the view

FDA’s new tobacco rules may have unintended effect

E-cigarette smoker.

E-cigarettes previously were unregulated. The FDA's new regulations now bar the sale of e-cigarettes to anyone under the age of 18.

By DAVID J. HILL

Published May 6, 2016 This content is archived.

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Gary Giovino.
“There is concern that these regulations will put e-cigarettes back under the control of the multinational tobacco corporations. ”
Gary Giovino, professor and chair
Department of Community Health and Health Behavior

The U.S. Food and Drug Administration’s long-awaited ruling yesterday establishing new regulations for e-cigarettes and other tobacco products will help better inform consumers, but there is a down side, according to UB tobacco expert Gary Giovino.

“There is concern that these regulations will put e-cigarettes back under the control of the multinational tobacco corporations. That could be a bad thing because by giving control to the big companies, they will promote the most profitable products — likely combusted cigarettes,” says Giovino, professor and chair of the Department of Community Health and Health Behavior, School of Public Health and Health Professions.

“I think the new regulations will pose problems for smaller businesses that make e-cigarettes. These companies likely will not have the resources to deliver all the information the FDA is asking for. This could stifle innovation and hurt public health in the long run — to the extent that innovative e-cigarette products will help people move off of combusted tobacco products,” adds Giovino, who in 2012 led the world’s largest tobacco use study, which surveyed more than 435,000 respondents representing 3 billion people from 16 countries.

The FDA’s new regulations bar the sale of e-cigarettes to anyone under age 18. They also require manufacturers whose products went on sale after Feb. 15, 2007, to obtain FDA approval in order to continue selling their products. The agency’s regulations extend to cigars, hookah tobacco and pipe tobacco, in addition to e-cigarettes, all of which were previously unregulated by the FDA.

“The free-market system relies on a fully informed consumer, and in the case of tobacco there has been an enormous market failure in that regard, which has cost millions of lives in the United States alone,” says Giovino, who previously served as chief of the epidemiology branch of the Centers for Disease Control and Prevention’s Office on Smoking and Health.

“By asserting jurisdiction over multiple tobacco products not covered in the original Tobacco Control Act, the FDA has the potential to correct, to some extent at least, that market failure. Time will tell how well it does that,” he adds.