Federal Agencies Continue To Disrespect Smokeless Tobacco Users

Last week I presented my correspondence with the director of the federal Centers for Disease Control and Prevention, which resulted in a retraction of CDC’s use of the pejorative term “spit tobacco” in a formal report (read it here).

This week I am very disappointed to report that the FDA uses the demeaning term on a web page (here) that was last updated on July 8.

Although the offending page is supposed to present information about warning labels, it launches into an unnecessary and unsubstantiated attack on smokeless tobacco and, of course, its users:

“Smokeless tobacco is still tobacco. It is addictive and causes cancer. Quit today. For help, visit ‘Spit Tobacco: A Guide for Quitting’ or call 1-800-QUIT-NOW.”

It is unacceptable and irresponsible for the FDA to use such language to describe the product it is supposed to regulate in a balanced, fair and scientific manner. But it gets worse. The Spit Tobacco Quitting Guide is an embedded link to a document on the website of the National Institute of Dental and Craniofacial Research (here). The document exposes smokeless users to even more abuse:

“If the health effects don’t worry you, think of how other people see your addiction. The smell of spit tobacco in your mouth is not pleasant. While you may have become used to the odor and don’t mind it, others around you notice. Check out your clothes. Do you have tobacco juice stains on your clothes, your furniture, or on your car’s upholstery? Your tobacco spit and drool could be making a mess. Look at your teeth. Are they stained from tobacco juice? Brushing your teeth won’t make this go away.”

This is appalling language, and it is disgraceful that two federal agencies have officially adopted and endorsed it.

Three years ago, the director of the Centers for Disease Control rejected the use of the biased and pejorative term “spit tobacco.” Unfortunately, the practice persists today at two other federal agencies. I have written to Dr. Lawrence Deyton, director of the FDA Center for Tobacco Products, and to Dr. Lawrence Tabak, director of the National Institute of Dental and Craniofacial Research, asking them to remove these offensive website items and order professionals in their agencies to stop using this term in all official matters.

Users of smokeless products may want to call, write or email Drs. Deyton and Tabak, asking them to remove “spit tobacco” from their agencies’ vocabulary. Here is their contact information:

Dr. Deyton: 1-877-287-1373 (toll-free)
AskCTP@fda.hhs.gov

Dr. Tabak: 1-301-496-3571
Lawrence.Tabak@nih.gov

Health Professionals Who Disrespect Smokeless Tobacco Users

When I started conducting research on tobacco harm reduction in the early 1990s, I noticed a disturbing trend: replacement of the term “smokeless tobacco” with the demeaning and disrespectful term “spit tobacco.”

This degrading term was not only used by extremists at the margin of tobacco control; by 1994, health professionals were using it in medical journals. The first instances were in the Journal of the American Medical Association (citation here) and the Journal of the American Dental Association (abstract here). The latter article was the first of 10 by Margaret Walsh, a professor of dentistry at the University of California/San Francisco; her most recent publication was in 2009 (abstract here).

Other professionals who have used this terminology include John Ebbert and Lowell Dale of the Mayo Clinic (here, here and here) and Dorothy Hatsukami at the University of Minnesota (here and here). Dr. Hatsukami’s adoption of the loaded term is especially troublesome since she now sits on the FDA tobacco products advisory panel.

The most egregious use of the spit terminology has been by the American Cancer Society and the CDC. The Cancer Society published research studies in 2005 and 2007, prominently using “spit” (here and here). The CDC institutionalized the practice in a 2006 federal report in collaboration with the National Center for Health Statistics (here).

The 2006 CDC report was especially deplorable, because it treated smokeless tobacco use differently than three other adult health risk behaviors -- cigarette smoking, cigar use and alcohol consumption.

On February 19, 2007, I wrote to CDC Director Julie Gerberding and NCHS Director Edward Sondik (available here). I pointed out that “the report’s use of [‘spit’ tobacco] is clearly inconsistent with its use of other terms relating to tobacco use and drinking behaviors. Furthermore, I believe that the use of ‘spit’ tobacco violates NCHS and CDC guidelines for ensuring the quality of information disseminated to the public. The NCHS and CDC guidelines are identical with respect to this matter, as it is each agency’s policy to ‘ensure and maximize the quality, objectivity, utility, and integrity of information that it disseminates to the public.’”

I strongly urged “CDC and NCHS to issue a corrected version of the Advance Data Report Number 378. Furthermore, I am asking that CDC/NCHS officials and staff to avoid the use of the term ‘spit’ tobacco in future official government publications, and to remove the term from existing web pages. This term is inappropriate because it is inaccurate, biased and unobjective. In addition, its use is inconsistent with the fully appropriate and non-pejorative terms ‘cigarettes,’ ‘cigars’ and ‘alcohol’ used in this and other government documents.”

In April, I received a response from Dr. Gerberding (read it here). She acknowledged that “an inappropriate term was used in this report. We agree that the term ‘smokeless tobacco’…would provide a better description of the information and we will take swift action to make that change. A revised version of [the report] will be posted on NCHS’ website. The printed version of this report will be changed should we reprint in the future.”

In May 2007, I wrote to John Seffrin, CEO of the American Cancer Society. I included a copy of Dr. Gerberding’s decision, and I listed several specific publications in which Cancer Society officials had used “spit tobacco”. I made the following key points:

“In a March 27 Wall Street Journal article, American Cancer Society Vice President Dr. Michael Thun summarized a growing consensus among tobacco research and policy experts regarding the vast difference in risk between smoked and smokeless products: ‘There's no question that switching to spit tobacco and quitting tobacco altogether are both far less lethal than continuing to smoke.’ Recognizing these differential risks is consistent with the American Cancer Society mission, which includes ‘preventing cancer, saving lives, and diminishing suffering from cancer.’ Describing all tobacco products in objective and professional terms would enhance the essential humanity of your mission by treating all tobacco users with dignity and respect.

“I believe that the American Cancer Society strives for high standards in its professional reports and communications, and I request that Society officials describe tobacco use in a non-pejorative, unbiased and objective manner consistent with the change made by the CDC. Specifically, I ask that Cancer Society officials and staff not use the term ‘spit tobacco’ in future reports and communications, and that the term be removed from existing web pages and other electronic reports and documents.”

In July 2007, Dr. Seffrin wrote back: “Thank you for sharing your concerns regarding the use of the term ‘spit tobacco’ by health and policy professionals at the American Cancer Society. I have forwarded your letter to the appropriate staff for further review and any appropriate action.”

I don’t believe that Cancer Society officials at the national level have used “spit tobacco” since that time.

Use of the phrase “spit tobacco” shows that anti-tobacco extremists are completely out of touch with contemporary use of smokeless products. The “Swedish miracle” has shown the world that smokeless tobacco can be an effective substitute for cigarettes, resulting in population-level health improvement. Swedes have also shown how to use smokeless tobacco without spitting. They place smokeless products in the upper lip, reducing or eliminating the need to spit.

Modern dissolvable products (here and here), which are about the size of small breath mints, can also be used invisibly in any social situation. No tobacco juices are produced when these products are used, so spitting is as unnecessary as the derogatory terminology.

Down the Rabbit Hole: Tobacco Control Through Radical Nicotine Reduction

June 22 marked the one-year anniversary of the Tobacco Act, which gave the FDA regulatory authority over tobacco products. Anti-tobacco extremists like Matthew Myers were delighted: “It's remarkable what the FDA has been able to accomplish in this first year.”

But the occasion was notable for another reason, the re-emergence of the most idiotic idea ever proposed by tobacco control advocates: Force smokers to quit by reducing the nicotine content of tobacco products. The Tobacco Act permits the FDA to reduce nicotine to any level above zero, thus allowing de facto nicotine prohibition.

Nicotine prohibition has been championed in the Washington Post (read it here) and elsewhere by Dr. David Kessler, former FDA commissioner and former medical school dean at the University of California/San Francisco.

This strategy was introduced in a 1994 commentary in the New England Journal of Medicine by Dr. Neal Benowitz and Dr. Jack Henningfield, tobacco opponents who now sit on the FDA tobacco products advisory panel. An ethics watchdog group has challenged their appointments based on conflicting financial interests (read it here). Their nicotine prohibition scheme, based on several highly speculative assumptions, casts doubt on their ability to provide the FDA with sound counsel.

Benowitz and Henningfield adopted, without hard evidence, the position that smokers of five or fewer cigarettes per day, are not addicted to nicotine. They even acknowledged the weakness of their assumption, commenting: “Of course, there is no sharply demarcated threshold level, and there are some people who smoke fewer than five cigarettes per day and have great difficulty in quitting and others who can smoke more than five cigarettes per day and quit with ease.”

Building on this unscientific position, Benowitz and Henningfield opined that “an absolute limit of 0.4 to 0.5 mg of nicotine per cigarette should be adequate to prevent or limit the development of addiction in most young people.” They believed that “the level of nicotine in tobacco could be reduced gradually, with a goal of reaching a target nicotine level over perhaps 10 to 15 years.”

Benowitz and Henningfield acknowledged that reducing nicotine could harm the nation’s 45 million current smokers. “Switching from higher-yield to lower-yield cigarettes has been shown to result in smoking more cigarettes or smoking more intensively [overcompensation], both of which are associated with increased exposure to carbon monoxide and other toxins.” But they were willing to make an unacceptable compromise: “Even if there is some element of overcompensation and smokers are exposed to increased levels of toxins, their short-term (10-year) risk may be offset by the long-term benefit of a greater likelihood that they will stop smoking (as cigarettes become less satisfying) and by the enormous benefit of preventing nicotine addiction in future generations.”

This radical nicotine reduction scheme would put smokers’ lives at risk, even though Benowitz and Henningfield admitted that “a threshold level for nicotine addiction is a theoretical concept.” In their commentary, they conceded that the theory “that restricting levels of nicotine would prevent addiction needs to be verified empirically,” but they reversed course in a subsequent letter to the journal: “There is no way of empirically testing the proposition that nonsmokers would be less likely to become addicted to low-nicotine cigarettes as we define them.”

Simply put, the Benowitz-Henningfield nicotine prohibition plan is to expose current smokers to increased levels of toxins over a 10-year period, in the hope that they will stop smoking in the long term, and that children might never start. They recognize that their plan needs to be tested, yet they acknowledge that testing is impossible. It is reminiscent of an Alice in Wonderland musing, “Sometimes I believe in as many as six impossible things before breakfast.”

The FDA must not follow Benowitz and Henningfield down the rabbit hole of nicotine prohibition.

Canadians Who Care About Tobacco Harm Reduction

Toronto’s Non-Smokers’ Rights Association has just become the first Canadian organization to endorse tobacco harm reduction. Together with the Smoking and Health Action Foundation, the NSRA published “Harm Reduction in Tobacco Control: What is it? Why should you care?”

The report (available here) is an accurate and balanced discussion of the issue. It describes smokeless tobacco products (including Swedish snus) and e-cigarettes, and it makes the following recommendations:

1. “Establish a regulatory framework for nicotine products.”

In theory, this is a reasonable approach; a regulatory agency could evaluate all tobacco and nicotine products with consistent criteria. The report suggests that “…availability, price/taxation, and permitted forms of promotion should all be related to the level of risk inherent in their use.” It is unfortunate that American legislation giving the FDA authority over tobacco contained no provisions for regulating tobacco products according to risk.

2. “Shift current tobacco users to the least harmful nicotine product – [pharmaceutical] nicotine replacement therapy.”

The report recommends that smokers be given accurate information about nicotine, specifying that it “is not the harmful substance in cigarettes.” It also points out that pharmaceutical nicotine should be made more affordable and accessible.

3. “Shift smokers who are unable to quit or unwilling to make a quit attempt to a less harmful product – snus.”

The report strongly counsels against misinforming smokers: “The public has the right under Canadian tort law to accurate information about the relative risks of using tobacco products and to make choices based on the facts. The current warning on smokeless tobacco products, ‘This product is not a safe alternative to smoking,’ is woefully inadequate as it provides no information regarding relative risks.

“Governments and health organizations must improve messaging, both on the product and in other media, about the relative risks of cigarettes, smokeless tobacco products, and non-tobacco nicotine products to ensure that the public is better informed and does not rely on tobacco companies for risk information.”

Although NSRA doesn’t trust tobacco manufacturers, it’s ironic that governments and health organizations are now the dominant sources of inaccurate risk information.

4. “Monitor the impact of alternative nicotine products.”

The report calls on “Health Canada and or other government authorities” to “conduct post-market surveillance of the promotion…” and “health impact of alternative nicotine products” like e-cigarettes, as well as safer smokeless alternatives. That’s a reasonable requirement. In comparison, the U.S. FDA legislation requires manufacturers of safer tobacco products to prove that they will have no population effect BEFORE they are marketed (described here).


The NSRA joins three other respected professional organizations in endorsing tobacco harm reduction. In 2006, the strategy was endorsed by the American Council on Science and Health, whose mission is to promote sound science in regulation and in public policy and to assist consumers in distinguishing real health threats from purely hypothetical ones. Throughout its history, ACSH has published many articles about the health risks of smoking, and it has held the tobacco industry accountable for its role in the devastating toll from tobacco. In the late 1970s, ACSH founder Elizabeth Whelan published a landmark anti-smoking book, A Smoking Gun: How the Tobacco Industry Gets Away with Murder. More information is available here.

In 2007, Britain’s Royal College of Physicians, one of the oldest and most prestigious medical societies, strongly endorsed tobacco harm reduction. The Royal College concluded “…that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved… Harm reduction is a fundamental component of many aspects of medicine and, indeed, everyday life, yet for some reason effective harm reduction principles have not been applied to tobacco smoking.” The Royal College report is available here.

In 2008, the American Association of Public Health Physicians became the first U.S. medical organization to formally adopt a policy of “…encouraging and enabling smokers to reduce their risk of tobacco-related illness and death by switching to less hazardous smokeless tobacco products.” Their report is available here.

It is gratifying to see the sound medical principles of tobacco harm reduction being adopted by the broader public health community.

The Bermuda Triangle of Tobacco-Specific Nitrosamines

Let’s start this post with some indisputable facts about smokeless tobacco:

1. Despite decades of epidemiologic research, long-term use of Swedish or American smokeless tobacco products (other than dry powdered snuff) has not been associated in a significant way with ANY disease.

2. Just like the foods we consume, contemporary smokeless tobacco products contain trace amounts of contaminants.

3. Tobacco-specific nitrosamines (TSNAs) are contaminants found only in tobacco products. They are present in vanishingly small concentrations – mainly in the single-digit parts-per-million range.

4. Two TSNAs, labeled NNN and NNK, have been designated by advisory organizations as human carcinogens, based entirely on laboratory experiments; there is no supporting evidence from human studies.

5. A recent meta-analysis concluded that modern smokeless tobacco products have cancer risks that are so low that they are not measurable with any precision by modern epidemiologic methods.

Again: These facts are indisputable. This is important because the FDA tobacco product advisory committee has just launched an investigation into tobacco product constituents. As a consequence, there will be a lot of talk about levels of bad constituents. With respect to smokeless tobacco, most of this will be nonsense. Let’s look at TSNAs.

It’s a given that, regardless of current TSNA levels, anti-tobacco extremists will call for reductions. However, since there is virtually no evidence that current TSNA levels are associated with ANY measurable cancer risks, it is inconceivable that a reduction in levels will produce any measurable benefit.

Tobacco prohibition advocate Dr. Deborah Winn, in a congressional hearing exchange with Congressman Steve Buyer (transcribed in my recent post here), argued for reduced TSNAs, but with no epidemiologic evidence that they are related to cancer now, nor that reductions would have any health effect:


Buyer: Do you acknowledge that if I can reduce the [TSNAs] in a product, that I can reduce the risk?

Winn: There’s no epidemiologic evidence that shows that that is the case. It’s certainly important that [TSNA] levels be reduced.


Some tobacco manufacturers want the FDA to take action on TSNAs, primarily because they make lower TSNA products. For example, Star Tobacco president Paul Perito issued a press release after the FDA meeting on June 8 (here), stating: “It is our hope that the FDA will… publish a list of the toxicants and carcinogens that are well documented to be linked with tobacco harm…” It is fair to ask Mr. Perito, What specific carcinogen has been documented to be linked with what specific tobacco harm? No legitimate scientist has demonstrated such a connection.

It is reasonable to expect tobacco manufacturers to maintain TSNAs at their historically low levels. It is entirely unreasonable to require further reductions without a scientific rationale relating such change to risk reduction, unless the goal is to drive the industry out of existence. Smokers and smokeless tobacco users should not be sucked into this Bermuda triangle of extremism.

Dr. Winn’s Misinformation and Congressman Buyer’s Remorse

When the FDA eventually looks at low-risk alternatives to cigarettes, it will ask experts at the National Cancer Institute for advice on relative risks. Dr. Deborah Winn, a 30-year veteran provider of misinformation about smokeless tobacco (evidence here and here), will be the NCI’s lead authority. Regrettably, Dr. Winn has proven incapable or unwilling to distinguish the risks related to combustible and smoke-free tobacco.

I recently reviewed Dr. Winn’s testimony before the House Subcommittee on Health. All 3.5 hours of this tirade against smokeless tobacco is available (here). Her appalling disregard of facts was highlighted in the following exchange (occurring at about 1 hour 57 minutes) with Congressman Steve Buyer:

Buyer: I’m trying to reconcile a couple of comments...you acknowledge that there is a continuum of risk within tobacco products…smoking to smokeless, pharmaceutical to quitting…a continuum of risk, you acknowledge that, correct? From very high risk to very low risk, you acknowledge that?

Winn: Um, quantitating it at high or low, they all have risks.

Buyer: You acknowledge that there’s a continuum of risk, from very high risk to very minimal risk, you acknowledge that?

Winn: Very high risk to moderate risk.

Buyer: To moderate risk? So if I can with proven science say that there is a product on the market that would remove 99% of the nitrosamines, you would define the 1% as moderate?

Winn: Um…all smokeless tobaccos have some risk of health effects.

Buyer: That’s correct. I concur with that. Now let me go back and acknowledge this. Let’s not play games. Do you acknowledge that there is a continuum of risk, from very high risk to very low risk, to the health effects with the use of tobacco products?

Winn: Some tobacco, for example, chronic obstructive pulmonary disease...

Buyer: All right, all right, I’m not going to quibble with you...because it appears that if you will not even acknowledge that there’s a continuum of risk, then you’re placing yourself in the camp of complete abstinence. Now I will concur with you that tobacco products are not healthy. I concur with that. But to ignore that there is a continuum of risk from very high risk, cigars, to very low risk, which would be a product…Let me ask it this way…If you are able to put a product on the market that reduces the nitrosamines, does that eliminate, then, health risks?

Winn: What causes us concern under those circumstances is the population effect that might be influenced by people smoking and adopting a smokeless tobacco product.

Buyer: Do you acknowledge that if I can reduce the nitrosamines in a product, that I can reduce the risk?

Winn: There’s no epidemiologic evidence that shows that that is the case. It’s certainly important that nitrosamine levels be reduced.

Buyer: So, are you saying to me then, that an Orb or a Stick that has 99% reduced nitrosamines is just as harmful as smoking a cigar? That’s what your statement is saying.

Winn: Yes.

Buyer: And you concur with that?

Winn: Um, assessing nitrosamine levels or reduced nitrosamine products is under the purview of the FDA. So I would…

Buyer: Great. Your staff just gave you that so you could read it. But just answer the specific question.

Winn: We don’t know that there is any level of nitrosamines known to be safe.

Buyer: [Laughs] Wow. So you are unwilling to recognize the differentials of risk within tobacco products. That’s what I’m hearing from you. You do not acknowledge that there is differential risks among tobacco products?

Winn: There is a continuum of risk.

Buyer: Thank you, thank you. We got there, didn’t we? We got there. There is a continuum of risk. Now why is that important? It’s important because, as a country, those who are advocates of an abstinence approach are locking us in to a system of failure…

This is a harbinger of what will transpire as abstinence-only federal nannies slowly tighten the regulatory noose around snus and other smokeless alternatives to cigarettes. Even worse, Congress is losing the only member who understands tobacco harm reduction, and has the courage and integrity to challenge the misinformation spewing from prohibitionists. Steve Buyer will not stand for re-election in 2010, which is a terrible setback for American smokers.

Congressional Craziness: Requiring Population-Level Proof for Harm Reduction

In 2009, anti-tobacco extremists won adoption of the Tobacco Act, which is likely to effectively prohibit tobacco manufacturers from participating in tobacco harm reduction.

The Tobacco Act forbids manufacturers’ communication with consumers about the relative risks of different tobacco products. This prohibition is not limited to commercial speech (i.e., advertising); it could be applied to essentially any public statement by tobacco company scientists or executives. If a manufacturer wants to market a tobacco product as a lower-risk alternative to cigarettes, Section 911 of the law contains evidentiary requirements that are nearly impossible to fulfill, even though the product already has been proven to be safer than cigarettes.

Section 911 is aptly numbered; it will significantly extend a tragic health crisis for legions of inveterate cigarette smokers.

In order to market a smokeless product as a less harmful alternative to cigarettes, a manufacturer has to satisfy the FDA that (a) the product will “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and (b) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

Is it possible to implement a clinical trial that could evidence the population benefit of safer tobacco alternatives? A recent analysis, published in Regulatory Toxicology and Pharmacology, attempts to provide an answer. The first author of the study (abstract here) was Lenn Murrelle from Altria; collaborators included statisticians and epidemiologists from consulting firms. It does not provide much hope that a clinical trial will ever be conducted.

Murrelle and colleagues start with some reasonable assumptions. First, they propose to study a very low-risk cigarette alternative such as snus. They designed the clinical trial to include four groups: continuing smokers, smokers who quit altogether, smokers who switch to snus, and nonsmokers. The latter group is important because of the Tobacco Act’s mandate to monitor possible future snus use among those who never used tobacco.

Murrelle used lung cancer as the outcome measure, which was the only practical choice. Smoking is the dominant risk factor for lung cancer, and snus use plays no role in this disease, so this maximizes the differences between continuing smokers and those who quit or switch. In fact, Murrelle assumed that the lung cancer rate among smokers who switch to snus would be the same as that among quitters.

Murrelle et al. found that a clinical trial would need to enroll 8,000 subjects (2,000 in each of the four groups) and follow them for 5 years in order to see differences in lung cancer between smokers who quit or switched to snus, and those who continued to smoke. Most clinical trials enroll a few hundred subjects at most, so 8,000 is an enormous number.

Such a trial, including 5 years of follow-up, would cost tens of millions of dollars. But that’s not the only problem. First, an ethical review board would never permit an investigator to assign a smoker to keep puffing. Challenges with the switch-to-snus group include finding an acceptable product, monitoring compliance and consumption, and determining who pays for the products. The quit-altogether group would be almost impossible to maintain, because sustained quit rates among smokers are so miserable. Finally, it would be terribly awkward to enroll people who don’t currently use tobacco, because they would have to be truthfully informed about the entire study.

The “claim” that might result would be very narrow: “Switching to this (specific) snus product could reduce your risk of lung cancer to the level of quitting tobacco altogether.” Murrelle and colleagues point out that if manufacturers want data for claims involving other diseases and/or products having smaller risk differentials than snus and lung cancer, they might have to enroll up to 10 times the number of subjects. That’s as many as 80,000!

Congress invoked this virtually unattainable population standard under the influence of tobacco prohibitionists. It is important to point out that setting such an extraordinarily high evidentiary bar is unprecedented. For example, consider the lack of such an evidentiary requirement to support the federal requirement for automobile seatbelts, another type of harm reduction. First pioneered by Swedish carmakers Saab and Volvo, (history here), seat belts were mandated by the federal government for all new automobiles starting January 1, 1968 (regulation here). While there was adequate laboratory evidence that wearing seat belts provide protection (but in rare instances slightly increase risks, similar to smokeless), there was virtually no population-level proof until this decade that seat belts actually save lives (an example).

It would have been disastrous if Congress had passed a bill in 1968 requiring population-level evidence before seat belts could be marketed for harm reduction. The same applies to smokeless tobacco.