on FDA’s Smokeless Tobacco Standards Rule

CASAA has submitted a comment via regulations.gov urging the FDA to withdraw its proposed rule regarding a product standard that would set an arbitrary and unreasonable level of N-Nitrosonornicotine in smokeless tobacco products. You can read the full comment below.

(A PDF version of our comment is available for download here.)

Comments on this rule will be accepted until 11:59 PM (EDT), Monday, July 10, 2017. If you have not already commented, we have provided an easy tool for you to use here.

___________________________________

July 10, 2017

To: U.S. Food and Drug Administration

From: Brian Carter, PhD

Director of Scientific Communications

The Consumer Advocates for Smoke-free Alternatives Association (CASAA)

Alex Clark

Chief Executive Officer

The Consumer Advocates for Smoke-free Alternatives Association (CASAA)

Julie Woessner

National Policy Director

The Consumer Advocates for Smoke-free Alternatives Association (CASAA)

RE: Docket No. FDA-2016-N-2527

VIA REGULATIONS.GOV

Comment Tracking Number: 1k1-8xft-xv8j

Introduction.

The following comments are submitted on behalf of The Consumer Advocates for Smoke-free Alternatives Association (CASAA) asking that FDA withdraw the proposed rule, “Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products,” Docket No. FDA-2016-N-2527. CASAA is a 501(c)(4) nonprofit public health and education NGO and is the leading representative of consumers who use or might in the future use smoke-free tobacco and nicotine products. It is a U.S. membership organization with over 200,000 members. CASAA advocates on behalf of consumers, and does not represent the interests of industry.

Section 907(a)(3) of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) requires that any tobacco product standard be appropriate for the protection of public health. In the proposed rule, FDA states, “Because products with higher NNN levels pose higher risks of cancer, FDA finds that establishing a NNN limit in finished smokeless tobacco products is appropriate for the public health.”1 FDA does not take into consideration the likely effect of this rule would be to decimate the U.S. smokeless tobacco industry and virtually eliminate meaningful consumer choice and access to low-risk, smoke-free tobacco products.

In fact, as more fully discussed in this comment, FDA has not demonstrated that this rule is appropriate for the protection of the public health. To the contrary, we believe that if enacted, this rule will actually work against the interests of genuine public health and result in a net public health loss at the population level. We can only speculate as to why FDA’s first effort at promulgating product standards for tobacco is aimed at the lowest-risk product (which FDA estimates in its proposed rule causes less than 300 deaths per year) instead of high-risk combustible products (which CDC estimates causes more than 480,000 deaths per year).2

If FDA is truly committed to reducing the health burden associated with tobacco use (virtually all of which comes from combustible tobacco products), the single-best thing it could do would be to accurately inform consumers that smokeless tobacco and vapor products are low-risk alternatives to smoking. Instead, it continues to mislead consumers into thinking that all tobacco products carry similar and significant health risks, which leads many people to continue smoking rather than switch to a lower-risk product. Accurately communicating the much lower-risk nature of smokeless tobacco and vapor products would have a far more positive impact on the public’s health and well-being as opposed to enacting a rule that will virtually eliminate consumer choice, drive up costs, and likely create a public health loss as opposed to a benefit.

Errors in data and interpretation result in a fatally flawed analysis and a corruption of good scientific practice.

As noted in several comments already on the docket, FDA made errors in computation, as well as errors in the analysis of data. Specifically, we refer to the comments of (1) Dr. Brad Rodu3, Professor of Medicine at the University of Louisville School of Medicine, where he challenges FDA’s estimates of oral and pharyngeal cancer deaths associated with smokeless tobacco use. To the extent that past studies of dry snuff have been pooled with moist snuff and other types of smokeless tobacco, this artificially and inaccurately drives up the risk for all products in the smokeless tobacco category since the use of moist snuff and chewing tobacco impose minimal risks for oral and pharyngeal cancer.4 This is particularly troubling when one considers that dry snuff (with the highest levels of NNN) currently makes up only a tiny fraction of market share in the U.S. (FDA estimates that dry snuff represents less than 1% of smokeless tobacco sales.5)

We also note the comments by Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company6 and RAI Services Company7 where they identify a serious error in FDA’s calculation of the wet-weight to dry-weight conversation, which invalidates FDA’s estimate that 30% of moist snuff products on the market currently meet the 1 ppm dry-weight limit. This is a significant problem in that this error would result in dramatically overstating the number of products on the market that currently meet the standard (and, obviously, dramatically understating the number of products that do not meet the standard).

Errors such as these significantly invalidate FDA’s analysis, and necessitate that the proposed rule be withdrawn for further consideration.

FDA ignored the ANPRM process and failed to obtain relevant information from stakeholders, resulting in a proposed rule that is fatally flawed.

The subject matter of this rule is more appropriately addressed through the Advanced Notice of Proposed Rulemaking (ANPRM) process. ANPRM would have allowed the public and various stakeholders to inform the FDA of critical facts that FDA either ignored or simply got wrong.

The Tobacco Control Act requires FDA to consider technical achievability of compliance with the standard. It is striking that this rule, which imposes product standards that will fundamentally change the entire smokeless tobacco product category, was formulated with no formal input from industry stakeholders to determine whether the product standards were truly achievable in the base case or, if technically achievable for some products, whether those products would be readily accepted by consumers. It appears from several comments made by industry stakeholders that the standard for the most part is not technically achievable for most smokeless products produced in the U.S.8

FDA also failed to engage consumer stakeholders in formulating this rule. If they had, they would have understood the importance of consumer preferences and would have given more serious consideration to the ramifications of (1) removing certain products from the marketplace and (2) changing product formulations that impact taste and consumer acceptance. Much of FDA’s analysis and assumptions are flawed because they simply failed to take into account important factors regarding consumer use, habits, choice, practice, preferences, and beliefs. This failure is troubling since consumers are directly affected by the rule and are arguably the most important stakeholders.

Moreover, while FDA chose not to seek input from industry or consumer stakeholders, it appears likely that at least six organizations preferentially received information about the proposed rule in advance of its publication. Specifically, we refer to the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco Free Kids, and Truth Initiative, which groups filed a joint comment within hours of the publication of the proposed rule. We agree wholeheartedly with the comment by Brian J. Fojtik, Senior Fellow with Reason Foundation:

Given how little time elapsed between publication of the rule and the filing of the comment, questions arise as to whether there was coordination or consultation by the CTP with these groups prior to publication . . . . Even in the most forgiving of lights, the appearance is unseemly and should necessitate the withdrawal of the proposed rule.9

Our membership is largely skeptical (if not downright distrustful) of organizations that support the imposition of regulations that have the effect of making low-risk tobacco products less affordable, accessible, or acceptable to adult consumers. Even the suggestion that FDA might have coordinated its activities with these organizations has devastating ramifications in terms of already incredibly eroded consumer trust in the FDA.

The appearance of collusion, together with the significant missteps of FDA resulting from failing to use the ANPRM process, require that the proposed rule be withdrawn.

FDA ignored issues involving consumer choice, preference, practice, habit, and use patterns and their effect on the analysis of the rule’s impact on public health.

At the heart of this proposed rule is the notion that reducing NNN levels in all smokeless tobacco will result in significant health benefits. Leaving aside the issue of FDA’s flawed analysis of the risks associated with smokeless tobacco, we believe there is a strong likelihood that this rule may well result in an overall increase in harm to public health.

While FDA acknowledges that NNN levels vary substantially across subcategories of smokeless tobacco, it fails to acknowledge the significance of the other differences among those subcategories. While Swedish-style snus products may have lower levels of NNN than other types of smokeless tobacco product categories, not all consumers will find Swedish-style snus an acceptable alternative to the American-style product they currently use and enjoy.

FDA does not explore, even in the most cursory fashion, how acceptable consumers will find the mandatorily reduced NNN products, or how they will feel and react to their preferred products being removed from the market or reformulated so as to no longer (1) impart the flavor they enjoy, (2) provide the experience they enjoy, or (3) permit the cultural practices or experiences associated with products they are accustomed to. For example, FDA notes that one of the factors affecting NNN levels is the curing process. It also notes in a rather off-hand manner that the curing process imparts characteristic flavor. But FDA fails to address how effectively eliminating flue- and fire-curing would affect characteristics of the product other than simply NNN levels and how those changed characteristics will be received by consumers.

Consumer acceptance of mandatorily reduced NNN products is a critical issue. If a consumer’s preferred product is taken off the market or reformulated in a fashion that makes it no longer acceptable, one cannot assume that the consumer will simply quit using all tobacco products or will switch to using another mandatorily reduced NNA smokeless tobacco product.

FDA explores the question of whether this proposed rule might cause an uptake in smokeless tobacco use if the general public perceives that FDA has made the product category less risky, and notes that they would expect additional reduction in risk to individual users who might choose to switch from smoking to smokeless.10 FDA also explores the possibility that some non-tobacco users might decide to initiate smokeless tobacco use, but opines that it would still be a net health gain since “the prevalence of smokeless tobacco use would have to nearly triple in order to offset the expected excess cancer risk reduction due to the proposed rule.”11

And yet FDA never considers the far more damaging–and far more likely–possibility, namely, that the effect of this rule will be to cause more smoking as smokeless tobacco users’ preferred products are removed from the market or rendered unpalatable due to product formulation changes, nor does FDA quantify how many smokeless-tobacco-users-turned-smokers it would take to eliminate any of the anticipated health gains associated with the rule. Given the dramatic risk differential between smoking and smokeless tobacco, this is a significant issue which could well result in the a massive health benefit loss.

FDA failed to adequately address the issue of reduced risk across product categories and consumer misperceptions, resulting in the likelihood that this rule may actually result in a population-level loss of health benefit.

As noted previously, at the heart of this proposed rule is the notion that reducing NNN levels in all smokeless tobacco will result in significant health benefits. And while FDA has rather cursorily attempted to quantify the impact vis-a-vis the smokeless tobacco category, it failed to consider the possible impact of making the product category less attractive to the current consumers of these products as a result of product withdrawals and mandatory reformulations. Aside from the considerable welfare costs to many consumers of loss of enjoyment, there may well be a move away from the product class by current consumers. And, as discussed previously, we can expect that while some movement may consist of some consumers quitting smokeless tobacco use, we can also expect that some movement may consists of some smokeless tobacco users becoming smokers (or increasing their current smoking habit).

This would be a direct result of consumers failing to understand the risk differential between smoking and smokeless tobacco use. FDA ignores the incredible amount of misinformation in the public arena about the relative risks of smokeless tobacco versus smoking. The public perception is overwhelmingly that smokeless tobacco is as harmful as smoking.12 This misperception has been fueled by anti-tobacco messaging campaigns by federal and state governmental agencies, and by special-interest nonprofit groups that conflate risks by repeating the unhelpful (and deceptive) mantras that all tobacco products are harmful, no tobacco product is safe, and smokeless tobacco is not a safe alternative to smoking.

To the extent that many smokeless tobacco users see smokeless tobacco as being as risky as smoking, it is likely that a number of those smokeless tobacco users will consider smoking as a potentially acceptable alternative if their preferred products are no longer available. This is especially true given that we know that some smokeless tobacco users smoke (either daily or occasionally).13

Conclusion.

Based on the foregoing, we submit that FDA must withdraw the proposed rule in order to correct errors in analysis and computation and to consider all relevant information. We are also very concerned to see the elevation of bad science as the basis for national policy making. We urge FDA to methodically and patiently use the rulemaking process and to consider only the highest quality of science when proposing any new standards for low-risk tobacco and nicotine products.

Misleading the public is never good public policy. The public will be better served by receiving accurate information about low-risk alternatives to smoking, such as smokeless tobacco. Rather than proposing a rule that is a de facto ban on nearly all low-risk smokeless tobacco products, FDA must seize this opportunity to empower consumers to make safer choices when consuming nicotine.

_______________

1 Federal Register, Volume 82, No. 13, January 23, 2017, p. 8004. [link]

2 We do not necessarily embrace these estimates as accurate, but simply note that this is the information that the FDA considers persuasive and upon which the agency bases its conclusions.

3 Comment by Dr. Brad Rodu dated February 14, 2017. [link]

4 Rodu B., Cole P. Smokeless tobacco use and cancer of the upper respiratory tract. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. : US Department of Health and Human Services, Washington, DC; 2002 May 1;93(5):511-5. [link]

5 Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded Mandates Reform Act Analysis for Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products, Docket No. FDA-2016-N-2527, p. 19. [link]

6 Comment by Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company dated March 3, 2017. [link]

7 Comment by RAI Services Company dated [link]

8 See, for example, comments by Kentucky Farm Bureau Federation dated April 10, 2017 [link]; Eastern Dark Fired Tobacco Growers Association dated April 4, 2017 [link]; Dark Leaf Tobacco Dealers and Exporters Association dated March 21, 2017 [link]; Altria Client Services LLC on behalf of U.S. Smokeless Tobacco Company dated February 13, 2017 [link].

9 Comment by Brian J. Fojtik, Senior Fellow with Reason Foundation, dated March 9, 2017, pp. 3-4. [link]

10 Federal Register, Volume 82, No. 13, January 23, 2017, p. 8025. [link]

11 Federal Register, Volume 82, No. 13, January 23, 2017, p. 8025. [link]

12 According to a recent study, approximately 9 out of 10 individuals did not know that smokeless tobacco products were less hazardous than smoking. See Kiviniemi M, Kozlowski L, Deficiencies in public understanding about tobacco harm reduction: results from a United States national survey. Harm Reduct J.  2015; 12:21. [link]  

13 See, for example, Tomar S., Alpert H., Connolly G. Patterns of dual use of cigarettes and smokeless tobacco among US males: findings from national surveys. Tobacco Control 2010;19:104-109:  “[A]nalyses of data from four nationally representative surveys indicate that dual use of cigarettes and ST is relatively common among young males.” [link]

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NIAAA Prostitutes Its Scientific Integrity and Helps Alcohol Industry Promote Drinking

In one of the greatest episodes of corruption of a U.S. governmental health agency during my career, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) has sold itself out to the alcohol industry by agreeing to accept $68 million for a shoddily-designed study intended to examine the potential health benefits of moderate drinking but without similarly assessing the potential risks.

According to the New York Times: “the National Institutes of Health is starting a $100 million clinical trial to test for the first time whether a drink a day really does prevent heart attacks. And guess who is picking up most of the tab? Five companies that are among the world’s largest alcoholic beverage manufacturers — Anheuser-Busch InBev, Heineken, Diageo, Pernod Ricard and Carlsberg — have so far pledged $67.7 million to a foundation that raises money for the National Institutes of Health, said Margaret Murray, the director of the Global Alcohol Research Program at the National Institute on Alcohol Abuse and Alcoholism, which will oversee the study.”

The Rest of the Story

According to the New York Times article: “George F. Koob, the director of the alcohol institute, said the trial will be immune from industry influence and will be an unbiased test of whether alcohol “in moderation” protects against heart disease. “This study could completely backfire on the alcoholic beverage industry, and they’re going to have to live with it,” Dr. Koob said. “The money from the Foundation for the N.I.H. has no strings attached. Whoever donates to that fund has no leverage whatsoever — no contribution to the study, no input to the study, no say whatsoever.””
What a bunch of crap!
The money has huge strings attached: namely, the money is to be used for a trial to examine the potential benefits of drinking
In other words, the alcohol industry doesn’t need any further leverage because they have already won. They have succeeded in getting the NIAAA to spend 20% of its entire budget on a study which is designed to identify potential benefits of drinking. The study is not examining potential negative health effects of moderate drinking: namely, increased cancer risk, and especially breast cancer risk.
Very few people understand that the greatest influence that industry can have on research is not on the way the research is conducted, but on the topic of the research in the first place. The tobacco industry also funded research with “no strings attached.” The tobacco industry completely divorced itself from the decisions of many of its funded scientists. However, the industry had already won because it essentially dictated the research agenda. The industry made decisions about what to fund and what not to fund. That is the true, critical point of leverage.
So, for example, the tobacco industry funded many studies on genetic causes of lung cancer, non-tobacco-related causes of cancer, etc., while funding few, if any, studies on the severity of nicotine addiction, nicotine addiction in youth, the exposure of youth to tobacco advertising, the positive impact of anti-tobacco regulations, etc. 
No strings attached? The strings have already been attached.

If the alcohol companies were willing to donate money to NIH that could be used for any purpose that an NIH researcher proposed, such as a study to examine the effects of increased alcohol taxes on reducing youth alcohol consumption, then one could say that there are no strings attached. But this money is clearly earmarked – and beyond that, earmarked for a study that is essentially designed to show some positive health effects of moderate alcohol consumption.

Dr. Koob’s contention that this trial is an “unbiased” test is also laughable. How can it be unbiased when its major funder is the industry that markets the product under study? But the bias doesn’t end there. It turns out that many of the investigators running the study have individual conflicts of interest with the alcohol industry. At my institution, such researchers would not even be allowed to be involved in a clinical trial in which they have a significant conflict of interest. Our general policy is that an investigator with a significant conflict of interest cannot conduct a clinical trial on a product made by the relevant company. We do allow conflicted investigators to conduct pre-clinical studies, such as laboratory research; however, the line is drawn definitively at the level of a clinical trial.
Just how strong are the conflicts of interest of the lead researchers for the study?
According to the New York Times article: “Harvard, the hub of the clinical trial, has a long relationship with the alcoholic beverage industry. In 2015 the university accepted $3.3 million from the Foundation for Advancing Alcohol Responsibility, a group founded by distillers, to establish an endowed professorship in psychiatry and behavioral science.” 
In addition: “One of the trial’s principal investigators, Dr. Eric Rimm of the Harvard T. H. Chan School of Public Health, has acknowledged through various financial disclosures that he has been paid to speak at conferences sponsored by the alcohol industry and received reimbursement for travel expenses.”
Moreover: “Dr. Diederick Grobbee, another principal investigator, who is based in the Netherlands and is in charge of clinical sites outside the United States, said in a telephone interview that he has received research money from the International Life Sciences Institute, an industry group that supports scientific research.”
Furthermore: “In Baltimore, the trial will be run by Dr. Mariana Lazo-Elizondo of Johns Hopkins, who received research grants in 2013 and 2014 totaling $100,000 from the Alcoholic Beverage Medical Research Foundation. She declined to be interviewed.”
And to add insult to injury: “The Barcelona study arm will be run by Dr. Ramon Estruch, who in February helped lead a “Wine & Health” conference in the wine region of La Rioja, Spain, that was supported by the wine industry. Dr. Estruch recently refused to disclose his financial conflicts of interest to The Journal of Studies on Alcohol and Drugs and has not responded to requests for comment.”
It is clear that many of the principal investigators in the trial have personal conflicts of interest with the alcohol industry. And the lead investigator for the Barcelona study arm not only has severe personal conflicts of interest but has failed to disclose them, apparently despite numerous requests from the journal to do so. But his conflicts with Big Alcohol run deep. As I revealed in a 2016 column:
Dr. Ramon Estruch – is on the board of or receives money from three different research foundations, each of which is funded by alcohol companies. According to a published article: “Dr. Estruch reports serving on the board of and receiving lecture fees from the Research Foundation on Wine and Nutrition (FIVIN); serving on the boards of the Beer and Health Foundation and the European Foundation for Alcohol Research (ERAB).”

Well, it turns out that the Research Foundation on Wine and Nutrition is funded by alcohol companies.

And the Beer and Health Foundation is funded by the Spanish beer industry.

And the European Foundation for Alcohol Research acknowledges that it: “is supported by The Brewers of Europe, the voice of the brewing industry in Europe, whose members are the national brewing trade associations, representing more than 90% of European beer production.”

I have also previously discussed why Harvard’s objectivity regarding this research has already been severely compromised (see: Harvard Medical School Teams Up with Makers of Bacardi Rum, Smirnoff Vodka, Jim Beam Bourbon, and Jack Daniels Whiskey, Providing Great PR at Bargain Rates).
The study design doesn’t even pass the laugh test in terms of basic epidemiology. The study is excluding nondrinkers, who are the only people who really matter because they are the ones who would potentially benefit – or be harmed – by efforts to promote moderate drinking. People who are already drinking aren’t the ones who would be most affected by such a campaign.

The study is also excluding problem drinkers. People who are already drinking, but are not problem drinkers, have already demonstrated that they are capable of moderate drinking. The real issue is what happens when you successfully convince a non-drinker to start drinking every day. This trial specifically avoids (and is designed to avoid) examining that research question. But that research question is really what is at the heart of any evaluation of whether promoting moderate drinking might have public health benefit.

Even the tobacco industry, to the best of my knowledge, never succeeded in persuading the prestigious NIH to accept industry funding for a study of interest to the tobacco companies. The tobacco companies had to resort to funding their own research bodies (e.g., the Council for Tobacco Research). But here, the NIAAA is giving the alcohol industry an unprecedented gift: the acceptance of industry money to conduct a clinical trial, under the pretense of being an objective government study.

The rest of the story is that by accepting this funding from the alcohol industry to support what is supposed to be an objective NIH research agenda, the NIAAA has compromised its scientific integrity, selling out to the alcohol industry and helping the industry to promote drinking. This is not the appropriate role of the NIAAA.

This clinical trial is tainted before it has even begun. Hopefully, its participants will be informed that the study is essentially a sham – that it is funded by the alcohol industry, which has — in a dream come true scenario — somehow gotten the NIAAA to agree to conduct a study that is designed only to examine potential positive health effects of moderate drinking, while ignoring (and not looking for) any serious potential risks, such as cancer.
The study investigators may not reveal this critical information to the human subjects in these trials; however, there are a number of public health groups that are planning to publicize this information so that the public is aware of this scam before it does real damage to the public’s health. It has already done damage to the scientific credibility of the NIAAA specifically, and of government public health research in general.

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FDA – Comment NOW on proposed–unrealistic–standard for smokeless tobacco

The deadline for commenting on an FDA rule regarding product standards for smokeless tobacco (ST) is Monday, July 10th, 2017. Comment Now!

By way of background, the FDA published a rule for public comment on January 23, 2017 regarding a proposed standard for N-nitrosonornicotine (NNN) levels in ST products. The proposed limit for NNN concentration would be 1 ppm of dry weight. Although some products do exist that would meet this arbitrary standard, the vast majority range somewhere between 1 ppm and 10 ppm.

Imposing a cap on NNN concentration at 1 ppm of dry weight would:

    • Not result in a significant risk reduction. Any reduction in risk associated with forcing NNN levels to be reduced is likely to be zero and will be more than offset by the cost to consumers of limiting choice and destroying the diversity in the marketplace of these already incredibly low-risk products.
  • Set an unreasonable standard that most products–even if they were reformulated–would not be able to meet. Much like the PMTA issue with e-cigarettes, this would be a de facto ban on most ST products sold in the United States.
  • Reduce consumer access to the lowest risk tobacco products on the market today. This will have the effect of forcing U.S. consumers to shop overseas (increasing their cost), and for many, may cause them to replace their smokeless habit with smoking.

Take action NOW – Submit a comment!

Choose some points below to add to your comment:

  • Do you use smokeless tobacco as a form of tobacco harm reduction?
      • Do you use smokeless tobacco instead of smoking, or did you quit smoking by switching to smokeless tobacco?
      • Do you use smokeless tobacco in places where you cannot vape?
  • How important is the variety of smokeless tobacco products to you?
      • Are you “brand loyal” or do you benefit from being able to use different types of smokeless tobacco?
      • Do you know if your preferred brand will be able to meet this 1ppm of dry weight standard? (see this chart for reference)
  • What will you do if you are unable to purchase smokeless tobacco in the United States?
      • Do you think you would return to smoking?
      • Will you shop online, overseas?
  • For more information:
    • Comment from Reason Foundation here.
    • Dr. Brad Rodu provides background and insights here, with links to other comments on the rule.
    • Dr. Carl Phillips has provided an in-depth analysis in a three part series here, here, and here
* You are commenting on a publicly viewable docket on Regulations.gov. Any personal information you provide in your comment will be publicly available. The information you provide to CASAA in order to complete this engagement will not appear on Regulations.gov.

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