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.