Boston University School of Public Health

Bicknell lecturer Gregory Connolly addresses the issue of what it means for the FDA to have authority over the regulation of tobacco.

(Slide show)

New legislation that gives the Food and Drug Administration authority to regulate tobacco is by no means perfect, but is a first step in reining-in the "outlaw" tobacco industry and setting some standards that could ultimately reduce health risks, tobacco expert Gregory Connolly summed up in presenting the 2009 William J. Bicknell Lectureship in Public Health.

"What we require in this country to deal with this [smoking] epidemic is a comprehensive policy," said Connolly, professor of the practice of public health at the Harvard School of Public Health and former director of the Massachusetts Department of Public Health's Tobacco Control Program.  He said the tobacco industry is "driven solely by making a profit, not by health. . .  It's time that we had an agency to protect us.

"This nation has finally passed a law that has set up a protocol" to examine health risks to consumers, he said. "This law has changed the whole dynamics."

Connolly was the keynote speaker at the annual Bicknell Lectureship in Public Health, established at BUSPH in 1999 and endowed by William J. Bicknell, chair emeritus and professor of International Health and professor of sociomedical sciences and community medicine at the BU School of Medicine. This year's lecture was headlined: "Is There Such a Thing as a Safe(r) Cigarette? Tobacco Regulation and the FDA."

Connolly and three panelists debated the pros and cons of a recently passed federal law that gives the FDA broad new powers to regulate tobacco, including requiring larger health warnings on tobacco products and setting sales and marketing restrictions. But critics note that the legislation also makes it harder for new and potentially safer products to be introduced into the marketplace, and they say it puts the federal government in the troubling position of endorsing a product known to cause hundreds of thousands of deaths each year.

Connelly acknowledged flaws in the law, including a provision that bans all flavorings except for menthol, which is a popular seller among young smokers and African-Americans. He said the FDA’s role may not be "so much to encourage the development of 'safer' cigarettes, but to assure that what’s out there . . . meets rigorous and relevant scientific standards."

Absent any government regulation, he said, tobacco companies can make all kinds of claims about "reduced carcinogens" or "light" cigarettes, with no agency responsible for examining or restricting those claims. He said states and universities don't have the expertise or resources to test and regulate tobacco products, and that "an agency with scientific expertise should."

Connolly suggested that the law can be strengthened if public-health advocates work with communities to expand on its provisions, such as combining a "good, strong warning label campaign" with targeted media outreach that highlights the health risks of smoking.

Other panelists were blunter about the shortcomings of the law. Cheryl Healton, founding president and chief executive officer of the American Legacy Foundation, said she welcomes the FDA legislation, in part, because there is little chance that tobacco will ever be deemed illegal, and "if you're not going to do that, then what the hell do you do? … If you're not going to do that, you [at least] regulate it."

Healton said she hoped the FDA would rise to the occasion, so that the bill would prove to be "a public health victory" instead of a "public health sham."

"The perfect bill does not exist, and we have to try to make lemonade out of lemons," she said. She acknowledged flaws in the bill, saying "Congress has been bought and sold by the tobacco industry." But she added, "I think we should stop the Monday morning quarterbacking and work with the bill as it exists now."

Healton said the legislation still leaves room for advocacy groups to keep pushing for a ban on menthol and other restrictions. She cited statistics indicating that 44 percent of teenagers report smoking menthol brands.

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.

Healton said safety questions about e-cigarettes need to be resolved, but she advocated that testing of any tobacco-cessation aids should be put "on a fast track."

BUSPH Dean Bob Meenan thanked the panelists for an enlightening discussion that encompassed public health, politics and corporate power, and for "disagreeing in an agreeable fashion."

Submitted by Lisa Chedekel
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it