They melt in your mouth...

[E]xclusive use of DTPs [dissolvable tobacco products] would greatly reduce risk for smoking caused disease compared with regular use of cigarettes. While we at ACSH make this point on a regular basis, this time, this statement actually comes from an FDA advisory panel. The agency s Tobacco Products Safety Advisory Committee (TPSAC), tasked with evaluating a variety of modified risk tobacco products (MRTPs), has just issued a report on DTPs, and its findings are largely favorable.

TPSAC has been hearing statements and studying MRTPs over the course of the past eight months, including three separate hearings, but this is the first report it has issued on MRTPs, which include a spectrum of products. ACSH s Dr. Gilbert Ross, who attended an August 2011 workshop on MRTPs and presented testimony before the panel at its January meeting this year, is pleased to see that the panel s assessment acknowledges the harm-reduction potential of dissolvable tobacco products. In addition to concluding that these products would significantly reduce the risk of smoking-related disease, the panel noted that the reduced risk of dissolvables compared to cigarettes is based on an understanding that it s the toxins inhaled in tobacco smoke that make smoking so hazardous.

However, TPSAC also commented on the paucity of available research on the health effects of DTPs a fact that lent a generally cautious tone to the report. Among the panel s reservations was a dearth of information on whether dissolvables would encourage smokers to quit, as well as a fear that greater availability of these products might lead to an increase in the use of tobacco products. Yet Dr. Ross, while acknowledging that more data on these questions exist for snus-type smokeless tobacco than for dissolvables, points to research showing that it is very rare for non-smokers to take-up MRTPs. He also reiterates the most important aspect of these products: They are so much less hazardous than cigarettes that public health would be well-served even if more people used tobacco in this form, provided that the number of smokers declined dramatically. And, in fact, the TPSAC report suggests such an outcome.

Despite TPSAC s mostly favorable assessment of MRTPs, the report has no immediate impact on the regulation of these products. As Dr. Ross observed in a recent op-ed on the subject, the real sticking point may be the absence of research deemed acceptable by the FDA. The FDA s position is that the benefits of reduced risk products for harm reduction must be proven before they can be recommended to smokers in America, Dr. Ross wrote in Forbes. But here s the Catch-22: Only the tobacco industry has the requisite expertise and finances to perform the long-term, large-scale, super-expensive studies needed to prove the benefit of these products to the FDA s satisfaction. The tobacco industry is explicitly barred, however, from supplying the needed data.

Until this Catch-22 is resolved, manufacturers of MRTPs won t be allowed to market them as smoking cessation aids that are significantly less harmful than cigarettes. That s a shame because, as the TPSAC report has acknowledged, these products have the potential to help a lot of people. We hope that the current TPSAC statement will allow the FDA to be more flexible with its final rules on MRTP regulation, as opposed to the unreasonable strictures previously considered, says ACSH's Dr. Beth Whelan. That would increase the possibility of saving a lot of smokers lives.