Wisdom (or Lack Thereof) of FDA Tobacco Law Debated at Boston University School of Public Health's Bicknell Lectureship

A summary of the Bicknell symposium is available on the School's web site. The actual video of the event will be made available soon.

As far as my opinions and similar sentiments by Patrick Basham (Democracy Institute) expressed during the panel discussion, the article summarizes them as follows:

"The other two panelists -- Patrick Basham, founding director of the Democracy Institute, and Michael Siegel, professor of community health sciences at BUSPH -- argued that handing tobacco regulation over to the FDA was a colossal mistake that would benefit cigarette manufacturer Philip Morris, rather than smokers. They noted that Philip Morris executives had a hand in crafting the bill, and they argued that provisions making it difficult for companies to introduce new, potentially safer smoking-related products into the marketplace would protect the company's market share." ...

"The uncomfortable reality we face this morning is that this legislation is simply bad news," Basham said. He said the FDA was not up to the task of finding ways to "make an unsafe product safer." He also said that the process of "validating new low-risk products is so cumbersome, it discourages new products... The FDA may deny smokers access to new products that may save their lives."

"Siegel was equally critical of the law, calling it "an absolutely absurd approach to the tobacco problem" that sets a "terrible precedent." "It puts the FDA into the business of approving deadly products. I think it really undermines the entire federal system of health regulation. They are approving products that are killing people," he said. Siegel argued that the legislation puts the FDA in the position of "deceiving consumers" by putting its stamp of approval on products that the agency may deem as "safer cigarettes" because they have reduced levels of carcinogens."

"There's no connection necessarily between levels of carcinogens and safety of the product," Siegel said, explaining that tobacco smoke contains more than 10,000 chemicals, only a fraction of which have been identified."

"Is there a safer cigarette?" he asked. "No, not in terms of what FDA can do -- tinkering with ingredients. We don’t know if those changes will result in a reduction in disease. We don’t have biomarkers for disease risk. We don’t have scientific knowledge to know if we have produced a safer cigarette. We don’t have that science."

"Siegel argued that the FDA's recent warnings about the possible dangers of e-cigarettes -- battery-powered devices that provide tobacco-less doses of nicotine in a vaporized solution -- were troubling, given that such devices are sure to be proven safer than actual cigarettes. Holding up an e-cigarette loaded with a glycerine cartridge, he said, "If we put in a nicotine cartridge, is it 'safe'? Probably not. But is it safer [than tobacco-containing cigarettes]? Yes."

"He said he worried that it would take years for the FDA to evaluate and approve e-cigarettes for sale, when they have been shown to be an effective quit-smoking product."