Editor’s Note: The author of the following article concludes:
“The FDA has done an admirable job – to date – resisting the entreaties of anti-tobacco protesters to use the legislation as a vehicle for a full on assault on cigarette makers.”
We agree and suggest that all stakeholders express their support for FDA’s insistence on basing decisions on sound science. However CRE is very concerned about the following statement:
” Activists have managed to infiltrate the middle ranks of the agency’s center“
We expect the Deyton era emphasis on sound science will continue in the Zeller era since both are duty bound to the sound science mandates of both the President and the Cognress.
Under the scheme, Washington brought the tobacco industry under the thumb of federal regulation. FDA now oversees everything from the way cigarettes are marketed, to the manner in which they are made. In exchange, the tobacco industry was promised a regulatory track out of their current (declining) business model.
FDA was to create a path to enable cigarette makers to transition away from smoked tobacco and win government approval of consumable products that used tobacco but presumably harbored less, and perhaps even none of the health risks posed by smoking. When this quid pro quo was pushed through Congress, the industry’s critics and allies each positioned it as a win-win. But it was dependent on FDA being able to establish – and maintain – a regulatory path that let tobacco get approval for new products that posed a “reduced harm” over traditional smoked cigarettes.
It always seemed a naïve aspiration — that FDA would ever sanction such products – and even more uncertain that the anti-tobacco crowd would let this paradigm advance. Now, each side’s ambitions (and the law’s spirit) are being tested.
The tobacco industry’s critics are trying to impede a critical first step that FDA must take in creating that new regulatory architecture. The ability to fulfill all of the law’s goals is on the line.
Proponents of the legislation, after all, admittedly supported it as a vehicle to squeeze tobacco firms under the weight of FDA regulation. Their stated aim was always the dismantling these firms. Could these critics countenance a regulatory scheme that lets tobacco makers’ transition into new lines of work, even if these firms moved away from making more risky smoking products?
In short, would critics accept the proposition that ANY tobacco-based product could pose less risk, even if it were formulated into a non-smoked consumable?
The answers to these questions are emerging. FDA is proposing to hold a workshop on what science could support claims of “reduced risk” from new kinds of tobacco-based products. The anti-tobacco crowd is appalled that the agency plans to have (gasp!) the tobacco firms that are developing these products participating. These critics also seem even more disturbed that it will be up to these same cigarette firms to develop the science needed to support their own applications to FDA seeking approval of these new products.
Set aside the fact that the requirement for submission of sponsor-generated data is the same manner in which every other aspect of FDA’s traditional, pre-market oversight operates. The onus is always put on manufacturers to develop the evidence to support specific claims around their products. Before this objection can be addressed, there’s a much more fundamental question at stake: Whether the regulatory scheme envisioned in the tobacco legislation will ever be able to operate.
That scheme smacked of cynicism on both sides. But at its core, there was at least a kernel of virtue.
Whatever one thinks of cigarette makers, if the industry was earnest about transitioning away from the manufacture of smoked cigarettes, and getting into the development of new products that would still satisfy peoples’ taste for nicotine (with hopefully much lower risks) there could be public health virtue. The overall incidence of smoking related disease could be sharply diminished.
The tobacco industry has since been formulating those new products. These are taking the form of things such as smokeless films that dissolve on the tongue, and flavored sucking sticks derived from highly purified tobacco. These products contain nicotine but presumably pose few of the risks of smoked cigarettes and perhaps few (or maybe even none) of the same risks of traditional dips and other oral products.
But even as Washington tightens its regulatory grip over the existing cigarette lines, it seems less and less likely that the tobacco firms are going to be able to fulfill their half of the aspiration enshrined in the legislation. Among other things, critics are concerned that any nicotine-based product will only serve as a gateway to smoking.
The latest challenge comes in the form of a series of hostile missives from anti-tobacco activists to blow up the upcoming FDA meeting. But if anti-tobacco activists can’t countenance a public meeting to discuss the foundational science to support the legislation’s prescribed pathway, then the law’s aspiration is doomed.
The research in question is contained in sections 910 and 911 of the original tobacco legislation. The opposition can be found in a series of missives published in a blog affiliated with the British Medical Journal (a publication where I previously served as a medical staff writer). The research that FDA is trying to define is aimed at supporting the submission of applications for “reduced harm” tobacco products.
The FDA has done an admirable job – to date – resisting the entreaties of anti-tobacco protesters to use the legislation as a vehicle for a full on assault on cigarette makers. The agency has taken great care in trying to establish at least the semblance of a path for “reduced harm” tobacco products, even if the hurdle to actually getting one to market remains exceedingly high. In short, FDA has respected the spirit of the statute. But it remains an open question whether that temperance will continue.
The FDA is losing the widely respected head of its Tobacco Center. Activists have managed to infiltrate the middle ranks of the agency’s center. And there will never be any love lost for the tobacco industry inside the agency proper. After all, FDA’s public-health orientation (and its physician ranks) imbues it with a pervasive antipathy of cigarettes and visceral concern for the health effects of smoking.
How FDA handles this workshop is going to be an important test of the shape of the future. It’s a test of whether FDA will continue to implement the plain language of the law even as it undergoes a transition of its leadership.
Underneath this all, there’s a more basic issue: Whether it was ever reasonable to think that cigarette adversaries could make peace with tobacco firms through a regulatory compromise.
The anti-tobacco researchers want to shut down cigarette makers. It’s really that simple. The cigarette makers, presumably, don’t want to go away. By many measures, it’s clear that some tobacco firms want to transition into new products that carry fewer legal, business, and hopefully health risks.
The compromise the two parties struck in Washington was supposed to satisfy both sides’ aspirations. But in the end, only one party may win.