A lot of things are said in the heat of debate on the floor at the General Assembly. As PolitiFact Rhode Island listened during a July 1, 2013 discussion of legislation on electronic cigarettes, a categorical remark by a state representative caught our attention.
Rep. Teresa Tanzi, D-South Kingstown, declared, "We have no idea what is contained in that vapor" when an e-cigarette is used.
Is there really no information available to the public, as she seemed to suggest?
Our exploration of her statement took us into the world of "vaping" -- the act of using an e-cigarette. An e-cigarette is a battery-powered nicotine delivery system that resembles a cigarette; it heats a liquid and turns it into a colorless, odorless vapor without combustion. Unlike puffing on a tobacco cigarette, the user inhales vapor, not smoke.
The Assembly in June enacted a measure that would ban the sale of e-cigarettes to minors, but Governor Chafee vetoed it. He said the proposal would circumvent existing Rhode Island law on tobacco control and taxation. The Assembly has not scheduled any veto override session.
It didn’t take us long to discover that, despite Tanzi’s assertion, there have been numerous scientific studies about the content of e-cigarette vapors.
One of the leading voices in the national tug-of-war over e-cigarettes is Dr. Michael Siegel, a professor in the Department of Community Health Sciences at the Boston University School of Health, and a Brown University graduate.
He co-authored a definitive academic paper in 2010 in the peer-reviewed Journal of Public Health Policy that reviewed the available science on e-cigarettes.
He cited 16 studies, most of them sponsored by the industry, but all conducted by independent laboratories. The studies concluded that the primary components of the vapor are propylene glycol, vegetable glycerin and nicotine.
Trace amounts of cancer-causing ingredients also have been detected. Of course, actual cigarettes are a known cause of cancer. Siegel pointed out that most e-cigarette users are former smokers or smokers who are trying to quit.
"The issue is not finding out what’s in there. We know what’s in them," he said in an interview with The Journal. "The question is what are the long-term ramifications. And how do you weigh that against the risks of continuing to smoke."
We telephoned Tanzi, who said that, in her comment during the House debate, she was referring to the U.S. Food and Drug Administration regulating tobacco but not e-cigarettes. As a result, she said, there are no government standards regarding the content of e-cigarettes and their possible secondhand effects. In the absence of such standards, Tanzi contended, e-cigarettes should not be sold to anyone.
But that’s not what she said on the House floor. Nor is she quite right in her characterization of the FDA position.
We contacted the FDA, whose web sites and spokeswoman told us that e-cigarettes are subject to regulation in two ways as the result of a federal court ruling -- as tobacco products and as therapeutic devices.
Subject to regulation, in the case of tobacco products, does not mean they are actually regulated today. The FDA’s Jennifer Haliski said the agency has announced its intent to issue a proposed rule deeming products defined as e-cigarettes to be subject to regulation under the Family Smoking Prevention and Tobacco Control Act.
After the rule is adopted, she explained, the FDA will be able to exercise its authority over e-cigarettes as tobacco products.
But Haliski said e-cigarettes are regulated by the FDA if a seller makes a therapeutic claim -- in other words, the seller boasts, as spelled out in the Food, Drug and Cosmetic Act, that "it treats or prevents disease or otherwise affects the structure or any function of the body . . ."
So Tanzi is half-right when she says that the FDA does not regulate e-cigarettes. They are not regulated as a tobacco product but they are regulated as a drug device.
No e-cigarette maker has yet applied to the FDA for approval of a therapeutic claim. When a maker does, Haliski said, the FDA will review the scientific evidence submitted and then rule. The agency has warned a handful of e-cigarette distributors about alleged unsubstantiated claims and alleged poor manufacturing practices.
Haliski said that as an official matter, because manufacturers have not applied for approvals, backed with science, the FDA does not yet know what is in the vapor. In limited lab studies of certain samples, though, the FDA said it found mismatches between labeling and contents indicative of manufacturing quality problems.
"We need more research," Haliski said.
State Rep. Teresa Tanzi said, "We have no idea what is contained in [electronic cigarette] vapor."
But we found that numerous studies have identified the primary components of the vapor. Tanzi said she was referring to a lack of federal regulation of the products and the setting of safety standards. But that’s not what she said in the House debate.
The judges rule her claim False.
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