FDA Extends Commenting Period for Electronic Cigarette Regulation
After finally releasing its proposed e-cigarette regulations, on April 24, the US Food and Drug Administration has announced it will be extending the public commenting period on the proposed rule set, beyond July 9.
The FDA decided to extend the commenting period by an extra 30 days,pushing the deadline to August 8, after receiving numerous requests from within the e-cigarette industry and others, as well as lots of input on how to best regulate the popular products. In its original draft, the FDA proposed rules that would ban the sale of electronic cigarettes to minors, both in person and online, but would not restrict online sales to adults, flavors and advertising.
The proposed e-cigarette regulations were considered middle-of-the road by both supporters and opponents of electronic cigarettes, which is apparently what the FDA was going for. At a recent Legacy Foundation Warner Series webinar, Mitch Zeller, director of the agency’s Center for Tobacco Products said he is aware of the concerns from both sides. “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. “The reality is it’s going to be some of both”.
However, he did make it very clear that one of the FDA’s top priorities under his mandate are harm reduction and a comprehensive nicotine policy. “Nicotine is the very same compound FDA has approved for over 30 years as a safe and effective medication,” he told the audience. “People are dying from 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? It’s time to take an honest look at the role of nicotine. The FDA’s first and, I admit, long overdue step was deeming”.
“I know the term ‘harm reduction’ is a loaded phrase within the field,” Zeller added. “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.”
Talking about electronic cigarettes, and the concerns raised about them being a possible gateway to smoking for minors, Mitch Zeller said the agency is aware of the risk, but is trying to keep an open mind about the products. “We share the concerns about the marketing of e-cigarettes to kids,” he said, “We share the concerns that flavors certainly look like they would be appealing to kids; but let’s not lose sight of the bigger picture here–tobacco use remains the leading cause of preventable death and disease principally because of the ongoing use of products that burn tobacco. 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.”
The CTP director also acknowledged the shortcomings of conventional nicotine replacement therapies, like gum, lozenges and patches, which deliver nicotine at a much slower rate than tobacco cigarettes and e-cigarettes. This could turn out to be a big factor in how the FDA decided to regulate electronic cigarettes, as it basically comes down to choosing the most efficient delivery method and the least harmful.
The FDA has received around 176,000 comments from the on the issue of tobacco products regulation, and intends to review all of them. “We are seriously considering all the comments as we consider our regulatory options,” Zeller said, adding that “we can only go as far as the science will take us.” So far, despite all the fear mongering and damaging statements in the media, the science is in favor of electronic cigarettes. If the FDA honestly intends to base its regulations on the scientific evidence we have so far and the concept of harm reduction, there is reason to hope for a bright future for e-cigarettes.
