A Reasonable Draft Report on Dissolvable Tobacco

When Congress passed the 2009 Tobacco Act, it directed the FDA to study the issue of dissolvable tobacco products (DTPs). After meetings in July 2011 and last month, the Tobacco Products Scientific Advisory Committee (TPSAC) released a draft report summary (available here). In general, the draft is a reasonable and even-handed discussion of available information on DTPs.

The Tobacco Act required TPSAC to review and provide recommendations to the FDA regarding “the nature and impact of the use of dissolvable tobacco products on the public health, including such use among children.”

The report contains some positive statements. First and foremost, “TPSAC members concurred that available evidence supports a conclusion that DTPs are likely to be associated with far lower disease risks than cigarettes.” The committee appropriately acknowledges the much lower risk profile of DTPs compared with cigarettes.

Lower risk was also noted earlier in the draft: “Based on information on TSNAs [tobacco-specific nitrosamines], nicotine, and studies of cancer risk of SMTs [this acronym was not defined, but the context suggests that it refers to smokeless tobacco], exclusive use of DTPs should be less hazardous than either cigarettes or SMTs now marketed in the United States.”

Although the overall message is affirmative, it is not clear how the committee concluded that DTPs “should be less hazardous” than “SMTs now marketed in the United States.” As I have documented (here and here), TSNA levels in all popular American smokeless products are minuscule. There is no way to prove that DTPs are safer than smokeless products now marketed in the U.S., because the latter have risk profiles that are barely elevated, if at all.

The report makes some reasonable comments about the overall population effects of dissolvable tobacco. Referring to the report’s flow chart (that contains errors and is unclear), “[t]he TPSAC framework indicates several ways that DTPs could reduce the disease burden caused by tobacco use: decreasing the number of smokers, if availability of DTPs increases successful cessation, and decreasing the risk of tobacco caused disease, if availability of DTPs sufficiently reduces cigarette smoking or use of other types of SMT.”

However, the report also suggests that DTPs could cause population harm, “by either increasing the number of tobacco users or reducing cessation,” which are persistent but speculative concerns within the tobacco control community. First, because the risks of DTP use are, at most, about 2% of the risks of smoking, the increase in users would have to be over 50-fold to increase population harm. The reduced-cessation concern is also not evidence-based. Currently, cessation is abysmal among American smokers; fewer than 5% quit in any given year. Furthermore, a study published in 2010 (discussed by me here) documented that that there is “no evidence that smokeless tobacco (Ariva or Stonewall) undermines quitting. To the contrary, readiness to quit (in the next 1 month and within the next 6 months) significantly increased among smokers who used a smokeless tobacco product relative to those who continued to smoke conventional cigarettes.” This is unmistakable evidence that DTPs don’t deter smokers from quitting.

The TPSAC report concludes with recommendations for additional product testing, surveillance and research; I heartily concur with the call for improved surveillance. As discussed recently in this blog (here), there is a deficit of information in federal surveys on smokeless tobacco use in general, and especially on newer products like dissolvables and e-cigarettes. Adequate information is a necessary prerequisite for meaningful regulatory action.

CDC Study: Americans Are Misinformed About Snus and Dissolvable Tobacco

Last week I made the case that the CDC was largely responsible for the information void related to smokeless tobacco use. (here). Staff from the CDC Office on Smoking and Health have published a report documenting that many adults in the U.S. are not even aware of snus and dissolvable tobacco, and they are mostly clueless about differential health risks of these products versus cigarettes.

Annette Regan was the first author of this study, published in the American Journal of Preventive Medicine (abstract here). She and her colleagues analyzed several thousand responses to the 2009 ConsumerStyles and HealthStyles Surveys conducted by Synovate Inc. The results are representative of the U.S. population.

Regan et al. wrote that “44% of [American adults] had heard of Camel or Marlboro snus…” but only “5.4% of adults reported trying snus and 1.8% used snus currently.” Only 10% of adults were aware of dissolvable tobacco, only 0.5% had tried it and a scant 0.3% currently used it.

Awareness and use of snus and dissolvables are modest, but the beliefs about risks were, well…unbelievable. Here is what respondents thought about the health risks of snus and dissolvables, compared with cigarettes:

What American Adults Think About the Health Risks of Snus and Dissolvable Tobacco
	Snus	Dissolvable
More harmful than cigarettes	8%	7%
Just as harmful	50%	39%
Less harmful	5%	4%
Unsure	37%	50%

It is astounding that only tiny fractions of American adults (5% and 4%) are correctly informed that snus and dissolvables are less harmful than cigarettes. It is even more remarkable that Regan et al. did not even comment on this. Instead, they resorted to the same old mantra:

“All tobacco use is harmful; however, uptake of some of these products may pose unique health concerns. For example, snus and dissolvable tobacco products are marketed for use by cigarette smokers in places where smoking is not permitted. These discrete smokeless tobacco products can be used to deal with nicotine cravings while circumnavigating smokefree policies, and as a result deter smoking-cessation attempts. Because smoking cessation would result in substantial health benefıts, this behavior would be detrimental to health.” (references omitted)

Regan et al. don’t acknowledge that Americans are misinformed, and they perpetuate the misinformation by repeating that “all tobacco is harmful.” They opine that snus and dissolvables keep people smoking, but that is ridiculous. Their study shows that it is misinformation that keeps smokers from switching to lifesaving alternatives.

The Dissolvable Deficit: FDA and CDC Must Fill Data Void

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) held a public hearing January 18-20 on dissolvable smokeless tobacco products. The information gleaned there will help inform a congressionally mandated report on the subject, due March 23.

The proceedings (agenda here) underscored the dearth of information on dissolvable tobacco use. Committee members repeatedly observed that there is no reliable data on who uses these products and in what context. Are dissolvables temporary or permanent substitutes for cigarettes? Do they promote tobacco initiation among teenagers?

These are legitimate questions for which we need definitive answers. One problem is that dissolvables from major manufacturers have only been in limited markets since 2009, when RJ Reynolds test-marketed Camel Orbs, Strips and Sticks in Indianapolis, Columbus and Portland, Oregon. Testing was discontinued early last year, but Reynolds later launched the products in Denver and Charlotte. In 2011, Altria introduced Skoal and Marlboro Sticks in Kansas. A smaller player, Star Tobacco, has sold Ariva dissolvable tobacco since 2001.

It is not surprising that we know next to nothing about dissolvable tobacco use; little is known about smokeless tobacco use generally, despite the fact that some 6 million U.S. adults consume these products. This information deficit can be blamed on the federal government, and specifically on the Centers for Disease Control and Prevention (CDC).

Each year, the CDC publishes detailed information on U.S. smoking prevalence, based on the annual National Health Interview Survey. What about smokeless tobacco? It turns out that the CDC has only produced detailed smokeless tobacco information twice in the last decade, in 2000 and in 2005, when the NHIS included a special supplement sponsored by the National Cancer Institute. There is a lot of information in these supplements, as I documented in 2009 publication (abstract here).

There has been growing discussion over the past decade about smokeless tobacco as a substitute for cigarettes. The U.S. House of Representatives in 2003 held a hearing titled “Can Tobacco Cure Smoking: A Review of Tobacco Harm Reduction” (my testimony here). It should have been a wakeup call for government officials to collect more information on smokeless tobacco use. Instead, there is evidence that NHIS staff decided to collect less.

In addition to smokeless tobacco information, the 2000 NHIS also collected information on the techniques used by smokers during their last attempt to quit. This data proved that tobacco harm reduction with smokeless tobacco was working. As I noted in a published study (abstract here):

“An estimated 359,000 men switched to smokeless tobacco in their most recent quit attempt. This method had the highest proportion of successes among those attempting it (73%), representing 261,000 successful quitters (switchers)… Switching to ST compares very favorably with pharmaceutical nicotine as a quit-smoking aid among American men, despite the fact that few smokers know that the switch provides almost all of the health benefits of complete tobacco abstinence. The results of this study show that tobacco harm reduction is a viable cessation option for American smokers.”

If the 2000 NHIS survey proved that tobacco harm reduction was viable, what did the 2005 NHIS survey show? Absolutely nothing. NHIS removed the switch-to-smokeless option from the 2005 survey, despite the huge explosion in awareness of and discussion about tobacco harm reduction.

Today, the TPSAC committee is preparing to make important decisions concerning tobacco harm reduction... lacking basic information about smokeless tobacco use and with no current data about transitions between cigarettes and smoke-free products.

This information deficit is unacceptable. The FDA Center for Tobacco Products, generously funded by fees from tobacco manufacturers, must act. At a minimum, it should fund annual use of the 2000 NHIS smokeless tobacco supplement – with appropriate revisions for e-cigarettes – in every annual survey, in order to collect unbiased information about use of smoke-free tobacco products.

Discussing Dissolvable Smokeless Tobacco

When Congress gave the FDA regulatory authority over tobacco in 2009, it directed the agency to evaluate dissolvable smokeless tobacco. This week the FDA Tobacco Product Scientific Advisory Committee is holding hearings, and this has prompted a media blitz by anti-tobacco extremists.

Thomas J. Glynn, the director of science and trends for the American Cancer Society, issued a strange statement (here): “At this point, we don't know the full range of what is in them.”

Dr. Glynn may not be aware that dissolvable tobacco has been analyzed extensively (discussed here), and we do know what is in them: tobacco, flavors, non-caloric sweeteners and a few food-grade additives.

Two months ago Dr. Glynn authored an “Expert Voices” blog post titled “Here Come the Dissolvables” (here), in which he included some reasonable comments about dissolvable tobacco and one demonstrably false statement. ACS describes the blog as providing “timely insight on cancer topics from experts.” I have previously discussed other statements from Dr. Glynn (here).

ACS, at last, acknowledged that smokeless tobacco use is less hazardous than smoking. Dr. Glynn: “Certainly, as with all smokeless tobacco products, [dissolvable tobacco] will be less lethal than smoked cigarettes…” He added that “smokers should certainly continue to be made aware of that.”

A few paragraphs later, Dr. Glynn repeated the smokeless-is-safer theme: “…there is little doubt that, if all smokers in the U.S. suddenly switched from smoked cigarettes to smokeless tobacco – and stayed switched – we would see far fewer cancers and less heart disease 20 years from now…” He again noted, “smokers should continue to be made aware of the reduced, but by no means empty, threat posed by smokeless tobacco…”

Unfortunately, Dr. Glynn didn’t acknowledge ACS’s refusal to educate smokers about vastly safer smokeless tobacco, or the organization’s refusal to release critical information about the relative safety of smokeless tobacco (here).

Dr. Glynn made a passing reference to my research when he said, “Some proponents of smokeless tobacco, including dissolvables, make the argument that smokeless tobacco is as much as 98% less harmful than smoked cigarettes.” Later he opined that the “‘98% less harmful’ figure is suspect,” though he provides no evidence to support his suspicion.

Glynn’s core position remained prohibitionist. “It would be irresponsible,” he wrote, “for the public health community to urge [smokers to switch to smokeless tobacco] because there is also no evidence that smokers won’t just end up using both forms of tobacco, rather than using only smokeless – or better yet, quitting altogether.”

It is disappointing that Dr. Glynn repeatedly disrespected smokeless users by using the term “spit tobacco”. I previously reported this inappropriate and unprofessional practice to the ACS president (here), and I had been told that it had been discontinued.

Dr. Glynn made a demonstrably false statement when he predicted that “…if all smokers in the U.S. suddenly switched from smoked cigarettes to smokeless tobacco – and stayed switched…we would also see an increased number of oral cancers…”

The risk for oral cancer among smokeless tobacco users is much lower than the risk among smokers. In fact, since 1990, no epidemiologic study has reported any significantly elevated risk among smokeless users.

It is almost certain that a large-scale permanent switch from cigarettes to smokeless tobacco would not only result in a significant reduction in the number of oral cancers, it would substantially reduce all smoking-related diseases.

Chemical Analysis of Camel Dissolvables Reveals Tobacco, Flavors and Sweeteners

In 2009, R.J. Reynolds test-marketed dissolvable tobacco products in Indianapolis. Chemists at Indiana University-Purdue University Indianapolis, led by Christina Rainey, have just published the results of an extensive chemical analysis of Camel Orbs, Sticks and Strips in the Journal of Agricultural and Food Chemistry (abstract here).

Using several extraction methods, Rainey et al. documented that Camel Orbs, Sticks and Strips contain tobacco, flavors and sweeteners:

1. Tobacco: Measuring the nicotine content of the products, the researchers findings were similar to those reported in Reynolds’ product literature: 1 mg. per Orb, 3.1 mg. per Stick and 0.6 mg. per Strip.

2. Flavors: Rainey et al. found menthol, ethyl citrate, cinnamaldehyde, coumarin, vanillin and carvone. Readers will immediately recognize menthol, cinnamon and vanilla flavors. Carvone is a flavor component of spearmint, caraway and dill, so it also has a long history of use in foods (more here). Ethyl citrate is a derivative of citric acid (lemons and limes); it is a food additive.

Rainey et al. claim that “coumarin is a harmful ingredient and causes liver damage in rodents…and has been banned as a flavor additive to food.” This statement is misleading, as it implies that coumarin is a dangerous chemical that has been added to the dissolvables.

It is true that coumarin is toxic to the liver of rats, but this is due to the fact that rats process this agent via an enzyme system that humans lack. Extrapolating rat liver damage to humans is specious.

It is true that the FDA prohibits adding coumarin to human food (here). Why was it found in Camel dissolvables? It is well known that coumarin is present in some varieties of cinnamon; Rainey et al. found coumarin only in an Orb flavored with cinnamon (more information about coumarin is available here). In 2008, scientists from Germany found coumarin in bakery products and breakfast cereals flavored with cinnamon (here). Should Orbs be considered as dangerous as cinnamon buns and breakfast cereal?

3. Sweeteners: Xylitol and/or sorbitol, non-caloric sweeteners used in many products, were found in all three Camel dissolvables.

4. Others: Rainey et al. note that Orbs contain palmitic and stearic acid, food-grade additives that probably aid in the physical properties of the product (e.g., shape and texture). Strips contain glycerin, a food additive that helps products retain moisture.

In summary, smokers who switch to Camel Dissolvables are consuming smoke-free tobacco products that are consistent with government standards for human foods.

Tacit Incremental Prohibition - Tobacco Elimination (TIP-TOE)

Outright prohibition of psychoactive substances has proven futile, time and again. The disastrous consequences of U.S. prohibition of alcohol (1920 to 1933) and marijuana (ongoing) are well documented (examples here and here). Zealous prohibitionists have now targeted nicotine, using a strategy I call Tacit Incremental Prohibition - Tobacco Elimination, or TIP-TOE. Their aim is to employ an escalating series of legislative and regulatory controls in order, over time, to remove all tobacco products from the marketplace.

TIP-TOE has been promoted by a cadre of individuals using the cover of reputable organizations, including the Mayo Clinic (here), the American Cancer Society (here), the American Heart Association (here), the federal Centers for Disease Control (here) and the National Cancer Institute (here). The principals believe that a world without nicotine is both desirable and achievable, yet they are not courageous enough to demand outright prohibition. Instead, they’ve implemented the subtle TIP-TOE strategy of chipping away at consumer rights and industry initiatives. Several elements of their campaign were in view in recent weeks.

On February 15, Senators Frank Lautenberg (D, NJ) and Dick Durbin (D, IL) urged Major League Baseball commissioner Bud Selig and players’ association director Michael Weiner to ban smokeless tobacco in their sport. At the obvious prodding of TIP-TOE advocates, the senators pressed for a “solution” to a “problem” that doesn’t exist, as I discussed in a previous blog entry (here).

Another TIP-TOE initiative is the move to ban flavored tobacco products, an issue I addressed over a year ago (here). A bill in the Washington legislature (HB 1246, here) would ban flavored smokeless tobacco products and all dissolvable products. A Utah bill (HB 170, here) would ban flavored smokeless tobacco products and electronic cigarettes.

These TIP-TOE bills are especially egregious. They would ban tobacco products that are almost risk-free, while assuring continued market dominance by vastly more hazardous cigarettes.

Using TIP-TOE tactics, tobacco prohibitionists are sprinting toward a public health disaster.

Unbalanced FDA Guidance on Substantial Equivalence

On January 5, the FDA issued “guidance” concerning an important provision of the Tobacco Act – the demonstration of substantial equivalence for tobacco products. This post will explain why the provision might result in a regulatory nightmare for tobacco harm reduction by threatening existing smokeless products and completely inhibiting new-product innovation. Intrepid readers might wish to read the entire 17-page document (here).

According to the Act, any tobacco product in the American market on February 15, 2007 – a seemingly arbitrary date – is not subject to FDA review. For any product that was changed or introduced between February 15, 2007, and March 22, 2011, manufacturers are required to submit a 905(j) report by March 22, assuring the FDA that the product is “substantially equivalent” to a predicate product that was on the market February 15, 2007.

What information does the FDA require in 905(j) reports? Under normal circumstances, a federal agency would interpret legislation by formulating proposed regulations, submitting them for public comment, and eventually publishing final regulations. However, because the FDA is under pressure to get this equivalence provision into place, the agency issued a guidance document which says, “In the future, FDA intends to initiate a rulemaking that would establish requirements and standards for substantial equivalence.” For now, the guidance only “provides recommendations on the form and content of section 905(j) reports.”

According to the FDA, “guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.” (emphasis in original)

The FDA “suggests” that manufacturers submit a vast amount of information in 905(j) reports, including side-by-side comparisons of each new product with its predicate with respect to:

1. Ingredients and their levels

2. Design features and other materials; description of the heating source and composition (these mostly apply to cigarettes)

3. Harmful and potentially harmful constituents. The Tobacco Products Scientific Advisory Committee has started to develop this list of over 100 agents (see this document).

In addition to these basic requirements, manufacturers may need to submit “additional data.” The FDA guidance elements for additional information relating to consumer perception, clinical, abuse liability and toxicology data are so sweeping that I include them verbatim:

4. “Consumer Perception Studies - data comparing consumer perceptions with respect to the new tobacco product and the predicate that could affect initiation, cessation, frequency of use, patterns of use, smoking behavior, and perceptions of harm or addictiveness.”

5. “Clinical data - data comparing the biomarkers of exposure and biomarkers of potential harm and human toxicity of the new tobacco product as compared to the predicate tobacco product …Your report should include a summary of all studies conducted. In addition, your pivotal studies should be submitted and include: final approved study protocols, statistical analysis plans, any modifications to the study(ies), raw data, analysis platforms, and full reports.”

6. “Abuse liability data - data comparing the abuse liability of the new tobacco product to the predicate tobacco product ... Abuse liability can be assessed by a battery of studies, such as animal models of conditioned place preference, drug discrimination and self-administration, and human behavioral pharmacology studies that assess self-administration and subjective effects of the new tobacco product.”

7. “Toxicology data - data comparing the toxicity of the new tobacco product to the predicate tobacco product ... Comparisons between the new tobacco product and the predicate tobacco product can be assessed by a battery of studies, including nonclinical studies such as in vitro and in vivo mutagenicity and clastogenicity studies, general toxicology studies that include hematological, clinical chemistry, and histopathological endpoints, toxicology studies designed to specifically address cardiac, respiratory, and reproductive/developmental toxicity and studies to assess the carcinogenic potential.”

If you have read this far, you may suspect that the agency is pursuing an anti-tobacco agenda. Even if the FDA’s “guidance” is not binding or “legally enforceable,” the agency’s “current thinking” on this issue is clear: Require tobacco manufacturers to spend millions of dollars to keep their existing tobacco products on the market, and prevent the introduction of new products. If the FDA upgrades its guidance to binding regulations, it could strangle the tobacco industry. It would not be surprising if most U.S. cigarette and smokeless products have been altered in some manner since February 15, 2007; any such changes would subject their manufacturers to the onerous new data-production regulations.

Will consumers be any safer for all the corporate and government expense? Will such sweeping regulations dissuade companies from attempting to introduce new and safer smokeless tobacco products?

Last week, R.J. Reynolds and Altria made separate announcements about test markets of dissolvable tobacco products (here). Reynolds announced it will resume test markets in Denver and Charlotte of Camel Orbs, Strips and Sticks, products that had been tested in Columbus, Indianapolis and Portland, Oregon, in 2009-2010. In March, Altria will introduce in Kansas Marlboro and Skoal Smokeless Tobacco Sticks, which are 2.5-inch-long wooden sticks coated with finely milled tobacco.

These are exciting developments, demonstrating that cigarette manufacturers are committed to offering smokers vastly safer smoke-free options. It would be a public health tragedy if the FDA used equivalence criteria to deny smokers these products, thus assuring the continued market dominance of deadly cigarettes.

Imagining Tobacco Without Nicotine

In June, I called attention to the unscientific proposal by two FDA tobacco advisory committee members, Drs. Jack Henningfield and Neal Benowitz, to radically reduce nicotine in cigarettes in order to force smokers to quit and prevent children from starting to smoke (read my post here). They are now the co-authors of another thinly veiled call for reducing nicotine to “non-addictive levels” in cigarettes, just published in the journal Tobacco Control (abstract here).

Henningfield and Benowitz are joined by fellow committee member Dr. Dorothy Hatsukami, the National Cancer Institute’s Dr. Cathy Backinger (read about her previous pronouncements here), FDA staffer Dr. David Ashley, and Mitch Zeller, a lawyer. Zeller works for a consulting firm employed by GlaxoSmithKline, the pharmaceutical manufacturer that last week called on the FDA to ban dissolvable tobacco products (read about it here). According to Dr. Elizabeth Whelan of the American Council on Science and Health, “GSK is clearly trying to protect its own market…” by eliminating tobacco products that it perceives as competition with its medicinal nicotine products.” (For insights on medicinal nicotine’s dismal track record, see my previous blog post).

The Tobacco Control article is an urgent call for research that would inform policy decisions regarding reduced nicotine cigarettes. Here are the questions these “six leading tobacco research and policy experts” (as they describe themselves in their press release) want answered about reducing cigarette nicotine content:

"What is the nicotine threshold dose(s) for addiction…? What are the effects of reduced nicotine cigarettes on the brain in adult smokers and in adolescents…? What is the extent of compensatory smoking…and what interventions can be used to minimize compensatory smoking, such as making nicotine available through less hazardous delivery systems (e.g. nicotine replacement therapy)…? What are the effects of reduced nicotine cigarettes in subpopulations (consumers who smoke for self-medication purposes such as those with comorbidity or who are severely addicted)…and how can negative consequences be mitigated? What would be the public’s reaction…? How could we frame the message and educate the public…? What are the potential unintended consequences from reduced nicotine cigarettes, how can [the consequences] be determined and monitored, and what needs to be done to mitigate against negative consequences?"

In other words, these “experts” can’t even define a threshold dose for nicotine addiction, and they are clueless about the effects of radically reducing nicotine in cigarettes. Yet, their press release (here ) makes nicotine prohibition sound like the perfect solution. Dr. Hatsukami ignored all those important questions, proclaiming in the release that “Reducing the nicotine in cigarettes to a level that is non-addicting could have a profound impact on reducing death and disability related to cigarettes and improving overall public health.” It appears that she has already reached conclusions before the research is performed.

Lawyer Zeller was even more fanciful: “Imagine a world where the only cigarettes that kids could experiment with would neither create nor sustain addiction.”

Unfortunately, it doesn’t take an active imagination to appreciate the disaster that would result from radical reduction (prohibition) of nicotine in cigarettes. One need only look at the nation’s reaction to alcohol prohibition, as chronicled by Daniel Orient in his outstanding book, Last Call (description here).

In 1914, U.S. per capita beer consumption was 20 gallons. In anticipation of alcohol prohibition, launched in 1920 by the 18th Amendment to the Constitution, breweries produced an alcohol-free drink, informally called near beer. Six months into prohibition, sales of near beer plummeted, and brewers turned to a more attractive and profitable alternative: malt syrup, the key ingredient for making beer. It was sold in grocery stores across the nation, and it spawned a mini-industry offering filters, bottles, bottle stoppers, and most importantly, yeast. It is not a coincidence that California vineyards survived Prohibition in a similar manner. Millions of Americans legally consumed alcohol during Prohibition by making their own beer and wine.

The prohibitionists’ response to home brewing was to call for more prohibition. In 1925, Wayne B. Wheeler, a key prohibition architect (profiled here), asked one of his friends in Congress if “the time is ripe to prohibit the sale and distribution of these malt syrups and malt supplies.” Orient writes, “It wasn’t, nor would it ever be.”

Near beer, which tasted like real beer, didn’t sell precisely because it didn’t provide alcohol, an addictive drug with benefits. Today, neo-prohibitionists, with little research and a lot of imagination, are trying to sell Americans on near cigarettes that are devoid of addictive but rewarding nicotine.

Is the time ripe for such foolishness, especially when smokers have increasing access to vastly safer smokeless alternatives? It isn’t, nor will it ever be.

Evidence That Dissolvable Tobacco Works for American Smokers

Researchers from the Department of Psychiatry at the Medical University of South Carolina have published a small, but persuasive, study documenting that dissolvable tobacco products “led to a significant reduction (40%) in cigarettes per day, no significant increases in total tobacco use, and significant increases in two measures of readiness to quit, either in the next month or within the next 6 months.”

The study was funded by the National Institute on Drug Abuse, a U.S. government agency, and it was published by Matthew Carpenter and Kevin Gray in the online edition of Nicotine and Tobacco Research.

Carpenter and Gray randomly assigned 31 smokers who were uninterested in quitting to receive Ariva or Stonewall, dissolvable smokeless products from Star Tobacco (that I have recommended to smokers for many years here and here), or to continue smoking cigarettes. Smokers were given “minimal instructions on how to use” these products and were “told that there is no safe tobacco product and that the best thing they can do for their health is to quit entirely.”

Carpenter and Gray wrote that their findings suggest “that Ariva and Stonewall are effective products to curb withdrawal and craving.” In other words, these products satisfy smokers.

Perhaps the researchers’ most important conclusion was that there is “no evidence that smokeless tobacco (Ariva or Stonewall) undermines quitting. To the contrary, readiness to quit (in the next 1 month and within the next 6 months) significantly increased among smokers who used a smokeless tobacco product relative to those who continued to smoke conventional cigarettes.”

This is important because tobacco prohibitionists have complained that telling smokers about vastly safer smokeless substitutes will “undermine quitting.” Never mind that this puts their dream for a tobacco-free society ahead of the health of people who smoke. The new research shows that tobacco harm reduction is completely consistent with both the health of smokers and broader public health goals.

Had Carpenter-Gray successfully completed a lung cancer vaccine trial, it would have made international headlines. Instead, their monumental study on smokeless tobacco, with major implications for immunizing smokers against lung cancer, has gone unnoticed. With the lives of millions of smokers at stake, their work deserves greater attention.

Dissolvable Tobacco

During the past month the U.S. Congress passed landmark legislation authorizing the federal Food and Drug Administration to regulate tobacco. In classic Washington terms the bill was portrayed as saving our children from tobacco's evil grasp, although a detailed review by the American Association of Public Health Physicians concluded that it would have little effect on teen smoking rates. Senators Sherrod Brown (D-OH) and Jeff Merkley (D-OR), accused RJ Reynolds of marketing "tobacco candy" to children. The target of this attack was a new dissolvable tobacco product called Camel Orbs, which is being test marketed by Reynolds in Columbus, Indianapolis and Portland, Oregon.

Senator Brown said there is no doubt that these products "…are aimed squarely at children." His evidence: Orbs come in "mellow" and "fresh" flavors, and "are sold in containers that resemble cell phones. From a distance, the packaging and design of the individual Orbs are virtually indistinguishable from breath mints."


It is almost beyond belief that two U.S. senators would engage in an unsubstantiated and specious attack on a manufacturer who is trying to convert its consumers (and those of other cigarette manufacturers) from a product that is very hazardous (cigarettes) to one that has almost no demonstrable health risks (smokeless tobacco). Instead of challenging the senators to validate their allegations, American media reported this story with little regard for the truth.

It is clear that the senators had no substantive evidence that Reynolds is actually marketing these products to children. If they had proof, they could simply turn it over to a State Attorney General. Since the 1998 Master Settlement Agreement (MSA), tobacco manufacturers have been prohibited from directly or indirectly targeting children, and many states have an expedited process for policing and enforcing MSA provisions.

Brown was wrong on another critically important point: He called the Orbs "dangerous." In fact, there is broad scientific consensus that smokeless tobacco products are 98% safer than smoking. Unlike cigarettes, smokeless tobacco does not cause lung cancer, heart disease or emphysema. The risk for mouth cancer with smokeless is far lower than it is with cigarettes. Statistically, smokeless users have about the same risk of dying from a tobacco-related illness as automobile users have of dying in a car wreck. Apparently, the senator doesn’t understand that tobacco smoke is the real killer. Eliminate the smoke, and you eliminate nearly all the risk. I refer interested readers to my website, www.smokersonly.org, for more information.

Senators Brown and Merkley sponsored an amendment to the FDA bill that would require the new Tobacco Products Scientific Advisory Committee to immediately study the public health effects of dissolvable tobacco and report its findings to the FDA. The committee will find that the products are not marketed to children, that they satisfy adult smokers who are unwilling or unable to quit nicotine and tobacco altogether, and that they are far safer than continuing to smoke.


According to the Public Health Physicians, "the most substantial problem with this severely flawed [FDA] bill is the fact that it ignores the plight of the 45 million Americans who are current adult cigarette smokers. All of the 8 million deaths due to cigarette smoking that will occur over the next 20 years in the United States... in this group." They are not children today; they are adults, 35 years and older. Preventing youth access to tobacco is important, but that effort should never be used as a smokescreen to condemn smoking parents and grandparents to premature death.

If any other consumer product was as dangerous as cigarettes, society would demand safer alternatives, and it would be scandalous if consumers were denied them. But Senators Brown and Merkley want these products banned, which is counterproductive. Smokers in Ohio and Oregon and Indiana and every other state are literally dying for ways to step away from the fire. They deserve accurate information about safer smokeless substitutes.