FDA Going ‘Full Speed Ahead’ on E-Cig Regulations

Published May 28, 2015

U.S. Food and Drug Administration (FDA) Acting Commissioner Dr. Stephen Ostroff announced the agency’s intention to proceed “full steam ahead” on regulations intended to reduce e-cigarette use.

Ostroff says FDA intends to enact a “deeming rule” expanding the agency’s regulation of tobacco products to include e-cigarettes, which do not contain tobacco. 

California Polytechnic State University professor of economics Michael L. Marlow says this is a bad idea because e-cigarettes are a useful tool for reducing health damage and helping smokers kick the habit.

‘Doesn’t Make Much Sense’

“If e-cigarettes help smokers reduce consumption of more harmful tobacco or maybe even allow them to quit cigarettes, even if e-cigarettes themselves are somewhat harmful, it still would be an overall reduction of harm,” Marlow said. “If you just ignore that theory, and the FDA certainly has, an economist would say it [still] doesn’t make much sense.”

Marlow says e-cigarettes are a positively disruptive invention some special-interest groups want to suppress.

“In fact, e-cigarettes have become the greatest source of ‘creative destruction’ that we’ve seen against the tobacco industry,” Marlow said. “But unfortunately, maybe it’s also a source of creative destruction for those who make a living out of tobacco control.”

Growing Evidence

Marlow says studies show e-cigarettes help people quit smoking, a stated goal of policymakers and public health organizations.

“Evidence is growing that these e-cigarettes are extremely useful,” Marlow said. “The Tobacco Control Journal recently published a paper that said that the various nicotine replacement therapies that had been approved by the FDA work no better than going cold turkey.”

Keeping Alternatives off Market

Dr. Gilbert Ross, the medical and executive director of the American Council on Science and Health, says the government crackdown on e-cigarettes is hampering efforts to reduce smoking.

“The real story is the bias against harm reduction products at the FDA and other public health agencies,” Ross said.

Ross says some opposition to harm-reduction products is financially motivated.

“Some of the groups advocating for this anti-science, anti-public-health charade … are influenced by undisclosed but generous financial support from the pharmaceutical industry, which is devoted to keeping effective competition to its poorly performing nicotine replacement therapy patches, gums, and drugs off the market,” said Ross.

‘A Sad State of Affairs’

Ross says e-cigarettes decrease the difficulty of quitting and provide less harmful alternatives to tobacco use.

“This is a sad state of affairs, especially for America’s 42 million adult smokers and the frightful toll of 480,000 dead each year thanks to the difficulty of quitting,” Ross said. “Clearly, e-cigs or vapor products would provide a much less harmful alternative to smoking and will be able to help many smokers quit who otherwise would not be able to.”

Ross says government health officials should encourage the use of these less-harmful alternatives, instead of reducing their availability.

“I don’t know why the FDA and the [Centers for Disease Control and Prevention] want to regulate e-cigarettes as if they were tobacco and regulate them right off the market, but that seems to be their plan,” Ross said. “It’s like going through the looking glass. Here we have a potential remedy to one of the biggest public health threats in the Western world, and they want to regulate it so no one can use it.” 

Warner Todd Huston ([email protected]) writes from Streamwood, Illinois.