The US Food and Drug Administration issued its final guidance for e-cigarette makers to submit premarket tobacco product applications, giving these companies a clearer path to seek official authorization to market their products, the agency announced Tuesday.
In doing so, companies must show that their products “would be appropriate for the protection of the public health,” the agency says.
The announcement comes about a month after a federal judge ordered the agency to speed up its review of thousands of vaping products now on the market. That decision, part of an ongoing lawsuit filed by multiple health groups, said that the agency has acted illegally by allowing e-cigarettes to remain on the market until 2022 before requiring companies to apply for FDA authorization.
“There are no authorized e-cigarettes currently on the market,” Acting FDA Commissioner Dr. Ned Sharpless said in a statement Tuesday, adding that the agency’s oversight of such products “is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death.”
“The final guidance issued today provides companies seeking to market e-cigarette and [electronic nicotine delivery system] products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product,” Sharpless said.
The FDA said it must consider how vaping products may change people’s behaviors, including the prospect of nonsmokers picking up the e-cig habit, as well as how often e-cig users tend to quit. The guidance also outlines the agency’s plans to examine the ingredients and additives in vaping products, how they are packaged and labeled, and how these devices are designed and made. This could address known risks of exploding batteries and accidental nicotine poisoning among children, the agency said.
Dr. Robert Jackler, founder of the Stanford Research into the Impact of Tobacco Advertising, previously told CNN that many e-liquids with high nicotine concentrations represent “a huge poisoning risk,” with some bottles lacking childproof caps and containing enough nicotine to kill an entire preschool class. With the rise in e-cig popularity has come a rise in calls to poison control centers, he added.
