It was my privilege to address the audience at the Tobacco Merchants Association (TMA) annual conference yesterday in Williamsburg, Virginia, along with a panel of other public health experts in tobacco control, including Dr. Joel Nitzkin, Dr. Carl Phillips, and Dr. Brad Rodu.
The most interesting thing about the conference, to me, was the desire of the TMA to hear specifically from experts in public health and to air the presentation of views that may be contrary to many of its members. This is quite unlike my recent experiences at tobacco control conferences, where only one view on the issues is allowed, and dissenting views are suppressed.
Our panel, which focused on the issue of science-based policy making and FDA regulation of tobacco products, was preceded by yesterday's talk by Dr. Lawrence Deyton, the director of the FDA's Center for Tobacco Products, reported on here by John Reid Blackwell and Dave Ress of the Richmond Times-Dispatch. Dr. Deyton expressed to the Association members a desire to enter into a dialogue on the issues, although he also warned them that the Agency would take firm action against companies that do not fully cooperate with Agency regulations. He also emphasized the Agency's commitment to science-based policy.
My talk focused on the modified risk products provisions of the FDA Tobacco Act (section 911) and whether or not these provisions were science-based. I pointed out that there are two possible pathways for modified risk tobacco products: the reduced risk pathway and the reduced exposure pathway. Reduced risk products are those for which the manufacturer wishes to claim that the product is safer than other products on the market. Reduced exposure products are those for which the manufacturer will not make any explicit health claim, but will merely inform consumers that it contains less of a certain constituent, or is free of a particular constituent.
For the reduced risk pathway, the manufacturer must show that the product will reduce health risks to individual users. I argued that this is a very high scientific standard, one that can only be met through long-term epidemiologic studies with thousands of product users in order to establish the long-term relative risks of using these products.
However, this produces a catch-22 situation: A manufacturer cannot market a product until it demonstrates that it reduces individual risk. But a manufacturer cannot demonstrate that the product reduces individual risk unless it first markets the product.
Thus, it is virtually, if not literally impossible for any reduced risk product ever to be approved by the FDA.
For the reduced exposure pathway, the manufacturer need only show that the product does indeed decrease exposure to a particular constituent or constituents and that a corresponding reduction in health risk is "reasonably likely." This is possible to do with laboratory studies, so it is feasible to make the necessary demonstrations to the Agency.
However, there is a third requirement: the manufacturer must show that as it plans to package and market the product, consumers will not believe that the product reduces their risk. In other words, even though consumers know that the product reduces exposure, they must not believe that it reduces risk.
This, again, creates a nearly impossible task. If consumers are aware that a product reduces exposure to one or more harmful substances, they are naturally going to believe that it reduces their risk of disease. The only way to avoid this perception would be not to tell consumers that the product reduces exposure. But in that case, the product is no longer a reduced exposure product and so it cannot be approved for marketing in the United States.
Thus, the FDA Tobacco Act creates another catch-22: A manufacturer cannot market a product as reduced exposure unless it can show that consumers will not perceive it to be less harmful. But consumers will only perceive that the product is not any less harmful if it is not marketed as reduced exposure.
This provision, in other words, makes it virtually, if not literally impossible to market a reduced exposure product. One would have to make very limited claims that do not result in consumers believing the product is any safer. But if consumers don't believe the product is any safer, then why would they want to switch to that product?
The rest of the story is that the Act simply makes no sense. It is essentially a hoax, designed to make it look like the policy makers and health groups are interested in protecting the health of smokers, but instead, if you actually read the fine print, you'll find that the law sacrifices the health of smokers by making it impossible for tobacco companies or public health groups to pursue a harm reduction strategy.
The Act preserves the existing market of the highest risk tobacco products and stifles competition from alternative products that might truly reduce health risks.
This is not science-based policy. It is protectionism. Protection of the status quo. Protection of the existing tobacco market. The anti-smoking groups are not interested in actually protecting the health of smokers by encouraging them to use potentially less harmful alternatives. Instead, they are protecting the highest risk products and making sure that smokers continue smoking these high-risk products and that they do not switch to products that could potentially save their lives, or at least greatly reduce their risk of disease.