The U.S Food and Drug Administration (FDA) today announced its long-anticipated deeming regulations, extending its authority to e-cigarettes, cigars, hookah tobacco and pipe tobacco, among other tobacco-related products.
The FDA will stick to its position that hitherto unregulated tobacco products that hit stores after Feb. 15, 2007, would have to be approved by the FDA.
The grandfather date has caused considerable concern within the young vapor industry, which introduced most of its products after 2007. Many vapor companies say they lack the resources to comply with the FDA’s expensive and time-consuming product-approval process.
Gregory Conley, president of the American Vaping Association, says each review could cost more than a million dollars. “There are thousands of small businesses and tens of thousands of jobs on the line,” he said.
During a press conference announcing the regulations, Mitch Zeller, director of FDA Center for Tobacco Products, put the average cost of an application at “several hundreds of thousands of dollars.”
Established in the Tobacco Control Act of 2009, the grandfather date can be changed only by an act of Congress. An amendment currently working its way through the U.S. House would change the date so more e-cigarettes would be grandfathered in.
The legislation would prevent the FDA from requiring retroactive safety reviews of e-cigarettes that are already on the market and exempt some premium and large cigars from those same regulations. E-cigarette products introduced in the future would still undergo the safety reviews.
“While the FDA’s decision to use the Feb. 2007 predicate date was not a surprise, the agency considered itself bound by that date because of the Tobacco Control Act,” said Jeff Stier, director of risk analysis at The National Center for Public Policy Research.
“The publication of the rule only gives more urgency to the Cole/Bishop amendment to change the predicate date. That bill is wending its way through the House appropriations process.”
Zeller said passage of the amendments would have an adverse impact on public health and the FDA’s ability to do its job. For this reason, he added, the administration opposes the amendments.
Bonnie Herzog, senior analyst at Wells Fargo Securities, expressed concern that the announced regulations would suppress innovation.
“Our main concern is that these final deeming regs could realistically stifle innovation, which could dramatically slow industry growth by disincentivizing consumer conversion from combustible cigs,” she wrote.
“This would ultimately have a net negative impact on public health, which is clearly in direct opposition to the FDA’s goal.”
Asked about the impact of e-cigarettes on smoking cessation, Zeller said that the FDA was required by law to evaluate its policies at the population level. While the agency was aware of instances in which e-cigarettes had helped individual smokers quit tobacco, he said such anecdotal evidence was insufficient to build policy upon.