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.

E-Cigarettes Vary Widely

Investigators from the University of California Riverside have published a study underscoring the wide variation in performance of e-cigarette brands, including Liberty Stix (here), Crown Seven (here), Smoking Everywhere (here), and VapCigs (here).

Tests conducted by Monique Williams and Prue Talbot measured airflow rates required to produce an aerosol, and the number of puffs available per unit, among other things (abstract here).

They reported, “Significant variation was found among e-cigarette brands in the airflow rate required to produce aerosol,…in aerosol density, and in the manner in which e-cigarettes performed over time….Consumers and researchers should be aware that e-cigarettes vary in performance across brands and within models from the same brand, that some brands will require harder inhalation to use than [combustible] cigarettes, and that aerosol density varies between puffs which may affect nicotine delivery.”

This research followed work published last year (abstract here), in which Williams, Talbot and first author Anna Trtchounian used a smoking machine to compare the puffing characteristics and smoke/aerosol densities of Liberty Stix, Smoking Everywhere, Crown Seven and NJOY (here) with those of combustible cigarettes. They found that most e-cigarettes required a much higher vacuum for puffing than commercial cigarettes, and that the vacuum required for Liberty Stix was the lowest of all tested products. In addition, puff strength had to be increased as puff number increased. They also found considerable variation in the maximum number of puffs delivered by the products, which ranged from 177 (Smoking Everywhere) to 313 (NJOY). In the current study, Smoking Everywhere also delivered only 160 puffs, while VapCigs delivered 250 and Crown Seven delivered 400 (no results were presented for Liberty Stix).

There are numerous e-cigarette brands available in retail stores, shopping mall kiosks and online; starter-pack prices range from about $20 to $100. Smokers should be aware of the variability among and within brands, so they won’t reject this cigarette alternative on the basis of one e-cigarette experience. Smokers should talk with consumers who have made the switch; learn about e-cigarette options and observations on the Internet; and try several products, if necessary, to find one that is satisfying.

While e-cigarettes vary widely, they are capable of improving and extending the lives of cigarette smokers.

An Informative Study on Tobacco-Specific Nitrosamines

Last week, I noted that University of Minnesota researchers, arguing for additional reductions of tobacco-specific nitrosamines (TSNAs) in moist snuff products (here), complained that “No evidence has been found that Conwood [a Reynolds company] and USST [United States Smokeless Tobacco, an Altria company] took any meaningful steps to reduce the relatively high levels of NNN and NNK in their products.” (The lead author was Stephen Hecht.)

The Hecht allegations are another false alarm, as a new study in Food and Chemical Toxicology (abstract here) provides evidence that, “…since 1997, average TSNA levels have declined by approximately half in USST moist smokeless tobacco products.” The authors, including lead author Michael Fisher, are from Altria.

Fisher et al. provide valuable information about how agricultural and production practices influence TSNA development. They collected samples from thousands of bales of tobacco over the past 15 years, and discovered that “…there is a general relationship between average rainfall during the tobacco curing season and TSNA in cured tobacco.”

Moist snuff is primarily made from dark-leaf tobacco, grown in western Tennessee and western Kentucky, and barn-cured in late-summer and autumn with smoke from hardwood fires. Fisher et al. show that the most important factors in TSNA formation are humid and/or moist curing conditions. Excess nitrogen fertilizer is also a factor, although tobacco needs high concentrations of nitrogen in order to thrive. As Hecht et al. pointed out in their article, American moist snuff has marginally higher TSNA levels than Swedish snus, which is also made with dark-leaf tobacco that is air cured. This suggests that fire curing may also play a minor role in TSNA formation.

In the past manufacturing may have also played a small role in TSNA formation, when particular bacterial strains used some of the nitrogen (in the form of nitrate) to form nitrite. The nitrate-reducing bacteria may be present in harvested tobacco, and in fermentation facilities, but in 2005 USST initiated strict sanitation practices and other programs to inhibit these bacteria. This resulted in TSNA levels in finished products that were consistent with the levels found in the incoming leaf.

As I have noted previously, TSNA levels in moist snuff products from Altria and Reynolds are at historically low levels. This study documents that TSNA levels are mainly influenced by weather conditions during the curing process. Furthermore, it is important to emphasize that there is no evidence that current TSNA levels are associated with ANY significant cancer risks.