FDA gives vaping companies a clearer path for marketing their products
The US Food and Drug Administration issued its final
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
“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
Dr. Robert Jackler, founder of the