Two weeks ago AP writer Michael Felberbaum published an interesting story, “FDA review of tobacco products grinds to a halt,” about how the FDA has failed to review 3,500 product applications required by the 2009 Tobacco Act (here).
Felberbaum notes, “The reviews, which are supposed to take 90 days, has [sic] dragged on for years in some cases. About 90 percent of applications have lingered for more than a year.”
The story’s title is not entirely accurate, since it implies that the FDA review had been active. In fact, the agency has not completed any reviews.
The number of applications is large, primarily because the Tobacco Act requires manufacturers to submit them even for minor product changes, and even if the new product is “substantially equivalent” to those already on the market. I wrote in March 2011 that the FDA would “Require tobacco manufacturers to spend millions of dollars to keep their existing tobacco products on the market, and prevent the introduction of new products.” (here).
The accuracy of my prediction is confirmed by Felberbaum: “For example, [Lorillard CEO Murray] Kessler said that under the FDA's guidelines, if the nation's third-biggest tobacco company wanted to take a Kent brand cigarette and rename it ‘Newport,’ it would be subject to review even though ‘it's not substantially equivalent — it's exactly equivalent.’”
At first glance, this FDA bottleneck looks like a win for public health, as it effectively blocks new cigarette introductions. But as I noted almost two years ago, this process would result “in a regulatory nightmare for tobacco harm reduction by threatening existing smokeless products and completely inhibiting new-product innovation.”
There is additional evidence of FDA inaction. On December 17 the agency held a public hearing “to obtain comments …on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and to request input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence.” (here).
Officials heard surprisingly consistent testimony – from advocates of tobacco harm reduction and e-cigarettes, strident anti-tobacco groups and tobacco and drug companies – that smoking, not nicotine and tobacco, is the public health problem and that the current federal government obsession with tobacco and nicotine abstinence is an utter failure. The agency was encouraged to give smokers truthful information about the comparative risks of all tobacco products and, most importantly, to implement sensible regulations that would enhance smokers’ awareness of and access to vastly safer and satisfying cigarette substitutes that are already on the market.
There is little reason to expect that the hearing will have any impact on FDA behavior. Over two years ago the agency held a public workshop entitled “Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products” (here). The consensus among experts was that long-term nicotine use has negligible risks and considerable benefits, but the hearing had no appreciable effect on the abstinence-only agenda.
In the past, the FDA has frequently been criticized for its regulatory actions, but hardly ever for regulatory inaction, which may partially explain its behavior. Lars Erik Rutqvist, senior vice president of scientific affairs at snus manufacturer Swedish Match, thinks there is an industry focus: “I think there's suspicion within industry that this is how it's going to be in the future and this is more or less a way of punishing the industry.”
The FDA is not just punishing the industry. By failing to review applications for new smoke-free products, the agency becomes an enabler of cigarette consumption, assuring continued market domination of the deadliest of nicotine delivery systems. That is a public health tragedy.