FDA Extends Deeming eCigarette Comment Period


The public has been given more time to weigh in on a federal proposal that will regulate electronic cigarettes and other tobacco products.

After getting much input and numerous requests from the ecigarette industry on how to regulate electronic cigarettes, this past Friday, the Food and Drug Administration announced that they will be extending the public comment period an additional 30 days to August 8—it was originally set to end on July 9.

The FDA has also extended their proposal for their regulation of cigars, hookahs, nicotine gels, and pipe tobacco. This past April the FDA had proposed a ban on the sales of ecigarettes to any persons under the age of 18 both in person and online, to add warning labels on the products, and a requirement of their approval for new products. But the FDA did not place any restrictions on marketing for ecigarette manufacturers; they also did not have plans to ban fruit or candy flavors, which are prohibited for use in tobacco cigarettes.

In addition to requiring warning labels on products indicating that nicotine is habit-forming, the rules would also require ecigarette manufacturers to disclose all product ingredients. Under this same proposal, manufacturers would not be allowed to claim that their products are safer than other tobacco products on the market. They also will not be able to give out free samples or sell ecigarettes in vending machines unless the vending machine is located in a place that is only open to adults—such as a bar.

These proposed regulations were considered to be middle ground by both supporters and opponents of ecigarettes, which is what the FDA was aiming for. Recently at a Legacy Foundation Warner Series webinar, Mitch Zeller, the director of the FDA’s Center for Tobacco Products said that he is well aware of the concerns that both sides have. “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”.

He did make it clear though, that the one of the top priorities of the FDA regarding this issue are harm reduction and a thorough nicotine policy. Addressing the concern of ecigarettes being a gateway drug to smoking for minors, Zeller noted that he and the FDA are quite aware of the risk, but they are still keeping an open mind about the benefits of the products.

"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 (ecigarette 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 FDA has received around 176,000 comments on the issue of the regulation of tobacco products and they intend to review all of them.

Even with the fearmongering tactics and negative statements all over the media, science seems to be in favor of ecigs. If the FDA does intend to base this proposal and the regulations outlined in it and these policies on scientific data and the concept of harm reduction—then there is truly a silver lining out there for the future of electronic cigarettes.

To submit your comments please visit the FDA Proposed Regulations website before August 8th, 2014. You may submit comments, identified by Agency name, Docket No. FDA-2014-N-0189, and/or Regulatory Information Number (RIN) 0910-AG38.