FDA Must Have 'Open Mind' on E-Cig Benefits
Regulators need to focus on nicotine delivery, acknowledge risk continuum: Zeller
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.
"Nicotine is the very same compound FDA has approved for over 30 years as a safe and effective medication," said Zeller. "People are dying from the tobacco-related diseases from the smoke particles, not the nicotine. It's a challenge to all of us. Can we start to take a different look at this?"
Zeller admitted the FDA's shortcomings when it comes to its views of nicotine. In a therapeutic context, Zeller noted, FDA-approved nicotine delivery systems such as gum, patches and lozenges deliver nicotine at a much slower rate than the seven seconds cigarettes take; in terms of regulations, Zeller said he hopes the agency is moving in the right direction, even if it has taken a while.
"It's time we take an honest look at the role of nicotine," he said. "The FDA's first, and I admit, long-overdue step was deeming."
Still, many attending the Legacy Foundation event expressed concerns that the CTP did not go far enough with its proposed deeming regulations, fretting that, by allowing flavors, Internet sales and marketing, we are due to return to the "dark ages" of irresponsible tobacco practices.
"I've certainly participated in many discussions about the potential benefits of these new technologies as well as the risk and harm they could cause," Zeller said in response to these concerns. "The reality is it's going to be some of both."
Additionally, according to the standard set by Congress, the CTP is not responsible for the safety and efficacy standards, but "regulating tobacco products under the law in a manner that's appropriate for the protection of the public health."
"Those are the actual words of the statute," Zeller said. "It means 'get a handle on the product, understand impact on individual behavior and figure out what is going on at the population level'."
Which isn't to say that Zeller and his CTP team don't share concerns over marketing to children; but the agency is legally bound to consider the broader effect, positive and negative, that electronic cigarettes might have on public health and use science to support any regulatory actions.
"Let's not lose sight of the bigger picture here," said Zeller. "Tobacco use remains the leading cause of preventable death and disease primarily because of the use of combustible tobacco products. If there's some kind of emerging technology (e-cigarette or otherwise) in a regulated environment, I think we have to have an open mind on the potential of these emerging technologies to benefit public health."