FDA Must Have ‘Open Mind’ on E-Cig Benefits

From: CSPnet.com

Regulators need to focus on nicotine delivery, acknowledge risk continuum: Zeller

By  Melissa Vonder Haar, Tobacco Editor

WASHINGTON — A comprehensive nicotine policy is one of Mitch Zeller’s top priorities, the director of the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) said during a Legacy Foundation Warner Series webinar. It was something that was brought up in the preamble to the CTP’s recently released proposed deeming regulations of electronic cigarettes and vaping products.

“I know the term ‘harm reduction’ is a loaded phrase within the field,” he said. “But the principles of relative risk and relative toxicity, we tried to frame questions about what relevance and what applicability those principles should have when deeming goes into effect, when we’re actually regulating this broader spectrum of nicotine delivery systems that meet the statutory definition of tobacco product.”

It was hardly a new position: Zeller has repeatedly acknowledged that although nicotine is an addictive compound, regulators need to focus on how nicotine is delivered and acknowledge a continuum of risk.

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